ADYNOVI Powder and solvent for solution for injection (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
ADYNOVI 250 IU/5 ml powder and solvent for solution for injection. ADYNOVI 500 IU/5 ml powder and solvent for solution for injection. ADYNOVI 1000 IU/5 ml powder and solvent for solution for injection. ...
Qualitative and quantitative composition
ADYNOVI 250 IU/5 ml powder and solvent for solution for injection: Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of ...
Pharmaceutical form
Powder and solvent for solution for injection. Powder: White to off-white friable powder. Solvent: Clear and colourless solution.
Therapeutic indications
Treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A (congenital factor VIII deficiency).
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 ADYNOVI in previously untreated patients have ...
Contraindications
Hypersensitivity to the active substance, to the parent molecule octocog alfa or to any of the excipients listed in section 6.1. Known allergic reaction to mouse or hamster protein.
Special warnings and precautions for use
Hypersensitivity Allergic type hypersensitivity reactions are possible with ADYNOVI. The medicinal product contains traces of mouse and hamster proteins. If symptoms of hypersensitivity occur, patients ...
Interaction with other medicinal products and other forms of interaction
No interactions of human coagulation factor VIII (rDNA) products with other medicinal products have been reported.
Fertility, 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
ADYNOVI 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
No symptoms of overdose with recombinant coagulation factor VIII have 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
The pharmacokinetics (PK) of ADYNOVI were evaluated in a crossover study with octocog alfa in 26 subjects (18 adults and 8 adolescents) and in 22 subjects (16 adults and 6 adolescents) after 6 months of ...
Preclinical safety data
In the repeat dose toxicity study in Cynomologous monkey, two animals showed vacuolation in the kidney in the mid dose group (350IU/kg). The vacuolations did not recover after 2 weeks. The human relevance ...
List of excipients
Powder: Mannitol Trehalose dihydrate Histidine Glutathione Sodium chloride Calcium chloride dihydrate Tris(hydroxymethyl)aminomethane Polysorbate 80 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 Unopened vial: 2 years. Before opening the product may be stored at room temperature (up to 30°C) for a period of up to 3 months. The end of the 3-month storage at room temperature should be ...
Special precautions for storage
Store refrigerated (2° to 8°C). Do not freeze. ADYNOVI with BAXJECT II Hi-Flow device: Keep the vial in the outer carton in order to protect from light. ADYNOVI in BAXJECT III system: Keep the sealed blister ...
Nature and contents of container
Type I glass vial, closed with a chlorobutyl rubber stopper, containing 250 IU, 500 IU, 1000 IU or 2000 IU of powder. Type I glass vial, closed with a chlorobutyl rubber stopper, containing 5 ml of sterilised ...
Special precautions for disposal and other handling
The reconstituted medicinal product should be inspected visually for particulate matter and discoloration prior to administration. The solution should be clear or slightly opalescent. Solutions that are ...
Marketing authorization holder
Baxalta Innovations GmbH, Industriestrasse 67, A-1221, Vienna, Austria
Marketing authorization number(s)
EU/1/17/1247/003 EU/1/17/1247/004 EU/1/17/1247/007 EU/1/17/1247/008 EU/1/17/1247/011 EU/1/17/1247/012 EU/1/17/1247/013 EU/1/17/1247/014
Date of first authorization / renewal of the authorization
Date of first authorisation: 08 January 2018
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