Pajjiż: Iżrael
Lingwa: Ingliż
Sors: Ministry of Health
TRIENTINE DIHYDROCHLORIDE
RAZ PHARMACEUTICS LTD, ISRAEL
A16AX12
CAPSULES
TRIENTINE DIHYDROCHLORIDE 250 MG
PER OS
Required
TILLOMED LABORATORIES LIMITED, UK
TRIENTINE
For the treatment of Wilson’s disease in patient's intolerant of D-Penicillaminetherapy, in adults, adolescents and children aged 5 years or older.
2022-07-26
SUMMARY OF PRODUCT CHARACTERISTICS 1. Name of the medicinal product TRIENTINE RAZ 250mg 2. Qualitative and quantitative composition Each hard capsule contains 167 mg trientine, equivalent to 250 mg trientine dihydrochloride. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Capsule, hard. Brown opaque hard gelatin Size 1 capsule imprinted with "HP551" in black ink on the capsule body and cap, filled with white to pale yellow powder. 4. Clinical particulars 4.1 Therapeutic indications For the treatment of Wilson's disease in patient's intolerant of D-Penicillamine therapy, in adults, adolescents and children aged 5 years or older. 4.2 Posology and method of administration Treatment should only be initiated by specialist physicians with experience in the management of Wilson's disease. Posology: The starting dose would usually correspond to the lowest dose in the range and the dose should subsequently be adapted according to the patient's clinical response (see section 4.4). Adults (including elderly): 1.0 -2.0 grams (4-8 capsules) daily in 2 to 4 divided doses. The recommended doses are expressed as grams or mg of the trientine dihydrochloride salt. Special populations _Elderly_ No dose adjustment is required in elderly patients. _Renal impairment_ There is limited information in patients with renal impairment. No specific dose adjustment is required in these patients (see section 4.4). _Hepatic impairment_ There is no data available for the use of trientine in patients with impaired liver function. However, monitoring may be necessary to avoid either toxicity or inefficacy (see section 4.4). Paediatric population The starting dose in paediatrics is lower than for adults and depends on age and body weight. _Children≥ 5 years:_ The weight-based dose is not established, but the initial dose generally used is 20 mg/kg/day rounded off to the nearest 250 mg capsule of trientine dihydrochloride given in two – three divided doses. The recommended initial dose of trientine dihydrochloride capsul Aqra d-dokument sħiħ