KOVALTRY Powder and solvent for solution for injection (2020)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Kovaltry 250 IU powder and solvent for solution for injection. Kovaltry 500 IU powder and solvent for solution for injection. Kovaltry 1000 IU powder and solvent for solution for injection. Kovaltry 2000 ...
Qualitative and quantitative composition
<u>Kovaltry 250 IU powder and solvent for solution for injection:</u> One mL Kovaltry 250 IU contains approximately 100 IU (250 IU/2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) ...
Pharmaceutical form
Powder and solvent for solution for injection. Powder: solid, white to slightly yellow. Solvent: water for injections, a clear solution.
Therapeutic indications
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Kovaltry 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 reactions to mouse or 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 (rDNA) products with other medicinal products have been reported.
Fertility, pregnancy and lactation
Pregnancy 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 is not ...
Effects on ability to drive and use machines
If patients experience dizziness or other symptoms affecting their ability to concentrate and react, it is recommended that they do not drive or use machines until the reaction subsides.
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 symptoms of overdose with recombinant human coagulation factor VIII have been reported.
Pharmacodynamic properties
Pharmacotherapeutic group: antihemorrhagics: blood coagulation factor VIII ATC code: B02BD02 Mechanism of action The factor VIII/von Willebrand factor (vWF) complex consists of two molecules (factor VIII ...
Pharmacokinetic properties
The Pharmacokinetic (PK) profile of Kovaltry was evaluated in PTPs with severe haemophilia A following 50 IU/kg in 21 subjects ≥18 years, 5 subjects ≥12 years and <18 years and 19 subjects <12 years of ...
Preclinical safety data
Non-clinical data reveal no special risk for humans based on safety pharmacology, in vitro genotoxicity, and short term repeat-dose toxicity studies. Repeat-dose toxicity studies longer than 5 days, reproductive ...
List of excipients
<u>Powder:</u> Sucrose Histidine Glycine Sodium chloride Calcium chloride dihydrate Polysorbate 80 Acetic acid, glacial (for pH adjustment) <u>Solvent:</u> 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 for reconstitution and injection because ...
Shelf life
30 months. The chemical and physical in-use stability after reconstitution has been demonstrated for 3 hours at room temperature. After reconstitution, from a microbiological point of view, the product ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Keep the vial and the pre filled syringe in the outer carton in order to protect from light. Within its overall shelf life of 30 months the product when ...
Nature and contents of container
Each single package of Kovaltry contains: one vial with powder (10 mL clear glass type 1 vial with grey halogenobutyl rubber blend stopper and aluminium seal) one pre-filled syringe with 2.5 mL (for 250 ...
Special precautions for disposal and other handling
Detailed instructions for preparation and administration are contained in the package leaflet provided with Kovaltry. The reconstituted medicinal product is a clear and colourless solution. Kovaltry powder ...
Marketing authorization holder
Bayer AG, 51368, Leverkusen, Germany
Marketing authorization number(s)
EU/1/15/1076/002 1 x (Kovaltry 250 IU solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/012 1 x (Kovaltry 250 IU solvent (2.5 mL); pre-filled syringe (5 mL)) EU/1/15/1076/004 1 x (Kovaltry ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 18 February 2016
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
