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

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

bosentan monohydrate, Quantity: 129.082 mg

Διαθέσιμο από:

Alphapharm Pty Ltd

INN (Διεθνής Όνομα):

bosentan monohydrate

Φαρμακοτεχνική μορφή:

Tablet, film coated

Σύνθεση:

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

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

60

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

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: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Καθεστώς αδειοδότησης:

Licence status A

Ημερομηνία της άδειας:

2016-12-19

Αρχείο Π.Χ.Π.

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