Uptravi

Country: Нови Зеланд

Језик: Енглески

Извор: Medsafe (Medicines Safety Authority)

Активни састојак:

Selexipag 600ug

Доступно од:

Janssen-Cilag (New Zealand) Ltd

INN (Међународно име):

Selexipag 600 µg

Дозирање:

600 mcg

Фармацеутски облик:

Film coated tablet

Састав:

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

Тип рецептора:

Prescription

Произведен од:

Almac Sciences Limited

Терапеутске индикације:

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.

Резиме производа:

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

Датум одобрења:

2015-01-05

Информативни летак

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

Карактеристике производа

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