OPSUMIT Film-coated tablet (2020)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
Opsumit 10 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 10 mg macitentan. Excipients with known effect: Each film-coated tablet contains approximately 37 mg of lactose (as monohydrate) and approximately 0.06 mg of soya bean ...
Pharmaceutical form
Film-coated tablet (tablet). 5.5 mm, round, biconvex, white to off-white film-coated tablets, debossed with 10 on both sides.
Therapeutic indications
Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III. Efficacy has been ...
Posology and method of administration
Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH. Posology The recommended dose is 10 mg once daily. Special populations Elderly No dose adjustment is ...
Contraindications
Hypersensitivity to the active substance, soya or to any of the excipients listed in section 6.1. Pregnancy (see section 4.6). Women of childbearing potential who are not using reliable contraception (see ...
Special warnings and precautions for use
The benefit/risk balance of macitentan has not been established in patients with WHO class I functional status of pulmonary arterial hypertension. Liver function Elevations of liver aminotransferases (AST, ...
Interaction with other medicinal products and other forms of interaction
In vitro studies The cytochrome P450 enzymes CYP3A4, CYP2C8, CYP2C9, and CYP2C19 are involved in the metabolism of macitentan and formation of its metabolites (see section 5.2). Macitentan and its active ...
Fertility, pregnancy, and lactation
Use in women of childbearing potential/Contraception in males and females Opsumit treatment should only be initiated in women of childbearing potential when the absence of pregnancy has been verified, ...
Effects on ability to drive and use machines
Macitentan has minor influence on the ability to drive and use machines. No studies on the effects on the ability to drive and use machines have been performed. However, undesirable effects may occur (e.g., ...
Undesirable effects
Summary of the safety profile. The most commonly reported adverse reactions are nasopharyngitis (14%), headache (13.6%) and anaemia (13.2%, see section 4.4). The majority of adverse reactions are mild ...
Overdose
Macitentan has been administered as a single dose of up to 600 mg to healthy subjects. Adverse reactions of headache, nausea, and vomiting were observed. In the event of an overdose, standard supportive ...
Pharmacodynamic properties
Pharmacotherapeutic group: anti-hypertensives, anti-hypertensives for pulmonary arterial hypertension ATC code: C02KX04 Mechanism of action Endothelin (ET)-1 and its receptors (ET<sub>A</sub> and ET<sub> ...
Pharmacokinetic properties
The pharmacokinetics of macitentan and its active metabolite have mainly been documented in healthy subjects. Exposure to macitentan in patients with PAH was approximately 1.2-fold greater than in healthy ...
Preclinical safety data
In dogs, macitentan decreased blood pressure at exposures similar to the therapeutic human exposure. Intimal thickening of coronary arteries was observed at 17-fold the human exposure after 4 to 39 weeks ...
List of excipients
Tablet core: Lactose monohydrate Microcrystalline cellulose (E460i) Sodium starch glycolate Type A Povidone K-30 Magnesium stearate (E572) Polysorbate 80 (E433) Film coating: Poly(vinyl-alcohol) (E1203) ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 5 years.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
White, opaque PVC/PE/PVdC/Aluminium blisters in cartons containing 15 or 30 film-coated tablets. White high-density polyethylene (HDPE) bottles with child-resistant closure and a silica gel desiccant. ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Janssen-Cilag International NV, Turnhoutseweg 30, B 2340, Beerse, Belgium
Marketing authorization number(s)
EU/1/13/893/001 EU/1/13/893/002 EU/1/13/893/003
Date of first authorization / renewal of the authorization
Date of first authorisation: 20 December 2013 Date of latest renewal: 23 August 2018
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