KOATE DVI 1000

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

FACTOR VIII (HUMAN)

Tilgængelig fra:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

ATC-kode:

B02BD02

Lægemiddelform:

POWDER FOR SOLUTION FOR INJECTION

Sammensætning:

FACTOR VIII (HUMAN) 1000 IU/VIAL

Indgivelsesvej:

I.V

Recept type:

Required

Fremstillet af:

GRIFOLS THERAPEUTICS LLC., USA

Terapeutisk gruppe:

COAGULATION FACTOR VIII

Terapeutisk område:

COAGULATION FACTOR VIII

Terapeutiske indikationer:

For the treatment of classical hemophilia (hemophilia A) in which there is a demonstrated deficiency of activity of the plasma clotting factor, factor VIII . Koate-DVI provides a means of temporarily replacing the missing clotting factor in order to control or prevent bleeding episodes, or in order to perform emergency and elective surgery on individuals with hemophilia.

Autorisation dato:

2015-02-28

Produktets egenskaber

1
PRESCRIBING INFORMATION
KOATE
®
-DVI
250/500/1000
Factor VIII (Human)
250/500/1000 IU/vial
Powder for solution for injection
For intravenous use after reconstitution only.
1
THERAPEUTIC INDICATIONS
Koate-DVI is indicated for the treatment of classical hemophilia
(hemophilia A) in which there is a
demonstrated deficiency of activity of the plasma clotting factor,
factor VIII.
Koate-DVI provides a means of temporarily replacing the missing
clotting factor in order to control
or prevent bleeding episodes, or in order to perform emergency and
elective surgery on individuals
with hemophilia.
2
DOSAGE AND ADMINISTRATION
Each vial of Koate-DVI is labeled with the actual Factor VIII potency
in international units (IU).
The reconstituted product must be administered intravenously by either
direct syringe injection or
drip infusion. The product must be administered within 3 hours after
reconstitution.
GENERAL APPROACH TO TREATMENT AND ASSESSMENT OF TREATMENT EFFICACY
The dosages described below are presented as general guidance. It
should be emphasized that the
dosage of Koate-DVI required for hemostasis must be individualized
according to the needs of the
patient, the severity of the deficiency, the severity of the
hemorrhage, the presence of inhibitors,
and the factor VIII level desired. It is often critical to follow the
course of therapy with factor VIII
level assays.
The clinical effect of Koate-DVI is the most important element in
evaluating the effectiveness of
treatment. It may be necessary to administer more Koate-DVI than would
be estimated in order to
attain satisfactory clinical results. If the calculated dose fails to
attain the expected factor VIII
levels, or if bleeding is not controlled after administration of the
calculated dosage, the presence of
a circulating inhibitor in the patient should be suspected. Its
presence should be substantiated and
the inhibitor level quantitated by appropriate laboratory tests.
When an inhibitor is present, the dosage requirement for
Antihemophilic Factor (Human) is
extr