ADEMPAS Film-coated tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Adempas 0.5 mg film-coated tablets. Adempas 1 mg film-coated tablets. Adempas 1.5 mg film-coated tablets. Adempas 2 mg film-coated tablets. Adempas 2.5 mg film-coated tablets.
Qualitative and quantitative composition
<u>Adempas 0.5 mg film-coated tablets:</u> Each film-coated tablet contains 0.5 mg of riociguat. <u>Adempas 1 mg film-coated tablets:</u> Each film-coated tablet contains 1 mg of riociguat. <u>Adempas ...
Pharmaceutical form
Film-coated tablet (tablet). <u>0.5 mg tablet:</u> white, round, biconvex tablets of 6 mm, marked with the Bayer cross on one side and 0.5 and an R on the other side. <u>1 mg tablet:</u> pale yellow, round, ...
Therapeutic indications
Chronic thromboembolic pulmonary hypertension (CTEPH) Adempas is indicated for the treatment of adult patients with WHO Functional Class (FC) II to III with inoperable CTEPH, persistent or recurrent CTEPH ...
Posology and method of administration
Treatment should only be initiated and monitored by a physician experienced in the treatment of CTEPH or PAH. Posology Dose titration The recommended starting dose is 1 mg three times daily for 2 weeks. ...
Contraindications
Co-administration with PDE5 inhibitors (such as sildenafil, tadalafil, vardenafil) (see sections 4.2 and 4.5). Severe hepatic impairment (Child Pugh C). Hypersensitivity to the active substance or to any ...
Special warnings and precautions for use
In pulmonary arterial hypertension, studies with riociguat have been mainly performed in forms related to idiopathic or heritable PAH and PAH associated with connective tissue disease. The use of riociguat ...
Interaction with other medicinal products and other forms of interaction
Pharmacodynamic interactions Nitrates In a clinical study the highest dose of Adempas (2.5 mg tablets three times daily) potentiated the blood pressure lowering effect of sublingual nitroglycerin (0.4 ...
Pregnancy and lactation
Women of childbearing potential/Contraception Women of childbearing potential must use effective contraception during treatment with Adempas. Pregnancy There are no data from the use of riociguat in pregnant ...
Effects on ability to drive and use machines
Adempas has moderate influence on the ability to drive and use machines. Dizziness has been reported and may affect the ability to drive and use machines (see section 4.8). Patients should be aware of ...
Undesirable effects
Summary of the safety profile The safety of Adempas has been evaluated in phase III studies of 681 patients with CTEPH and PAH receiving at least one dose of riociguat (see section 5.1). Most of the adverse ...
Overdose
Inadvertent overdosing with total daily doses of 9 to 25 mg riociguat between 2 to 32 days was reported. Adverse reactions were similar to those seen at lower doses (see section 4.8). In case of overdose, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antihypertensives (antihypertensives for pulmonary arterial hypertension) ATC code: C02KX05 Mechanism of action Riociguat is a stimulator of soluble guanylate cyclase (sGC), ...
Pharmacokinetic properties
Absorption The absolute bioavailability of riociguat is high (94%). Riociguat is rapidly absorbed with maximum concentrations (C<sub>max</sub>) appearing 1-1.5 hours after tablet intake. Intake with food ...
Preclinical safety data
Non-clinical data revealed no specific hazard for humans based on conventional studies of safety pharmacology, single dose toxicity, phototoxicity, genotoxicity and carcinogenicity. Effects observed in ...
List of excipients
<u>Tablet core:</u> Cellulose microcrystalline Crospovidone (type B) Hypromellose 5 cP Magnesium stearate Lactose monohydrate Sodium laurilsulfate <u>Film-coat:</u> Hydroxypropylcellulose 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
PP/Aluminium foil blister. Pack sizes: 42, 84, 90 or 294 film-coated tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Bayer AG, 51368, Leverkusen, Germany
Marketing authorization number(s)
Adempas 0.5 mg film-coated tablets: EU/1/13/907/001 EU/1/13/907/002 EU/1/13/907/003 EU/1/13/907/016 Adempas 1 mg film-coated tablets: EU/1/13/907/004 EU/1/13/907/005 EU/1/13/907/006 EU/1/13/907/017 Adempas ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 27 March 2014 Date of latest renewal: 18 January 2019
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