ACTIKERALL Cutaneous solution Ref.[50747] Active ingredients: Fluorouracil Salicylic acid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Almirall Hermal GmbH, Scholtzstrasse 3, 21465 Reinbek, Germany

Product name and form

Actikerall 5 mg/g + 100 mg/g Cutaneous Solution.

Pharmaceutical Form

Cutaneous solution.

Actikerall is a clear, colourless to slightly orange-white solution.

Qualitative and quantitative composition

1 g (= 1.05 ml) cutaneous solution contains 5 mg of fluorouracil and 100 mg of salicylic acid.

Excipient with known effect: 1 g of solution contains 80 mg of dimethyl sulfoxide/g of solutionand 160 mg ethanol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Fluorouracil

Fluorouracil is an antineoplastic anti-metabolite. Anti-metabolites masquerade as purine or pyrimidine – which become the building blocks of DNA. They prevent these substances from becoming incorporated into DNA during the “S” phase (of the cell cycle), stopping normal development and division. Fluorouracil blocks an enzyme which converts the cytosine nucleotide into the deoxy derivative. In addition, DNA synthesis is further inhibited because Fluorouracil blocks the incorporation of the thymidine nucleotide into the DNA strand. Fluorouracil is used for the topical treatment of multiple actinic or solar keratoses. In the 5% strength it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Fluorouracil injection is indicated in the palliative management of some types of cancer, including colon, esophageal, gastric, rectum, breast, biliary tract, stomach, head and neck, cervical, pancreas, renal cell, and carcinoid.

Salicylic acid

Salicylic acid has bacteriostatic and fungicidal actions, but it is its keratolytic properties which are important for this medicinal product. When applied externally it produces slow and painless destruction of the epithelium.

List of Excipients

Dimethyl sulfoxide
Ethanol, anhydrous
Ethyl acetate
Pyroxyline
Poly(butyl methacrylate, methyl methacrylate)

Pack sizes and marketing

This medicinal product is packed in a brown glass bottle with a child resistant closure of white polypropylene in a cardboard carton. The closure of the bottle is connected to a brush to apply the solution. The brush applicator (CE mark) consists of polyethylene (HDPE and LDPE 1:1) with brush hairs of nylon secured in shaft with stainless steel (V2A).

Pack size: 25 ml cutaneous solution.

Marketing authorization holder

Almirall Hermal GmbH, Scholtzstrasse 3, 21465 Reinbek, Germany

Marketing authorization dates and numbers

PL 33016/0015

Date of first authorisation: 03 June 2011
Date of latest renewal: 04 May 2016

Drugs

Drug Countries
ACTIKERALL Austria, Canada, Estonia, Spain, Finland, Lithuania, Mexico, Poland, United Kingdom

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