Opsumit

देश: न्यूज़ीलैंड

भाषा: अंग्रेज़ी

स्रोत: Medsafe (Medicines Safety Authority)

सक्रिय संघटक:

Macitentan 10mg;  ;  

थमां उपलब्ध:

Janssen-Cilag (New Zealand) Ltd

INN (इंटरनेशनल नाम):

Macitentan 10 mg

डोज़:

10 mg

फार्मास्यूटिकल फॉर्म:

Film coated tablet

रचना:

Active: Macitentan 10mg     Excipient: Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry White OY-B-28920 AMB Polysorbate 80 Povidone Sodium starch glycolate

प्रिस्क्रिप्शन प्रकार:

Prescription

द्वारा बनाया गया:

Jetpharma SA

चिकित्सीय संकेत:

Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II, III, or IV. Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.

उत्पाद समीक्षा:

Package - Contents - Shelf Life: Blister pack, PVC/PE/PVDC/Al - 30 tablets - 5 years from date of manufacture stored at or below 30°C protect from moisture

प्राधिकरण की तारीख:

2014-02-17

सूचना पत्रक

OPSUMIT(221027)ACMI
1
OPSUMIT
®
(OP-SUH-MIT)
_Macitentan (ma-SEE-ten-tan) 10 mg Tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about OPSUMIT.
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, SPEAK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT OPSUMIT IS
USED FOR
OPSUMIT tablets contain macitentan
which belongs to the class of
medicines called "endothelin receptor
antagonists".
OPSUMIT is used for the treatment
of pulmonary arterial hypertension
(PAH), it can be used on its own or
with other drugs to treat PAH. PAH
is high blood pressure in the blood
vessels (the pulmonary arteries) that
carry blood from the heart to the
lungs. In people with PAH, these
arteries get narrower, so the heart has
to work harder to pump blood
through them. This causes people to
feel tired, dizzy, and short of breath.
OPSUMIT widens the pulmonary
arteries, making it easier for the heart
to pump blood through them. This
lowers the blood pressure and
relieves the symptoms and improves
the course of the disease.
Your doctor however, may prescribe
OPSUMIT for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
BEFORE YOU TAKE
OPSUMIT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE OPSUMIT IF YOU
ARE PREGNANT OR IF YOU ARE PLANNING
TO BECOME PREGNANT, OR IF YOU
COULD BECOME PREGNANT BECAUSE
YOU ARE NOT USING RELIABLE BIRTH
CONTROL (CONTRACEPTION).
Talk to your doctor about what birth
control methods are reliable whilst
taking OPSUMIT.
DO NOT TAKE OPSUMIT IF YOU HAVE
EVER HAD AN ALLERGIC REACTION TO
MACITENTAN, SOYA OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
Symptoms of an allergic reaction
may b

उत्पाद विशेषताएं

14.220707
Page 1 of 20
OPSUMIT (221027) ADS
OPSUMIT®
MACITENTAN
NEW ZEALAND DATA SHEET
OPSUMIT
® MAY CAUSE BIRTH DEFECTS AND IS CONTRAINDICATED IN PREGNANCY.
SEE SECTION 4.3 CONTRAINDICATIONS AND SECTION 4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR USE.
1
PRODUCT NAME
OPSUMIT 10mg Film coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Macitentan 10mg
Excipients with known effect – lactose monohydrate and soya
lecithin.
For the full list of excipients, see Section 6.1
3
PHARMACEUTICAL FORM
Opsumit is a white to off-white, round, biconvex film-coated tablet,
debossed with “10” on both sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Opsumit, as monotherapy or in combination, is indicated for the
long-term treatment of pulmonary
arterial hypertension (PAH) in adult patients of WHO Functional Class
(FC) II, III or IV.
Efficacy has been shown in a PAH population including idiopathic and
heritable PAH, PAH associated
with connective tissue disorders, and PAH associated with corrected
simple congenital heart disease.
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment with OPSUMIT should only be initiated and monitored by a
physician experienced in the
treatment of PAH.
DOSAGE
OPSUMIT is to be taken orally at a dose of 10 mg once daily, with or
without food. The film-coated
tablets are not breakable and are to be swallowed whole, with water.
Doses higher than 10 mg daily
have not been studied and are not recommended.
14.220707
Page 2 of 20
OPSUMIT (221027) ADS
DOSAGE ADJUSTMENT IN ELDERLY PATIENTS
No dose adjustment is required in patients over the age of 65 years.
DOSAGE ADJUSTMENT IN PATIENTS WITH HEPATIC IMPAIRMENT
Based on pharmacokinetic data, no dose adjustment is required in
patients with mild or moderate
hepatic impairment. There is no clinical experience with the use of
OPSUMIT in PAH patients with
moderate or severe hepatic impairment.
OPSUMIT is contraindicated in patients with severe hepatic impairment,
or clinically significant
elevated hepatic aminotransferases (greater than 3 times the Up