THELIN Film-coated tablet (2011)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Thelin 100 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 100 mg sitaxentan sodium. Excipients: Also contains 166.3mg of lactose monohydrate. For a full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet. Capsule shaped yellow-to-orange film-coated tablets, debossed with T-100 on one side.
Therapeutic indications
Treatment of patients with pulmonary arterial hypertension (PAH) classified as WHO functional class III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and in pulmonary ...
Posology and method of administration
Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH. Thelin is to be taken orally as a dose of 100 mg once daily. It may be taken with or without food and ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients. Mild to severe hepatic impairment (Child-Pugh Class A-C). Elevated aminotransferases prior to initiation of treatment (aspartate aminotransferase ...
Special warnings and precautions for use
The efficacy of Thelin as monotherapy has not been established in patients with NYHA/WHO functional class IV PAH. Transfer to a therapy that is recommended at the severe stage of the disease (eg, epoprostenol) ...
Interaction with other medicinal products and other forms of interaction
Sitaxentan sodium is metabolised in the liver by cytochrome P450 CYP2C9 and CYP3A4/5 isoenzymes. Sitaxentan sodium is an inhibitor of CYP2C9 and, to a lesser extent, CYP2C19, CYP3A4/5 and CYP2C8. Plasma ...
Fertility, pregnancy and lactation
Pregnancy There are no human data regarding the use of sitaxentan sodium during pregnancy. Sitaxentan sodium caused teratogenicity in rats (see section 5.3). Potential effects in humans are unknown. Thelin ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. A known undesirable effect is dizziness, which could influence the ability to drive or use machines.
Undesirable effects
General description Safety of Thelin has been evaluated in clinical trials of more than 1200 patients with PAH, as well as post-marketing safety data. At the recommended dose during placebo-controlled ...
Overdose
There is no specific experience with the management of Thelin overdose. In the event of overdose, symptomatic and supportive measures should be employed. During clinical trials, Thelin was given as a daily ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other antihypertensives ATC code: C02KX03 Mechanism of action Endothelin-1 (ET-1) is a potent vascular paracrine and autocrine peptide in the lung, and can also promote fibrosis, ...
Pharmacokinetic properties
Absorption Sitaxentan sodium is rapidly absorbed following oral administration. In PAH patients, peak plasma concentrations are generally achieved within 1-4 hours. The absolute bioavailability of Thelin ...
Preclinical safety data
In repeated-dose toxicity studies, dose-related liver changes (weight, centrilobular hypertrophy, occasionally necrosis), induction of hepatic drug metabolising enzymes and slightly decreased erythron ...
List of excipients
Tablet core: Cellulose, microcrystalline (E460) Lactose monohydrate Hypromellose (E464) Sodium starch glycolate Magnesium stearate (E470b) Disodium phosphate, anhydrous (E339) Ascorbyl palmitate (E304) ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 24 months.
Special precautions for storage
Store below 25°C.
Nature and contents of container
PVC/ACLAR/paper-backed aluminium blisters containing 14 tablets. Cartons contain 14, 28, 56, or 84 tablets. High-density polyethylene (HDPE) bottles containing 28 tablets. Not all pack sizes may be marketed. ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom
Marketing authorization number(s)
EU/1/06/353/001 EU/1/06/353/002 EU/1/06/353/003 EU/1/06/353/004 EU/1/06/353/005
Date of first authorization / renewal of the authorization
10 August 2006
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