Ambrisentan

Страна: Нова Зеландія

мова: англійська

Джерело: Medsafe (Medicines Safety Authority)

Активний інгредієнт:

Ambrisentan 5mg

Доступна з:

Devatis Limited

Дозування:

5 mg

Фармацевтична форма:

Film coated tablet

Склад:

Active: Ambrisentan 5mg Excipient: Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry pink 85G540056

Тип рецепту:

Prescription

Терапевтичні свідчення:

Indicated for the treatment of: - idiopathic pulmonary arterial hypertension (PAH), - pulmonary arterial hypertension associated with connective tissue disease (PAH-CTD), in patients with WHO functional class II, III or IV symptoms.

Огляд продуктів:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al blister - 30 tablets - 36 months from date of manufacture stored at or below 30°C

Дата Авторизація:

2017-11-21

Характеристики продукта

AMBRISENTAN 5 & 10 MG FILM COATED TABLETS
MODULE 1.3.1 NEW ZEALAND DATA SHEET
DEVATIS LIMITED Property-Strictly confidential
Page 1 / 17
Version: NZ-V02/August 2021
TERATOGENICITY
AMBRISENTAN MAY CAUSE BIRTH DEFECTS AND IS CONTRAINDICATED IN
PREGNANCY (SEE CONTRAINDICATIONS).
1. PRODUCT NAME
Ambrisentan 5 & 10 mg Film Coated Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each 5 mg tablet contains 5 mg Ambrisentan
Each 10 mg tablet contains 10 mg Ambrisentan
EXCIPIENT WITH KNOWN EFFECT:
_5 mg film-coated tablets _
Each tablet contains approximately 70.72 mg of lactose (as
monohydrate), approximately 0.105 mg of lecithin
and approximately 0.04 mg of Allura red AC Aluminum Lake (E129).
_ _
_10 mg film-coated tablets _
Each tablet contains approximately 141.44 mg of lactose (as
monohydrate), approximately 0.21 mg of lecithin
and approximately 0.35 mg of Allura red AC Aluminum Lake (E129).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
_5 mg film-coated tablets_: Pale-pink, square, 6×6 mm wide, biconvex
film-coated tablets.
_10 mg film-coated tablets: _Dark-pink, oval, 6.6×10 mm wide,
biconvex film-coated tablets.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ambrisentan
is indicated in adults aged ≥18 years for the treatment of:

idiopathic pulmonary arterial hypertension (iPAH),

pulmonary arterial hypertension associated with connective tissue
disease (PAH-CTD),
in patients with WHO functional class II, III or IV symptoms.
4.2 DOSE AND METHOD OF ADMINISTRATION
POSOLOGY/DURATION AND FREQUENCY OF ADMINISTRATION
Treatment should only be initiated by a physician experienced in the
treatment of PAH.
Ambrisentan should be taken orally at a dose of 5 mg once daily.
Additional benefit may be obtained by
increasing the dose to 10 mg (see section 4.8 and 5.1).
Limited data suggest that the abrupt discontinuation of Ambrisentan is
not associated with rebound worsening
of PAH.
USE WITH CYCLOSPORIN A
When co-administered with cyclosporine A, th