Maa: Uusi-Seelanti
Kieli: englanti
Lähde: Medsafe (Medicines Safety Authority)
Selexipag 600ug
Janssen-Cilag (New Zealand) Ltd
Selexipag 600 µg
600 mcg
Film coated tablet
Active: Selexipag 600ug Excipient: Carnauba wax Hyprolose Hypromellose Disintergrant/Low substituted hydroxypropyl cellulose Iron oxide black Iron oxide red Magnesium stearate Maize starch Mannitol Propylene glycol Titanium dioxide
Prescription
Almac Sciences Limited
UPTRAVI, is indicated for the treatment of: · idiopathic pulmonary arterial hypertension · heritable pulmonary arterial hypertension · pulmonary arterial hypertension associated with connective tissue disease · pulmonary arterial hypertension associated with congenital heart disease with repaired shunts · pulmonary arterial hypertension associated with drugs and toxins in patients with WHO functional class II, III or IV symptoms. UPTRAVI is effective in combination with an endothelin receptor antagonist (ERA) or a phosphodiesterase-5 (PDE-5) inhibitor, or in triple combination with an ERA and a PDE-5 inhibitor, or as monotherapy.
Package - Contents - Shelf Life: Blister pack, Polyamide/al/HDPE/PE with desiccant agent/HDPE with Al foil (Alu/Alu blister with desiccant) - 60 dose units - 3 years from date of manufacture stored at or below 30°C protect from moisture
2015-01-05
UPTRAVI (211220) NZ ACMI 1 UPTRAVI ® (UP-TRA-VEE) _Selexipag (se-le-xi-pag) 200, 400, 600, 800, 1000, 1200, 1400, 1600 micrograms film coated tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about UPTRAVI. 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 UPTRAVI IS USED FOR UPTRAVI contains the active substance selexipag. It is a medicine that acts on a receptor that is the target of a natural substance called "prostacyclin". UPTRAVI is used for the long-term treatment of pulmonary arterial hypertension (PAH) in adults. It can be used on its own or with other medicines for PAH. PAH is high blood pressure in the blood vessels that carry blood from the heart to the lungs (the pulmonary arteries). In people with PAH, these arteries narrow, so the heart has to work harder to pump blood through them. This may cause people to feel tired, dizzy, short of breath, or experience other symptoms. UPTRAVI widens the pulmonary arteries and reduces their hardening. This makes it easier for the heart to pump blood through the pulmonary arteries. It relieves the symptoms of PAH and improves the course of the disease. Your doctor however, may prescribe UPTRAVI for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. BEFORE YOU TAKE UPTRAVI _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE UPTRAVI IF: 1. YOU HAVE EVER HAD AN ALLERGIC REACTION TO SELEXIPAG OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. PLEASE CONSULT YOUR DOCTOR IMMEDIATELY IF YOU EXPERIENCE ANY SIGNS OR SYMPTOMS OF A SERIOUS ALLERGIC REACTION: • WHEEZING • SWELLING OF THE Lue koko asiakirja
UPTRAVI NEW ZEALAND DATA SHEET CCDS 210802 Page 1 of 28 UPTRAVI (211005) ADS 1 PRODUCT NAME UPTRAVI® selexipag 200 microgram film coated tablets UPTRAVI® selexipag 400 microgram film coated tablets UPTRAVI® selexipag 600 microgram film coated tablets UPTRAVI® selexipag 800 microgram film coated tablets UPTRAVI® selexipag 1000 microgram film coated tablets UPTRAVI® selexipag 1200 microgram film coated tablets UPTRAVI® selexipag 1400 microgram film coated tablets UPTRAVI® selexipag 1600 microgram film coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION U UPTRAVI 200 microgram film coated tablets U Each film coated tablet contains 200 micrograms of selexipag U UPTRAVI 400 microgram film coated tablets U Each film coated tablet contains 400 micrograms of selexipag U UPTRAVI 600 microgram film coated tablets U Each film coated tablet contains 600 micrograms of selexipag U UPTRAVI 800 microgram film coated tablets U Each film coated tablet contains 800 micrograms of selexipag U UPTRAVI 1000 microgram film coated tablets U Each film coated tablet contains 1000 micrograms of selexipag U UPTRAVI 1200 microgram film coated tablets U Each film coated tablet contains 1200 micrograms of selexipag U UPTRAVI 1400 microgram film coated tablets U Each film coated tablet contains 1400 micrograms of selexipag U UPTRAVI 1600 microgram film coated tablets U Each film coated tablet contains 1600 micrograms of selexipag 3 PHARMACEUTICAL FORM U UPTRAVI 200 microgram film coated tablets U Round light yellow, film-coated tablet with '2' debossed on one side U UPTRAVI 400 microgram film coated tablets U Round red yellow, film-coated tablet with '4' debossed on one side U UPTRAVI 600 microgram film coated tablets U Round light violet, film-coated tablet with '6' debossed on one side U UPTRAVI 800 microgram film coated tablets U Round green, film-coated tablet with '8' debossed on one side U UPTRAVI 1000 microgram film coated tablets U Round orange, film-coated tablet with '10' debossed on one side UPTRAVI NEW ZEALAND DATA SHEE Lue koko asiakirja