Uptravi
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
28-06-2022
Valmisteyhteenveto
(SPC)
28-06-2022
Julkisesta arviointikertomuksesta
(PAR)
19-07-2017
Aktiivinen ainesosa:
Selexipag
Saatavilla:
Janssen Cilag International NV
ATC-koodi:
B01AC27
INN (Kansainvälinen yleisnimi):
selexipag
Terapeuttinen ryhmä:
Antithrombotic agents
Terapeuttinen alue:
Hypertension, Pulmonary
Käyttöaiheet:
Uptravi is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class (FC) II–III, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies. 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.,
Tuoteyhteenveto:
Revision: 13
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2016-05-12
Pakkausseloste
33
B. PACKAGE LEAFLET
34
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
UPTRAVI 200 MICROGRAM FILM-COATED TABLETS
UPTRAVI 400 MICROGRAM FILM-COATED TABLETS
UPTRAVI 600 MICROGRAM FILM-COATED TABLETS
UPTRAVI 800 MICROGRAM FILM-COATED TABLETS
UPTRAVI 1,000 MICROGRAM FILM-COATED TABLETS
UPTRAVI 1,200 MICROGRAM FILM-COATED TABLETS
UPTRAVI 1,400 MICROGRAM FILM-COATED TABLETS
UPTRAVI 1,600 MICROGRAM FILM-COATED TABLETS
selexipag
READ ALL OF THIS LEAFLET CAREFULLY BEFORE TAKING THIS MEDICINE BECAUSE
IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you have any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet (see section 4).
WHAT IS IN THIS LEAFLET
1.
What Uptravi is and what it is used for
2.
What you need to know before you take Uptravi
3.
How to take Uptravi
4.
Possible side effects
5.
How to store Uptravi
6.
Contents of the package and other information
1.
WHAT UPTRAVI IS AND WHAT IT IS USED FOR
Uptravi is a medicine that contains the active substance selexipag. It
acts on blood vessels in a similar
way to the natural substance prostacyclin, making them relax and
widen.
Uptravi is used for the long-term treatment of pulmonary arterial
hypertension (PAH) in adult patients
insufficiently controlled with other types of medicines for PAH known
as endothelin receptor
antagonists and phosphodiesterase type 5 inhibitors. Uptravi can be
used on its own if the patient is not
a candidate for these medicines.
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 sy
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Uptravi 200 microgram film-coated tablets
Uptravi 400 microgram film-coated tablets
Uptravi 600 microgram film-coated tablets
Uptravi 800 microgram film-coated tablets
Uptravi 1,000 microgram film-coated tablets
Uptravi 1,200 microgram film-coated tablets
Uptravi 1,400 microgram film-coated tablets
Uptravi 1,600 microgram film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Uptravi 200 microgram film-coated tablets
Each film-coated tablet contains 200 micrograms of selexipag.
Uptravi 400 microgram film-coated tablets
Each film-coated tablet contains 400 micrograms of selexipag.
Uptravi 600 microgram film-coated tablets
Each film-coated tablet contains 600 micrograms of selexipag.
Uptravi 800 microgram film-coated tablets
Each film-coated tablet contains 800 micrograms of selexipag.
Uptravi 1,000 microgram film-coated tablets
Each film-coated tablet contains 1,000 micrograms of selexipag.
Uptravi 1,200 microgram film-coated tablets
Each film-coated tablet contains 1,200 micrograms of selexipag.
Uptravi 1,400 microgram film-coated tablets
Each film-coated tablet contains 1,400 micrograms of selexipag.
Uptravi 1,600 microgram film-coated tablets
Each film-coated tablet contains 1,600 micrograms of selexipag.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Uptravi 200 microgram film-coated tablets
Round, 7.3 mm diameter, light-yellow, film-coated tablets,with “2”
debossed on one side.
Uptravi 400 microgram film-coated tablets
3
Round, 7.3 mm diameter, red, film-coated tablets with “4” debossed
on one side.
Uptravi 600 microgram film-coated tablets
Round, 7.3 mm diameter, light-violet, film-coated tablets with “6”
debossed on one side.
Uptravi 800 microgram film-coated tablets
Round, 7.3 mm diameter, green, film-coated tablets with “8”
debossed on one side.
Uptravi 1,000 microgram film-coated tablets
Round, 7.3 mm diameter, orange, film-coated tablets with “10”
debo
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