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In a message dated 9/22/2006 1:15:56 PM Eastern Daylight Time,

linnmiller@... writes:

> The chemical make-up of Prometrium doesn't match exactly the chemical

> make-up of progesterone though. It was my understanding that a

> patent cannot be given unless the product is slightly altered.

> Prometrium also lists some side effects similar to synthetic

> progesterone.

>

> Linn

>

>

You know, Linn, this is something that i've always had questions

about, despite all the times that i've read that it's completely bio-

identical. What you say does make sense to me, unfortunately.

I'm going to look into this further. . . . When i first joined the NTH

group last December, i remember reading a thread concerning T3

and the alterations invovled in patenting Cytomel. Was that you

who was providing some of those posts about the chemical drug

structure?

In the case of Armour, there is no patent, correct? What does this

mean as far as marketing goes? Profits? And what about adrenal

support? If what you're saying is true, then is something like Cortef

really not bio-identical? That's a little scary to me.

Hollis

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The product can be slightly altered by adding different fillers or

components. The chemical make up of the progesterone used in Prometrium, is

identical to the human progesterone hormone. It is engineered to be

identical even if it is not identical in wild yams, by the time the lab is

done with it, it will be bioidentical to human progesterone, in order to

qualify for FDA approval as a bioidentical hormone. Like the growth hormone

I use is bioidentical to human growth hormone.

Growth hormone used to be natural and unsynthesized in that it came from

human cadavers. Unfortunately it also contained the deadly neurological

disorder similar to mad cow disease. The company got sued and developed

recombinant DNA produced bioidentical growth hormone. Several companies

have patents on this due to adding an amino acid at the end of the chemical

compound, that was inactive. To me this is silly to mess with a chemical

structure but organically, it is 181 amino acids in exactly the same

configuration as human growth hormone. There must be 8 companies that have

patents on bioidentical growth hormone but the hormone is identical in all

companies except for this non active extra amino acid or two. How they

accomplish this, I do not know. I have used 3 different brands of growth

hormone and they all worked the same.

Growth hormone manufacturers play another little patent game. Using the

same hormone but suspending it in a different liquid. One company provides

sterile water, another company provides water with some kind of additive in

it that I cannot recall. Even sterile water has additives.

Another difference with growth hormone manufacturing of the bioidentical

hormone is that some companies use pig cells and reprogram the cell's DNA to

make growth hormone. Some companies use bacteria and reprogram the bacteria

to make the growth hormone. This was explained to me by my endocrinologist,

who used to work in research at a pharma company so I might not have all the

details correct.

There was no natural progesterone pill that had a patent...................

...until Prometrium. It cannot be called bioidentical unless it is the same

chemical configuration of human progesterone. So if it were not the same

bioidentical molecule, it would be false advertising and not marketed as

bioidentical.

Used to, one could only get the bioidentical progesterone, at a compounding

pharmacy. Women who had bad reactions to synthetic progesterones from horse

urine, could instead get the bioidentical hormone compounded for a huge

price. The drug company that markets Prometrium got smart and marketed this

adding peanut oil or coconut oil.

Horse urine derived-hormones had contaminants and other forms of estrogens

or progestins, that did not occur in humans, which makes them not

bioidentical.

-- Re: Prometrium

The chemical make-up of Prometrium doesn't match exactly the chemical

make-up of progesterone though. It was my understanding that a

patent cannot be given unless the product is slightly altered.

Prometrium also lists some side effects similar to synthetic

progesterone.

Linn

> In a message dated 9/22/2006 8:25:38 AM Eastern Daylight Time,

> linnmiller@... writes:

>

> >

> > Prometrium is a synthetic progesterone.

> >

> ,

>

> Technically, Linn is right: Bio-identical does not always equal

> " natural " -- as in naturally occuring in nature. Prometrium

> IS synthetic, made in a lab. But, while it's not " natural, " the

> end result IS bio-identical to the hormone that the body

> naturally produces. The semantics of differentiating between

> the terms " synthetic, " " natural, " and " bio-identical " can get

> very confusing! For example, Premarin, derived from mare's

> urine is completely " natural, " but certainly NOT bio-identical

> to any hormone a female human produces.

>

>> .

>

>

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You'd have to ask for the manufacturer's fine print when you get your

prescription filled. They don't automatically give it out anymore.

I have to run out right now, but I'll look for the info I found when

I get back. There's always a chemical make-up included in the fine

print. If you compare that to the chemical make-up of progesterone,

it is not identical.

Linn

On Sep 22, 2006, at 12:13 PM, C. Mannelli, Ed.D. wrote:

> I would be interested in seeing where you looked this up. I would

> like to

> see the chemical make up you are referring to.

>

>

> Here is the following source: http://www.obgyn.net/women/women

> asp?page=/industry/articles/980107_solvay

>

> PROMETRIUM Capsules is a natural micronized progesterone that is

> identical

> in chemical structure to endogenous (naturally occurring)

> progesterone, and

> thus should mimic the hormone that women produce naturally. It is

> currently

> under review by the Food and Drug Administration (FDA), and has

> received an

> approvable letter from the agency for the treatment of secondary

> amenorrhea.

> Unlike progestins (synthetic forms of progesterone), PROMETRIUM

> Capsules,

> when approved, will be the only oral progesterone available in the

> U.S.

> PROMETRIUM Capsules are intended to be taken orally, once-a-day

> with the

> evening meal.

>

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Then we should sue the company for false advertising, since they clearly

advertise that it is bioidentical, lol!

I do have the full print out from the manufacturer..........................

.......

-- Re: Prometrium

You'd have to ask for the manufacturer's fine print when you get your

prescription filled. They don't automatically give it out anymore.

I have to run out right now, but I'll look for the info I found when

I get back. There's always a chemical make-up included in the fine

print. If you compare that to the chemical make-up of progesterone,

it is not identical.

Linn

On Sep 22, 2006, at 12:13 PM, C. Mannelli, Ed.D. wrote:

> I would be interested in seeing where you looked this up. I would

> like to

> see the chemical make up you are referring to.

