Bosentan Dr Reddy's

Χώρα: Νέα Ζηλανδία

Γλώσσα: Αγγλικά

Πηγή: Medsafe (Medicines Safety Authority)

Δραστική ουσία:

Bosentan monohydrate 64.541mg equivalent to Bosentan 62.5 mg

Διαθέσιμο από:

Dr Reddy's New Zealand Limited

INN (Διεθνής Όνομα):

Bosentan monohydrate 64.541 mg (equivalent to Bosentan 62.5 mg)

Δοσολογία:

62.5 mg

Φαρμακοτεχνική μορφή:

Film coated tablet

Σύνθεση:

Active: Bosentan monohydrate 64.541mg equivalent to Bosentan 62.5 mg Excipient: Ethylcellulose Glycerol Magnesium stearate Maize starch Opadry yellow 03K82318 Povidone Sodium starch glycolate Starch

Τρόπος διάθεσης:

Prescription

Κατασκευάζεται από:

Megafine Pharma (P) Limited

Θεραπευτικές ενδείξεις:

The medicine 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.

Περίληψη προϊόντος:

Package - Contents - Shelf Life: Blister pack, Cold formed tri laminate made of polyamid, Alu/PVC and Alu foil - 60 dose units - 24 months from date of manufacture stored at or below 25°C - Blister pack, Alu/Alu - 60 dose units - 24 months from date of manufacture stored at or below 25°C

Ημερομηνία της άδειας:

2016-01-12

Αρχείο Π.Χ.Π.

NEW ZEALAND DATASHEET
1 PRODUCT NAME
BOSENTAN DR REDDY’S
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Bosentan (as monohydrate) 62.5 mg & 125 mg tablets
3 PHARMACEUTICAL FORM
BOSENTAN DR REDDY’S 62.5 mg tablets are orange white, film coated,
round biconvex
tablet debossed with ’62.5’ on one side and plain on other side.
BOSENTAN DR REDDY’S 125 mg tablets are orange white, film coated,
round biconvex
tablet debossed with ’125’ on one side and plain on other side.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
BOSENTAN
MAY
CAUSE
BIRTH
DEFECTS
AND
IS
CONTRAINDICATED
IN
PREGNANCY,
SEE
CONTRAINDICATIONS AND WARNINGS AND PRECAUTIONS.
RARE CASES OF HEPATIC CIRRHOSIS AND HEPATIC FAILURE HAVE BEEN REPORTED
IN PATIENTS
USING BOSENTAN, SEE WARNINGS AND PRECAUTIONS
Bosentan 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
_GENERAL _
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.
Tablets should be administered morning and evening with or without
food.
Serum liver aminotransferase (AST & ALT) levels must be measured prior
to initiation of
treatment with bosentan and monthly thereafter for the duration of
treatment (see WARNINGS
AND PRECAUTIONS; potential liver injury). If elevated aminotransferase
levels are seen,
changes in monitoring and treatment must be initiat