OCTANATE 500

Land: Israel

Språk: engelska

Källa: Ministry of Health

Aktiva substanser:

FACTOR VIII

Tillgänglig från:

DOVER MEDICAL & SCIENTIFIC EQUIPMENT LTD, ISRAEL

ATC-kod:

B02BD02

Läkemedelsform:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Sammansättning:

FACTOR VIII 500 IU/VIAL

Administreringssätt:

I.V

Receptbelagda typ:

Required

Tillverkad av:

OCTAPHARMA AG, SWITZERLAND

Terapiområde:

COAGULATION FACTOR VIII

Terapeutiska indikationer:

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency)This preparation does not contain von Willebrand factor in pharmacologically effective quantities and is therefore not indicated in von Willebrand's disease.

Tillstånd datum:

2021-02-28

Produktens egenskaper

_1/13 _
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
OCTANATE 500
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Octanate 500 contains nominally 500 IU human coagulation factor VIII
per vial.
The product contains approximately 50 IU* per ml human coagulation
factor VIII when
reconstituted with 10 ml of the supplied solvent.
Produced from the plasma of human donors. The product contains
approximately ≤ 30 IU per
ml von Willebrand factor (VWF:RCo).
*The potency (IU) is determined using the European Pharmacopoeia
chromogenic assay. The
specific activity is ≥ 100 IU/mg protein.
Produced from the plasma of human donors.
Excipient with known effect:
Sodium up to 1.75 mmol (40 mg) per dose.
Sodium concentration after reconstitution: 125 – 175 mmol/l
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
The powder is white or pale yellow, also appearing as a friable solid.
The solvent is a clear, colourless liquid.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prophylaxis of bleeding in patients with haemophilia A
(congenital factor VIII
deficiency).
This preparation does not contain von Willebrand factor in
pharmacologically effective
quantities and is therefore not indicated in von Willebrand’s
disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated under the supervision of a physician
experienced in the
treatment of haemophilia.
_2/13 _
POSOLOGY
The dosage and duration of the substitution therapy depend on the
severity of the factor VIII
deficiency, on the location and extent of the bleeding, and on the
patient’s clinical condition.
The number of units of factor VIII administered is expressed in
International Units (IU),
which are related to the current World Health Organisation (WHO)
international standard for
factor VIII products. Factor VIII activity in plasma is expressed
either as a percentage
(relative to normal human plasma) or in