>

>

> Here is the following source: http://www.obgyn.net/women/women

> asp?page=/industry/articles/980107_solvay

>

> PROMETRIUM Capsules is a natural micronized progesterone that is

> identical

> in chemical structure to endogenous (naturally occurring)

> progesterone, and

> thus should mimic the hormone that women produce naturally. It is

> currently

> under review by the Food and Drug Administration (FDA), and has

> received an

> approvable letter from the agency for the treatment of secondary

> amenorrhea.

> Unlike progestins (synthetic forms of progesterone), PROMETRIUM

> Capsules,

> when approved, will be the only oral progesterone available in the

> U.S.

> PROMETRIUM Capsules are intended to be taken orally, once-a-day

> with the

> evening meal.

>

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It IS bioidentical. See my other post about it,

hopefully it will clear all this up.

Happy Birthday Linn! Hope you have a great one!

--- " C. Mannelli, Ed.D. "

wrote:

> Then we should sue the company for false

> advertising, since they clearly

> advertise that it is bioidentical, lol!

>

> I do have the full print out from the

> manufacturer..........................

> ......

>

> -- Re: Prometrium

>

> You'd have to ask for the manufacturer's fine print

> when you get your

> prescription filled. They don't automatically give

> it out anymore.

> I have to run out right now, but I'll look for the

> info I found when

> I get back. There's always a chemical make-up

> included in the fine

> print. If you compare that to the chemical make-up

> of progesterone,

> it is not identical.

>

> Linn

>

> On Sep 22, 2006, at 12:13 PM, C. Mannelli,

> Ed.D. wrote:

>

> > I would be interested in seeing where you looked

> this up. I would

> > like to

> > see the chemical make up you are referring to.

> >

> >

> > Here is the following source:

> http://www.obgyn.net/women/women

> > asp?page=/industry/articles/980107_solvay

> >

> > PROMETRIUM Capsules is a natural micronized

> progesterone that is

> > identical

> > in chemical structure to endogenous (naturally

> occurring)

> > progesterone, and

> > thus should mimic the hormone that women produce

> naturally. It is

> > currently

> > under review by the Food and Drug Administration

> (FDA), and has

> > received an

> > approvable letter from the agency for the

> treatment of secondary

> > amenorrhea.

> > Unlike progestins (synthetic forms of

> progesterone), PROMETRIUM

> > Capsules,

> > when approved, will be the only oral progesterone

> available in the

> > U.S.

> > PROMETRIUM Capsules are intended to be taken

> orally, once-a-day

> > with the

> > evening meal.

__________________________________________________

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I know!! I have said that all along!!!! I agree it is bioidentical. I

never thought it was not. ; )

-- Re: Prometrium

>

> You'd have to ask for the manufacturer's fine print

> when you get your

> prescription filled. They don't automatically give

> it out anymore.

> I have to run out right now, but I'll look for the

> info I found when

> I get back. There's always a chemical make-up

> included in the fine

> print. If you compare that to the chemical make-up

> of progesterone,

> it is not identical.

>

> Linn

>

> On Sep 22, 2006, at 12:13 PM, C. Mannelli,

> Ed.D. wrote:

>

> > I would be interested in seeing where you looked

> this up. I would

> > like to

> > see the chemical make up you are referring to.

> >

> >

> > Here is the following source:

> http://www.obgyn.net/women/women

> > asp?page=/industry/articles/980107_solvay

> >

> > PROMETRIUM Capsules is a natural micronized

> progesterone that is

> > identical

> > in chemical structure to endogenous (naturally

> occurring)

> > progesterone, and

> > thus should mimic the hormone that women produce

> naturally. It is

> > currently

> > under review by the Food and Drug Administration

> (FDA), and has

> > received an

> > approvable letter from the agency for the

> treatment of secondary

> > amenorrhea.

> > Unlike progestins (synthetic forms of

> progesterone), PROMETRIUM

> > Capsules,

> > when approved, will be the only oral progesterone

> available in the

> > U.S.

> > PROMETRIUM Capsules are intended to be taken

> orally, once-a-day

> > with the

> > evening meal.

__________________________________________________

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If you look up the chemical structure of human progesterone and

compare it with the chemical structure of Prometrium, they are not

the same. There are also other ingredients in Prometrium. I've

found this numerous times in looking up info. I don't know how they

explain it, but you can look it up and see for yourself.

No, it wasn't me on the Cytomel. I haven't looked up the Cortef, but

it wouldn't surprise me to find that it's not identical. Patents

only last for a certain number of years (not sure anymore how long

that is but I think it used be around 18 - 20 years). As long as a

manufacturer has the patent no others can financially benefit, once

the patent expires other manufacturers, usually generics step in and

can financially profit also, that's when you see the cost drastically

reduce and usually the old manufacturer comes out with a new and

better product, i.e. just about the time Prilosec's patent ran out

they introduced Nexium.

Linn

This info is from a link at

What are the risks associated with PROMETRIUM Capsules?

* Risk to the Fetus: Rare cases of cleft palate, cleft lip, and

congenital heart defects have been reported in the infants of women

using PROMETRIUM Capsules during early pregnancy. Although it is not

clear that these events were drug related, you should check with your

healthcare provider about the risks to your unborn child of any

medication taken during pregnancy.

* Abnormal Blood Clotting: Use of progestational drugs has been

associated with changes in the blood-clotting system. These changes

allow the blood to clot more easily, possibly allowing clots to form

in the bloodstream. If blood clots do form in your bloodstream, they

can cut off the blood supply to vital organs, causing serious

problems. These problems may include a stroke (by cutting off blood

to part of the brain), a heart attack (by cutting off blood to part

of the heart), a pulmonary embolus (by cutting off blood to part of

the lungs), visual loss or blindness (by cutting off blood vessels in

the eye), or other problems. Any of these conditions may cause death

or serious longterm disability. Call your healthcare provider

immediately if you suspect you have any of these conditions. He or

she may advise you to stop using this drug.

* Eye Abnormalities: Discontinue medication and call your

healthcare provider immediately if you experience sudden partial or

complete loss of vision, blurred vision, or sudden onset of bulging

eyes, double vision, or migraine.

What are the possible side effects of PROMETRIUM Capsules?

