Страна: Ізраїль
мова: англійська
Джерело: Ministry of Health
METRONIDAZOLE
LAPIDOT MEDICAL IMPORT AND MARKETING LTD
J01XD01
SOLUTION FOR INFUSION
METRONIDAZOLE 500 MG / 100 ML
I.V
Required
B.BRAUN MELSUNGEN AG, GERMANY
METRONIDAZOLE
METRONIDAZOLE
Treatment and prophylaxis of infection which are or may be due to anerobic bacteria,especially Bacteriodes species,including Bacteriodes fragilis, Fusobacterium,Eurobacterium and Clostridium species.
2020-10-31
24.11.2020 ,ה/דבכנ ת/חקור ה/אפור אפורל ןולעב ןוכדע לע ךעידוהל וננוצרב METRONIDAZOLE B. BRAUN, SOLUTION FOR INJECTION : ליעפ רמוח METRONIDAZOLE B. BRAUN 500 MG / 100 ML טסקט ,הרמחה ותועמשמ בוהצ ןמוסמ טסקט, ןוכדע ותועמשמ קורי ןמוסמ טסקט( אפורל ןולעב םינוכדע ןלהל :)הקיחמ ותועמשמ 4.3 CONTRAINDICATIONS In patients with prior history of hypersensitivity to Metronidazole or other nitroimidazole derivatives. During the first trimester of pregnancy in patients with trichomoniasis. Hypersensitivity to metronidazole or other nitroimidazole derivatives or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE _Warnings _ Convulsive Seizures and Peripheral Neuropathy: Convulsive seizures and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity, have been reported in patients treated with metronidazole. The appearance of abnormal neurologic signs demands the prompt evaluation of the benefit / risk ratio of the continuation of therapy. _Precautions _ In case of organic diseases of the C.N.S. and blood dyscrasia such as granulocytopenia, metronidazole should be used with necessary caution. Metronidazole interferes with the spectrophotometric determination of SGOT, SGPT, LDH resulting in decreased values. In patients with severe hepatic disease, who metabolize metronidazole slowly, doses below those usually recommended should be administered cautiously _Side effects _ A serious adverse reaction: convulsive seizures. 2 Very seldom may occur: G.I. upset (nausea, vomiting, epigastric distress, diarrhea). Burning sensation in the tongue, metallic taste, overgrowth of Candida, rash, urticaria. Central disorders (headache, dizziness, somnolence, in coordination, depressions). Drug fever. Thrombophlebitis. Darkened urine. Mild leucopenia may occur. Thus regular blood count is required. Peripheral neuropathy has been Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Metronidazole B.Braun 500 MG / 100 ML 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml of solution contains 5 mg of metronidazole 100 ml of solution contain 500 mg of metronidazole _EXCIPIENT WITH KNOWN EFFECT : _ 1 ml solution contains Sodium chloride 7.4 mg Disodium phosphate dodecahydrate 1.5 mg _ELECTROLYTE CONTENT (PER 100 ML): _ Sodium 14 mmol Chloride 13 mmol This medicinal product contains 14 mmol (or 322 mg) sodium per 100 ml. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion Clear, colourless up to faintly, straw- coloured solution, practically free from particles 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment and prophylaxis of infection which are or may be due to anerobic bacteria,especially Bacteriodes species,including Bacteriodes fragilis, Fusobacterium,Eurobacterium and Clostridium species . The treatment is effective in cases of: • Infections of the C.N.S (e.g. brain abscess, meningitis), • Infections of the lung and pleura (e.g. necrotizing pneumonia, aspiration pneumonia, lung abscess), • Endocarditis, • After operations (e.g. recto-colonic surgery) and infections of the G.I. tract, • Suppurating diseases in the abdominal and pelvic area (peritonitis, liver abscess, endometritis), • Gynaecologic infections (e.g. hysterectomy, caesarian section, childbed fever, septic abortus), • Osteomyelitis, • Septicaemia in thrombophlebitis, • Severe form of intestinal and hepatic amoebiasis. A prophylactic use is always indicated in operations with a high risk of anaerobic infections (gynaecologic and intra-abdominal operations). 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology Unless otherwise directed the following dosage guidelines are recommended: ADULTS AND CHILDREN OVER 12 YEARS: Maintenance dose: Approximately 7.5 mg Metronidazole/kg body weight over one hour every 8 hours, corresponding to 100 ml (500 mg) Metronidazole injection for a 70 Kg adult. L Прочитайте повний документ