LYCLEAR Cream (2020)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Lyclear Dermal Cream.
Qualitative and quantitative composition
Permethrin, Medical Grade 5.0% w/w (Cis/Trans Isomer 25/75). For the full list of excipients, see section 6.1.
Pharmaceutical form
Cream for topical application.
Therapeutic indications
Lyclear Dermal Cream is indicated for the treatment of scabies in adults and children aged from 2 months, and crab lice in adults.
Posology and method of administration
Posology Treatment of scabies Adults and adolescents over 12 years of age Apply up to 30 g of cream (corresponding to one tube of 30 g). Paediatric population Children aged from 6-12 years: Apply up to ...
Contraindications
Hypersensitivity to the active substance permethrin or other substances of the pyrethrin group or to any of the excipients listed in section 6.1. In such cases treatment should be switched to a chemically ...
Special warnings and precautions for use
In the case of hypersensitivity to chrysanthemums or other compositae, treatment should only be given if strictly indicated. In such cases treatment should be switched to a chemically different agent. ...
Interaction with other medicinal products and other forms of interaction
No interactions are known. The treatment of eczematous-like reactions with corticosteroids should be withheld prior to treatment with Lyclear Dermal Cream, as there is a risk of exacerbating the scabies ...
Pregnancy and lactation
There are limited data on the use of Lyclear Dermal Cream in pregnancy which provide no indication of any risk to the foetus. Furthermore the amount of permethrin absorbed systemically following a whole ...
Effects on ability to drive and use machines
None known.
Undesirable effects
In scabies patients, skin discomfort, usually described as burning, stinging or tingling, occurs in a few individuals soon after Lyclear Dermal Cream is applied. This occurs more frequently in patients ...
Overdose
There are no reports of overdosage with Lyclear Dermal Cream. Application of a full tube of cream to a 2 month old would result in a dose of approximately 350 mg/kg bodyweight to skin. It is unlikely that ...
Pharmacodynamic properties
The principal physiological action in insects (lice) exposed to permethrin is induction of electrochemical abnormalities across the membranes of excitable cells, leading to sensory hyperexcitability, inco-ordination ...
Pharmacokinetic properties
Investigations with the 5% cream in humans revealed an average percutaneous absorption rate of 0.47 ± 0.3% in healthy subjects and of 0.52 ± 0.3% in patients. Pharmacokinetic properties were studied in ...
Preclinical safety data
From acute and chronic toxicity studies there is no evidence indicating the occurrence of previously unknown adverse effects in humans. Furthermore there is no evidence on relevant genotoxic or carcinogenic ...
List of excipients
Fractionated coconut oil Glyceryl monostearate Macrogol (2) cetyl ether Cetomacrogol 1000 Isopropyl myristate Lanolin alcohols/liquid paraffin Mixture (amerchol 1-101) Butylated hydroxytoluene Glycerol ...
Incompatibilities
None known.
Shelf life
60 months.
Special precautions for storage
Do not store above 25°C. Do not freeze.
Nature and contents of container
Plastic foil laminate ointment tubes (30g) with Polyolefin screw caps. Or Internally lacquered membrane sealed collapsible aluminium tubes (30g) with high density polyethylene caps.
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Omega Pharma Ltd., 1st Floor, 32 Vauxhall Bridge Road, LONDON, SW1V 2SA, United Kingdom
Marketing authorization number(s)
PL 02855/0014
Date of first authorization / renewal of the authorization
17th January 2005
Date of revision of the text
01/2020
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
