TARGRETIN Soft capsule (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Targretin 75 mg soft capsules.
Qualitative and quantitative composition
Each capsule contains 75 mg of bexarotene. Excipient(s) with known effect: sorbitol For the full list of excipients, see section 6.1.
Pharmaceutical form
Soft capsule. Off-white capsule, containing a liquid suspension and imprinted with Targretin.
Therapeutic indications
Targretin is indicated for the treatment of skin manifestations of advanced stage cutaneous T-cell lymphoma (CTCL) in adult patients refractory to at least one systemic treatment.
Posology and method of administration
Bexarotene therapy should only be initiated and maintained by physicians experienced in the treatment of patients with CTCL. Posology The recommended initial dose is 300 mg/m²/day. Initial dose calculations ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Pregnancy and lactation. Women of child-bearing potential without effective birth-control measures. History of ...
Special warnings and precautions for use
General Targretin capsules should be used with caution in patients with a known hypersensitivity to retinoids. No clinical instances of cross-reactivity have been noted. Patients receiving bexarotene should ...
Interaction with other medicinal products and other forms of interaction
Effects of other substances on bexarotene No formal studies to evaluate interactions with bexarotene have been conducted. On the basis of the oxidative metabolism of bexarotene by cytochrome P450 3A4 (CYP3A4), ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate data from the use of bexarotene in pregnant women. Studies in animals have shown reproductive toxicity. Based on the comparison of animal and patient exposures to bexarotene, ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However, dizziness and visual difficulties have been reported in patients taking Targretin. Patients who experience ...
Undesirable effects
Summary of the safety profile The safety of bexarotene has been examined in clinical studies of 193 patients with CTCL who received bexarotene for up to 118 weeks and in 420 non-CTCL cancer patients in ...
Overdose
No clinical experience with an overdose of Targretin has been reported. Any overdose should be treated with supportive care for the signs and symptoms exhibited by the patient. Doses up to 1000 mg/m²/day ...
Pharmacodynamic properties
Pharmacotherapeutic group: other antineoplastic agents ATC code: L01XX25 Mechanism of action Bexarotene is a synthetic compound that exerts its biological action through selective binding and activation ...
Pharmacokinetic properties
Absorption Absorption/dose proportionality Pharmacokinetics were linear up to a dose of 650 mg/m². Terminal elimination half-life values were generally between one and three hours. Following repeat once ...
Preclinical safety data
Bexarotene is not genotoxic. Carcinogenicity studies have not been conducted. Fertility studies have not been conducted; however, in sexually immature male dogs, reversible aspermatogenesis (28-day study) ...
List of excipients
Capsule content: Macrogol Polysorbate Povidone Butylated hydroxyanisole Capsule shell: Gelatin Sorbitol special-glycerin blend (glycerin, sorbitol, sorbitol anhydrides (1,4-sorbitan), mannitol and water) ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Do not store above 30°C. Keep the bottle tightly closed.
Nature and contents of container
High-density polyethylene bottles with child-resistant closures containing 100 capsules.
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
Eisai GmbH, Lyoner Straße 36, 60528 Frankfurt am Main, Germany, e-mail: medinfo_de@eisai.net
Marketing authorization number(s)
EU/1/01/178/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 29 March 2001 Date of latest renewal: 24 April 2006
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