KOVALTRY 500 IU

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

RECOMBINANT HUMAN COAGULATION FACTOR VIII

Available from:

BAYER ISRAEL LTD

ATC code:

B02BD02

Pharmaceutical form:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Composition:

RECOMBINANT HUMAN COAGULATION FACTOR VIII 500 IU

Administration route:

I.V

Prescription type:

Required

Manufactured by:

BAYER AG, GERMANY

Therapeutic area:

COAGULATION FACTOR VIII

Therapeutic indications:

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Kovaltry can be used for all age groups.

Authorization date:

2022-04-30

Patient Information leaflet

PMR 89611407 Technical Template (GFJBE/00-N) Pantone: Black
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) -1986
This medicine is dispensed with a doctor’s prescription only
KOVALTRY
® 250 IU
KOVALTRY
® 500 IU
KOVALTRY
® 1000 IU
KOVALTRY
® 2000 IU
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Each vial of powder contains:
Nominally 250, 500, 1000, or 2000 IU (International Units) recombinant
human coagulation factor VIII (octocog alfa).
After reconstitution with water for injection:
1 mL of Kovaltry 250 IU contains approximately 100 IU (250 IU/2.5 mL)
of
recombinant human coagulation factor VIII (octocog alfa),
1 mL of Kovaltry 500 IU contains approximately 200 IU (500 IU/2.5 mL)
of
recombinant human coagulation factor VIII (octocog alfa),
1 mL of Kovaltry 1000 IU contains approximately 400 IU (1000 IU/2.5
mL)
of recombinant human coagulation factor VIII (octocog alfa),
1 mL of Kovaltry 2000 IU contains approximately 400 IU (2000 IU/5 mL)
of recombinant human coagulation factor VIII (octocog alfa).
Inactive ingredients and allergens:
See section 2 under “Important
information about some of this medicine’s ingredients”
and section 6
“Additional Information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
This leaflet contains concise information about this medicine. If you
have
any further questions, consult your doctor or pharmacist.
This medicine has been prescribed for the treatment of your illness.
Do
not pass it on to others. It may harm them even if it seems to you
that their
illness is similar to yours.
1) WHAT IS THIS MEDICINE INTENDED FOR?
Kovaltry is used for
treatment
and prevention of
bleeding in adults,
adolescents and children of all ages with haemophilia A (congenital
factor
VIII deficiency).
THERAPEUTIC GROUP:
Kovaltry belongs to a group of medicines for
prevention of bleeding that contains the coagulation factor number
VIII.
The medicine contains the active substance human recombinant
coagulation factor VIII,
also called oc

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
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 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
•
Kovaltry 250IU powder and solvent for solution for injection
Kovaltry contains approximately 250 IU (100 IU / 1 mL) of recombinant
human coagulation
factor VIII (INN: octocog alfa) after reconstitution
•
Kovaltry 500IU powder and solvent for solution for injection
Kovaltry contains approximately 500 IU (200 IU / 1 mL) of recombinant
human coagulation
factor VIII (INN: octocog alfa) after reconstitution.
•
Kovaltry 1000IU powder and solvent for solution for injection
Kovaltry contains approximately 1000 IU ( 400 IU / 1 mL) of
recombinant human coagulation
factor VIII (INN: octocog alfa) after reconstitution .
•
Kovaltry 2000IU powder and solvent for solution for injection
Kovaltry contains approximately 2000 IU (400 IU / 1 mL) of recombinant
human coagulation
factor VIII (INN: octocog alfa) after reconstitution.
The potency (IU) is determined using the European Pharmacopoeia
chromogenic assay. The specific
activity of Kovaltry is approximately 4000 IU/mg protein.
Octocog alfa (Full length recombinant human coagulation factor VIII
(rDNA)) is a purified protein
that has 2,332 amino acids. It is produced by recombinant DNA
technology in baby hamster kidney
cells (BHK) into which the human factor VIII gene has been introduced.
Kovaltry is prepared without
the addition of any human or animal derived protein in the cell
culture process, purification or final
formulation.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection (vial adapter)
Powder: solid, white to slightly yellow.
Solvent: water for injections, a clear solution.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Treatment a