EURAX Cream (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Eurax Cream Or Boots Dermacare Itch Relief Cream
2. Qualitative and quantitative composition
<u>Active ingredient:</u> Crotamiton 10%. Excipient(s) with known effects: Stearyl alcohol Methyl Hydroxybenzoate Sodium lauryl sulphate (0.45%w/w) Perfume (contains geraniol, citronellol, coumarin, benzyl ...
3. Pharmaceutical form
Cream. A white to cream coloured cream, with a slight characteristic odour.
4.1. Therapeutic indications
For the relief of itching and skin irritation caused by, for example, sunburn, dry eczema, itchy dermatitis, allergic rashes, hives, nettle rash, chickenpox, insect bites and stings, heat rashes and personal ...
4.2. Posology and method of administration
Pruritus Adults (including the elderly) Apply to the affected area 2-3 times daily. Eurax/Boots Dermacare Itch Relief Cream will provide relief from irritation for 6 to10 hours after each application. ...
4.3. Contraindications
Acute exudative dermatoses. Hypersensitivity to the active substance or to any of the excipients (see section 6.1, List of excipients).
4.4. Special warnings and precautions for use
For external use only. Eurax/Boots Dermacare Itch Relief Cream can be used for children; However, for children under three years of age usage should only be under medical supervision. Should not be used ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6. Fertility, pregnancy and lactation
Pregnancy There are no controlled studies of Eurax/Boots Dermacare Itch Relief Cream in human pregnancy. Therefore Eurax/Boots Dermacare Itch Relief Cream is not recommended during pregnancy, especially ...
4.7. Effects on ability to drive and use machines
Eurax/Boots Dermacare Itch Relief Cream has no influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile The most commonly reported adverse reaction during treatment is pruritus. Contact dermatitis and hypersensitivity reactions like rash, eczema, erythema, skin irritation and ...
4.9. Overdose
In cases of accidental ingestion, acute intoxication symptoms may be observed such as nausea, vomiting and irritation of the buccal, oesophageal and gastric mucosa. Rare cases of loss of consciousness ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> other antipruritics (ATC code D04AX) and other ectoparasiticides, including scabicides (ATC code P03AX). Crotamiton has a symptomatic action on pruritus and is an acaricide. ...
5.2. Pharmacokinetic properties
Eurax penetrates rapidly into human skin. Low but measurable concentrations of crotamiton are found in plasma, with a maximum level after 4-10 hours, declining rapidly thereafter.
5.3. Preclinical safety data
No preclinical studies were performed using Eurax Cream. Preclinical data do not show teratogenic nor genotoxic risk for crotamiton. Abnormalities of foetal development were observed following administration ...
6.1. List of excipients
Methyl hydroxybenzoate Phenylethyl alcohol Glycerol Triethanolamine Sodium lauryl sulphate (0.45%w/w) Ethylene glycol monostearate Stearyl alcohol Strong ammonia solution 25% Stearic acid Hard paraffin ...
6.2. Incompatibilities
None.
6.3. Shelf life
30 months.
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
Internally lacquered aluminium tube with an inner coating made of epoxy-phenol resin lacquer closed with a polyethylene screw cap, in a cardboard carton. <u>Pack sizes:</u> 20, 30 and 100g
6.6. Special precautions for disposal and other handling
None.
7. Marketing authorization holder
Thornton & Ross Ltd., Linthwaite, Huddersfield, HD7 5QH, UK
8. Marketing authorization number(s)
PL 00240/0461
9. Date of first authorization / renewal of the authorization
01/09/1997
10. Date of revision of the text
08/10/2020
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