국가: 남아프리카
언어: 영어
출처: South African Health Products Regulatory Authority (SAHPRA)
Pharmacare Limited û Woodmead
See ingredients
INJECTION
EACH 0,8 ml SOLUTION CONTAINS NADROPARIN CALCIUM 7600 iu axa
Registered
2000-10-10
_ _ _ _ _ _ _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 전체 문서 읽기