NUTRAPLUS Cream (2017)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Nutraplus 10% w/w Cream.
Qualitative and quantitative composition
Each gram of cream contains 100mg of Urea. Excipients with known effect: Methyl parahydroxybenzoate (E218) 1.8 mg/g, Propyl parahydroxybenzoate (E216) 0.9 mg/g, Propylene glycol 45mg/g, Cetearyl alcohol ...
Pharmaceutical form
Cream. Smooth white, almost odourless cream (water in oil emulsion).
Therapeutic indications
An emollient, moisturising and protective cream for the treatment of dry or damaged skin.
Posology and method of administration
Adults, paediatric population and older people Apply evenly to the dry skin areas two to three times daily, or as directed by the physician or pharmacist.
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. The product should not be used extensively in patients with severe renal impairment.
Special warnings and precautions for use
Avoid contact with the eyes and mucous membranes. If irritation occurs, discontinue use temporarily and consult a physician. Apply with caution only to damaged or inflamed skin or to the face. The product ...
Interaction with other medicinal products and other forms of interaction
Urea may enhance the efficacy of topical formulations of 5-fluorouracil and dithranol, and increase the release and the permeation into the skin of active ingredients from other topical products such as ...
Pregnancy and lactation
There are no clinical data available concerning use in pregnancy. There are no adequate experimental animal studies available concerning the effects on pregnancy, embryonic development, foetal development ...
Effects on ability to drive and use machines
Nutraplus has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Skin and subcutaneous tissue Hypersensitivity reactions to the ingredients or skin irritation in the treatment of acute inflammatory skin disorders are possible. Erythema, skin burning sensation and pruritus ...
Overdose
Intoxication after the use of Nutraplus is not known and is not to be expected due to the composition of the preparation. Skin irritation caused by overdose subsides quickly when the preparation is discontinued. ...
Pharmacodynamic properties
Pharmacotherapeutic group: Protectives and emollients ATC code: D02AE01 Urea is a recognised hydrating agent that has been widely used topically to treat dry or damaged skin.
Pharmacokinetic properties
Not applicable. Nutraplus is a topical (cutaneous) preparation.
Preclinical safety data
No specific information is presented given the widespread use of topically applied urea on humans over many years.
List of excipients
Glycerol monostearate Octyl palmitate Myristyl lactate Mineral oil Promulgen D (contains Cetearyl alcohol and ceteareth-20) Propylene glycol Propyl parahydroxybenzoate (E216) Methyl parahydroxybenzoate ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not store above 25°C. As with all medicines, Nutraplus Cream should be stored out of the sight and reach of children.
Nature and contents of container
White, polyethylene tube with a white polypropylene screw cap as the closure. Pack sizes: 60g and 100g. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts, WD17 1DS, UK
Marketing authorization number(s)
PL 10590/0002
Date of first authorization / renewal of the authorization
04<sup>th</sup> June 1991
Date of revision of the text
31<sup>st</sup> July 2017
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