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Re: Rhogam - Where can I find a package insert?

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The package insert on Rhogam seems to be quite elusive online! Here's some

info I found though:

http://www.nccn.net/~wwithin/rhogam.htm

http://www.vaccinetruth.org/rhogam.htm

http://www.whale.to/a/rhogam.html

On Thu, May 1, 2008 at 1:47 PM, kellymac92 <cs-mom@...> wrote:

>

> I am supposed to get the Rhogam shot next week. I have looked up the

> manufacturer - Ortho Clinical Diagnostics - but can't find a package

> insert. Does anyone know where I can find one online? I'd like to read

> it before getting to the doctor's office and taking forever to study

> it there. The website claims it's mercury free, but I still want to

> check it out myself and research all the ingredients online.

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How about the Physician's Desk Reference at the library? Would it be

there? Or you could call the doctor's office and ask them to mail you

a copy of the package insert prior to your appointment...if they can't,

tell them you would like to come in an hour early to review the package

insert.

>

> I am supposed to get the Rhogam shot next week. I have looked up the

> manufacturer - Ortho Clinical Diagnostics - but can't find a package

> insert. Does anyone know where I can find one online? I'd like to read

> it before getting to the doctor's office and taking forever to study

> it there. The website claims it's mercury free, but I still want to

> check it out myself and research all the ingredients online.

>

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This is what I've found on the Australian version - looks like Rhogam

may not be licensed here?

Rh(D) Immunoglobulin-VF

MIMS Abbreviated Prescribing Information

Immunoglobulin (anti-RhD)

CSL

Section: 10(B) Immunoglobulins - Immunology

Permitted in sport

Use: Prevention of Rh sensitisation in Rh(D) negative females at or

below childbearing age

Contraindications: Rh(D) positive or Du positive; Rh(D) negative or Du

negative patient previously sensitised to Rh(D); admin to Rh(D) positive

infants; isolated IgA deficiency (unless no circulating anti-IgA a/bs);

severe thrombocytopenia, coagulation disorder; IV admin

Precautions: Previous reactions to human immunoglobulin; elderly;

pregnancy, lactation, children

Adverse Reactions: Pyrexia; urticaria; malaise; infection risk

(theoretical); local effects; drowsiness; others, see full PI

Interactions: Live attenuated virus vaccines (2 wks before or 3 mths

after this product); lab tests, blood typing

Rh(D) Immunoglobulin-VF (Injection) Rx (S4) CMI

Anti-D IgG (human)

Pack 250 IU [1]

Pack 625 IU [1]

Dose: Sensitising events in pregnancy: 1st trimester: usu 250 IU.

Confirmed, suspected > 1st trimester; twin, multiple pregnancies: usu

625 IU by deep slow IMI within 72 hrs of delivery, potential immunising

event. 100 IU protects against 1 mL D+ve RBCs. Rh(D) +ve blood

transfusion: 100 IU/mL D+ve RBCs

MIMS Full Prescribing Information

MIMS revision date: 1/12/2006

Composition Active. Human anti-D (RhO) immunoglobulin.

Inactive. Glycine.

Description Rh(D) Immunoglobulin-VF is a sterile, preservative free

solution containing human plasma proteins 160 mg/mL and glycine 22.5

mg/mL. The solution has a pH of 6.6. At least 98% of the protein is

immunoglobulins (mainly IgG), with an anti-D (RhO) antibody content of

625 or 250 IU per vial. Rh(D) Immunoglobulin-VF is prepared by Cohn

cold-ethanol fractionation of human plasma obtained from voluntary

donors who have been immunised to the Rh antigen D. Donations are

selected on the basis that they contain high levels of antibodies to the

Rh antigen D. Immunoglobulins for intramuscular injection, prepared by

this process from plasma screened by current methods, have not been

implicated in the transmission of viral infectious diseases including

human immunodeficiency virus (HIV). Studies using plasma spiked with HIV

have shown that the Cohn cold-ethanol fractionation process produces a

very large reduction in virus titre with undetectable levels in the

immunoglobulin fraction. Epidemiological studies have not recognised any

cluster of AIDS patients or HIV seroconversion in immunoglobulin

recipients. The manufacturing process for Rh(D) Immunoglobulin-VF

contains specific steps to reduce the possibility of viral transmission

including pasteurisation for viral inactivation and nanofiltration for

virus removal.

