Kraj: Malezja
Język: angielski
Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TRAMADOL HYDROCHLORIDE
KOMEDIC SDN BHD
TRAMADOL HYDROCHLORIDE
500 Capsule Capsules; 100 Capsule Capsules
MEDOCHEMIE LTD
1 PACKAGE INSERT – MABRON 1. NAME OF THE MEDICINAL PRODUCT MABRON 50mg, capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 50mg tramadol hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Yellow/ dark green, size number 4, hard gelatin capsule. For oral administration. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Severe acute to chronic pain 4.2. POSOLOGY AND METHOD OF ADMINISTRATION The dosage should be adjusted to the intensity of the pain. Unless otherwise prescribed, Tramadol HCL should be taken as follows - independent of meals: Single dose for adults and adolescents over 14 years of age: 1 capsule to be taken with little liquid. This is usually sufficient to relieve the pain. If however, pain relief is unsatisfactory a further Tramadol HCL capsule may be taken after about 30 -60 minutes. In general the daily dose should not exceed 400 mg Tramadol HCL. _Adults and adolescents (12 years and older) _ MABRON is not approved for use in patients below 12 years old_ _ _ _ _ _ _Paediatric population _ The safety and efficacy of MABRON has not been studied in the paediatric population. Therefore, use of MABRON is not recommended in patients under 12 years of age. In impaired renal or hepatic function it may be necessary to adjust the dose. _ _ Method of administration The capsules are to be taken whole, not divided or chewed, with sufficient liquid, with or without food Duration of administration Tramadol should under no circumstances be administered for longer than absolutely necessary. If long-term pain treatment with tramadol is necessary in view of the nature and severity of the illness, then careful and regular monitoring should be carried out (if necessary with breaks in treatment) to establish whether and to what extent further treatment is necessary. 4.3. CONTRAINDICATIONS MABRON is contraindicated: in hypersensitivity to the active substance or any of the excipients listed in section 6.1 in acute intoxication with a Przeczytaj cały dokument