KONAKION® MM 10 mg-1 mL Ampoules; KONAKION® 10 mg Tablets

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Shelby,

I couldn't find KOKAKION in the PDR bc it is from South African Manufacturer/Distributor: Roche Products (Pty)Ltd. However, I found this information from here: http://home.intekom.com/pharm/

KONAKION® MM 10 mg/1 mL AmpoulesKONAKION® 10 mg TabletsSCHEDULING STATUSS1 - Ampoules onlyPROPRIETARY NAME(and dosage form)KONAKION® MM 10 mg/1 mL AmpoulesKONAKION® 10 mg TabletsCOMPOSITIONSynthetic Vitamin K1(phytomenadione): Tablets 10 mg; The ampoules contain 10 mg phytomenadione in a mixed micelles vehicle of glycocholic acid and lecithin.PHARMACOLOGICAL CLASSIFICATIONCategory A: 22 - Vitamins.PHARMACOLOGICAL ACTIONAs component of an enzyme system, vitamin K1 promotes the formation in the liver of the coagulation factors II (prothrombin), VII, IX and X. Anticoagulants of the coumarin and indandione series cause a reversible displacement of vitamin K1 from this enzyme system. Konakion is thus a specific antagonist for coumarin type and similar anticoagulants.INDICATIONSHaemorrhage or threatened haemorrhage associated with vitamin K1 deficiency of coagulation factors II, VII, IX and X due, for instance, to overdosage of anticoagulants of the dicoumarol type or their combination with phenylbutazone, or to other forms of hypovitaminosis K (e.g obstructive jaundice, liver and intestinal disorders, or prolonged administration of antibiotics, sulfonamides or salicylates).Haemorrhage in the newborn: refer Konakion Paediatric package insertCONTRA-INDICATIONSUse in patients with a known hypersensitivity to any of the constituents.Safety in pregnancy and lactation has not been established.DOSAGE AND DIRECTIONSFOR USEHaemorrhage or threatened haemorrhage in the newborn: Refer Konakion Paediatric package insert.Adults:As an antidote to anticoagulant drugs: The anticoagulant should be withdrawn and an intravenous injection of Konakion MM given slowly in a dose of 2,5 - 10 mg (up to 20 mg has been given). The prothrombin level should be estimated three hours later, and if the response has been inadequate the dose should be repeated. For potentially fatal and severe haemorrhages: Konakion MM therapy should be accompanied by a more immediate effective treatment such as transfusions of whole blood or blood clotting factors.Less severe haemorrhage: Oral treatment with Konakion tablets may be used.Use in elderly:Elderly patients tend to be more sensitive to reversal of anticoagulation with Konakion; dosage in this group should be at the lower end of the ranges recommended.Konakion MM ampoules are for intravenous injection. Konakion MM ampoules solution should not be diluted or mixed with other injectables, but may be injected into the lower part of an infusion apparatus.The pleasant tasting dragees should be chewed thoroughly or allowed to dissolve slowly in the mouth.SIDE-EFFECTS ANDSPECIAL PRECAUTIONSIf surgical intervention should be necessary in a patient receiving anticoagulants of the coumarin or indandione series, their anticoagulant action, if not required for the purpose of the operation, may be counteracted by means of Konakion. If there is a recurrence of thrombosis while Konakion is being used, i.v. administration of heparin is recommended as a first measure.Note: When a patient on Konakion is referred to another doctor, it is particularly important to notify the latter that Konakion has been prescribed.In rare cases, anaphylactoid reactions have been reported after parenteral use of Konakion MM. Local irritation may occur at the injection site but is unlikely due to the small injection volume.PrecautionsWhen treating patients with severely impaired liver function, the formation of prothrombin may be impaired. Therefore a careful monitoring of the coagulation parameters after administration of Konakion is necessary.At the time of use, the ampoule contents should be clear. Following incorrect storage, the contents may become turbid or present a phase-separation. In this case the ampoule must no longer be used.In potentially fatal and severe haemorrhage due to overdosage of coumarin anticoagulants, intravenous injections ofKonakion MM (maximum of 40 mg in 24 hours) should be accompanied by a more immediate effective treatment such as transfusion of whole blood or blood clotting factors. When patients with prosthetic heart valves are given transfusions for the treatment of severe or potentially fatal haemorrhage, fresh frozen plasma should be used.Large doses of Konakion should be avoided if it is intended to continue with anticoagulant therapy.Vitamin K1 is not an antidote to heparin.Since Vitamin K reverses the effects of oral anticoagulants, there have been reports of phytomenadione reducing anticoagulant activity.KNOWN SYMPTOMS OFOVERDOSAGE ANDPARTICULARS OF ITSTREATMENTSee side-effects and special precautions. Treatment is symptomatic and supportive.IDENTIFICATIONTablets: round, biconvex, white, sugar-coated tablets. Diameter approximately 13,5 mm. Thickness approximately 8,0 mm.The ampoule solution is clear to slightly opalescent, pale yellow in colour and contains the active constituent in a mixed micelles vehicle of glycocholic acid and lecithin.PRESENTATION

Chewable dragees 10 mg

10

Ampoules 10 mg/1 mL

10

STORAGE INSTRUCTIONSTablets: Store below 25°C.The ampoule solution should be protected from light. The recommended maximum storage temperature is 25°C and the solution should not be frozen.Keep out of reach of children.REFERENCE NUMBER

Ampoules 10 mg/mL

H2250 (Act 101/1965)

Sugar-coated tablets 10 mg

H2251 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANTRoche Products (Pty) Limited4 Brewery StreetIsandoSouth AfricaDATE OF PUBLICATION OF THIS PACKAGE INSERT05 June 199561544/9701 Britepak SAEPI HOME PAGE TRADE NAME INDEX GENERIC NAME INDEX FEEDBACK

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