Actions Pharmacology. Rh(D) Immunoglobulin-VF contains high levels of

antibodies (mainly IgG) directed against the D antigen of Rh positive

red cells. Rh(D) Immunoglobulin-VF acts by suppressing the immune

response in Rh negative individuals to Rh(D) positive red cells. Such

exposure follows the passage of cells from the fetal to the maternal

circulation or the accidental transfusion of Rh(D) positive red cells to

an Rh(D) negative individual.

Clinical studies indicate that the administration of anti-D

immunoglobulin to an Rh(D) negative mother within 72 hours of the birth

of an Rh(D) positive infant reduces the incidence of Rh isoimmunisation

from 12 to 13% to 1 to 2%. A small number (1.5 to 1.8%) of Rh negative

mothers are immunised by their Rh positive fetuses despite

administration of anti-D immunoglobulin postpartum. Studies have shown

that this number can be reduced to less than 1.0% by administering two

doses of anti-D immunoglobulin, the first at 28 weeks gestation and the

second following delivery.

Clinical trials. A comparative clinical trial was conducted to

investigate the effect of pasteurisation on the in vivo behaviour of

intramuscular immunoglobulins using hepatitis B immunoglobulin

(pasteurised and unpasteurised) as the representative of this group of

products. 58 healthy subjects (28 males and 30 females) each received an

intramuscular injection of pasteurised (viral inactivated) or

unpasteurised hepatitis B immunoglobulin. No significant clinical

differences were observed.

28 subjects received the viral inactivated product. Maximal serum

concentration of IgG was reached after 8.0 +/- 5.5 days (mean +/- SD),

and the estimated half-life of IgG was 27.2 +/- 6.6 days (mean +/- SD).

These values are consistent with ranges observed with other

intramuscular immunoglobulin products.

A clinical trial with Rh(D) Immunoglobulin-VF has not been conducted.

Indications Prevention of Rh sensitisation in Rh(D) negative females at

or below childbearing age.

Contraindications An Rh(D) positive or Du positive individual.

An Rh(D) negative and Du negative individual previously sensitised to

the Rh(D) antigen.

Note. Although there is no benefit in administering Rh(D) Immunoglobulin

to a woman who is already sensitised to the Rh factor, there is no more

risk than when it is given to a woman who is not sensitised.

Individuals with isolated immunoglobulin A (IgA) deficiency, unless they

have been tested and shown not to have circulating anti-IgA antibodies.

Severe thrombocytopenia or any coagulation disorder that would

contraindicate intramuscular injections.

Precautions Rh(D) Immunoglobulin-VF must not be administered

intravenously because of the potential for anaphylactic reactions.

Injections must be made intramuscularly, and care should be taken to

draw back on the plunger of the syringe before injection in order to be

certain that the needle is not in a blood vessel.

Rh(D) Immunoglobulin-VF should be given with caution to patients with a

history of prior systemic allergic reactions following the

administration of human immunoglobulin preparations. In the case of

shock, treatment should follow the guidelines of shock therapy.

Rh(D) Immunoglobulin-VF must not be given to the Rh(D) positive

postpartum infant. Babies born of women given Rh(D) Immunoglobulin-VF

antepartum may have a weakly positive Coombs' test at birth.

Pathogen safety. This product is made from human plasma. Products made

from human plasma may contain infectious agents, such as viruses and

theoretically Creutzfeldt- Disease (CJD) agents, that can cause

disease. The risk that such products will transmit an infectious agent

has been reduced by screening plasma donors for prior exposure to

certain infectious agents and by testing for the presence of certain

viral markers.

In addition, virus removal and inactivation procedures are included in

the manufacturing process. The current procedures applied in the

manufacture of this product are effective against enveloped viruses,

such as HIV, hepatitis B and hepatitis C viruses (HBV and HCV), and the

nonenveloped viruses, such as hepatitis A (HAV) and human parvovirus

B19. Additionally, the product contains specific antibodies directed

against human parvovirus B19.

Despite these measures, such products may still potentially transmit

disease. There is also the possibility that other known or unknown

infectious agents may be present in such products.

Vaccination for patients in receipt of medicinal products from human

plasma should be considered where appropriate.

