FRAXIPARINE 0,3 ml INJECTION

País: República de Sud-àfrica

Idioma: anglès

Font: South African Health Products Regulatory Authority (SAHPRA)

Disponible des:

Pharmacare Limited û Woodmead

Dosis:

See ingredients

formulario farmacéutico:

INJECTION

Composición:

EACH 0,3 ml SOLUTION CONTAINS NADROPARIN CALCIUM 2850,0 iu axa

Estat d'Autorització:

Registered

Data d'autorització:

2000-10-10

Fitxa tècnica

_ _
_ _
_ _
_ZA_FRAXINJ_0207_02 _
_ _
_ _
_ _
_ _
_ _
_ _
_ Page 1 of 15 _
1.3.1.1
PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE
SCHEDULING STATUS
S4
PROPRIETARY NAME AND DOSAGE FORM
FRAXIPARINE 0,2 ML (solution for injection)
FRAXIPARINE 0,3 ML (solution for injection)
FRAXIPARINE
0,4 ML (solution for injection)
FRAXIPARINE 0,6 ML (solution for injection)
FRAXIPARINE 0,8 ML (solution for injection)
FRAXIPARINE 1,0 ML (solution for injection)
_ _
COMPOSITION
FRAXIPARINE is a sterile clear preservative-free solution for
subcutaneous injection.
Each 0,2 ml of FRAXIPARINE 0,2 ml contains nadroparin calcium 1 900 IU
AXa.
_Excipient: _
Water for injection
Sugar free
Each 0,3 ml of FRAXIPARINE 0,3 ml contains nadroparin calcium 2 850 IU
AXa.
_Excipient: _
Water for injection
Sugar free
Each 0,4 ml of FRAXIPARINE 0,4 ml contains nadroparin calcium 3 800 IU
AXa.
_ _
_ _
_ _
_ZA_FRAXINJ_0207_02 _
_ _
_ _
_ _
_ _
_ _
_ _
_ Page 2 of 15 _
_Excipient: _
Water for injection
Sugar free
Each 0,6 ml of FRAXIPARINE 0,6 ml contains nadroparin calcium 5 700 IU
AXa.
_Excipient: _
Water for injection
Sugar free
Each 0,8 ml of FRAXIPARINE 0,8 ml contains nadroparin calcium 7 600 IU
AXa.
_Excipient: _
Water for injection
Sugar free
Each 1,0 ml of FRAXIPARINE 1,0 ml contains nadroparin calcium 9 500 IU
AXa.
_Excipient: _
Water for injection
Sugar free
CATEGORY AND CLASS
A 8.2 Anticoagulants
PHARMACOLOGICAL ACTION
PHARMACODYNAMIC PROPERTIES
Nadroparin calcium is a low molecular weight heparin manufactured by
depolymerisation of
standard heparin. It is a glycosaminoglycan with a mean molecular
weight of approximately
4 500 daltons. It is derived from porcine heparin.
_ _
_ _
_ _
_ZA_FRAXINJ_0207_02 _
_ _
_ _
_ _
_ _
_ _
_ _
_ Page 3 of 15 _
Nadroparin calcium has antithrombotic activity.
PHARMACOKINETIC PROPERTIES
The excretion is principally renal and in patients with impaired renal
function, a reduced
dosage should be considered as elimination of AXa activity is
prolonged in such patients.
AXa denotes anti-factor Xa activity (in