Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
selexipag, Quantity: 200 microgram
Janssen-Cilag Pty Ltd
selexipag
Tablet, film coated
Excipient Ingredients: iron oxide yellow; Carnauba Wax; maize starch; magnesium stearate; hyprolose; propylene glycol; mannitol; titanium dioxide; hypromellose
Oral
140 film coated tablets, 60 film coated tablets, 10 film coated tablets
(S4) Prescription Only Medicine
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
Visual Identification: UPTRAVI 200 microgram, light yellow, debossed with '2' on one side, round, film-coated tablet.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2016-03-24
UPTRAVI (220919) ACMI 1 This leaflet was prepared in September 2022. Please check with your pharmacist if an updated version of this leaflet has been made available. 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. PLEAS Read the complete document
11.210802 1 UPTRAVI (220826) API AUSTRALIAN PRODUCT INFORMATION UPTRAVI ® (SELEXIPAG) FILM-COATED TABLET 1 NAME OF THE MEDICINE UPTRAVI selexipag 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Selexipag is a pale yellow crystalline powder that is practically insoluble in water. In the solid state selexipag is very stable, is not hygroscopic, and is not light sensitive. Each round film-coated tablet contains 200 micrograms or multiples thereof (respectively 400, 600, 800, 1000, 1200, 1400, or 1600 micrograms) selexipag. The film-coated tablets are not light sensitive. Refer to Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM UPTRAVI 200 micrograms, light yellow, debossed with '2', round, film-coated tablet. UPTRAVI 400 micrograms, red, debossed with '4', round, film-coated tablet. UPTRAVI 600 micrograms, light violet, debossed with '6', round, film-coated tablet. UPTRAVI 800 micrograms, green, debossed with '8', round, film-coated tablet. UPTRAVI 1000 micrograms, orange, debossed with '10', round, film-coated tablet. UPTRAVI 1200 micrograms, dark violet, debossed with '12', round, film-coated tablet. UPTRAVI 1400 micrograms, dark yellow, debossed with '14', round, film-coated tablet UPTRAVI 1600 micrograms, brown, debossed with '16', round, film-coated tablet Refer to Section 6.5 NATURE AND CONTENTS OF CONTAINER. 11.210802 2 UPTRAVI (220826) API 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS 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. 4.2 D OSE AND METHOD OF ADMINISTRATION Treatment should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension (PAH). Selexipag Read the complete document