PANRETIN Gel (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Panretin 0.1% gel.
Qualitative and quantitative composition
1 g of gel contains 1 mg alitretinoin (0.1%). For the full list of excipients, see section 6.1.
Pharmaceutical form
Gel. Clear yellow gel.
Therapeutic indications
Panretin gel is indicated for the topical treatment of cutaneous lesions in patients with AIDSrelated Kaposis sarcoma (KS) when: lesions are not ulcerated or lymphoedematous treatment of visceral KS is ...
Posology and method of administration
Posology Panretin therapy should only be initiated and maintained by specialist physicians experienced in the treatment of patients with KS. Men Patients should apply Panretin to cutaneous KS lesions using ...
Contraindications
Hypersensitivity to retinoids in general, to the active substance alitretinoin or to any of the excipients listed in section 6.1. Pregnancy and breast-feeding (see section 4.6). Women planning a pregnancy. ...
Special warnings and precautions for use
Retinoids as a class have been associated with photosensitivity. There were no reports of photosensitivity associated with the use of Panretin gel in the clinical studies. However, patients must be cautioned ...
Interaction with other medicinal products and other forms of interaction
The use of other topical products on Panretin treated KS lesions should be avoided. Mineral oil may be used between Panretin applications in order to help prevent excessive dryness or itching. However, ...
Pregnancy and lactation
Women of child-bearing potential Women of child-bearing potential must use effective contraception during, and up to one month after cessation of treatment. Men using Panretin should take precautions to ...
Effects on ability to drive and use machines
Panretin gel is for cutaneous use and is unlikely to have an effect on the ability to drive and use machines.
Undesirable effects
Adverse events associated with the use of Panretin gel in AIDS-related KS occurred almost exclusively at the site of application. The dermal toxicity typically begins as erythema; with continued application ...
Overdose
No case of overdose has been reported. Systemic toxicity following acute overdose with topical application of Panretin gel is unlikely.
Pharmacodynamic properties
Pharmacotherapeutic group: other antineoplastic agents ATC code: LO1XX22 Although the molecular action of alitretinoin is thought to be mediated through interaction with the retinoid receptors, the exact ...
Pharmacokinetic properties
Plasma concentrations of 9-cis-retinoic acid were evaluated during clinical studies in patients with cutaneous lesions of AIDS-related KS after repeated multiple-daily dose application of Panretin gel ...
Preclinical safety data
Toxicology Three doses of alitretinoin (0.01%, 0.05%, or 0.5%) in a topical gel formulation were given to rats in a 28-day dermal toxicology study. Observed effects at the application site included erythema, ...
List of excipients
Ethanol Macrogol 400 Hydroxypropylcellulose Butylhydroxytoluene
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. The use of other topical products on treated KS lesions should be avoided. Panretin gel ...
Shelf life
Shelf life Unopened: 3 years. In-use: Any remaining tube should be discarded 90 days after first opening.
Special precautions for storage
Do not store above 25°C. Store in the original container in order to protect from light. Keep the container tightly closed. After opening the tube for application, the tube cap must be replaced and closed ...
Nature and contents of container
Panretin gel is supplied in a multi-use 60 g epoxy-lined aluminium tube. Each carton contains one tube of gel.
Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements. Panretin gel contains alcohol, keep away from naked flame.
Marketing authorization holder
Eisai GmbH, Lyoner Straße 36, 60528, Frankfurt am Main, Germany, E-mail: medinfo_de@eisai.net
Marketing authorization number(s)
EU/1/00/149/001
Date of first authorization / renewal of the authorization
Date of first authorization: 11 October 2000 Date of latest renewal: 27 September 2010
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