Consult your healthcare provider if you experience any of the side

effects mentioned below or other side effects.

SIDE EFFECTS REPORTED IN STUDIES OF PATIENTS AT DOSES OF 100 MG/DAY

to 400 MG/DAY:

Blood and Lymphatic System: swelling of the lymph nodes

Cardiovascular System: high blood pressure, hot flashes, pounding or

racing of the heart

Digestive System: bloating, constipation, diarrhea, dry mouth,

heartburn, indigestion, nausea/vomiting

General Disorders: abdominal pain (cramping), back pain, chest pain,

fatigue, fever, fluid retention, headache, intestinal pain, stomach

pain, swelling, swelling of the legs and arms

Infections: bronchitis, fungal vaginal infection, infections,

inflammation of the vagina, upper respiratory tract infection,

urinary tract infection, viral infection

Musculoskeletal System: arthritis, joint pain, muscle or bone pain,

leg cramps, muscle cramps

Nervous/Psychiatric System: anxiety, confusion, decreased

concentration, depression, dizziness*, drowsiness*, irritability,

mood swings, personality disorder, sleep disorder, worry

Respiratory System: coughing, fluid in sinus cavities, nasal

congestion, sore throat, fluid in the lungs

Reproductive System: breast pain, breast tenderness, vaginal

discharge, vaginal dryness, uterine fibroid

Skin: acne, night sweats

Eyes: blurred vision

Kidney and Urinary System: urinary problems

* Use caution when driving a motor vehicle or operating machinery as

dizziness or drowsiness may occur.

During the marketing of PROMETRIUM Capsules, other adverse events

have been reported, including reversible cases of liver problems,

particularly in patients taking high doses. Additionally, rare

occurrences of fainting and/or low blood pressure have also been

reported.

These are some of the warning signs of serious side effects:

Be alert for unusual signs and symptoms. If any of these warning

signals (or any other unusual symptoms) happen while you are using

PROMETRIUM Capsules, call your healthcare provider immediately:

* Breast lumps (Ask your healthcare provider to show you how to

examine your breasts monthly.)

* Pain, swelling, or tenderness in the abdomen

* Tremors or seizures, migraine headaches, shortness of breath

or asthma, heart problems, or kidney problems

* Abnormal bleeding from the vagina

* Feelings of depression

* Pains in the calves or chest; a sudden shortness of breath; or

coughing blood, indicating possible clots in the legs, heart or lungs

* Severe headache, vomiting, dizziness, faintness, or changes in

vision or speech; weakness or numbness in an arm or leg, indicating

possible clots in the brain or eye

General information about safe and effective use of PROMETRIUM Capsules

* Medicines are sometimes prescribed for conditions that are not

mentioned in patient information leaflets. Do not take PROMETRIUM

Capsules for conditions for which it was not prescribed.

* Your healthcare provider has prescribed this drug for you and

you alone. Do not give PROMETRIUM Capsules to other people, even if

they have the same symptoms you have. It may harm them.

* PROMETRIUM Capsules should be taken as a single daily dose at

bedtime. Some women may experience extreme dizziness and/or

drowsiness during initial therapy. In a small percentage of women,

these effects may be increased including blurred vision, difficulty

speaking, difficulty walking, and feeling abnormal. If you experience

these symptoms, discuss them with your healthcare provider

immediately. A single bedtime dose may reduce the impact of these

symptoms.

* Use caution when driving a motor vehicle or operating

machinery as dizziness or drowsiness may occur.

Keep PROMETRIUM Capsules out of the reach of children.

This leaflet provides a summary of the most important information

about PROMETRIUM Capsules. If you would like more information, talk

with your healthcare provider or pharmacist. You can ask for

information about PROMETRIUM Capsules that is written for health

professionals. You can get more information by calling the toll free

number 1-.

What are the ingredients in PROMETRIUM Capsules?

Active ingredient: 100 mg or 200 mg micronized progesterone

The inactive ingredients for PROMETRIUM Capsules 100 mg include:

peanut oil NF, gelatin NF, glycerin USP, lecithin NF, titanium

dioxide USP, D & C Yellow No. 10, and FD & C Red No. 40.

The inactive ingredients for PROMETRIUM Capsules 200 mg include:

peanut oil NF, gelatin NF, glycerin USP, lecithin NF, titanium

dioxide USP, D & C Yellow No. 10, and FD & C Yellow No.

> In a message dated 9/22/2006 1:15:56 PM Eastern Daylight Time,

> linnmiller@... writes:

>

> > The chemical make-up of Prometrium doesn't match exactly the

> chemical

> > make-up of progesterone though. It was my understanding that a

> > patent cannot be given unless the product is slightly altered.

> > Prometrium also lists some side effects similar to synthetic

> > progesterone.

> >

> > Linn

> >

> >

>

> You know, Linn, this is something that i've always had questions

> about, despite all the times that i've read that it's completely bio-

> identical. What you say does make sense to me, unfortunately.

> I'm going to look into this further. . . . When i first joined the NTH

> group last December, i remember reading a thread concerning T3

> and the alterations invovled in patenting Cytomel. Was that you

> who was providing some of those posts about the chemical drug

> structure?

>

> In the case of Armour, there is no patent, correct? What does this

> mean as far as marketing goes? Profits? And what about adrenal

> support? If what you're saying is true, then is something like Cortef

> really not bio-identical? That's a little scary to me.

>

> Hollis

>

> .

>

>

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Thanks, I've decided to call it the 21st anniversary of my 29th

birthday instead!!!

Linn

> It IS bioidentical. See my other post about it,

> hopefully it will clear all this up.

>

> Happy Birthday Linn! Hope you have a great one!

>

>

>

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I have looked it up, as I said in previous posts. There are many

metabolites of progesterone and I am convinced the progesterone they are

making, is as identical as any can claim, with our present knowledge. But

Prometrium is bioidentical to ovarian progesterone in humans.

In regard to the side effects, it has not been on the market long enough to

show these side effects, and the side effects you posted are general side

effects from synthetic horse urine-made progestins.