Use in pregnancy and lactation. The safety of this medicinal product for

use in human pregnancy or during lactation has not been established in

controlled clinical trials. The use of anti-D immunoglobulin during the

third trimester in doses as high as 1,500 IU antibody has been reported

to produce no evidence of haemolysis in the infant. The presence of

passively administered Rh(D) Immunoglobulin-VF in the maternal blood

sample can, however, affect the interpretation of laboratory tests to

identify the patient as a candidate for Rh(D) Immunoglobulin-VF.

Immunoglobulins are excreted in breast milk, however, it is not known

whether this applies to passively administered Rh(D) Immunoglobulin-VF.

Paediatric use and use in the elderly. The safe use of this product in

the paediatric and elderly populations has not been established in

appropriate studies. To date, these populations are not over-represented

in spontaneous reports of adverse events associated with the use of

CSL's intramuscular immunoglobulin products.

Carcinogenesis, mutagenesis, impairment of fertility. No genotoxicity,

carcinogenicity or reproductive toxicity studies have been conducted

with Rh(D) Immunoglobulin-VF. There have been no reports of such effects

with the use of CSL's plasma derived products.

Interactions Rh(D) Immunoglobulin-VF should not be mixed with other

pharmaceutical products, except as indicated (see Dosage and

Administration).

Live attenuated virus vaccines. Passively acquired antibody can

interfere with the response to live attenuated virus vaccines. Therefore

administration of such vaccines, e.g. poliomyelitis or measles, should

be deferred until approximately three months after passive immunisation.

By the same token, immunoglobulins should not be administered for at

least two weeks after such a vaccine has been given.

Laboratory tests. Passive transfer of antibodies and effect on

laboratory tests. After injection of immunoglobulin, the transitory rise

of the various passively tranferred antibodies in the patient's blood

may result in misleading positive results in serological testing.

The results of blood typing and antibody testing including the Coombs'

test are significantly affected by the administration of anti-D

immunoglobulin.

There is no evidence to date that parvovirus B19 can be transmitted by

Rh(D) Immunoglobulin-VF, which is known to contain antibodies to the

virus and the nanofiltration step of the manufacturing process has been

shown to remove such viruses (or viruses of similar size).

Adverse Reactions Local tenderness, erythema and stiffness may occur at

the site of injection and may persist for several hours. This may occur

after any intramuscular injection. In the clinical trial with hepatitis

B immunoglobulin, the following general and local reactions were

recorded in the 58 healthy subjects (total number of events, up to and

including seven days postinjection; pasteurised/ unpasteurised product:

malaise (20/22 events), drowsiness (13/17 events), induration (10/4

events), sensation of fever (4/4 events), chills (3/3 events), sweating

(3/1 events) and warmth/heat when touched (0/4 events). There was an

overall higher reporting of local tolerance adverse events at the

injection site for the unpasteurised product, such as pain (32/52

events), bruising (10/22 events), redness (2/8 events) and irritation

(2/4 events).

Mild pyrexia, malaise, drowsiness and urticaria have been reported

occasionally after injections of immunoglobulins. True allergic

responses are rare. Skin lesions, headache, dizziness, nausea,

generalised hypersensitivity reactions and convulsions have been

reported on rare occasions.

Dosage and Administration Sensitising events in pregnancy (unless the

blood type of the fetus is confirmed to be Rh (D) negative). The

recommended dose of anti-D immunoglobulin is 250 IU after sensitising

events in the first trimester of pregnancy and 625 IU after sensitising

events beyond the first trimester.

If the gestational age is not known with certainty and the possibility

exists that the gestational age is 13 weeks or more, 625 IU should be

given.

In twin and multiple pregnancies in the first trimester, 625 IU should

be given.

The dose should be given as soon as possible and within 72 hours of the

event.

Sensitising events include normal delivery, miscarriage, termination of

pregnancy, ectopic pregnancy, chorionic villus sampling, amniocentesis,

cordocentesis, abdominal trauma considered sufficient to cause

feto-maternal haemorrhage, antepartum haemorrhage and external cephalic

version.

Since evidence of the efficacy of these doses is limited, it is

recommended that the magnitude of feto-maternal haemorrhage is assessed

and further doses given as necessary. As a guide, a dose of 625 IU will

protect against a feto-maternal haemorrhage of up to 6 mL of Rh (D)

positive red blood cells. For haemorrhages greater than 6 mL, the

recommended dose is 100 IU per mL Rh (D) positive red blood cells.

