GRISOL Cutaneous spray, solution (2018)
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
GRISOL 1% Spray Solution.
Qualitative and quantitative composition
Griseofulvin 1% w/w. Each spray delivers 400 micrograms of griseofulvin (0.05ml per dose). For excipients, see 6.1
Pharmaceutical form
Cutaneous spray, solution.
Therapeutic indications
The treatment of tinea pedis (athletes foot).
Posology and method of administration
Method of Administration Cutaneous use; to be applied topically to the feet. When applied to the feet it may be necessary to hold the toes apart to reveal the full area to be treated. The affected areas ...
Contraindications
Hypersensitivity to griseofulvin or organic solvents.
Special warnings and precautions for use
Grisol is for external use only and should only be applied to the feet. Do not spray onto any other parts of the body. Avoid spraying Grisol into the eyes. The solution should not be allowed to come into ...
Interaction with other medicinal products and other forms of interaction
None known.
Pregnancy and lactation
Systemic treatment with griseofulvin should be avoided in pregnancy and although human studies have not shown any significant absorption into the systemic circulation following topical administration of ...
Effects on ability to drive and use machines
None known.
Undesirable effects
Grisol may cause skin irritation, i.e. slight stinging or burning on application, although this is unlikely to necessitate discontinuation of treatment. Reporting of suspected adverse reactions Reporting ...
Overdose
If Grisol is accidentally ingested, overdosage from griseofulvin active ingredient is unlikely to require treatment, however the component solvents could give rise to symptoms of alcoholic intoxication ...
Pharmacodynamic properties
The active ingredient of Grisol, griseofulvin, is an antifungal agent which, when applied topically in this formulation, penetrates the skin in the tissues of which it remains active against dermatophyte ...
Pharmacokinetic properties
Studies in humans have demonstrated no significant absorption. When taken orally griseofulvin is metabolised by the liver mainly to 6-desmethyl- griseofulvin which is excreted in the urine. A large amount ...
Preclinical safety data
Animal studies undertaken with respect to Grisol relate appropriately to local toxicity and absorption. Twenty-eight day studies of the effects of griseofulvin, benzyl alcohol, acetone and isopropyl alcohol ...
List of excipients
Acetone Benzyl alcohol Isopropyl alcohol
Incompatibilities
None known.
Shelf life
3 years.
Special precautions for storage
Do not store above 25°C. Protect from direct light and heat. Highly flammable, keep away from naked flames.
Nature and contents of container
Glass bottles of nominal volume 20 ml, each fitted with a spray pump assembly designed to deliver approximately 0.05 ml per actuation and fitted with a protective plastic cap. Each bottle is packed in ...
Special precautions for disposal and other handling
Highly flammable, keep away from naked flames. Store the container in an upright position. Before using the spray, one dose should be directed at a piece of waste paper or tissue to make sure the spray ...
Marketing authorization holder
Transdermal Limited, Merlin House, Brunel Road, Theale, Reading RG7 4AB, United Kingdom
Marketing authorization number(s)
14308/0001
Date of first authorization / renewal of the authorization
07/04/2009
Date of revision of the text
10/01/2018
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