It is like the side effects that you can read about hydrocortisone. The

warnings are for huge amounts of HC that are not generally usedbut they

still post those side effects and warnings even if you take a minimal amount

of HC for a day or two. That is how they cover their butts from law suits.

I understand you are convinced that it is not identical. I am convinced it

is as bioidentical as we are capable of producing in a lab right now. I

also do not like the fact that my growth hormone is said to be bioidentical

even tho it is identical to human growth hormone, 181 atoms and all. But

one type is made by bacteria and another type is made from pig cells.

There is not alternative at this time so we can only use what we hope is

bioidentical..........................

In the future, we may see that anything synthesized in a lab still carries

micro remnants of where it came from, like Vit C being made from corn may

still possess some remnants of corn so if you are allergic to corn, you may

have a reaction to C made from corn but not to Vit C made from potatoes.

From your definition nothing is capable of being made bioidentical. But

like growth hormone, there are a set number of carbons, hydrogens, in a

particular configuration, that can be seen in the lab and mimicked to show

the same hormone configuration and structure, making it bioidentical. To

detect some hidden aspect that is not detected at this time, we cannot say

anything is identical.

-- Re: Prometrium

If you look up the chemical structure of human progesterone and

compare it with the chemical structure of Prometrium, they are not

the same. There are also other ingredients in Prometrium. I've

found this numerous times in looking up info. I don't know how they

explain it, but you can look it up and see for yourself.

No, it wasn't me on the Cytomel. I haven't looked up the Cortef, but

it wouldn't surprise me to find that it's not identical. Patents

only last for a certain number of years (not sure anymore how long

that is but I think it used be around 18 - 20 years). As long as a

manufacturer has the patent no others can financially benefit, once

the patent expires other manufacturers, usually generics step in and

can financially profit also, that's when you see the cost drastically

reduce and usually the old manufacturer comes out with a new and

better product, i.e. just about the time Prilosec's patent ran out

they introduced Nexium.

Linn

This info is from a link at

What are the risks associated with PROMETRIUM Capsules?

* Risk to the Fetus: Rare cases of cleft palate, cleft lip, and

congenital heart defects have been reported in the infants of women

using PROMETRIUM Capsules during early pregnancy. Although it is not

clear that these events were drug related, you should check with your

healthcare provider about the risks to your unborn child of any

medication taken during pregnancy.

* Abnormal Blood Clotting: Use of progestational drugs has been

associated with changes in the blood-clotting system. These changes

allow the blood to clot more easily, possibly allowing clots to form

in the bloodstream. If blood clots do form in your bloodstream, they

can cut off the blood supply to vital organs, causing serious

problems. These problems may include a stroke (by cutting off blood

to part of the brain), a heart attack (by cutting off blood to part

of the heart), a pulmonary embolus (by cutting off blood to part of

the lungs), visual loss or blindness (by cutting off blood vessels in

the eye), or other problems. Any of these conditions may cause death

or serious longterm disability. Call your healthcare provider

immediately if you suspect you have any of these conditions. He or

she may advise you to stop using this drug.

* Eye Abnormalities: Discontinue medication and call your

healthcare provider immediately if you experience sudden partial or

complete loss of vision, blurred vision, or sudden onset of bulging

eyes, double vision, or migraine.

What are the possible side effects of PROMETRIUM Capsules?

Consult your healthcare provider if you experience any of the side

effects mentioned below or other side effects.

SIDE EFFECTS REPORTED IN STUDIES OF PATIENTS AT DOSES OF 100 MG/DAY

to 400 MG/DAY:

Blood and Lymphatic System: swelling of the lymph nodes

Cardiovascular System: high blood pressure, hot flashes, pounding or

racing of the heart

Digestive System: bloating, constipation, diarrhea, dry mouth,

heartburn, indigestion, nausea/vomiting

General Disorders: abdominal pain (cramping), back pain, chest pain,

fatigue, fever, fluid retention, headache, intestinal pain, stomach

pain, swelling, swelling of the legs and arms

Infections: bronchitis, fungal vaginal infection, infections,

inflammation of the vagina, upper respiratory tract infection,

urinary tract infection, viral infection

Musculoskeletal System: arthritis, joint pain, muscle or bone pain,

leg cramps, muscle cramps

Nervous/Psychiatric System: anxiety, confusion, decreased

concentration, depression, dizziness*, drowsiness*, irritability,

mood swings, personality disorder, sleep disorder, worry

Respiratory System: coughing, fluid in sinus cavities, nasal

congestion, sore throat, fluid in the lungs

Reproductive System: breast pain, breast tenderness, vaginal

discharge, vaginal dryness, uterine fibroid

Skin: acne, night sweats

Eyes: blurred vision

Kidney and Urinary System: urinary problems

* Use caution when driving a motor vehicle or operating machinery as

dizziness or drowsiness may occur.

During the marketing of PROMETRIUM Capsules, other adverse events

have been reported, including reversible cases of liver problems,

particularly in patients taking high doses. Additionally, rare

occurrences of fainting and/or low blood pressure have also been

reported.

These are some of the warning signs of serious side effects:

Be alert for unusual signs and symptoms. If any of these warning

signals (or any other unusual symptoms) happen while you are using

PROMETRIUM Capsules, call your healthcare provider immediately:

* Breast lumps (Ask your healthcare provider to show you how to

examine your breasts monthly.)

* Pain, swelling, or tenderness in the abdomen

* Tremors or seizures, migraine headaches, shortness of breath

or asthma, heart problems, or kidney problems

* Abnormal bleeding from the vagina

* Feelings of depression

* Pains in the calves or chest; a sudden shortness of breath; or

coughing blood, indicating possible clots in the legs, heart or lungs

* Severe headache, vomiting, dizziness, faintness, or changes in

vision or speech; weakness or numbness in an arm or leg, indicating

possible clots in the brain or eye

General information about safe and effective use of PROMETRIUM Capsules

* Medicines are sometimes prescribed for conditions that are not

mentioned in patient information leaflets. Do not take PROMETRIUM

Capsules for conditions for which it was not prescribed.

* Your healthcare provider has prescribed this drug for you and

you alone. Do not give PROMETRIUM Capsules to other people, even if

they have the same symptoms you have. It may harm them.

