TRACLEER Film-coated tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Tracleer 62.5 mg film-coated tablets. Tracleer 125 mg film-coated tablets.
Qualitative and quantitative composition
<u>Tracleer 62.5 mg film-coated tablets:</u> Each film-coated tablet contains 62.5 mg bosentan (as monohydrate). <u>Tracleer 125 mg film-coated tablets:</u> Each film-coated tablet contains 125 mg bosentan ...
Pharmaceutical form
Film-coated tablet (tablets). <u>Tracleer 62.5 mg film-coated tablets:</u> Orange-white, round, biconvex, film-coated tablets, embossed with 62,5 on one side. <u>Tracleer 125 mg film-coated tablets:</u> ...
Therapeutic indications
Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO functional class III. Efficacy has been shown in: Primary (idiopathic and heritable) pulmonary ...
Posology and method of administration
Method of administration Tablets are to be taken orally morning and evening, with or without food. The film-coated tablets are to be swallowed with water. Patients should be advised not to swallow the ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Moderate to severe hepatic impairment, i.e. Child-Pugh class B or C (see section 5.2). Baseline values of liver ...
Special warnings and precautions for use
The efficacy of Tracleer has not been established in patients with severe PAH. Transfer to a therapy that is recommended at the severe stage of the disease (e.g. epoprostenol) should be considered if the ...
Interaction with other medicinal products and other forms of interaction
Bosentan is an inducer of the cytochrome P450 (CYP) isoenzymes CYP2C9 and CYP3A4. In vitro data also suggest an induction of CYP2C19. Consequently, plasma concentrations of substances metabolised by these ...
Fertility, pregnancy and lactation
Pregnancy Studies in animals have shown reproductive toxicity (teratogenicity, embryotoxicity; see section 5.3). There are no reliable data on the use of Tracleer in pregnant women. The potential risk ...
Effects on ability to drive and use machines
No specific studies have been conducted to assess the direct effect of Tracleer on the ability to drive and use machines. However, Tracleer may induce hypotension, with symptoms of dizziness, blurred vision ...
Undesirable effects
In 20 placebo-controlled studies, conducted in a variety of therapeutic indications, a total of 2,486 patients were treated with bosentan at daily doses ranging from 100 mg to 2000 mg and 1,838 patients ...
Overdose
Bosentan has been administered as a single dose of up to 2,400 mg to healthy subjects and up to 2,000 mg/day for 2 months in patients with a disease other than pulmonary hypertension. The most common adverse ...
Pharmacodynamic properties
Pharmacotherapeutic group: other antihypertensives ATC code: C02KX01 Mechanism of action Bosentan is a dual endothelin receptor antagonist (ERA) with affinity for both endothelin A and B (ET<sub>A</sub> ...
Pharmacokinetic properties
The pharmacokinetics of bosentan have mainly been documented in healthy subjects. Limited data in patients show that the exposure to bosentan in adult PAH patients is approximately 2-fold greater than ...
Preclinical safety data
A 2-year carcinogenicity study in mice showed an increased combined incidence of hepatocellular adenomas and carcinomas in males, but not in females, at plasma concentrations about 2 to 4 times the plasma ...
List of excipients
<u>Tablet core:</u> Maize starch Pregelatinised starch Sodium starch glycolate (Type A) Povidone Glycerol dibehenate Magnesium stearate <u>Film coat:</u> Hypromellose Glycerol triacetate Talc Titanium ...
Incompatibilities
Not applicable.
Shelf life
4 years. For white high-density polyethylene bottles, use within 30 days after the first opening.
Special precautions for storage
For PVC/PE/PVDC/aluminium-blisters: Do not store above 30°C. For white high-density polyethylene bottles: This medicinal product does not require any special storage conditions. For storage conditions ...
Nature and contents of container
Tracleer 62.5 mg film-coated tablets: PVC/PE/PVDC/aluminium-blisters containing 14 film-coated tablets. Cartons contain 14, 56 or 112 film-coated tablets. White high-density polyethylene bottles with a ...
Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium
Marketing authorization number(s)
Tracleer 62.5 mg film-coated tablets: EU/1/02/220/001 EU/1/02/220/002 EU/1/02/220/003 EU/1/02/220/007 Tracleer 125 mg film-coated tablets: EU/1/02/220/004 EU/1/02/220/005 EU/1/02/220/008
Date of first authorization / renewal of the authorization
Date of first authorisation: 15 May 2002 Date of latest renewal: 20 April 2012
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