Transfusion of Rh (D) positive blood. The recommended dose of anti-D

immunoglobulin is 100 IU per mL Rh (D) positive red blood cells.

Administration. If the product appears to be turbid by transmitted light

or contains any sediment it must not be used. The product does not

contain an antimicrobial preservative. It must, therefore, be used

immediately after opening the vial. Any unused solution must be

discarded appropriately.

Rh(D) Immunoglobulin-VF should be brought to room temperature before use

and given slowly by deep intramuscular injection using a large gauge

(20) needle. If a large dose (more than 5 mL) is required, it is

advisable to administer it in divided doses at different sites.

Hyaluronidase and/or a suitable local anaesthetic may be added to the

injection if desired.

Overdosage The consequences of overdosage are not known.

Presentation Vials, 250 IU, 625 IU: 1's. (The actual volume in the vial

is stated on the label.)

Storage Store at 2 to 8 deg. C. Refrigerate. Do not freeze. Protect

from light. Do not use after the expiry date shown on the label.

Note. Supplies of suitable plasma for Rh(D) Immunoglobulin-VF production

are scarce. Individuals who have Rh(D) antibodies should be urged to

enrol as voluntary blood donors.

Poison Schedule S4.

Date of TGA approval or last amendment 10/08/2006

Please refer to disclaimer

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From: Vaccinations [mailto:Vaccinations ]

On Behalf Of kellymac92

Sent: Friday, May 02, 2008 5:48 AM

Vaccinations

Subject: Rhogam - Where can I find a package insert?

I am supposed to get the Rhogam shot next week. I have looked up the

manufacturer - Ortho Clinical Diagnostics - but can't find a package

insert. Does anyone know where I can find one online? I'd like to read

it before getting to the doctor's office and taking forever to study

it there. The website claims it's mercury free, but I still want to

check it out myself and research all the ingredients online.

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Good idea about reviewing it an hour early. I have to be there early

anyway for my glucose test. I could review it while I wait.

> >

> > I am supposed to get the Rhogam shot next week. I have looked up

the

> > manufacturer - Ortho Clinical Diagnostics - but can't find a

package

> > insert. Does anyone know where I can find one online? I'd like

to read

> > it before getting to the doctor's office and taking forever to

study

> > it there. The website claims it's mercury free, but I still want

to

> > check it out myself and research all the ingredients online.

> >

>

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At 02:47 PM 5/1/2008, you wrote:

I am supposed to get the Rhogam shot next week. I have looked up the

manufacturer - Ortho Clinical Diagnostics - but can't find a package

insert. Does anyone know where I can find one online? I'd like to read

it before getting to the doctor's office and taking forever to study

it there. The website claims it's mercury free, but I still want to

check it out myself and research all the ingredients online.

and even if it is mercury - free - is it safe for your baby?

http://www.wellwithin1.com/rhogam.htm

http://www.orthoclinical.com/Products/products.aspx?id=9

Sheri

listowner

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So basically, if our blood doesn't mix before delivery (which it

probably won't), then he should be okay with or without the shot?

> I am supposed to get the Rhogam shot next week. I have looked up

the

> manufacturer - Ortho Clinical Diagnostics - but can't find a

package

> insert. Does anyone know where I can find one online? I'd like to

read

> it before getting to the doctor's office and taking forever to

study

> it there. The website claims it's mercury free, but I still want to

> check it out myself and research all the ingredients online.

>

>

> and even if it is mercury - free - is it safe for your baby?

> http://www.wellwithin1.com/rhogam.htm

>

> http://www.orthoclinical.com/Products/products.aspx?id=9

>

> Sheri

> listowner

>

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kellymac92 wrote:

>So basically, if our blood doesn't mix before delivery (which it

>probably won't), then he should be okay with or without the shot?

>

Yes, more than likely. Although the medical profession nowadays likes

to push the Rhogam shot before AND after pregnancy, years ago it was

ONLY administered immediately after birth and only if the baby was born

w/ positive blood and the mother had negative AND the mother planned to

have more children. There's never been a reason to give the shot DURING

pregnancy.

btw, most of Europe still practices the old ways (one shot after

pregnancy). But I'm sure that there are millions of pregnant women who

give birth successfully AND have subsequent pregnancies and never have a

Rhogam shot even tho it would be 'indicated by modern protocol'.

