VOLIBRIS ambrisentan 5mg tablet blister pack

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

ambrisentan, Quantity: 5 mg

Доступна с:

GlaxoSmithKline Australia Pty Ltd

ИНН (Международная Имя):

Ambrisentan

Фармацевтическая форма:

Tablet, film coated

состав:

Excipient Ingredients: croscarmellose sodium; magnesium stearate; microcrystalline cellulose; lactose monohydrate; titanium dioxide; purified talc; allura red AC aluminium lake; polyvinyl alcohol; macrogol 3350; lecithin

Администрация маршрут:

Oral

Штук в упаковке:

30 Tablets, 10 tablets

Тип рецепта:

(S4) Prescription Only Medicine

Терапевтические показания :

VOLIBRIS is 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. VOLIBRIS in combination with Tadalafil is indicated for the treatment of WHO Group 1 pulmonary arterial hypertension in patients with WHO functional class II, III or IV symptoms.

Обзор продуктов:

Visual Identification: Pale pink, square convex tablet engraved with 'GS' on one face and 'K2C' on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Статус Авторизация:

Licence status A

Дата Авторизация:

2008-11-24

тонкая брошюра

VOLIBRIS
_5 MG AND 10 MG FILM COATED TABLETS_
_Ambrisentan_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING
VOLIBRIS.
This leaflet answers some common
questions about VOLIBRIS. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking VOLIBRIS
against the benefits they expect it
will have for you.
IF YOU HAVE ANY QUESTIONS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT VOLIBRIS IS
USED FOR
VOLIBRIS contains the active
ingredient ambrisentan which is a
type of medicine called an endothelin
receptor antagonist (ERA). It is used
to treat adults with pulmonary
arterial hypertension (PAH), which is
high blood pressure in the blood
vessels (the pulmonary arteries) that
carry blood from the heart to the
lungs. In people with PAH, these
arteries get narrower, so the heart has
to work harder to pump blood
through them. This causes people to
become tired, dizzy and short of
breath. VOLIBRIS widens the
pulmonary arteries, making it easier
for your heart to pump blood through
them. This lowers the blood pressure
and relieves your symptoms.
VOLIBRIS is not recommended for
use in children as there have been no
studies of its effects in children.
VOLIBRIS must not be used for the
treatment of idiopathic pulmonary
fibrosis (IPF) and must not be used in
patients who have IPF with or
without secondary pulmonary
hypertension.
VOLIBRIS is available as 5 mg and
10 mg tablets.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
VOLIBRIS
DO NOT TAKE VOLIBRIS IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
ambrisentan
•
any of the ingredients listed at the
end of this leaflet
•
any other similar medicine.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or diffic

Характеристики продукта

1
AUSTRALIAN PRODUCT INFORMATION
VOLIBRIS (AMBRISENTAN) 5 MG AND 10 MG TABLETS
TERATOGENICITY
VOLIBRIS MAY CAUSE BIRTH DEFECTS AND IS CONTRAINDICATED IN PREGNANCY
(SEE SECTION 4.3
CONTRAINDICATIONS).
1
NAME OF THE MEDICINE
Ambrisentan
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Excipients with known effect:
Lactose monohydrate.
VOLIBRIS 5 mg and 10 mg film-coated tablets contain the excipients
microcrystalline
cellulose, lactose monohydrate, croscarmellose sodium, magnesium
stearate, polyvinyl
alcohol, purified talc, titanium dioxide, macrogol 3350 (PEG 3350),
lecithin USNF and Allura
Red AC Aluminum Lake (FD&C Red #40) (see section 4.4 SPECIAL WARNINGS
AND
PRECAUTIONS FOR USE, Excipients).
3
PHARMACEUTICAL FORM
Film-coated tablets
VOLIBRIS 5 mg tablets are pale pink, square convex tablet engraved
‘GS’ on one face and
‘K2C’ on the other.
VOLIBRIS 10 mg tablets are deep pink, oval convex tablet engraved 'GS'
on one face and
'KE3' on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VOLIBRIS is 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.
VOLIBRIS in combination with Tadalafil is indicated for the treatment
of WHO Group 1
pulmonary arterial hypertension in patients with WHO functional class
II, III or IV symptoms.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment should only be initiated by a physician experienced in the
treatment of PAH.
VOLIBRIS is for oral use and can be administered with or without food.
DOSE
VOLIBRIS as a single agent
VOLIBRIS 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 Sections 4.8 ADVERSE
EFFECTS
(UNDESIRABLE EFFECTS) and 5.1 PHARMACODYNAMIC PROPERTIES, Clinical
Trials].
VOLIBRIS used with tadalafil
When used in combination with tadalafil, the VOLIBRIS starting dose of
5 mg should be
titrated to 10 mg on