Nonafact

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

human coagulation factor IX

Available from:

Sanquin Plasma Products B.V.

ATC code:

B02BD04

INN (International Name):

human coagulation factor IX

Therapeutic group:

Antihemorrhagics

Therapeutic area:

Hemophilia B

Therapeutic indications:

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

Product summary:

Revision: 9

Authorization status:

Withdrawn

Authorization date:

2001-07-03

Patient Information leaflet

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
Medicinal product no longer authorised
1.
NAME OF THE MEDICINAL PRODUCT
Nonafact 100 IU/ml powder and solvent for solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nonafact contains 100 IU/ml (500 IU/5ml or 1000 IU/10ml) human
coagulation factor IX when
reconstituted with 5 m
l or 10 ml, respectively, of water for injections.
Each vial contains 500 IU or 1000 IU of human coagulation factor IX.
The potency (IU) is determined using a method equivalent to the test
method described in the
European Pha
rmacopoeia. The specific activity of Nonafact is at least 200 IU/mg
protein.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection. White powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prophylaxis of bleeding in patients with haem
ophilia B (congenital factor IX
deficiency).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
Treatment should be initiated under the supervision of
a physician experienced in the treatment of
haemophilia.
The dose and the duration of substitution therapy depend on the
severity
of the factor IX deficiency.
Other determining factors are the site and extent of the haemorrhage
and the patient’s clinical
condition.
The number of units of factor IX administered is expressed in
International Units (IU), which are
related to the current International Standard for factor IX concentrat
e as approved by the WHO. Factor
IX activity in plasma is expressed either as a percentage (relative to
normal human plasma) or in
International Units (relative to an international standard for factor
IX in plasma).
One International Unit (IU) of factor IX activity is rel
ated to the quantity of factor IX in the
International Standard for factor II, VII, IX and X in human plasma
(approved by the WHO) which
approximates to the quantity of factor IX in one ml of normal human
plasma. The calculation of the
required dosage of factor IX is based on the empirical findin

Summary of Product characteristics

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
Medicinal product no longer authorised
1.
NAME OF THE MEDICINAL PRODUCT
Nonafact 100 IU/ml powder and solvent for solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nonafact contains 100 IU/ml (500 IU/5ml or 1000 IU/10ml) human
coagulation factor IX when
reconstituted with 5 m
l or 10 ml, respectively, of water for injections.
Each vial contains 500 IU or 1000 IU of human coagulation factor IX.
The potency (IU) is determined using a method equivalent to the test
method described in the
European Pha
rmacopoeia. The specific activity of Nonafact is at least 200 IU/mg
protein.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection. White powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prophylaxis of bleeding in patients with haem
ophilia B (congenital factor IX
deficiency).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
Treatment should be initiated under the supervision of
a physician experienced in the treatment of
haemophilia.
The dose and the duration of substitution therapy depend on the
severity
of the factor IX deficiency.
Other determining factors are the site and extent of the haemorrhage
and the patient’s clinical
condition.
The number of units of factor IX administered is expressed in
International Units (IU), which are
related to the current International Standard for factor IX concentrat
e as approved by the WHO. Factor
IX activity in plasma is expressed either as a percentage (relative to
normal human plasma) or in
International Units (relative to an international standard for factor
IX in plasma).
One International Unit (IU) of factor IX activity is rel
ated to the quantity of factor IX in the
International Standard for factor II, VII, IX and X in human plasma
(approved by the WHO) which
approximates to the quantity of factor IX in one ml of normal human
plasma. The calculation of the
required dosage of factor IX is based on the empirical findin