UPTRAVI 400 microgram

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SELEXIPAG

Available from:

J-C HEALTH CARE LTD

ATC code:

B01AC27

Pharmaceutical form:

FILM COATED TABLETS

Composition:

SELEXIPAG 400 MCG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ACTELION PHARMACEUTICALS LTD., SWITZERLAND

Therapeutic area:

SELEXIPAG

Therapeutic indications:

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

Authorization date:

2022-02-28

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
Uptravi
®
200 microgram,
Uptravi
®
400 microgram,
Uptravi
®
600 microgram,
Uptravi
®
800 microgram,
Uptravi
®
1,000 microgram,
Uptravi
®
1,200 microgram,
Uptravi
®
1,400 microgram,
Uptravi
®
1,600 microgram
Film-coated tablets
The active ingredient and its quantity:
Uptravi 200 micrograms: each film-coated tablet contains 200
micrograms of
selexipag
Uptravi 400 micrograms: each film-coated tablet contains 400
micrograms of
selexipag
Uptravi 600 micrograms: each film-coated tablet contains 600
micrograms of
selexipag
Uptravi 800 micrograms: each film-coated tablet contains 800
micrograms of
selexipag
Uptravi 1,000 micrograms: each film-coated tablet contains 1,000
micrograms
of selexipag
Uptravi 1,200 micrograms: each film-coated tablet contains 1,200
micrograms
of selexipag
Uptravi 1,400 micrograms: each film-coated tablet contains 1,400
micrograms
of selexipag
Uptravi 1,600 micrograms: each film-coated tablet contains 1,600
micrograms
of selexipag
For the list of inactive ingredients, please see section 6 Additional
information .
Read this entire leaflet carefully before using this medicine. This
leaflet
contains concise information about the medicine. If you have any
further
questions, refer to your doctor or pharmacist.
This medicine has been prescribed for the treatment of your illness.
Do not pass
it on to others. It may harm them, even if you think that their
illness is similar.
This medicine is intended for patients over 18 years of age.
Patient Titration Guide
In addition to the Patient Leaflet, a Titration Guide for the patient
is provided
with the Uptravi 200 microgram pack
.
This guide contains important safety information that you must be
aware of
and adhere to before starting and during the course of treatment with
Uptravi.
Read the Titration Guide for the patient and patient leaflet before
using the
preparation. Keep the guide for furthe

Summary of Product characteristics

1
Uptravi_PI_November-2023
PRESCRIBING INFORMATION
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
®
1000 microgram film-coated tablets
UPTRAVI
®
1200 microgram film-coated tablets
UPTRAVI
®
1400 microgram film-coated tablets
UPTRAVI
®
1600 microgram film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
UPTRAVI
®
200 microgram
Each film-coated tablet contains 200 micrograms of selexipag.
UPTRAVI
®
400 microgram
Each film-coated tablet contains 400 micrograms of selexipag.
UPTRAVI
®
600 microgram
Each film-coated tablet contains 600 micrograms of selexipag.
UPTRAVI
®
800 microgram
Each film-coated tablet contains 800 micrograms of selexipag.
UPTRAVI
®
1,000 microgram
Each film-coated tablet contains 1,000 micrograms of selexipag.
UPTRAVI
®
1,200 microgram
Each film-coated tablet contains 1,200 micrograms of selexipag.
UPTRAVI
®
1,400 microgram
Each film-coated tablet contains 1,400 micrograms of selexipag.
UPTRAVI
®
1,600 microgram
Each film-coated tablet contains 1,600 micrograms of selexipag.
For the full list of excipients, see section 6.1.
Patient Titration Guide
The marketing of Uptravi is subject to risk management plan (RMP)
including a 'Patient Titration
Guide'. The patient titration guide emphasizes important safety
information that the patient should
be aware of before and during the treatment. The patient titration
guide is included in the Uptravi
200 microgram pack.
Please explain to the patient the need to review the guide before
starting treatment.
2
Uptravi_PI_November-2023
3. PHARMACEUTICAL FORM
Film-coated tablet
UPTRAVI
®
200 microgram
Round, light-yellow, film-coated tablets with “2” debossed on one
side.
UPTRAVI
®
400 microgram
Round, red, film-coated tablets with “4” debossed on one side.
UPTRAVI
®
600 microgram
Round, light-violet, film-coated tablets with “6” debossed on one
side.
UPTR