Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
TRAMADOL HYDROCHLORIDE
Grünenthal Ltd
N02AX02
TRAMADOL HYDROCHLORIDE
100mg/2ml Mg/Ml
Solution for Injection
Product subject to prescription which may be renewed (B)
Other opioids
Authorised
2004-12-22
ie-pl-solution-for-injection-clean Jul 2015 Details: Type IAin – change to HPRA from IMB Page 1 1 _INFORMATION FOR THE HEALTH PROFESSIONAL_ ZYDOL ® 100 MG / 2 ML SOLUTION FOR INJECTION TRAMADOL HYDROCHLORIDE _NAME OF THE MEDICINAL PRODUCT _ ZYDOL 100 mg / 2 ml Solution for Injection _QUALITATIVE AND QUANTITATIVE COMPOSITION _ Each ZYDOL 100 mg / 2 ml Solution for injection ampoule contains 100 mg tramadol hydrochloride in 2 ml solution, i.e. 50 mg tramadol hydrochloride per ml. Excipient with known effect: 1 ml of solution for injection contains 0.7 mg sodium. _ _ _PHARMACEUTICAL FORM _ Solution for injection or infusion Clear, colourless, aqueous solution. _ _ _CLINICAL PARTICULARS _ THERAPEUTIC INDICATIONS Treatment of moderate to severe pain. POSOLOGY AND METHOD OF ADMINISTRATION The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected. The total daily dose of 400 mg tramadol hydrochloride should not be exceeded, except in special clinical circumstances. Unless otherwise prescribed, ZYDOL should be administered as follows: Adults and adolescents above the age of 12 years The usual dose is 50 or 100mg 4-6 hourly. Intravenous injections must be given slowly over 2-3 minutes. For post-operative pain administer an initial bolus of 100mg. During the 60 minutes following the initial bolus, further doses of 50mg may be given every 10-20 minutes, up to a total dose of 250mg including the initial bolus. Subsequent doses should be 50mg-100mg 4-6 hourly up to a total daily dose of 400mg. Children above the age of 1 year The recommended single dose of tramadol is 1-2 mg/kg bod Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ZYDOL 100 mg / 2 ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ZYDOL 100 mg / 2 ml Solution for injection ampoule contains 100 mg tramadol hydrochloride in 2 ml solution, i.e. 50 mg tramadol hydrochloride per ml. Excipient with known effect: 1 ml of solution for injection contains 0.7 mg sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection or infusion. Clear colourless, aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of moderate to severe pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected. The total daily dose of 400 mg tramadol hydrochloride should not be exceeded, except in special clinical circumstances. Unless otherwise prescribed, ZYDOL should be administered as follows: Adults and adolescents above the age of 12 years The usual dosage is 50 or 100 mg 4-6 hourly (see section 5.1). Intravenous injections must be given slowly over 2-3 minutes. For post-operative pain, administer an initial bolus of 100 mg. During the 60 minutes following the initial bolus, further doses of 50mg may be given every 10-20 minutes, up to a total dose of 250mg including the initial bolus. Subsequent doses should be 50mg-100mg 4-6 hourly up to a total daily dose of 400mg. Children above the age of 1 year The recommended single dose of tramadol hydrochloride is 1 mg/kg to 2 mg/kg body weight. The total daily dose of 8 mg tramadol hydrochloride per kg body weight or 400 mg tramadol hydrochloride, whichever is lower, should not be exceede Lue koko asiakirja