HAEMOCTIN Powder and solvent for solution for injection (2019)
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Περιεχόμενα
Name of the medicinal product
Haemoctin 250 Haemoctin 500 Haemoctin 1000 Powder and solvent for solution for injection.
Qualitative and quantitative composition
Human plasma derived coagulation factor VIII. One vial contains nominally 250, 500 or 1000 IU human plasma derived coagulation factor VIII. Haemoctin 250 contains approximately 250 IU (50 IU/ml) human ...
Pharmaceutical form
Powder and solvent for solution for injection. White powder and clear, colourless solvent for solution for injection.
Therapeutic indications
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). This preparation does not contain von Willebrand factor in pharmacologically effective quantities ...
Posology and method of administration
Treatment should be under the supervision of a physician experienced in the treatment of haemophilia. Treatment monitoring During the course of treatment, appropriate determination of factor VIII levels ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Traceability In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Hypersensitivity Allergic type hypersensitivity ...
Interaction with other medicinal products and other forms of interaction
No interactions of human coagulation factor VIII products with other medicinal products have been reported.
Pregnancy and lactation
Animal reproduction studies have not been conducted with factor VIII. Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy and breast-feeding ...
Effects on ability to drive and use machines
Haemoctin has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, ...
Overdose
No case of overdose has been reported.
Pharmacodynamic properties
Pharmacotherapeutic Group: antihaemorrhagics: blood coagulation factor VIII ATC code: B02BD02 The factor VIII/von Willebrand factor complex consists of two molecules (factor VIII and von Willebrand factor) ...
Pharmacokinetic properties
Plasma factor VIII activity decreases by a two-phase exponential decay after intravenous use. In the initial phase, distribution between intravascular and other compartments (body fluids) occurs with a ...
Preclinical safety data
Human plasma coagulation factor VIII (from the concentrate) is a normal constituent of the human plasma and acts like the endogenous factor VIII. Single dose toxicity testing is of no relevance since higher ...
List of excipients
Powder: Glycine Sodium chloride Sodium citrate Calcium chloride Solvent: Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. Only the provided infusion sets should be used because treatment failure can occur as a ...
Shelf life
Shelf life: 2 years. After first opening, the product should be used immediately.
Special precautions for storage
Do not store above 25°C. Do not freeze. Keep the vials in the outer carton in order to protect from light.
Nature and contents of container
1 package Haemoctin contains: 1 vial (20 ml) with powder out of glass type I acc. to Ph. Eur. Freeze-drying stoppers out of halobutyl-caoutchouc, type I acc. to Ph. Eur. 1 vial with 5 ml solvent, glass ...
Special precautions for disposal and other handling
Reconstituted medicinal product should be inspected visually for particulate matter and discoloration prior to administration. The solution should be clear or slightly opalescent. Do not use solutions ...
Marketing authorization holder
Biotest Pharma GmbH, Landsteinerstrasse 5, 63303 Dreieich, Germany Tel.: +49 6103 801-0, Fax: +49 6103 801-150, Email: mail@biotest.com
Marketing authorization number(s)
PL 04500/0009 PL 04500/0010
Date of first authorization / renewal of the authorization
06/08/2008 and 04/09/2008 / 18/03/2013
Date of revision of the text
19/12/2019
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