SOLACUTAN Gel (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Solacutan 3% gel.
2. Qualitative and quantitative composition
Each gram of gel contains 30 mg diclofenac sodium. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gel. Clear, transparent, colourless to yellowish.
4.1. Therapeutic indications
For the cutaneous treatment of actinic keratoses (AKs) with a severity grade of 1 or 2 (according to Olsen), preferably on the face or scalp.
4.2. Posology and method of administration
Posology Adults Solacutan gel should be applied to the affected skin areas twice daily and smoothed into the skin gently. The amount used depends on the size of the area to be treated. Usually 0.5 g of ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Because of the potential for cross-reactions, the gel should not be used in patients who have experienced hypersensitivity ...
4.4. Special warnings and precautions for use
Due to the low systemic absorption of Solacutan gel, the likelihood of systemic adverse reactions following the external use of Solacutan gel is small compared to the frequency of adverse reactions with ...
4.5. Interaction with other medicinal products and other forms of interaction
Since systemic absorption of diclofenac from a topical formulation is very low, such interactions are very unlikely.
4.6. Fertility, pregnancy and lactation
Pregnancy The systemic concentration of diclofenac is lower after topical application compared to oral formulations. With reference to experience from treatment with non-steroidal anti-inflammatory medicinal ...
4.7. Effects on ability to drive and use machines
Cutaneous use of topical diclofenac has no influence on the ability to drive and use machines.
4.8. Undesirable effects
Common adverse reactions: The most frequently reported adverse reactions are local skin reactions such as contact dermatitis, erythema and rash or application site reactions such as inflammation, skin ...
4.9. Overdose
The low systemic absorption of topical diclofenac renders overdose very much unlikely. However, the skin should be rinsed with water. There have been no reports of clinical cases of overdosage from ingestion ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Other dermatologicals <b>ATC code:</b> D11AX18 Mechanism of action Diclofenac is a non-steroidal anti-inflammatory medicinal product. The mechanism of action of diclofenac ...
5.2. Pharmacokinetic properties
Absorption Mean absorption of diclofenac through the skin ranges from <1% to 12% with large interindividual variability. Absorption depends on the topically applied dose and the site of application. Distribution ...
5.3. Preclinical safety data
Published animal studies have shown that, when diclofenac is administered orally, adverse reactions affect mainly the gastrointestinal tract. Diclofenac inhibited ovulation in rabbits and impaired implantation ...
6.1. List of excipients
Sodium hyaluronate Macrogol 400 Benzyl alcohol Purified water
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years. After first opening: 6 months.
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
Aluminium tube with original sealing membrane and internal protective lacquer and HDPE screw cap. 10 g gel 25 g gel 26 g gel 30 g gel 50 g gel 60 g gel 90 g gel Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Mibe Pharma UK Ltd, 4 Coleman Street, 6th Floor; London, United Kingdom, EC2R 5AR
8. Marketing authorization number(s)
PL 49452/0001
9. Date of first authorization / renewal of the authorization
09.02.2017
10. Date of revision of the text
August 2018
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