* PROMETRIUM Capsules should be taken as a single daily dose at

bedtime. Some women may experience extreme dizziness and/or

drowsiness during initial therapy. In a small percentage of women,

these effects may be increased including blurred vision, difficulty

speaking, difficulty walking, and feeling abnormal. If you experience

these symptoms, discuss them with your healthcare provider

immediately. A single bedtime dose may reduce the impact of these

symptoms.

* Use caution when driving a motor vehicle or operating

machinery as dizziness or drowsiness may occur.

Keep PROMETRIUM Capsules out of the reach of children.

This leaflet provides a summary of the most important information

about PROMETRIUM Capsules. If you would like more information, talk

with your healthcare provider or pharmacist. You can ask for

information about PROMETRIUM Capsules that is written for health

professionals. You can get more information by calling the toll free

number 1-.

What are the ingredients in PROMETRIUM Capsules?

Active ingredient: 100 mg or 200 mg micronized progesterone

The inactive ingredients for PROMETRIUM Capsules 100 mg include:

peanut oil NF, gelatin NF, glycerin USP, lecithin NF, titanium

dioxide USP, D & C Yellow No. 10, and FD & C Red No. 40.

The inactive ingredients for PROMETRIUM Capsules 200 mg include:

peanut oil NF, gelatin NF, glycerin USP, lecithin NF, titanium

dioxide USP, D & C Yellow No. 10, and FD & C Yellow No.

> In a message dated 9/22/2006 1:15:56 PM Eastern Daylight Time,

> linnmiller@... writes:

>

> > The chemical make-up of Prometrium doesn't match exactly the

> chemical

> > make-up of progesterone though. It was my understanding that a

> > patent cannot be given unless the product is slightly altered.

> > Prometrium also lists some side effects similar to synthetic

> > progesterone.

> >

> > Linn

> >

> >

>

> You know, Linn, this is something that i've always had questions

> about, despite all the times that i've read that it's completely bio-

> identical. What you say does make sense to me, unfortunately.

> I'm going to look into this further. . . . When i first joined the NTH

> group last December, i remember reading a thread concerning T3

> and the alterations invovled in patenting Cytomel. Was that you

> who was providing some of those posts about the chemical drug

> structure?

>

> In the case of Armour, there is no patent, correct? What does this

> mean as far as marketing goes? Profits? And what about adrenal

> support? If what you're saying is true, then is something like Cortef

> really not bio-identical? That's a little scary to me.

>

> Hollis

>

> .

>

>

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LOLOL! I had to look twice at that one! lolol

good one. :-)

--- Linn wrote:

> Thanks, I've decided to call it the 21st anniversary

> of my 29th

> birthday instead!!!

>

> Linn

>

>

>

> > It IS bioidentical. See my other post about it,

> > hopefully it will clear all this up.

> >

> > Happy Birthday Linn! Hope you have a great one!

> >

> >

> >

>

>

>

> [Non-text portions of this message have been

> removed]

>

>

__________________________________________________

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Perhaps the picture of the chemical structure of what you viewed, was of

another of the progestogens?

If you cannot post both pics for us to see, all I can go by is what I see

on-line or in my biochem book. What I compared on-line has the same number

of carbons, hydrogens, same double-bonded oxygens, but some of the bonds

were not drawn in on one picture, but were drawn on another.

I taught organic chem for 9 years at Texas A & M. I am not saying this to

one-up. I am saying it cause I can tell from a picture if both compounds

are identical. but only to a point. Isomers look identical but are not

identical in action. Mirror image isomers may not look identical if they

are not superimposed and flopped in position but may be very similar in

action or one isomer may be completely inactive. But one cannot tell by

looking at them particularly if the drawings are done stick as opposed to

dot.

All I can go by is the literature, which states it is bioidentical. I do

acknowledge that labs may think they are making bioidentical but really not

be. But at this time, this is all we know and I myself cannot analyze with

the info available, if the makers are lying or not.

I also know that T3 is said to be 'bioidentical'. Val has made some

comments to me about the T3 SR that I don't understand as of yet. But all

the sources say the same so far.

http://www.3dchem.com/molecules.asp?id=248

Look at this interesting stuff about progesterone.

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Oh sorry! My mistake . I thought your remark

about suing indicated you were agreeing that it wasn't

bio-id. Now I understand it was just a point you were

making - my brain is a bit tired the last two days so

I didn't catch that the first time. Sorry! :-)

--- " C. Mannelli, Ed.D. "

wrote:

> I know!! I have said that all along!!!! I agree it

> is bioidentical. I

> never thought it was not. ; )

>

> -- Re: Prometrium

> >

> > You'd have to ask for the manufacturer's fine

> print

> > when you get your

> > prescription filled. They don't automatically give

> > it out anymore.

> > I have to run out right now, but I'll look for the

> > info I found when

> > I get back. There's always a chemical make-up

> > included in the fine

> > print. If you compare that to the chemical make-up

> > of progesterone,

> > it is not identical.

> >

> > Linn

__________________________________________________

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I didn't know that's how they used to get GH, good

grief! Let's see....prions, right? Kuru and all that?

Wowwwwwwww. Well, those people hopefully enjoyed their

free GH for at least a short time before they

croaked?!

Oh I meant to mention to you, did you know that there

is a pharmacy in Nevada that has come up with a

generic version of HGH? It's only about 250.00 a month

from what I understand, and very comparable to the

brand name.

--- " C. Mannelli, Ed.D. "

wrote:

> :

>

> The original growth hormone was not synthesized from

> plants or anything. It

> was spun off human cadaver blood. It was patented.

> So I am not sure that

> what you said here has always been the case.

>

> What a gig, spinning off plasma from cadavers and

> selling the growth hormone

> and killing a lot of people with mad cow-like

> disease. I cannot remember

> the company, Humatrope I think was the brand. (I

> used to have to iodinate

> it for research purposes.) The company got sued and

> the survivors have been

> provided free GH for the rest of their lives.

>

>

>

> -- Re: Prometrium

>

> It is altered and synthesized - from plants. That is

> why it is patentable. It is not " naturally occuring

> Progesterone " that we make in our bodies.

