Maa: Israel
Kieli: englanti
Lähde: Ministry of Health
TRAMADOL HYDROCHLORIDE
DEVRIES & CO. LTD
N02AX02
SOLUTION FOR INJECTION / INFUSION
TRAMADOL HYDROCHLORIDE 50 MG / 1 ML
S.C, I.M, I.V
Required
MEDOCHEMIE LTD, CYPRUS
TRAMADOL
Moderate to severe pain
2019-06-17
TRAMADOL MEDOCHEMIE 100 MG/2 ML 1. NAME OF THE MEDICINAL PRODUCT Tramadol Medochemie 100 mg/2 ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Tramadol Medochemie 100 mg/2 ml ampoule contains 100 mg tramadol hydrochloride in 2 ml aqueous solution. Excipient with known effect: This medicine contains less than 1 mmol sodium (23 mg) per 2 ml, that is to say essentially ‘sodium-free’. For the full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Solution for injection or infusion. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Moderate to severe pain 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with tramadol in order to minimise the risk of addiction and drug withdrawal syndrome (see section 4.4). The injection is for parenteral administration either intramuscularly, by slow intravenous injection or, when diluted in solution, by infusion or patient-controlled analgesia. As with all analgesic drugs the dosing of Tramadol Medochemie 100 mg/2 ml should be adjusted depending on the severity of the pain and the individual clinical response of the patient. _ _ _Adults:_ A single dose of 50 or 100 mg 4-6 hourly (1 or 2 ml of Tramadol Medochemie 100 mg/2 ml) is usually required. Intravenous injections must be given slowly over 2-3 minutes. In severe (post-operative) pain, an initial bolus of 100 mg is administered 10-20 minutes up to a total dose of 250 mg including the initial bolus. Subsequent doses should be 50 or 100 mg administered 4-6 hourly. If the administration of Tramadol Medochemie 100 mg/2 ml has been forgotten, the pain may return. The dose should not be doubled. Administration should be continued as before. A total daily dose of 400 mg should not be exceeded except in special clinical circumstances. Tramadol Medochemie 100 mg/2 ml is injected into the veins (usually into a blood vessel under the surface of the arm), muscles (usually the buttocks) or under the sk Lue koko asiakirja