OCTANINE F 500 IU

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FACTOR IX

Available from:

DOVER MEDICAL & SCIENTIFIC EQUIPMENT LTD, ISRAEL

ATC code:

B02BD04

Pharmaceutical form:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Composition:

FACTOR IX 100 IU/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

OCTAPHARMA AG, SWITZERLAND

Therapeutic group:

COAGULATION FACTOR IX

Therapeutic area:

COAGULATION FACTOR IX

Therapeutic indications:

Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).

Authorization date:

2018-06-30

Summary of Product characteristics

page 1/11
_octanine-spc-clean_copy-minor_changes-1.2017_
_ _
The format of this leaflet has been defined by the MOH and its content
has been
checked and approved
7.2013
INSTRUCTION FOR USE
(SUMMARY OF PRODUCT CHARACTERISTICS)
1
NAME OF THE MEDICINAL PRODUCT
OCTANINE F 500 IU
, 500 IU powder and solvent for solution for injection
OCTANINE F 1000 IU
, 1000 IU powder and solvent for solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
•
OCTANINE F 500 IU is presented as a powder and solvent for solution
for injection
containing nominally 500 IU human coagulation factor IX per vial.
The product contains approximately 100 IU/ml human coagulation factor
IX when
reconstituted with 5 ml water for injections (Ph.Eur.).
•
OCTANINE F 1000 IU is presented as a powder and solvent for solution
for injection
containing nominally 1000 IU human coagulation factor IX per vial.
The product contains approximately 100 IU/ml human coagulation factor
IX when
reconstituted with 10 ml water for injections (Ph.Eur.).
OCTANINE F is produced from plasma of human donors.
The potency (IU) is determined using the European Pharmacopoeia one
stage clotting test, in
comparison with an international standard from the World Health
Organisation (WHO). The
specific activity of OCTANINE F
is approximately
≥
100 IU/mg protein.
This medicinal product contains up to 3 mmol (or 69 mg) sodium for 1
vial OCTANINE F
500 IU and up to 6 mmol (or 138 mg) sodium for 1 vial OCTANINE F 1000
IU per dose. To
be taken into consideration by patients on a controlled sodium diet.
For a 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.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prophylaxis of bleeding in patients with haemophilia B
(congenital factor IX
deficiency).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
page 2/11
_octanine-spc-clean_copy-minor_changes-1.2017_
_ _
Treatment should be initiated under