BOSENTAN VIATRIS bosentan (as monohydrate) 125 mg film-coated tablet bottle

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

bosentan monohydrate, Quantity: 129.082 mg

Dostopno od:

Alphapharm Pty Ltd

INN (mednarodno ime):

bosentan monohydrate

Farmacevtska oblika:

Tablet, film coated

Sestava:

Excipient Ingredients: povidone; magnesium stearate; maize starch; pregelatinised maize starch; sodium starch glycollate type A; sodium lauryl sulfate; glyceryl behenate; titanium dioxide; hypromellose; purified talc; triacetin; purified water; strong ammonia solution; ethylcellulose; oleic acid; medium chain triglycerides

Pot uporabe:

Oral

Enote v paketu:

60

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

BOSENTAN VIATRIS 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 functional Class II, III or IV symptoms

Povzetek izdelek:

Visual Identification: A white to off-white, film coated, oval, biconvex, beveled edge tablet debossed with 'M' on one side of the tablet and 'BN2' on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Status dovoljenje:

Licence status A

Datum dovoljenje:

2016-12-19

Navodilo za uporabo

BOSENTAN MYLAN
_contains the active ingredient bosentan (as monohydrate)_
CONSUMER MEDICINE INFORMATION
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 using this medicine
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 YOUR
MEDICINE.
You may need to read it again.
WHAT BOSENTAN MYLAN
IS USED 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.
This medicine acts to reduce
abnormally high blood pressure by
widening these blood vessels. It
belongs to the class of medicines
known as endothelin receptor
antagonists.
Your doctor however, may prescribe
Bosentan Mylan for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is only available with
a doctor’s prescription.
BEFORE YOU TAKE
BOSENTAN MYLAN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
ARE:
•
PREGNANT OR INTEND TO BECOME
PREGNANT. YOU MUST STOP TAKING
THE 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 in the three
months before becoming
pregnant.
•
BREASTFEEDING
Tell your doctor immediately if
you are breastfeeding. You are
advised to stop breastfeeding if
this medicine is prescribed for
you because it is not known if this
drug passes into the milk in
women who are taking this
medicine.
•
being treated with cyclosporine A
(a medicine used after a
transplant or to treat psoriasis)
•
being treated with glibenclamide
(a medicine used for diabetes)
DO NOT TAKE BOSENTAN MYLAN IF YOU
ARE ALLER

Lastnosti izdelka

AUSTRALIAN PRODUCT INFORMATION
BOSENTAN MYLAN
_Bosentan (as monohydrate) film-coated tablet _
1
NAME OF THE MEDICINE
Bosentan (as monohydrate)
_._
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bosentan monohydrate, a white to off-white powder, is practically
insoluble at low pH (0.1 mg/100 mL at pH
1.1 and 4.0; 0.2 mg/100 mL at pH 5.0). Solubility increases at higher
pH values (43 mg/100 mL at pH 7.5). In
the solid state, bosentan monohydrate is very stable, is not
hygroscopic and shows no light sensitivity.
BOSENTAN MYLAN 62.5 mg film coated tablets each contain 64.5411 mg of
bosentan monohydrate,
equivalent to 62.5 mg of bosentan, as the active ingredient. BOSENTAN
MYLAN 125 mg film-coated tablets
each contain 129.082 mg of bosentan monohydrate, equivalent to 125 mg
of bosentan, as the active ingredient.
Excipients of Known effects: BOSENTAN MYLAN also contains traces of
sulfites
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
BOSENTAN 62.5 mg white to off-white, film-coated, round, biconvex,
beveled edge tablet debossed with
“M” on one side of the tablet and “BN1” on the other side.
BOSENTAN MYLAN 125 mg white to off-white, film-coated, oval, biconvex,
beveled 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 functional Class II, III or IV symptoms.
4.2
DOSE AND METHOD OF ADMINISTRATION
BOSENTAN MYLAN may cause birth defects and is contraindicated in
pregnancy. See SECTION 4.3
CONTRAINDICATIONS and SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR
USE.
Rare cases of hepatic cirrhosis and hepatic failure have been reporte