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REGAINE FOAM Cutaneous foam (2018)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα

Name of the medicinal product

Regaine for Women Once a Day Scalp Foam 5% w/w Cutaneous Foam.

Qualitative and quantitative composition

Minoxidil 50 mg/g (5% w/w). Contains butylhydroxytoluene (BHT), stearyl alcohol and cetyl alcohol. For full list of excipients, see section 6.1.

Pharmaceutical form

Cutaneous foam. White to off-white foam.

Therapeutic indications

This product is indicated for the treatment of alopecia androgenetica in women (also known as female pattern hair loss) in women aged between 18 and 65. Onset and degree of hair regrowth may be variable ...

Posology and method of administration

Women aged 18-65 Hair and scalp should be thoroughly dry prior to topical application of this product. A dose of 1 g (equivalent to the volume of half a capful) of this product should be applied to the ...

Contraindications

This product is contraindicated: In men. In users with a history of sensitivity to minoxidil or any of the other ingredients. In users with treated or untreated hypertension. In users with any scalp abnormality ...

Special warnings and precautions for use

Before using this product, the user should determine that the scalp is normal and healthy. Topical minoxidil should not be applied to inflamed, infected or painful scalp skin (see section 4.3). Topical ...

Interaction with other medicinal products and other forms of interaction

This product should not be used concomitantly with other medications applied topically on the scalp (see section 4.3). Topical drugs, such as corticosteroids, tretinoin or dithranol or petrolatumwhich ...

Pregnancy and lactation

This product should not be used during pregnancy or lactation. Pregnancy There are no adequate and well-controlled studies in pregnant women. Studies in animals have shown a risk to the foetus at exposure ...

Effects on ability to drive and use machines

This product may cause dizziness or hypotension (see section 4.8). If affected, patients should not drive or operate machinery.

Undesirable effects

The safety of topical minoxidil from clinical trials data is based on data from 7 placebo-controlled randomised clinical trials in adults evaluating either 2% or 5% minoxidil solution, and two placebo-controlled ...

Overdose

Increased systemic absorption of minoxidil may potentially occur if higher-than-recommended doses of this product are applied to larger surface areas of the body or areas other than the scalp. Because ...

Pharmacodynamic properties

Pharmacotherapeutic group: Other dermatologicals ATC code: D11AX Individual responses to Regaine for Women ONCE A DAY are variable and unpredictable. The efficacy of 5% minoxidil topical foam for the treatment ...

Pharmacokinetic properties

Absorption The systemic absorption of topically applied minoxidil from normal intact skin is low.Systemic absorption of minoxidil from topically applied solution ranges between 1% and 2% of the total applied ...

Preclinical safety data

Preclinical data reveal no special hazards for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or carcinogenic potential. Cardiac effects of minoxidil ...

List of excipients

Ethanol, anhydrous Purified water Butylated hydroxytoluene (E321) Lactic acid Citric acid anhydrous Glycerol Cetyl alcohol Stearyl alcohol Polysorbate 60 Propane/n-Butane/Iso-butane (as propellant)

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Store below 25°C. This product is an extremely flammable aerosol.

Nature and contents of container

A lined aluminium pressurised container with a child-resistant plastic or polypropylene overcap, containing 60 gram of product. Packs contain either one or two cans. Not all pack sizes may be marketed. ...

Special precautions for disposal and other handling

Precautions during use, storage and disposal Pressurized container: May burst if heated. Protect from sunlight and do not expose to temperatures above 50°C. Do not pierce or burn, even after use. Do not ...

Marketing authorization holder

McNeil Products Limited, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG, United Kingdom

Marketing authorization number(s)

PL 15513/0135

Date of first authorization / renewal of the authorization

09 October 2014

Date of revision of the text

01 May 2018

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