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Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
Κλαύδιος Γαληνός
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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Targretin Capsules (2012)

Εκδότης

Εκδότης Eisai Ltd
Διεύθυνση Teva UK Limited, Field House, Station Approach, Harlow, Essex, CM20 2FB
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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. For a 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 capsules are indicated for the treatment of skin manifestations of advanced stage cutaneous ...

Posology and method of administration

Bexarotene therapy should only be initiated and maintained by physicians experienced in the treatment ...

Contraindications

Known hypersensitivity to bexarotene or to any of the excipients of the product. Pregnancy and lactation. ...

Special warnings and precautions for use

General: Targretin capsules should be used with caution in patients with a known hypersensitivity to ...

Special warnings and precautions for use

Do not store above 30°C. Keep the bottle tightly closed.

Interaction with other medicinal products and other forms of interaction

Effects of other substances on bexarotene: no formal studies to evaluate interactions with bexarotene ...

Pregnancy and lactation

Pregnancy There are no adequate data from the use of bexarotene in pregnant women. Studies in animals ...

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 ...

Undesirable effects

The safety of bexarotene has been examined in clinical studies of 193 patients with CTCL who received ...

Overdose

No clinical experience with an overdose of Targretin has been reported. Any overdose should be treated ...

Pharmacodynamic properties

Pharmacotherapeutic Group: other antineoplastic agents ATC code: L01XX25 Bexarotene is a synthetic compound ...

Pharmacokinetic properties

Absorption/dose proportionality: pharmacokinetics were linear up to a dose of 650 mg/m2. Terminal elimination ...

Preclinical safety data

Carcinogenesis, mutagenesis, impairment of fertility Bexarotene is not genotoxic. Carcinogenicity studies ...

List of excipients

Capsule content: Macrogol Polysorbate Povidone Butylated hydroxyanisole Capsule shell: Gelatin Sorbitol ...

Incompatibilities

Not applicable.

Shelf life

3 years.

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.

Marketing authorization holder

Eisai Ltd. European Knowledge Centre Mosquito Way Hatfield Hertfordshire AL10 9SN United Kingdom

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: 29 March 2006

Date of revision of the text

6th Apr 2009
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.