OBIZUR Powder and solvent for solution for injection (2020)
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Περιεχόμενα
Name of the medicinal product
OBIZUR 500 U powder and solvent for solution for injection.
Qualitative and quantitative composition
Each powder vial contains nominally 500 Units of B domain deleted antihaemophilic Factor VIII (recombinant), porcine sequence, susoctocog alfa. OBIZUR contains approximately 500 U/ml susoctocog alfa after ...
Pharmaceutical form
Powder and solvent for solution for injection. The powder is white. The solvent is clear and colourless.
Therapeutic indications
Treatment of bleeding episodes in patients with acquired haemophilia caused by antibodies to Factor VIII. OBIZUR is indicated in adults.
Posology and method of administration
Treatment with OBIZUR should be under the supervision of a physician experienced in the treatment of haemophilia. The product is for in-patient administration only. It requires clinical supervision of ...
Contraindications
Known anaphylactic reactions to the active substance, hamster protein, or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Hypersensitivity Allergic type hypersensitivity reactions are possible with OBIZUR. The product contains trace amounts of hamster proteins. If symptoms of hypersensitivity occur, patients should be advised ...
Interaction with other medicinal products and other forms of interaction
No interactions of OBIZUR with other medicinal products have been reported.
Fertility, pregnancy and lactation
Animal reproduction studies have not been conducted with OBIZUR. Experience regarding the use of OBIZUR during pregnancy and breast-feeding is not available. Therefore, OBIZUR should be used during pregnancy ...
Effects on ability to drive and use machines
OBIZUR 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 injection site, chills, flushing, generalized urticaria, headache, hives, ...
Overdose
The effects of higher than recommended doses of OBIZUR have not been characterised.
Pharmacodynamic properties
Pharmacotherapeutic group: antihaemorrhagics, blood coagulation Factor VIII, porcine sequence ATC code: B02BD14 Mechanism of action Obizur is a recombinant, B-domain deleted, porcine sequence Factor VIII ...
Pharmacokinetic properties
Pharmacokinetic data from 5 subjects with acquired haemophilia whilst in a non-bleeding state are presented in Table 1. Table 1. Individual pharmacokinetic data for factor VIII activity after administration ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology or repeated dose toxicity.However, in repeated dose toxicity studies, the incidence and severity ...
List of excipients
Powder: Polysorbate 80 Sodium chloride Calcium chloride dihydrate Sucrose Tris Base Tris HCl Tri-sodium citrate dihydrate Solvent: Sterilised water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 30 months. The reconstituted solution should be used immediately, but no longer than 3 hours after reconstitution.
Special precautions for storage
Store in a refrigerator (2°C–8°C). Do not freeze. For storage conditions after reconstitution of the medicinal product, see section 6.3.
Nature and contents of container
One pack of OBIZUR contains 1, 5 or 10 each of the following: powder vials (type I glass) with a stopper (butyl rubber) and a flip-off seal pre-filled (type I glass) syringes with a stopper (butyl rubber), ...
Special precautions for disposal and other handling
After reconstitution, the solution is clear, colourless, free from particles and has a pH of 6.8 to 7.2. The osmolality of the formulation buffer ranges between 59 and 65 10% mOsm/kg H<sub>2</sub>O. Reconstituted ...
Marketing authorization holder
Baxalta Innovations GmbH, Industriestrasse 67, A-1221, Vienna, Austria
Marketing authorization number(s)
EU/1/15/1035/001 EU/1/15/1035/002 EU/1/15/1035/003
Date of first authorization / renewal of the authorization
Date of first authorisation: 11 November 2015
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