ALPROLIX Powder and solvent for solution for injection (2019)
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Περιεχόμενα
Name of the medicinal product
ALPROLIX 250 IU powder and solvent for solution for injection. ALPROLIX 500 IU powder and solvent for solution for injection. ALPROLIX 1000 IU powder and solvent for solution for injection. ALPROLIX 2000 ...
Qualitative and quantitative composition
ALPROLIX 250 IU powder and solvent for solution for injection: Each vial contains nominally 250 IU eftrenonacog alfa. After reconstitution, each mL of solution for injection contains approximately 50 IU ...
Pharmaceutical form
Powder and solvent for solution for injection. Powder: lyophilised, white to off-white powder or cake. Solvent: the solution is clear to colourless.
Therapeutic indications
Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency). ALPROLIX 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. Previously untreated patients The safety and efficacy of ALPROLIX in previously untreated patients ...
Contraindications
Hypersensitivity to the active substance (recombinant human coagulation factor IX, and/or Fc domain) or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Hypersensitivity Allergic type hypersensitivity reactions have been reported with ALPROLIX. If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the medicinal product ...
Interaction with other medicinal products and other forms of interaction
No interactions of ALPROLIX with other medicinal products have been reported. No interaction studies have been performed.
Fertility, pregnancy and lactation
Pregnancy and breast-feeding Animal reproduction studies have not been conducted with ALPROLIX. A placental transfer study in mice was conducted (see section 5.3). Based on the rare occurrence of haemophilia ...
Effects on ability to drive and use machines
ALPROLIX 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 infusion site, chills, flushing, generalised urticaria, headache, hives, ...
Overdose
The effects of higher than recommended doses of ALPROLIX have not been characterised.
Pharmacodynamic properties
Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor IX ATC code: B02BD04 Mechanism of action Factor IX is a single chain glycoprotein with a molecular mass of about 68,000 Dalton. It ...
Pharmacokinetic properties
All pharmacokinetic studies with ALPROLIX were conducted in previously treated patients with severe haemophilia B. Data presented in this section were obtained by one-stage clotting assay with a silica-based ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on thrombogenicity test in rabbits (Wessler stasis model) and repeated dose toxicity studies (which included assessment of local toxicity, male ...
List of excipients
Powder: Sucrose L-histidine Mannitol Polysorbate 20 Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Solvent: Sodium chloride 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 set should be used because treatment failure can occur as a consequence ...
Shelf life
Shelf life Unopened vial: 4 years. During the shelf-life, the product may be stored at room temperature (up to 30°C) for a single period not exceeding 6 months. The date that the product is removed from ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Keep the vial in the outer carton in order to protect from light. For storage conditions after reconstitution of the medicinal product, see section 6.3. ...
Nature and contents of container
Each pack contains: powder in a type 1 glass vial with a chlorobutyl rubber stopper 5 mL solvent in a type 1 glass pre-filled syringe with a bromobutyl rubber plunger stopper a plunger rod a sterile vial ...
Special precautions for disposal and other handling
The powder for injection in each vial must be reconstituted with the supplied solvent (sodium chloride solution) from the pre-filled syringe using the sterile vial adapter for reconstitution. The vial ...
Marketing authorization holder
Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden
Marketing authorization number(s)
EU/1/16/1098/001 EU/1/16/1098/002 EU/1/16/1098/003 EU/1/16/1098/004 EU/1/16/1098/005
Date of first authorization / renewal of the authorization
Date of first authorisation: 12 May 2016
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