AFSTYLA Powder and solvent for solution for injection (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
AFSTYLA 250 IU powder and solvent for solution for injection. AFSTYLA 500 IU powder and solvent for solution for injection. AFSTYLA 1000 IU powder and solvent for solution for injection. AFSTYLA 1500 IU ...
Qualitative and quantitative composition
AFSTYLA 250 IU powder and solvent for solution for injection: Each vial contains nominally 250 IU recombinant, single-chain coagulation factor VIII (rVIIISingleChain, INN = lonoctocog alfa). After reconstitution ...
Pharmaceutical form
Powder and solvent for solution for injection. White or slightly yellow powder or friable mass and clear, colourless solvent for solution for injection. pH: 6.6-7.3 Osmolality: 500-600 mOsm/kg
Therapeutic indications
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). AFSTYLA can be used for all age groups.
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. Known allergic reaction to hamster proteins.
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
AFSTYLA has no 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, generalised urticaria, headache, hives, ...
Overdose
In a completed clinical trial a patient who received more than double the prescribed dose of AFSTYLA experienced dizziness, feeling hot, and itching not considered related to AFSTYLA but more plausibly ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antihemorrhagics: Blood coagulation factor VIII ATC code: B02BD02 Mechanism of Action AFSTYLA (INN: lonoctocog alfa) is a recombinant human protein that replaces the missing ...
Pharmacokinetic properties
Adult population The pharmacokinetics (PK) of AFSTYLA was evaluated in 81 previously treated adult subjects who had been diagnosed with severe haemophilia A with <1% factor VIII and with age from 18-60 ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity studies, local tolerability and thrombogenicity assessments. ...
List of excipients
Powder: L-Histidine Polysorbate 80 Calcium chloride dihydrate Sodium chloride Sucrose Solvent: Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products or solvents except those mentioned in sections 2 and 6.5.
Shelf life
Shelf life: 3 years. After reconstitution the chemical and physical in-use stability has been demonstrated for 48 hours at room temperature (below 25°C). From a microbiological point of view, the product ...
Special precautions for storage
Store in a refrigerator (2°C to 8°C). Do not freeze. Keep vials in the outer carton in order to protect from light. AFSTYLA may be stored at room temperature, not to exceed 25°C, for a single period of ...
Nature and contents of container
AFSTYLA 250 IU powder and solvent for solution for injection: Powder (250 IU) in a 6 ml vial (type I glass) with a stopper (rubber), an orange disc (plastic), and a green striped cap (aluminium). 2.5 ml ...
Special precautions for disposal and other handling
General instructions: The solution should be almost colourless, clear or slightly opalescent. After filtering/withdrawal (see below) the reconstituted product should be inspected visually for particulate ...
Marketing authorization holder
CSL Behring GmbH, Emil-von-Behring-Str. 76, 35041, Marburg, Germany
Marketing authorization number(s)
EU/1/16/1158/001 EU/1/16/1158/002 EU/1/16/1158/003 EU/1/16/1158/004 EU/1/16/1158/005 EU/1/16/1158/006 EU/1/16/1158/007
Date of first authorization / renewal of the authorization
Date of first authorisation: 04 January 2017
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