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UPTRAVI Film-coated tablet (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

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 ...

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 ...

Pharmaceutical form

Film-coated tablet. <u>Uptravi 200 microgram film-coated tablets:</u> Round, light-yellow, film-coated tablets with 2 debossed on one side. <u>Uptravi 400 microgram film-coated tablets:</u> Round, red, ...

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 ...

Posology and method of administration

Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH. Posology Individualised dose titration Each patient should be up-titrated to the highest individually ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Severe coronary heart disease or unstable angina. Myocardial infarction within the last 6 months. Decompensated ...

Special warnings and precautions for use

Hypotension Uptravi has vasodilatory properties that may result in lowering of blood pressure. Before prescribing Uptravi, physicians should carefully consider whether patients with certain underlying ...

Interaction with other medicinal products and other forms of interaction

Effect of other medicinal products on selexipag Selexipag is hydrolysed to its active metabolite by carboxylesterases (see section 5.2). Selexipag and its active metabolite both undergo oxidative metabolism ...

Fertility, pregnancy and lactation

Women of childbearing potential Women of childbearing potential should practise effective contraception while taking selexipag. Pregnancy There are no data from the use of selexipag in pregnant women. ...

Effects on ability to drive and use machines

Uptravi has minor influence on the ability to drive and use machines. The clinical status of the patient and the adverse reaction profile of selexipag (such as headache or hypotension) should be kept in ...

Undesirable effects

Summary of the safety profile The most commonly reported adverse reactions are headache, diarrhoea, nausea and vomiting, jaw pain, myalgia, pain in extremity, arthralgia, and flushing. These reactions ...

Overdose

Isolated cases of overdose up to 3,200 micrograms were reported. Mild, transient nausea was the only reported consequence. In the event of overdose, supportive measures must be taken as required. Dialysis ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excluding heparin ATC code: B01AC27 Mechanism of action Selexipag is a selective IP receptor agonist distinct from prostacyclin ...

Pharmacokinetic properties

The pharmacokinetics of selexipag and its active metabolite have been studied primarily in healthy subjects. The pharmacokinetics of selexipag and the active metabolite, both after single- and multiple-dose ...

Preclinical safety data

In the repeated-dose toxicity studies in rodents, strong blood pressure decrease as a result of exaggerated pharmacology induced transient clinical signs and reduced food consumption and body-weight gain. ...

List of excipients

<u>Tablet core:</u> Mannitol (E421) Maize starch Low substituted hydroxypropyl cellulose Hydroxypropyl cellulose Magnesium stearate <u>Film coating:</u> Uptravi 200 microgram film-coated tablet: Hypromellose ...

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Polyamide/aluminium/HDPE/PE with an embedded desiccant agent/HDPE blister sealed with an aluminium foil. Uptravi 200 microgram film-coated tablets: Cartons of 10 or 60 film-coated tablets, and 60 or 140 ...

Special precautions for disposal and other handling

No special requirements for disposal.

Marketing authorization holder

Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

Marketing authorization number(s)

EU/1/15/1083/001 EU/1/15/1083/002 EU/1/15/1083/003 EU/1/15/1083/004 EU/1/15/1083/005 EU/1/15/1083/006 EU/1/15/1083/007 EU/1/15/1083/008 EU/1/15/1083/009 EU/1/15/1083/010 EU/1/15/1083/011

Date of first authorization / renewal of the authorization

Date of first authorisation: 12 May 2016

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