I would never subject myself nor the health of my unborn child to that

shot!

Just my $.02,

Bobbett

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At 02:47 PM 5/1/2008, you wrote:

>I am supposed to get the Rhogam shot next week. I have looked up the

>manufacturer - Ortho Clinical Diagnostics - but can't find a package

>insert. Does anyone know where I can find one online? I'd like to read

>it before getting to the doctor's office and taking forever to study

>it there. The website claims it's mercury free, but I still want to

>check it out myself and research all the ingredients online.

and even if it is mercury - free - is it safe for your baby?

http://www.wellwithin1.com/rhogam.htm

Sheri

listowner

>------------------------------------

>

>

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To answer the question yes you only want to get it after the baby is

born, if you decide to get it. Have them test the blood of the baby

to see what the baby's blood type is if the baby is o- there is no

need for it.

Furthermore, It can actually harm the baby, esp if the baby is o-

I am o- and wouldn't let them give it to me, and my baby came out o-

so now I don't even need it for the next pregnancy.

Please do you research, no shots or vaccines are good for you or the

baby.

Best Wishes,

.

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You might also like to get the father tested because if he is negative

also then there is NO WAY your child will be positive and you would

not need it. My DH and I are both O- and I had to sign a paper

stating I would not sue the doctor if my baby came out positive and I

became sensitized. If the child had somehow come out positive (would

have had to been immaculate conception or I got pregnant from a toilet

seat :) then I would have gotten the shot after birth.

I would seriously consider not getting it during pregnancy and only

after if it is needed because the child is positive.

>

> To answer the question yes you only want to get it after the baby is

> born, if you decide to get it. Have them test the blood of the baby

> to see what the baby's blood type is if the baby is o- there is no

> need for it.

>

> Furthermore, It can actually harm the baby, esp if the baby is o-

>

> I am o- and wouldn't let them give it to me, and my baby came out o-

> so now I don't even need it for the next pregnancy.

>

> Please do you research, no shots or vaccines are good for you or the

> baby.

>

> Best Wishes,

> .

>

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I would second getting the father tested if you haven't already. We were lucky

enough to

have a midwife the 1st time that suggested testing the father since I am A- and

it turns

out hubby was a negative also. I had to switch doctors for my second pregnancy

and I had

to fight them not to get the shot because I knew there was no risk. They kept

telling me it

was a standard thing they did. They tried to convince me to do it using an

excuse that

they believe everyone's blood type used to be negative but at some time there

was a

mutation and that started producing people with positive blood types. So, they

said it is

possible my baby could have mutated into having a positive blood type so it was

better to

be safe. All I was thinking to myself is you have to be crazy. I kept refusing

and finally

they never bothered me again. It still amazes at how hard Drs will push their

meds on

you, even when you have absolutely no reason to possibly need them.

Good luck,

Tomi

> >

> > To answer the question yes you only want to get it after the baby is

> > born, if you decide to get it. Have them test the blood of the baby

> > to see what the baby's blood type is if the baby is o- there is no

> > need for it.

> >

> > Furthermore, It can actually harm the baby, esp if the baby is o-

> >

> > I am o- and wouldn't let them give it to me, and my baby came out o-

> > so now I don't even need it for the next pregnancy.

> >

> > Please do you research, no shots or vaccines are good for you or the

> > baby.

> >

> > Best Wishes,

> > .

> >

>

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Can someone explain this Rh thing to me?

I am 25 weeks pregnant and no one has said anything to me about it. My

blood type is A positive.

Melinda C. in Mass.

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Guest guest

>

> Can someone explain this Rh thing to me?

> I am 25 weeks pregnant and no one has said anything to me about it.

My

> blood type is A positive.

> Melinda C. in Mass.

>

This is my understanding of it. It's a shot of antibodies given to

pregnant women with negative blood rhesus. It's done routinely " just in

case " . It's suppose to protect fetus with positive rhesus from mother's

blood attacking it. If your blood is + you don't need to worry about it

and that's why you did not hear anything about it.

Katarina

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Melinda,

If the mother's blood type is positive, then you don't have to worry

about it. My blood type is negative, and this is what I understand.

