NERIDERM Cream / Ointment (2014)
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Περιεχόμενα
Name of the medicinal product
Neriderm Cream. Neriderm Ointment.
Qualitative and quantitative composition
<u>Neriderm Cream:</u> 100g cream contains 0.1g diflucortolone valerate. <u>Neriderm Ointment:</u> 100g ointment contains 0.1g diflucortolone valerate.
Pharmaceutical form
Cream, Ointment.
Therapeutic indications
Corticoid responsive dermatoses in the absence of infection.
Posology and method of administration
Adults Initially, Neriderm should be applied thinly twice daily. When the condition improves or when longer periods of treatment are required one application daily is appropriate. Long-term continuous ...
Contraindications
Rosacea and peri-oral dermatitis. Acne vulgaris, undiagnosed perianal and genital pruritus, napkin eruptions, Tuberculous or syphilitic processes in the area to be treated; viral infections, primary bacterial ...
Special warnings and precautions for use
Additional, specific therapy is required in bacterially infected skin diseases and/or in fungus infections. If the skin dries out too much under protracted use of Neriderm cream, the patient should be ...
Interaction with other medicinal products and other forms of interaction
None stated.
Pregnancy and lactation
There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities in foetal development including cleft palate and intra-uterine ...
Effects on ability to drive and use machines
None stated.
Undesirable effects
Common local adverse reactions reported with Neriderm formulations in clinical studies include burning, pruritus, erythema, itching, vesiculation and irritations. In common with all other topical corticoids, ...
Overdose
On the basis of results from acute toxicity studies with both diflucortolone valerate and Neriderm preparations, no acute risk of intoxication is to be expected either after a single dermal application ...
Pharmacodynamic properties
Diflucortolone valerate is a topically acting fluoridated corticosteroid which suppresses inflammation in inflammatory and allergic skin conditions and alleviates the subjective complaints such as itching, ...
Pharmacokinetic properties
In order to exert its antiproliferative and anti-inflammatory effects, diflucortolone valerate has to diffuse from the preparation into the living epidermis and into the upper dermis. In vitro penetration ...
Preclinical safety data
There are no preclinical safety data which could be of relevance to the prescriber and which are not already included in other relevant sections of the SPC.
List of excipients
<u>Neriderm Cream:</u> Polyoxyl 40 stearate Stearyl alcohol Vaselin-white Paraffin liquid heavy Edetate disodium dihydrate Carbopol 980 Sodium Hydroxide Methyl parahydroxy benzoate Propyl parahydroxy benzoate ...
Incompatibilities
None stated.
Shelf life
5 years.
Special precautions for storage
Store in a cold place, below 25°C.
Nature and contents of container
Aluminium tubes containing 30g cream or ointment.
Instructions for Use/Handling
Keep out of reach of children.
Marketing authorization holder
Perrigo Israel Pharmaceuticals, Ltd., Yerucham
Marketing authorization number(s)
Neriderm Cream: 061-50-24636-00 Neriderm Ointment: 061-51-24637-00
Date of revision of the text
1.9.2014
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