Страна: Нова Зеландия
Език: английски
Източник: Medsafe (Medicines Safety Authority)
Trientine dihydrochloride 250mg
Clinect NZ Pty Limited
250 mg
Capsule
Active: Trientine dihydrochloride 250mg Excipient: Gelatin Stearic acid Sunset yellow FCF TekPrint black SW-9008 Titanium dioxide Water
Prescription
Trientine Waymade is indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine.
Package - Contents - Shelf Life: Bottle, plastic, 150 cc HDPE with screw cap - 100 capsules - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 60 days opened stored at or below 30°C
2020-03-06
Trientine Waymade 1 TRIENTINE WAYMADE CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. This medicine is new. Please report side effects. See the full CMI for further details. 1. WHY AM I USING TRIENTINE WAYMADE? Trientine Waymade contains the active ingredient trientine dihydrochloride. Trientine Waymade is used to treat Wilson’s disease in people who can not take another medicine called penicillamine because of side effects. For more information, see Section 1. Why am I using Trientine Waymade? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE TRIENTINE WAYMADE? Do not use if you have ever had an allergic reaction to trientine dihydrochloride or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Trientine Waymade? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Trientine Waymade and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE TRIENTINE WAYMADE? • Always take this medicine exactly as your doctor or pharmacist has told you. • Adults: The usual dose is between 3 and 5 capsules per day in divided doses. • Children: The dose will depend on age and weight. • The capsules should be swallowed whole with water and should not be opened or chewed. • The capsules should be taken on an empty stomach, at least one hour before meals or two hours after meals. The capsules should be taken at least one hour apart from any other medicine, food, or milk. More instructions can be found in Section 4. How do I use Trientine Waymade? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING TRIENTINE WAYMADE? THINGS YOU SHOULD DO • Remind any doctor, Прочетете целия документ
Trientine dihydrochloride Data Sheet 19 September 2023 1 NEW ZEALAND DATA SHEET 1 TRIENTINE WAYMADE 250MG CAPSULES Trientine Waymade 250 mg oral capsules. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 250 mg trientine dihydrochloride. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Cylindrical size “1” hard gelatin capsule with opaque orange colour cap printed with “NAV” in black ink and opaque white colour body printed with “101” in black ink. Capsule filled with white to off white colour powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Trientine Waymade is indicated in the treatment of patients with Wilson’s disease who are intolerant of penicillamine. 4.2 DOSE AND METHOD OF ADMINISTRATION _DOSE _ ADULTS AND CHILDREN The starting dose would usually correspond to the lowest recommended dose and the dose should subsequently be adapted according to the patient’s clinical response (see section 4.4 Special Warnings and Precautions for Use). The recommended initial dose of Trientine Waymade is 500 -750 mg/day for paediatric patients and 750 -1250 mg/day for adults given in divided doses two, three or four times daily. This maybe increased to a maximum of 2000 mg/day for adults or 1500 mg/day for paediatric patients age 12 or under. The daily dose of Trientine Waymade should be increased only when the clinical response is not adequate, or the concentration of free serum copper is persistently above 20 mcg/dL. Optimal long-term maintenance dosage should be determined at 6 to 12 month intervals. PATIENTS PRIMARILY PRESENTING HEPATIC SYMPTOMS The recommended dose in patients primarily presenting hepatic symptoms is the same as the recommended adult dose. It is advised, however, to monitor patients presenting with hepatic symptoms every two to three weeks after initiation of treatment with Trientine Waymade. PATIENTS PRIMARILY PRESENTING NEUROLOGICAL SYMPTOMS Dose recommendations are the same as for adults. However, up titration should Прочетете целия документ