Bosentan Viatris

País: Nova Zelanda

Idioma: anglès

Font: Medsafe (Medicines Safety Authority)

ingredients actius:

Bosentan monohydrate 64.541mg equivalent to bosentan anhydrous 62.5 mg;  ; Bosentan monohydrate 64.541mg equivalent to bosentan anhydrous 62.5 mg

Disponible des:

Viatris Limited

Designació comuna internacional (DCI):

Bosentan monohydrate 64.541 mg (= bosentan anhydrous 62.5 mg)

Dosis:

62.5 mg

formulario farmacéutico:

Film coated tablet

Composición:

Active: Bosentan monohydrate 64.541mg equivalent to bosentan anhydrous 62.5 mg   Excipient: Glyceryl behenate Magnesium stearate Maize starch Opadry yellow 03K82318 Povidone Sodium laurilsulfate Sodium starch glycolate Starch Surelease Clear E-7-19040 as solid Active: Bosentan monohydrate 64.541mg equivalent to bosentan anhydrous 62.5 mg Excipient: Glyceryl behenate Magnesium stearate Maize starch Opadry White 03K580000 Povidone Sodium laurilsulfate Sodium starch glycolate Starch Surelease Clear E-7-19040 as solid

Unidades en paquete:

Blister pack, PVC/PVDC/Al, 56 tablets

clase:

Prescription

tipo de receta:

Prescription

Fabricat per:

Mylan Laboratories Limited

indicaciones terapéuticas:

Indicated for the treatment of idiopathic pulmonary arterial hypertension, familial pulmonary arterial hypertension, pulmonary arterial hypertension associated with scleroderma or pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including Eisenmenger's physiology in patients with WHO Class III or IV symptoms.

Resumen del producto:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al - 56 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with PP closure - 60 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with PP closure - 100 tablets - 36 months from date of manufacture stored at or below 25°C

Data d'autorització:

2012-08-08

Informació per a l'usuari

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
BOSENTAN MYLAN
_BOSENTAN (AS MONOHYDRATE) 62.5 MG & 125 MG TABLETS_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about BOSENTAN
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 risks and
benefits. Your doctor has weighed
the risks of you taking BOSENTAN
MYLAN against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT BOSENTAN
MYLAN IS TAKEN FOR
BOSENTAN MYLAN is used for the
treatment of high blood pressure in
the blood vessels between the heart
and the lungs. This condition is
called pulmonary arterial
hypertension.
BOSENTAN MYLAN contains the
active ingredient bosentan. It
belongs to a class of medicines
called endothelian receptor
antagonists.
This medicine acts to reduce
abnormally high blood pressure by
widening the blood vessels between
the heart and the lungs.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU TAKE
BOSENTAN MYLAN
_WHEN YOU MUST NOT TAKE _
_IT_
DO NOT TAKE BOSENTAN MYLAN IF
YOU HAVE AN ALLERGY TO:

ANY MEDICINE CONTAINING
BOSENTAN

ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
Some of the symptoms of an
allergic reaction may include:
shortness of breath; wheezing or
difficulty breathing; swelling of
the face, lips, tongue or other
parts of the body; rash, itching or
hives on the skin.
DO NOT TAKE THIS MEDICINE IF YOU
ARE PREGNANT OR INTEND TO BECOME
PREGNANT OR YOU INTEND TO FATHER A
CHILD. YOU MUST STOP TAKING THIS
MEDICINE AT LEAST 3 MONTHS
BEFORE TRYING TO BECOME
PREGNANT.
It is known that this medicine
causes harm to the developing baby
if you take it during pregnancy and
the thr

Fitxa tècnica

Page 1 of 21
NEW ZEALAND DATA SHEET
BOSENTAN MYLAN
1. PRODUCT NAME
BOSENTAN MYLAN 62.5 mg and 125 mg film coated tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each BOSENTAN MYLAN tablet contains 62.5 mg or 125 mg of bosentan (as
monohydrate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
BOSENTAN MYLAN 62.5 mg tablets: white to off-white, film-coated,
round, biconvex, bevelled edge
tablet debossed with M on one side of the tablet and BN1 on the other
side.
BOSENTAN MYLAN 125 mg tablets: white to off-white, film-coated, oval,
biconvex, bevelled edge
tablet debossed with M on one side of the tablet and BN2 on the other
side.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
BOSENTAN MYLAN is indicated for the treatment of idiopathic pulmonary
arterial hypertension,
familial
pulmonary
arterial
hypertension,
pulmonary
arterial
hypertension
associated
with
scleroderma or pulmonary arterial hypertension associated with
congenital systemic to pulmonary
shunts including Eisenmenger's physiology in patients with WHO Class
III or IV symptoms.
_4.2 _
_DOSE AND METHOD OF ADMINISTRATION _
Bosentan should be administered under the supervision of a physician
experienced in the
management of pulmonary arterial hypertension. Bosentan treatment
should be initiated at a dose
of 62.5 mg twice daily for 4 weeks. Efficacy was demonstrated in
clinical trial subjects who increased
to a maintenance dose of 125 mg twice daily. Doses above 125 mg twice
daily did not appear to
confer additional benefit sufficient to offset the increased risk of
liver injury.
Serum liver aminotransferase (AST & ALT) levels must be measured prior
to initiation of treatment
with BOSENTAN MYLAN and monthly thereafter for the duration of
treatment (see section 4.4). If
elevated aminotransferase levels are seen, changes in monitoring and
treatment must be initiated,
as detailed below.
BOSENTAN MYLAN CAUSES BIRTH DEFECTS AND IS CONTRAINDICATED IN
PREGNANCY. SEE
SECTIONS 4.3 AND 4.4.
RARE CASES OF HEPATIC CIRRHOSIS AND HEPA