TRIENTINE RAZ 250 MG

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

TRIENTINE DIHYDROCHLORIDE

Disponibil de la:

RAZ PHARMACEUTICS LTD, ISRAEL

Codul ATC:

A16AX12

Forma farmaceutică:

CAPSULES

Compoziție:

TRIENTINE DIHYDROCHLORIDE 250 MG

Calea de administrare:

PER OS

Tip de prescriptie medicala:

Required

Produs de:

TILLOMED LABORATORIES LIMITED, UK

Zonă Terapeutică:

TRIENTINE

Indicații terapeutice:

For the treatment of Wilson’s disease in patient's intolerant of D-Penicillaminetherapy, in adults, adolescents and children aged 5 years or older.

Data de autorizare:

2022-07-26

Caracteristicilor produsului

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