1. If I were to be carrying a baby whose blood type were postitve, and

IF our blood were to mix during pregnancy, then my body would see the

baby as a foriegn object and attack it. I would develop antibodies

towards positive blood. Then, if I were to get pregnant again with

another positive baby, it could end in miscarriage very soon because

those antibodies would already be there.

2. If I were to be carrying a baby whose blood type were positive and

our blood DIDN'T mix during pregnancy (which it probably won't)then it

could mix during delivery, but the baby would be fine. However, my

body could create antibodies to attack a future positive baby.

Therefore, they would give me the shot after delivery to prevent this

from happening.

3. They give the RhoGam shot at 28 weeks to negative mothers to

prevent my body from creating antibodies IN CASE our blood mixes

during the 3rd trimester when it's most likely to occur.

4. After I give birth, they test the baby, and if he's negative, then

no problem, but if he's positive, then they give me another RhoGam

shot JUST IN CASE our blood mixed during delivery so that my body

won't produce the antibodies that could harm a future positive fetus.

I was really nervous about getting this shot, but researched it until

I found a brand RhoGam by Ortho Clinical Diagnostics, that doesn't use

thimerosal in the production of, or to preserve this shot.

>

> Can someone explain this Rh thing to me?

> I am 25 weeks pregnant and no one has said anything to me about it.

My

> blood type is A positive.

> Melinda C. in Mass.

>

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Thimerosal is NOT the only problem

Getting this during pregnancy can harm the baby you are carrying

http://www.wellwithin1.com/rhogam.htm

Most countries in the world do NOT give this during pregnancy

Only after delivery if the baby is NOT rH negative

They doubled their profits by making it 2 shots

Sheri

listowner

At 02:49 AM 5/22/2008, you wrote:

>Melinda,

>

>If the mother's blood type is positive, then you don't have to worry

>about it. My blood type is negative, and this is what I understand.

>

>

>1. If I were to be carrying a baby whose blood type were postitve, and

>IF our blood were to mix during pregnancy, then my body would see the

>baby as a foriegn object and attack it. I would develop antibodies

>towards positive blood. Then, if I were to get pregnant again with

>another positive baby, it could end in miscarriage very soon because

>those antibodies would already be there.

>

>2. If I were to be carrying a baby whose blood type were positive and

>our blood DIDN'T mix during pregnancy (which it probably won't)then it

>could mix during delivery, but the baby would be fine. However, my

>body could create antibodies to attack a future positive baby.

>Therefore, they would give me the shot after delivery to prevent this

>from happening.

>

>3. They give the RhoGam shot at 28 weeks to negative mothers to

>prevent my body from creating antibodies IN CASE our blood mixes

>during the 3rd trimester when it's most likely to occur.

>

>4. After I give birth, they test the baby, and if he's negative, then

>no problem, but if he's positive, then they give me another RhoGam

>shot JUST IN CASE our blood mixed during delivery so that my body

>won't produce the antibodies that could harm a future positive fetus.

>

>I was really nervous about getting this shot, but researched it until

>I found a brand RhoGam by Ortho Clinical Diagnostics, that doesn't use

>thimerosal in the production of, or to preserve this shot.

>

> >

> > Can someone explain this Rh thing to me?

> > I am 25 weeks pregnant and no one has said anything to me about it.

>My

> > blood type is A positive.

> > Melinda C. in Mass.

> >

>

>

>

>------------------------------------

>

>

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Guest guest

Well, it's too late now. I let them give it to me. Hope and pray

that I didn't mess this one up too. :(

My husband is positive and was very sick and nearly died at birth -

his mom was negative and didn't get the shot. So that kind of scared

me into it. :(

> >I am supposed to get the Rhogam shot next week. I have looked up

the

> >manufacturer - Ortho Clinical Diagnostics - but can't find a

package

> >insert. Does anyone know where I can find one online? I'd like to

read

> >it before getting to the doctor's office and taking forever to

study

> >it there. The website claims it's mercury free, but I still want

to

> >check it out myself and research all the ingredients online.

>

>

> and even if it is mercury - free - is it safe for your baby?

> http://www.wellwithin1.com/rhogam.htm

>

> Sheri

> listowner

>

>

>

>

>

>

> >------------------------------------

> >

> >

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