FEIBA Powder and solvent for solution for infusion (2011)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Baxter Healthcare Ltd |
|---|---|
| Διεύθυνση | Caxton Way, Thetford, IP243 SE, Norfolk, United Kingdom |
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Περιεχόμενα
Name of the medicinal product
FEIBA 1000 U powder and solvent for solution for infusion.
Qualitative and quantitative composition
Active substance:
Factor VIII Inhibitor Bypassing Activity.
As the active ingredient, FEIBA 1000 U* contains 1000 U factor VIII inhibitor bypassing activity in 400-1200 mg human plasma protein.
FE...
Pharmaceutical form
Powder and solvent for solution for infusion.
White, off-white or pale green powder. The pH value of the ready-to-use solution is between 6.8 and 7.6.
Therapeutic indications
Treatment of bleeding episodes in patients with hemophilia A and factor VIII inhibitors
Treatment of bleeding in non-hemophiliacs with acquired inhibitors to factor VIII.
Prophylaxis of bleeding in...
Posology and method of administration
The treatment is to be initiated and monitored by a physician experienced in the treatment of coagulation disorders.
Posology
Dosage and duration of treatment depend on the severity of the haemosta...
Contraindications
FEIBA must not be used in the following situations if therapeutic alternatives to FEIBA are available:
Hypersensitivity to the product or any of the components.
Disseminated Intravascular Coagulati...
Special warnings and precautions for use
WARNINGS
Risk of Thrombotic and Thromboembolic Events
Thrombotic and thromboembolic events, including disseminated intravascular coagulation (DIC), venous thrombosis, pulmonary embolism, myocardial...
Interaction with other medicinal products and other forms of interaction
It is not recommended to administer antifibrinolytics, such as epsilon aminocaproic acid, together with FEIBA.
If application of both, antifibrinolytics such as epsilon aminocaproic acid and FEIBA,...
Fertility, pregnancy and lactation
The safety of FEIBA during pregnancy and lactation has not been established.
Physicians should carefully consider the potential risks and benefits for each specific patient before prescribing FEIBA...
Effects on ability to drive and use machines
FEIBA has no, or negligible, influence on the ability to drive or to use machines.
Undesirable effects
The adverse reactions listed in the following were reported within the framework of either post-marketing surveillance or clinical trials.
Frequency categories: very common >1/10, common >1/1...
Overdose
Overdose of FEIBA may increase the risk of undesired events such as thromboembolism, DIC or myocardial infarction (see Section 4.4).
Pharmacodynamic properties
Pharmacotherapeutic group:
blood coagulation factors
ATC code:
B02BD03
Although FEIBA was developed in the early seventies and its factor VIII inhibitor bypassing activity has been proven in vit...
Pharmacokinetic properties
As the mode of action of FEIBA is still being discussed, it is not possible to make a conclusive statement about the pharmacokinetic properties.
Preclinical safety data
Based on acute toxicity studies in factor VIII knockout mice and in normal mice, and in rats, with doses higher than the maximum daily dose in humans (>200 U/kg body weight), it can be concluded...
List of excipients
Powder:
Sodium chloride
Sodium citrate
Solvent:
Sterilized Water for Injections
Incompatibilities
This medicinal product must not be mixed with other medicinal products except the solvent mentioned in Section 6.6. As in all blood coagulation preparations, the efficacy and tolerance of the medic...
Shelf life
Two years.
Chemical and physical in-use stability has been demonstrated for 3 hours at room temperature. From a microbiological point of view, unless the method of reconstitution precludes the risk...
Special precautions for storage
Do not store above 25°C. Do not freeze.
Store in the original package in order to protect from light. For storage conditions of the reconstituted medicinal product - see section 6.3.
Nature and contents of container
The powder is supplied in a vial made of surface treated, colorless glass (hydrolytic class II). The solvent is supplied in a vial made of surface treated, colorless glass (hydrolytic class I). The...
Special precautions for disposal and other handling
FEIBA is to be reconstituted immediately prior to administration. The solution should be used immediately (as the preparation does not contain preservatives).
Swirl gently until all material is dis...
Marketing authorization holder
Baxter Healthcare Limited, Caxton Way, Thetford, IP243 SE, Norfolk, United Kingdom
Marketing authorization number(s)
PA 167/138/2
Date of first authorization / renewal of the authorization
Date of first authorisation: 28th May 2010
Date of revision of the text
April 2011
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