KOVALTRY POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 500IUVIAL

País: Singapur

Idioma: inglés

Fuente: HSA (Health Sciences Authority)

Ingredientes activos:

Antihemophilic Factor (Recombinant)

Disponible desde:

BAYER (SOUTH EAST ASIA) PTE LTD

Código ATC:

B02BD02

formulario farmacéutico:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Composición:

Antihemophilic Factor (Recombinant) 500 IU

Vía de administración:

INTRAVENOUS

tipo de receta:

Prescription Only

Fabricado por:

Bayer HealthCare LLC

Estado de Autorización:

ACTIVE

Fecha de autorización:

2018-11-30

Ficha técnica

Kovaltry Powder/Solvent for IV PI-CCDS4, 22 July 2020
1.
NAME OF THE MEDICINAL PRODUCT
Principal Product Name: Kovaltry 250, 500, 1000, 2000, 3000 IU
Not all presentations may be available locally.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 250, 500, 1000, 2000, or 3000 IU coagulation factor
VIII produced by
recombinant DNA technology. It is a sterile, stable, purified,
nonpyrogenic, dried concentrate
that has been manufactured using recombinant DNA technology. It is
produced by Baby
Hamster Kidney (BHK) cells into which the human factor VIII gene has
been introduced.
The potency (IU) is determined using the chromogenic assay.
3.
PHARMACEUTICAL FORM_ _
It is a lyophilized powder for injection supplied with water for
injection as diluent.
4.
CLINICAL PARTICULARS
4.1
INDICATION(S)
Treatment and prophylaxis of bleeding in patients with haemophilia A
(congenital factor VIII
deficiency). Kovaltry can be used for all age groups.
Kovaltry does not contain von Willebrand factor and is not indicated
in von Willebrand
disease.
4.2
DOSAGE AND METHOD OF ADMINISTRATION
4.2.1
METHOD OF ADMINISTRATION
For intravenous use.
4.2.2
DOSAGE REGIMEN
The number of units of factor VIII administered is expressed in
International Units (IU),
which are related to the current WHO standard for factor VIII
products. Factor VIII activity in
plasma is expressed either as a percentage (relative to normal human
plasma) or in
International Units (relative to the International Standard for factor
VIII in plasma). One
International Unit (IU) of factor VIII activity is equivalent to that
quantity of factor VIII in
one mL of normal human plasma. The calculation of the required dosage
of factor VIII is
based on the empirical finding that 1 International Unit (IU) factor
VIII per kg body weight
raises the plasma factor VIII activity by 1.5% to 2.5% of normal
activity.
The dosage and duration of the substitution therapy to achieve
hemostasis must be
individualized according to the patient's needs (weight, severity of
disorder of the h