Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
trientine dihydrochloride, Quantity: 250 mg
Dr Reddys Laboratories Australia Pty Ltd
Capsule
Excipient Ingredients: titanium dioxide; magnesium stearate; purified water; Gelatin; iron oxide yellow; macrogol 3350; colloidal anhydrous silica
Oral
100
(S4) Prescription Only Medicine
Trientine dihydrochloride capsules are indicated for the treatment of patients with Wilson's disease who are intolerant of penicillamine.
Visual Identification: Yellow opaque, hard gelatin size 1 capsules imprinted with RDY on cap and 459 on body in black ink filled with white to pale yellow powder.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2021-03-29
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_Version 29 March 2021 _ 1 ▼ This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems. AUSTRALIAN PRODUCT INFORMATION – TRIENTINE DR.REDDY’S (TRIENTINE DIHYDROCHLORIDE) CAPSULES 1 NAME OF THE MEDICINE Trientine dihydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Capsules containing 250 mg of trientine dihydrochloride, equivalent to 167 mg trientine base . Capsules also contain gelatin. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM TRIENTINE DR.REDDY’S, trientine dihydrochloride capsules, 250 mg, are yellow opaque, hard gelatin size “1” capsules imprinted with “RDY” on cap and “459” on body in black ink filled with white to pale yellow powder. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Trientine dihydrochloride capsules are indicated for the treatment of patients with Wilson's disease who are intolerant of penicillamine. 4.2 D OSE AND METHOD OF ADMINISTRATION Systematic evaluation of dose and/or interval between dose has not been done. However, based on clinical experience, the recommended initial doses of trientine dihydrochloride capsules are given below. The doses are expressed in terms of trientine dihydrochloride and the equivalent dose of trientine free base. It should be noted that a dose of 250mg trientine dihydrochloride corresponds to a dose of 167mg trientine free base. This should be considered if a patient is transferred from one trientine formulation to another. _CHILDREN > 5 YEARS _ _ _ 500 to 750 mg trientine dihydrochloride /day (2 to 3 capsules) given in divided doses two or three times daily. This may be increased to a maximum of 1,500 mg/day for children aged > 5 years. The paediatric dosage _in terms of trientine free base _is 333 to 500 mg/day to a maximum of 1000mg/day. The initial dose for children > 5 years can be expresse Lesen Sie das vollständige Dokument