>

> However, the end result is exactly the same,

> chemically and structurally bioidentical to human

> Progesterone.

>

> Because they synthesize it from plants and move the

> molecules around to make it match human

> Progesterone,

> it is patentable.

>

> I think that they were required by the FDA to put

> those warnings on their product or they wouldn't

> have

> been able to market it. The warnings are applicable

> to

> synthetic Progesterone, not bioidentical

> Progesterone,

> but that wouldn't stop the FDA from requiring them

> from putting the same warnings on the Bio-Id stuff.

>

> The FDA and big pharmaceutical companies are VERY

> hostile to bioidentical hormonal products and it is

> not unusual at all for them to refer to bioidentical

> Progesterone as having the same risks that synthetic

> Progesterone has - when it doesn't.

>

>

__________________________________________________

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Well that's interesting. I can find out more about the

GH made by Teva in Israel. I suppose it requires a

prescription, but I wonder if they would accept one

from a US doc? If it doesn't require a prescription,

that would be awesome.

--- " C. Mannelli, Ed.D. "

wrote:

> :

>

> Also there was a big stink regarding even making

> generic estrogen or provera

> The big drug companies yelled that the generic had

> the very same

> contaminant (delta estrogen or some such) that they

> had but pretended they

> did not have. So basically big pharma kept the

> generics off the market. I

> am actually very surprised that Prometrium made it.

>

> There has been a generic growth hormone made by Teva

> in Israel. It is not

> allowed to be used here because it is so much

> cheaper. China has an

> extremely cheap generic growth hormone. Not allowed

> here. There was a

> generic growth hormone slated to be accepted here.

> If it has I have not

> heard and have not kept up with it. One doc in a

> state advertised he was

> selling it but I think he lost his license.

>

> The body builders use generic GH from China. Most

> times they get it and it

> does not get seized. Sometimes it is seized. Lots

> of games as you know.

>

>

__________________________________________________

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:

I knew someone was supposed to get their generic approved. I was counting

on Teva. Their product has had no problems. Do you know what pharmacy?

I actually did try the stuff from China. I was scared and warned but the

only side effect I noticed was redness at the injection site. It worked

very well. I just could not deal with getting it from China, too risky. It

was about two dollars an IU as compared to 10 or more dollars an IU. I was

paying cash for my prescription GH and it cost 600. oo a month back then.

My insurance would not cover it.......................why it is covering it

now, when there is generic, is crazy.

-- Re: Prometrium

>

> It is altered and synthesized - from plants. That is

> why it is patentable. It is not " naturally occuring

> Progesterone " that we make in our bodies.

>

> However, the end result is exactly the same,

> chemically and structurally bioidentical to human

> Progesterone.

>

> Because they synthesize it from plants and move the

> molecules around to make it match human

> Progesterone,

> it is patentable.

>

> I think that they were required by the FDA to put

> those warnings on their product or they wouldn't

> have

> been able to market it. The warnings are applicable

> to

> synthetic Progesterone, not bioidentical

> Progesterone,

> but that wouldn't stop the FDA from requiring them

> from putting the same warnings on the Bio-Id stuff.

>

> The FDA and big pharmaceutical companies are VERY

> hostile to bioidentical hormonal products and it is

> not unusual at all for them to refer to bioidentical

> Progesterone as having the same risks that synthetic

> Progesterone has - when it doesn't.

>

>

__________________________________________________

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You cannot order it from Israel from what I hear. Teva will not risk

selling it to us. This all may have changed as I have not tracked it and

Teva was the company that was supposed to get the approval.

Were you the one asking about GH? If you have PPO insurance and if your doc

will prescribe it, starting out low it is not that expensive.

I started out very very high dose from a rejuvenation clinic. Those clinics

were giving out scripts right and left. My doc there stopped doing it after

I was on it a year. It was very hard to scrape up the money and I had to

use my credit card.

Starting on a high dose was a mistake. Now after being on this list, I

realize I stressed my adrenals. I was started on about twice what I take

now.

Email me off group and I can give you more info on it.

Sanrda

-- Re: Prometrium

Well that's interesting. I can find out more about the

GH made by Teva in Israel. I suppose it requires a

prescription, but I wonder if they would accept one

from a US doc? If it doesn't require a prescription,

that would be awesome.

--- " C. Mannelli, Ed.D. "

wrote:

> :

>

> Also there was a big stink regarding even making

> generic estrogen or provera

> The big drug companies yelled that the generic had

> the very same

> contaminant (delta estrogen or some such) that they

> had but pretended they

> did not have. So basically big pharma kept the

> generics off the market. I

> am actually very surprised that Prometrium made it.

>

> There has been a generic growth hormone made by Teva

> in Israel. It is not

> allowed to be used here because it is so much

> cheaper. China has an

> extremely cheap generic growth hormone. Not allowed

> here. There was a

> generic growth hormone slated to be accepted here.

> If it has I have not

> heard and have not kept up with it. One doc in a

> state advertised he was

> selling it but I think he lost his license.

>

> The body builders use generic GH from China. Most

> times they get it and it

> does not get seized. Sometimes it is seized. Lots

> of games as you know.

>

>

__________________________________________________

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,

Not trying to give you a hard time, I'm just leery. My bio-identical

Cortisol carries the same warnings that I see on mainstream

prescriptions for HC, yet my compounded progesterone does not. That

makes me suspicious, especially when the literature lists the side

effects as Prometrium users, not just studies reflecting all

synthetic progestins. The only side effects listed for my compounded

progesterone are possible sore breasts and sleepiness in case you

take too much. I read that Prometrium is a 200 mg dose, is that

correct? That is way more than my doc would prescribe in the bio-

identical. I was taking 75 mg at one point which was the highest

dose they like to prescribe. 200 mgs is a lot for your liver to be

processing. I'm still leery and feel more comfortable with compounded.

Linn

On Sep 22, 2006, at 9:45 PM, C. Mannelli, Ed.D. wrote:

> I don't know what else to say. All of this is incorrect. I used to

> do drug

> studies as well. It has stated here many times, that the warnings

> for HC

> are for huge doses and for steroids in general and that HC in

> physiological

> doses does not have these side effects. Same with Prometrium. Like

> I said,

> they are listing these things to cover themselves.

