OCTANATE 1000

国家: 以色列

语言: 英文

来源: Ministry of Health

有效成分:

FACTOR VIII

可用日期:

DOVER MEDICAL & SCIENTIFIC EQUIPMENT LTD, ISRAEL

ATC代码:

B02BD02

药物剂型:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

组成:

FACTOR VIII 1000 IU/VIAL

给药途径:

I.V

处方类型:

Required

厂商:

OCTAPHARMA AG, SWITZERLAND

治疗领域:

COAGULATION FACTOR VIII

疗效迹象:

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.

授权日期:

2021-02-28

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
OCTANATE 1000
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Octanate 1000 contains nominally 1000 IU human coagulation factor VIII
per vial.
The product contains approximately 100 IU* per ml human coagulation
factor VIII when
reconstituted with 10 ml of solvent.
The product contains approximately ≤ 60 IU per ml von Willebrand
factor (VWF:RCo).
* The potency (IU) is determined using the European Pharmacopoeia
chromogenic assay. The
mean specific activity of Octanate 1000 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.
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 International Units (relative to an
Internati