SCENESSE Implant (2020)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
SCENESSE 16 mg implant.
Qualitative and quantitative composition
The implant contains 16 mg of afamelanotide. For the full list of excipients, see section 6.1.
Pharmaceutical form
Implant. Solid white to off-white rod approximately 1.7 cm in length and 1.5 mm in diameter
Therapeutic indications
SCENESSE is indicated for prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).
Posology and method of administration
SCENESSE should only be prescribed by specialist physicians in recognised porphyria centres and administration should be performed by a physician trained and accredited by the marketing authorisation holder ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Presence of severe hepatic disease Hepatic impairment (see section 5.2) Renal impairment (see section 5.2)
Special warnings and precautions for use
Concomitant disorders not studied Clinically significant disorders of the gastrointestinal, cardiovascular, respiratory, endocrine (including diabetes, Cushings disease, Addisons disease, Peutz-Jeghers ...
Interaction with other medicinal products and other forms of interaction
No specific interaction studies have been performed with this medicinal product. Pharmacokinetic data for afamelanotide or any of its metabolites are very limited. As an oligopeptide with a short half-life, ...
Fertility, pregnancy and lactation
Women of childbearing potential/contraception in females Women of childbearing potential have to use effective contraception during treatment with SCENESSE and for a period of three months thereafter. ...
Effects on ability to drive and use machines
Afamelanotide has moderate influence on the ability to drive and use machines, especially within 72 hours of administration. Following administration of this medicinal product, somnolence, fatigue, dizziness, ...
Undesirable effects
Summary of the safety profile The safety profile is based on pooled data from clinical studies in 425 patients. The most commonly reported adverse reactions are nausea, experienced by approximately 19% ...
Overdose
There are no data available on symptoms or treatment of overdose with afamelanotide.
Pharmacodynamic properties
Pharmacotherapeutic group: Emollients and protectives, protectives against UV-radiation for systemic use ATC code: D02BB02 Mechanism of action Afamelanotide is a synthetic tridecapeptide and a structural ...
Pharmacokinetic properties
Dose-finding studies have not been conducted. The pharmacokinetics of afamelanotide have not been fully characterised yet, i.e. distribution, metabolism or excretion are not clear. No pharmacokinetic information ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, toxicity to reproduction and development. In repeated dose ...
List of excipients
Poly (DL-lactide-co-glycolide)
Incompatibilities
Not applicable.
Shelf life
Shelf life: 4 years.
Special precautions for storage
Store in a refrigerator (2˚C-8˚C).
Nature and contents of container
Type I amber glass vial sealed with a PTFE coated rubber stopper. Pack of one vial containing one implant.
Special precautions for disposal and other handling
For instructions on correct administration and preparation see section 4.2. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
CLINUVEL EUROPE LIMITED, 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland
Marketing authorization number(s)
EU/1/14/969/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 22 December 2014 Date of latest renewal: 19 November 2019
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