>

> Again, I looked at Solvay and several other sites as well as my

> books. The

> chemical structures shown, are identical. Prometrium is identical to

> progesterone produced by the human ovaries.

>

> It is incorrect that a natural item has to have its very chemical

> structure

> altered to get a patent. Something can be added, like the multiple

> patents

> on the various bioidentical growth hormones, which are all the same

> exact

> chemical structure with inactive additions.

>

>> .

>

>

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:

That is expensive. Mexico sells Saizen over the counter for about that much

or less. Hum, I wonder who the manufacturer is.

I will look this up. Too bad the China stuff isn't legal. I actually liked

that brand the best. You could finely tune your dose since you mixed it

yourself. I never could figure out why the red marks after injection. They

would disappear in a day or two. Someone told me pH of the mixture. I

preferred the red marks to the bruising from some American brands.

And the China stuff was so cheap it was unbelievable. But the harassment

from it getting seized in the mail, even with a prescription, just was not

worth it to me. I did see a body builder selling it to other weight lifters

for profit. Interestingly, I did not have a weight problem on that

particular brand but the brand I am on now has not reduced my weight.

-- Re: Prometrium

> >

> > It is altered and synthesized - from plants. That

> is

> > why it is patentable. It is not " naturally

> occuring

> > Progesterone " that we make in our bodies.

> >

> > However, the end result is exactly the same,

> > chemically and structurally bioidentical to human

> > Progesterone.

> >

> > Because they synthesize it from plants and move

> the

> > molecules around to make it match human

> > Progesterone,

> > it is patentable.

> >

> > I think that they were required by the FDA to put

> > those warnings on their product or they wouldn't

> > have

> > been able to market it. The warnings are

> applicable

> > to

> > synthetic Progesterone, not bioidentical

> > Progesterone,

> > but that wouldn't stop the FDA from requiring them

> > from putting the same warnings on the Bio-Id

> stuff.

> >

> > The FDA and big pharmaceutical companies are VERY

> > hostile to bioidentical hormonal products and it

> is

> > not unusual at all for them to refer to

> bioidentical

> > Progesterone as having the same risks that

> synthetic

> > Progesterone has - when it doesn't.

> >

> >

__________________________________________________

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:

The people who croaked did so fairly quickly or suffered a long time. It is

the survivors who did not develop the disease that continue to get free GH

for the rest of their lives. Gee, like that is a huge thing for the drug

manufacturer to pay for.

I worked in a blood bank when I was in college. The only thing they screened

for back then was cytomegalo virus. So no telling how many people got Lyme,

AIDS, prions, etc. from receiving transfusions. These people were never

penalized.

My dad received a blood transfusion shortly before he died of lung cancer.

They sent him a letter saying he had received some type of antigen from the

donor blood. He broke out in hives. I always thought he got Lyme or some

infection from this blood. Of course they have no responsibility or

liability in damaging their patients.

That is why it makes me so ill to see the poster children for chemo and

radiation like Sherly Crow, ex New York mayor Giuliani (sorry cannot spell

it), Lance Armstrong. Your average patient does not fair well with the

treatments they say they went through. I watched my dad and sister die of

treatment!!

-- Re: Prometrium

>

> It is altered and synthesized - from plants. That is

> why it is patentable. It is not " naturally occuring

> Progesterone " that we make in our bodies.

>

> However, the end result is exactly the same,

> chemically and structurally bioidentical to human

> Progesterone.

>

> Because they synthesize it from plants and move the

> molecules around to make it match human

> Progesterone,

> it is patentable.

>

> I think that they were required by the FDA to put

> those warnings on their product or they wouldn't

> have

> been able to market it. The warnings are applicable

> to

> synthetic Progesterone, not bioidentical

> Progesterone,

> but that wouldn't stop the FDA from requiring them

> from putting the same warnings on the Bio-Id stuff.

>

> The FDA and big pharmaceutical companies are VERY

> hostile to bioidentical hormonal products and it is

> not unusual at all for them to refer to bioidentical

> Progesterone as having the same risks that synthetic

> Progesterone has - when it doesn't.

>

>

__________________________________________________

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--- Linn wrote:

> ,

>

> Not trying to give you a hard time, I'm just leery.

> My bio-identical

> Cortisol carries the same warnings that I see on

> mainstream

> prescriptions for HC, yet my compounded progesterone

> does not.

That's a part of a lawsuit with the FDA, filed by

Wyeth, a big Pharma company. Their synthetic products

ARE required by the FDA to have those warnings but in

their lawsuit to get compounding pharmacies banned,

they also tried to force the FDA to make compounding

pharmacies put the SAME warning labels on their bio-Id

hormones.

However, the compounding pharmacies and women all

across the country fought back hard, well armed with

proof that bio-id hormones do NOT cause the same side

effects and illnesses as big pharma company's

synthetics, and so far the FDA has not been able to

require the warnings to be put on the bioId hormones

and make it stick.

It's still an ongoing battle though. Big pharma is not

backing down, and compounding pharmacies and women all

over the country are still fighting back. The ultimate

goal of big pharma is to completely ban compounding

pharmacies altogether, including their making bio-id

hormones.

__________________________________________________

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I participated in that at request of Hotze clinic. All connected to

Codex isn't it?

Linn

> --- Linn wrote:

>

> > ,

> >

> > Not trying to give you a hard time, I'm just leery.

> > My bio-identical

> > Cortisol carries the same warnings that I see on

> > mainstream

> > prescriptions for HC, yet my compounded progesterone

> > does not.

>

> That's a part of a lawsuit with the FDA, filed by

> Wyeth, a big Pharma company. Their synthetic products

> ARE required by the FDA to have those warnings but in

> their lawsuit to get compounding pharmacies banned,

> they also tried to force the FDA to make compounding

> pharmacies put the SAME warning labels on their bio-Id

> hormones.

>

>> .

>

>

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I know exactly what you mean. I lost a 5 year old daughter to

aplastic anemia, went through several horrendous problems with blood

banks and hemotologists, etc.

