ANTHISAN BITE AND STING Cream (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Anthisan Bite and Sting 2% w/w Cream.
Qualitative and quantitative composition
Mepyramine Maleate 2% w/w. Also contains: Castor oil 23,60% w/w Ceto-stearyl alcohol 13,80% w/w Propylene glycol 600 monostearate 4,90% w/w Methyl hydroxybenzoate 0,20% w/w For a full list of excipients, ...
Pharmaceutical form
A smooth off-white cream.
Therapeutic indications
Symptomatic relief of skin irritation caused by insect stings, insect bites and nettle stings. Route of Administration Topical.
Posology and method of administration
Adults, elderly and children over 2 years of age and older. Anthisan Bite and Sting Cream should be applied directly to the affected parts two or three times a day for up to three days. Early application ...
Contraindications
Anthisan Bite and Sting Cream should not be used in eczematous conditions or on extensively broken skin surfaces, or if the skin is cut or grazed. Do not use on large areas of skin or on areas of sunburnt ...
Special warnings and precautions for use
Repeated application of Anthisan Bite and Sting Cream to the same area for longer than three days is not recommended and treatment should be discontinued immediately if skin sensitisation occurs.
Interaction with other medicinal products and other forms of interaction
No significant interactions described.
Pregnancy and lactation
There is no evidence of the safety of mepyramine maleate in human pregnancy, but it has been widely used for many years without apparent ill consequence. Absorption of a significant amount after topical ...
Effects on ability to drive and use machines
Anthisan Bite and Sting Cream has minor or moderate influence on the ability to drive and use machines. May theoretically be extensively absorbed through the skin when applied over large areas and cause ...
Undesirable effects
Skin sensitisation has been reported on rare occasions. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows ...
Overdose
A 20g tube of Anthisan Bite and Sting Cream contains 400mg mepyramine maleate. If the product is ingested in significant amounts, this could be life-threatening in young children. The chief symptoms of ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antihistamines for Topical Use ATC code: R06AC01 Mepyramine maleate is an antihistamine with anti-pruritic and local analgesic actions.
Pharmacokinetic properties
No pharmacokinetic data available by any route of administration.
Preclinical safety data
There are no findings of relevance to the prescriber, additional to those already included in other sections of the SPC.
List of excipients
Ceto-stearyl alcohol Polyethylene glycol 600 monostearate Castor oil Methyl hydroxybenzoate Foin coupe (fragrance) Silicone antifoam Purified water
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
Collapsible aluminium tube with extended nozzle and polyethylene screw cap containing 20g cream.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Aventis Pharma Limited, trading as Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, United Kingdom
Marketing authorization number(s)
PL 04425/0275
Date of first authorization / renewal of the authorization
Date of first authorisation: 7 June 2000 Date of latest renewal: 2 September 2005
Date of revision of the text
12/03/2020
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