국가: 남아프리카
언어: 영어
출처: South African Health Products Regulatory Authority (SAHPRA)
Fresenius Kabi Manufacturing SA (Pty) Ltd
See ingredients
INJECTION
EACH 2 ml VIAL CONTAINS AMIKACIN SULPHATE EQUIVALENT TO 100 mg AMIKACIN
Registered
1993-02-06
Page 1 of 5 APPROVED PATIENT INFORMATION LEAFLET SCHEDULING STATUS S4 PROPRIETARY NAMES AND DOSAGE FORM AMIKACIN FRESENIUS 50 MG/2 ML Injection AMIKACIN FRESENIUS 100 MG/2 ML Injection AMIKACIN FRESENIUS 250 MG/2 ML Injection AMIKACIN FRESENIUS 500 MG/2 ML Injection AMIKACIN FRESENIUS 1 G/4 ML Injection READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN AMIKACIN FRESENIUS. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or your pharmacist. AMIKACIN FRESENIUS has been prescribed for you personally and you should not share your medicine with other people. It may harm them even if their symptoms are the same as yours. WHAT AMIKACIN FRESENIUS CONTAINS The active substance is amikacin. EACH SINGLE DOSE 2 ML VIAL CONTAINS: 50 mg, 100 mg, 250 mg or 500 mg amikacin (as amikacin sulphate) _THE OTHER INGREDIENTS ARE: _ Antioxidant: sodium metabisulphite - 0,1 % _m/v_, 0,13 % _m/v,_ 0,33 % _m/v_ and 0,66 % _m/v_ respectively. Water for injection. Page 2 of 5 EACH SINGLE DOSE 4 ML SOLUTION (IN A 5 ML VIAL) CONTAINS: 1 g amikacin (as amikacin sulphate) _THE OTHER INGREDIENTS ARE: _ Antioxidant: sodium metabisulphite - 0,66 % _m/v_ Water for injection. WHAT AMIKACIN FRESENIUS IS USED FOR AMIKACIN FRESENIUS is used for treatment of infections caused by hospital acquired organisms that are resistant to other antibiotics. BEFORE YOU RECEIVE AMIKACIN FRESENIUS YOU SHOULD NOT BE GIVEN AMIKACIN FRESENIUS: if you are sensitive or allergic to amikacin or aminoglycosides or other ingredients of AMIKACIN FRESENIUS if you are pregnant or breastfeeding if you have myasthenia gravis (muscle weakness) if you have kidney impairment if you have a hearing problem TAKE SPECIAL CARE WITH AMIKACIN FRESENIUS: if you have a history of allergy if you have partial hearing loss PREGNANCY AND BREASTFEEDING: Do not receive AMIKACIN FRESENIUS if you are pregnant or breast feeding. Page 3 of 5 If you are pregnant or breastfeeding you baby please consult yo 전체 문서 읽기
Page 1 of 10 APPROVED PACKAGE INSERT FOR AMIKACIN FRESENIUS SCHEDULING STATUS S4 PROPRIETARY NAMES AND DOSAGE FORM AMIKACIN FRESENIUS 50 MG/2 ML AMIKACIN FRESENIUS 100 MG/2 ML AMIKACIN FRESENIUS 250 MG/2 ML AMIKACIN FRESENIUS 500 MG/2 ML AMIKACIN FRESENIUS 1 G/4 ML Injection COMPOSITION EACH SINGLE DOSE 2 ML VIAL CONTAINS: 50 mg, 100 mg, 250 mg or 500 mg amikacin (as amikacin sulphate) _INACTIVE INGREDIENTS: _ Antioxidant: sodium metabisulphite - 0,1 % _m/v_, 0,13 % _m/v_, 0,33 % _m/v_ and 0,66 % _m/v_ respectively. Water for injections. EACH SINGLE DOSE 4 ML SOLUTION (IN A 5 ML VIAL) CONTAINS: 1 g amikacin (as amikacin sulphate) _INACTIVE INGREDIENTS: _ Antioxidant: sodium metabisulphite - 0,66 % _m/v _ Water for injections. PHARMACOLOGICAL CLASSIFICATION A.20.1.1 Broad and medium spectrum antibiotics. Page 2 of 10 PHARMACOLOGICAL ACTION PHARMACODYNAMIC PROPERTIES Amikacin is a semisynthetic aminoglycoside, with a broad antimicrobial activity and exhibits resistance to aminoglycoside-inactivating enzymes. PHARMACOKINETIC PROPERTIES It is a bactericidal and is minimally protein bound. It is largely excluded from most cells, from the central nervous system and eye. Penetration into respiratory secretions is poor. Diffusion into pleural and synovial fluid is relatively slow, but concentrations that approximate those in the plasma may be achieved after repeated administration. High concentrations are found in the renal cortex and in the endolymph and perilymph of the inner ear. Inflammation increases its penetration into peritoneal and pericardial cavities. Inadequate concentrations for the treatment of meningitis are achieved in the cerebrospinal fluid in adults. Elimination of amikacin is almost entirely by glomerular filtration. Amikacin has a half-life of 2 - 3 hours, most of the dose being excreted within 24 hours. Amikacin is effective _ in vitro_ against many species of gram-negative bacteria including species of: _Citrobacter, Escherichia, Enterobacter,_ _Klebsiella, Proteus, Providencia, Pseudomonas_ and _S 전체 문서 읽기