AMBRISENTAN VIATRIS ambrisentan 10 mg film-coated tablet blister pack

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

ambrisentan, Quantity: 10 mg

Disponibil de la:

Alphapharm Pty Ltd

Forma farmaceutică:

Tablet, film coated

Compoziție:

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

Calea de administrare:

Oral

Unități în pachet:

30

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

AMBRISENTAN VIATRIS 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.

Rezumat produs:

Visual Identification: A pink, film-coated, capsule shaped, biconvex tablet debossed with M on one side of the tablet and AN1 on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Statutul autorizaţiei:

Registered

Data de autorizare:

2020-04-01

Prospect

AMBRISENTAN MYLAN
_Ambrisentan_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING
AMBRISENTAN MYLAN.
This leaflet answers some common
questions about AMBRISENTAN
MYLAN.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking AMBRISENTAN
MYLAN against the benefits
expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT AMBRISENTAN
MYLAN IS USED FOR
AMBRISENTAN MYLAN 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.
This medicine works by widening the
pulmonary arteries, making it easier
for your heart to pump blood through
them. This lowers the blood pressure
and relieves your symptoms.
AMBRISENTAN MYLAN is not
recommended for use in children and
patients under 18 years of age as
there have been no studies of its
effects in this age group.
AMBRISENTAN MYLAN 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.
AMBRISENTAN MYLAN is
available as 5 mg and 10 mg tablets.
This medicine is available only with
a doctor's prescription
BEFORE YOU TAKE
AMBRISENTAN
MYLAN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE AMBRISENTAN
MYLAN IF YOU HAVE AN ALLERGY TO:
•
any medicine containing
ambrisentan
•
any of the ingredients listed at the
end of this leaflet
�

Caracteristicilor produsului

AMBRISENTAN MYLAN_
Pg. 1
AUSTRALIAN PRODUCT INFORMATION
AMBRISENTAN MYLAN
_ambrisentan_
TERATOGENICITY
AMBRISENTAN MYLAN 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
Each tablet contains 5 mg or 10 mg of ambrisentan as the active
ingredient.
Excipients with known effect: Lactose.
For the full list of excipients, see
_Section 6.1 List of Excipients._
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
AMBRISENTAN MYLAN 5 mg tablets are pink, round biconvex tablets
debossed with ‘M’ on one
side and ‘AN’ on the other.
AMBRISENTAN MYLAN 10 mg tablets are pink, capsule shaped biconvex
tablets debossed with
‘M’ on one side and ‘AN1’ on the other.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
AMBRISENTAN MYLAN is indicated for 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.
4.2. DOSE AND METHOD OF ADMINISTRATION
Treatment
should
only
be
initiated
by
a
physician
experienced
in
the
treatment
of
PAH.
AMBRISENTAN MYLAN is for oral use and can be administered with or
without food.
It is recommended that the tablet is swallowed whole and should not be
split, crushed or chewed.
AMBRISENTAN MYLAN 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 Adverse Effects (Undesirable Effects) _
and
_5.1 Pharmacodynamic Properties,_
_Clinical Trials_
).
AMBRISENTAN MYLAN_
Pg. 2
AMBRISENTAN MYLAN – PRODUCT INFORMATION
Limited data suggest that the abrupt discontinuation of ambrisentan is
not associated with rebound
worsening of PAH.
USE WITH CICLOSPORIN A
When co-administered with ciclosporin A, the dose of ambrisentan
should be limited to 5 mg once
daily (see
_Section 4.5_
_Interactions with Other Medicines and Other Forms of Inte