Linn

On Sep 23, 2006, at 10:30 AM, C. Mannelli, Ed.D. wrote:

> :

>

> The people who croaked did so fairly quickly or suffered a long

> time. It is

> the survivors who did not develop the disease that continue to get

> free GH

> for the rest of their lives. Gee, like that is a huge thing for the

> drug

> manufacturer to pay for.

>

> I worked in a blood bank when I was in college. The only thing they

> screened

> for back then was cytomegalo virus. So no telling how many people

> got Lyme,

> AIDS, prions, etc. from receiving transfusions. These people were

> never

> penalized.

>

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:

When I worked at a hospital for 13 years, one job I had was drug study

coordinator or some such title. I did the paperwork for subjects enrolled

in the studies. I flew to Chicago for one study with the company in

Kalamazoo. Anyway, the money they gave me and all associated with the study

was sickening. I was able to buy a car with it!!

oh not to mention the drug had already been marketed (ironically, it is one

I have taken for Lyme, with great success). They wanted the drug to be

approved for the treatment of childhood ear infections. It was not enough

for it to be approved for almost everything else. It was found not to work

and my boss wrote an article saying so. It still got approved and marketed

for that. The subjects got paid pennies. They were usually very poor and

needed the money so badly. For 25 dollars a session, the small children and

babies were put through meringotimies, where the eardrum is puntured and

fluid sucked off. Horrible painful AND deadner (lidocaine) could be used

and infused painlessly by an electrical current pulling the lidocaine into

the eardrum. The docs elected to not use the deadner. Evil evil! Needless

to say I got out of that position asap.

-- Re: Prometrium

--- Linn wrote:

> ,

>

> Not trying to give you a hard time, I'm just leery.

> My bio-identical

> Cortisol carries the same warnings that I see on

> mainstream

> prescriptions for HC, yet my compounded progesterone

> does not.

That's a part of a lawsuit with the FDA, filed by

Wyeth, a big Pharma company. Their synthetic products

ARE required by the FDA to have those warnings but in

their lawsuit to get compounding pharmacies banned,

they also tried to force the FDA to make compounding

pharmacies put the SAME warning labels on their bio-Id

hormones.

However, the compounding pharmacies and women all

across the country fought back hard, well armed with

proof that bio-id hormones do NOT cause the same side

effects and illnesses as big pharma company's

synthetics, and so far the FDA has not been able to

require the warnings to be put on the bioId hormones

and make it stick.

It's still an ongoing battle though. Big pharma is not

backing down, and compounding pharmacies and women all

over the country are still fighting back. The ultimate

goal of big pharma is to completely ban compounding

pharmacies altogether, including their making bio-id

hormones.

__________________________________________________

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The Teva product was slated to be approved for generic use in the US in Feb

of 2005. I remember cause my endocrinologist who I travelled to Kansas to

see, told me this. And I went to see her when my dad was ill so that was

summer 2004.

I heard it did not get to market in the states but that another company got

the generic approval. I will have to search around to see who got the

approval. One of my docs was thinking of selling it at his practice since

he has some patients on it who are unable to obtain it. His prices are

similar to what was posted here earlier for generics. With my insurance I

pay a co pay of 75 bucks a month but now I will be switching insurances with

a new job coming up.

-- Re: Prometrium

Here is an interesting bit on Teva in the lower half

of this article.

The article states that the maker of this pen, Novo

Nordisk, sued Teva and it's licensor Savient

Pharmaceuticals, to keep them from being able to

market their generic HGH in the US, saying that

Teva/Savient had infringed on Novo's patenting of

genetic HGH.

Teva/Savient appealed and the lawsuit by Novo was

struck down as the courts said Novo's patent was

invalid and unenforceable on a biological product.

This was in 2004.

http://www.drugresearcher.com/news/ng.asp?id=55327-novo-launches-first

--- " C. Mannelli, Ed.D. "

wrote:

> You cannot order it from Israel from what I hear.

> Teva will not risk

> selling it to us. This all may have changed as I

> have not tracked it and

> Teva was the company that was supposed to get the

> approval.

>

> Were you the one asking about GH? If you have PPO

> insurance and if your doc

> will prescribe it, starting out low it is not that

> expensive.

>

> I started out very very high dose from a

> rejuvenation clinic. Those clinics

> were giving out scripts right and left. My doc

> there stopped doing it after

> I was on it a year. It was very hard to scrape up

> the money and I had to

> use my credit card.

>

>

> Starting on a high dose was a mistake. Now after

> being on this list, I

> realize I stressed my adrenals. I was started on

> about twice what I take

> now.

>

>

> Email me off group and I can give you more info on

> it.

>

> Sanrda

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:

I think the amount prescribed for creme use is 20 mgs.

Are you allergic to peanuts?

-- Re: Prometrium

Oh thats good to know about peanuts. I used to eat

peanut butter toast for hypoglycemia a lot, but won't

be doing that in the future if the hypoglycemia ever

comes back in force.

200 mgs Progesterone isn't high, taken orally. Most of

that gets destroyed in the liver.

The cream form is absorbed much better through your

skin and capillaries, so that doesn't happen.

So a 200 mg. amount in cream would mostly get through

into your body, but a 200 mg. amount orally would have

a large portion of it destroyed.

--- Linn wrote:

> The other concern to me is the peanut oil. Peanuts

> are a goitregen,

> and also the chemical process to produce the oil

> itself. It's a

> really high dosage at 200 mgs., that's a lot of

> excess for your body

> to process. I don't know, I'd still be very leery

> of using this.

> I'm a fan of Dr. Tim O'Shea, only what the body

> needs and nothing

> leftover to process out. Even good things become a

> problem when in

> excess.

>

> Linn

>

> On Sep 22, 2006, at 8:26 AM, C. Mannelli,

> Ed.D. wrote:

>

> >

> >

>

http://www.families-first.com/hotflash/faq/prometrium.htm

> > -------Original Message-------

> >

> >> .

> >

> >

>

>

>

> [Non-text portions of this message have been

> removed]

>

>

__________________________________________________

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