TRACLEER bosentan 125mg (as monohydrate) tablet bottle

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

bosentan monohydrate, Quantity: 129.08 mg (Equivalent: bosentan, Qty 125 mg)

Tilgængelig fra:

Janssen-Cilag Pty Ltd

Lægemiddelform:

Tablet, film coated

Sammensætning:

Excipient Ingredients: magnesium stearate; ethylcellulose; purified talc; pregelatinised maize starch; iron oxide red; iron oxide yellow; glyceryl behenate; triacetin; maize starch; titanium dioxide; sodium starch glycollate; hypromellose; povidone

Indgivelsesvej:

Oral

Enheder i pakken:

60 tablets

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

TRACLEER 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.

Produkt oversigt:

Visual Identification: ORANGE-WHITE, OVAL, BICONVEX, CYLINDRICAL TABLET EMBOSSED WITH '125' ON ONE SIDE; Container Type: Bottle; Container Material: HDPE; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisation status:

Registered

Autorisation dato:

2002-11-20

Indlægsseddel

TRACLEER
®
(200715) ACMI
1
TRACLEER
®
(TRAK-LEER)
_Bosentan (BOZ-en-tan) 62.5 mg/125 mg film-coated tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Tracleer.
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
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TRACLEER IS USED
FOR
Tracleer (TRAK-leer) 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
Tracleer for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is only available with
a doctor's prescription.
BEFORE YOU TAKE
TRACLEER
_WHEN YOU MUST NOT TAKE _
_TRACLEER _
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 TRACLEER I

Produktets egenskaber

1
TRACLEER(191016)API
AUSTRALIAN PI – TRACLEER (BOSENTAN AS MONOHYDRATE)
WARNING: Causes 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 reported
in patients using
TRACLEER. See Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
1
NAME OF THE MEDICINE
TRACLEER bosentan
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.
Refer to Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
TRACLEER 62.5 mg film-coated, round, biconvex, orange-white tablets,
embossed with identification
marking '62.5'.
TRACLEER 125 mg film-coated, oval, biconvex, orange-white tablets,
embossed with identification
marking '125'.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
TRACLEER 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
D
OSE AND METHOD OF ADMINISTRATION
GENERAL
TRACLEER
should
be
administered
under
the
supervision
of
a
physician
experienced
in
the
management of pulmonary arterial hypertension. TRACLEER 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.
Tablets s