Apo-Clomipramine

Страна: Новая Зеландия

Язык: английский

Источник: Medsafe (Medicines Safety Authority)

Активный ингредиент:

Clomipramine hydrochloride 10mg;  ;  

Доступна с:

Apotex NZ Ltd

ИНН (Международная Имя):

Clomipramine hydrochloride 10 mg

дозировка:

10 mg

Фармацевтическая форма:

Film coated tablet

состав:

Active: Clomipramine hydrochloride 10mg     Excipient: Carnauba wax Colloidal silicon dioxide Croscarmellose sodium Hypromellose Iron oxide yellow Lactose monohydrate Macrogol 3350 Magnesium stearate Microcrystalline cellulose Purified water Titanium dioxide

Штук в упаковке:

Blister pack, PVC/PVdC/Aluminium, 30 tablets

класс:

Prescription

Тип рецепта:

Prescription

Производитель:

Lundbeck Pharmaceuticals Italy SpA

Терапевтические показания :

The treatment of depressive states (in adults only) including endogenous, reactive, neurotic, organic, masked and involutional forms of depression, depression associated with schizophrenia and personality disorders, depressive syndromes due to presenility or senility, chronic painful conditions, and chronic somatic diseases, and depressive mood disorders of a reactive, neurotic or psychopathic nature. Chronic painful conditions

Обзор продуктов:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC/Aluminium - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVdC/Aluminium - 60 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVdC/Aluminium - 100 tablets - 36 months from date of manufacture stored at or below 25°C

Дата Авторизация:

2008-05-21

Характеристики продукта

NEW ZEALAND DATA SHEET
APO-CLOMIPRAMINE
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 1 of 14
1.
APO-CLOMIPRAMINE (10MG AND 25MG FILM COATED TABLETS)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
NAME AND STRENGTH OF THE ACTIVE SUBSTANCE
Clomipramine Hydrochloride (10mg)
Clomipramine Hydrochloride (25mg)
Excipient with known effect
Lactose
Apo-Clomipramine contains Lactose. If you have been told by your
doctor that you have an
intolerance to some sugars, contact your doctor before taking this
medicinal product.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
APO-CLOMIPRAMINE 10mg tablets are triangular, pale yellow, film-coated
biconvex tablets,
and engraved “10” on one side and “CP” on the other side. Each
tablet typically weighs 31mg
and contains 10mg Clomipramine hydrochloride.
APO-CLOMIPRAMINE 25mg tablets are round, pale yellow, film-coated
biconvex tablets, and
engraved
“25”
on
one
side.
Each
tablet
typically
weighs
78mg
and
contains
25mg
Clomipramine hydrochloride.
Do not halve tablet. Dose equivalence when the tablet is divided has
not been established.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The treatment of depressive states (in adults only) including
endogenous, reactive, neurotic,
organic,
masked
and
involutional
forms
of
depression,
depression
associated
with
schizophrenia and personality disorders, depressive syndromes due to
presenility or senility,
chronic painful conditions, and chronic somatic diseases, and
depressive mood disorders of a
reactive, neurotic or psychopathic nature.
Obsessive-compulsive syndromes
Phobias and panic attacks.
Cataplexy accompanying narcolepsy
Chronic painful conditions
4.2 DOSE AND METHOD OF ADMINISTRATION
The dosage and method of administration should be adapted to the
individual patient's
condition. The aim is to achieve an optimum effect while keeping the
doses as low as possible
and increasing them cautiously, particularly in elderly patients, who
generally show a stronger
resp