Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Almirall, S.A., Ronda General Mitre, 151, 08022 Barcelona, Spain
For the treatment of actinic keratosis (AK).
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 size of a pea) of the gel is used on a 5 cm x 5 cm lesion site. The maximum daily amount of 8 grams of product allows simultaneous treatment of up to 200 cm² skin surface area.
The usual duration of therapy is from 60 to 90 days. Maximum efficacy has been observed with treatment duration towards the upper end of this range. Complete healing of the lesion(s) or optimal therapeutic effect may not be evident for up to 30 days following cessation of therapy.
The usual adult dose may be used.
AK is a condition not generally seen within the paediatric population and was not studied. Therefore, dosage recommendations and indications for the use of Solaraze have not been established for use in children.
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 of Solaraze inducing overdosage.
In the event of accidental ingestion (100 g Solaraze gel contain the equivalent of 3000 mg diclofenac sodium) resulting in significant systemic side effects, general therapeutic measures normally adopted to treat poisoning with non-steroidal anti-inflammatories should be used.
Supporting and symptomatic treatment should be given for complications such as renal failure, convulsions, gastrointestinal irritation and respiratory depression. Gastric decontamination and the use of activated charcoal should be considered, especially within a short time of ingestion.
Specific therapies such as forced diuresis and dialysis will probably not be therapeutic in eliminating NSAIDs due to their high rate of protein binding.
Shelf life: 2 years.
After 1st opening: 6 months.
Do not store above 25°C.
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 marketed.
No special requirements.
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