SOLARAZE Gel (2019)

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Solaraze 3%, gel.

Qualitative and quantitative composition

Each gram contains 30 mg diclofenac sodium (3% w/w). For the full list of excipients, see section 6.1.

Pharmaceutical form

Gel. A clear, transparent, colourless or pale yellow gel.

Therapeutic indications

For the treatment of actinic keratosis (AK).

Posology and method of administration

Use in Adults Solaraze is applied locally to the affected area twice daily, with the gel smoothed into the skin gently. The amount needed depends on the size of the affected area. Normally 0.5 grams (the ...

Contraindications

Solaraze is contraindicated in patients with a known hypersensitivity to diclofenac, benzyl alcohol, macrogol monomethyl ether 350 and/or sodium hyaluronate. Because of cross-reactions, the gel should ...

Special warnings and precautions for use

The likelihood of systemic side effects occurring following the topical application of Solaraze is very small compared to the frequency of side effects with oral diclofenac, owing to low systemic absorption ...

Interaction with other medicinal products and other forms of interaction

Since systemic absorption of diclofenac from a topical application is very low such interactions are very unlikely.

Pregnancy and lactation

Pregnancy The systemic concentration of diclofenac is lower after topical administration, compared to oral formulations. With reference to experience from treatment with NSAIDs with systemic uptake, the ...

Effects on ability to drive and use machines

Cutaneous application of topical diclofenac has no influence on the ability to drive and use machines.

Undesirable effects

Most frequently reported reactions include skin reactions such as contact dermatitis, erythema and rash or application site reactions such as inflammation, irritation, pain and blistering. In studies there ...

Overdose

Due to the low systemic absorption of Solaraze, overdosage is extremely unlikely as a result of topical use. However, the skin should be rinsed with water. There have been no clinical cases of ingestion ...

Pharmacodynamic properties

ATC code: D11AX18 Other Dermatologicals Mechanisms of action Diclofenac is a non-steroidal anti-inflammatory drug. The mechanism of action of diclofenac in AK may be related to the inhibition of the cycloxygenase ...

Pharmacokinetic properties

Absorption Mean absorption through the skin varies between <1-12% with large inter-individual variability. Absorption is dependent on the amount of the topical dose applied and the site of application. ...

Preclinical safety data

Published animal studies have shown that when given orally, the principal adverse effect is on the gastrointestinal tract. Diclofenac inhibited ovulation in the rabbit and impaired implantation, as well ...

List of excipients

Sodium hyaluronate Benzyl alcohol Macrogol monomethyl ether 350 Purified water

Incompatibilities

Not applicable.

Shelf life

Shelf life: 2 years. After 1<sup>st</sup> opening: 6 months.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

The product is supplied in an epoxy-phenolic lined sealed aluminium tube with a white polypropylene screw on cap with a pierced tip, in 25 g, 50 g, 60 g, 90 g and 100 g sizes. Not all pack sizes may be ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Almirall, S.A., Ronda General Mitre, 151, 08022 Barcelona, Spain

Marketing authorization number(s)

PL 16973/0012

Date of first authorization / renewal of the authorization

1 September 2000 / 25 July 2007

Date of revision of the text

02 January 2019

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