ACTIKERALL Cutaneous solution (2020)
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Περιεχόμενα
1. Name of the medicinal product
Actikerall 5 mg/g + 100 mg/g Cutaneous Solution.
2. Qualitative and quantitative composition
1 g (= 1.05 ml) cutaneous solution contains 5 mg of fluorouracil and 100 mg of salicylic acid. <u>Excipient with known effect:</u> 1 g of solution contains 80 mg of dimethyl sulfoxide/g of solutionand ...
3. Pharmaceutical form
Cutaneous solution. Actikerall is a clear, colourless to slightly orange-white solution.
4.1. Therapeutic indications
Actikerall is indicated for the topical treatment of slightly palpable and/or moderately thick hyperkeratotic actinic keratosis (grade I/II) in immunocompetent adult patients. Grade I/II intensity is based ...
4.2. Posology and method of administration
Posology Adults Actikerall should be applied once daily to the affected area (up to 25 cm²) until the lesions have completely cleared or for up to a maximum of 12 weeks. If severe side effects occur, reduce ...
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Actikerall is contraindicated in pregnancy and lactation (see section 4.6). Actikerall must not be used to treat ...
4.4. Special warnings and precautions for use
DPD enzyme The enzyme dihydropyrimidine dehydrogenase (DPD) plays an important role in the breakdown of fluorouracil. Inhibition, deficiency or decreased activity of this enzyme can result in accumulation ...
4.5. Interaction with other medicinal products and other forms of interaction
The enzyme dihydropyrimidine dehydrogenase (DPD) plays an important role in the breakdown of fluorouracil. Antiviral nucleoside analogues such as brivudine and sorivudine may lead to a drastic increase ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are no data from the use of topical fluorouracil in pregnant women. A teratogenic effect of systemically administered fluorouracil has been observed in animals (see section 5.3). Salicylic ...
4.7. Effects on ability to drive and use machines
Actikerall has no influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile Mild to moderate irritation and inflammation at the application site occurred in the majority of patients treated with the solution for actinic keratosis. In case of severe ...
4.9. Overdose
When applied on the skin as recommended, systemic intoxication with either active is unlikely. Significantly more applications than recommended result in an increase of frequency of reactions at the application ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antineoplastic agents; Antimetabolites; Pyrimidine analogues <b>ATC code:</b> L01BC52 Mechanism of action of fluorouracil The active substance fluorouracil (FU) is a cytostatic ...
5.2. Pharmacokinetic properties
In an absorption study carried out on pigs no fluorouracil was detected in the serum after the cutaneous application even in large quantities i.e. the active substance was not absorbed in quantities ...
5.3. Preclinical safety data
No experimental data on the acute and sub-chronic toxicity of fluorouracil (FU) after topical application are available. In rats dose-dependent systemic bioavailability of FU occurs and results in severe ...
6.1. List of excipients
Dimethyl sulfoxide Ethanol, anhydrous Ethyl acetate Pyroxyline Poly(butyl methacrylate, methyl methacrylate)
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years. Shelf life after opening: 3 months.
6.4. Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze. Keep the bottle tightly closed to prevent drying up.
6.5. Nature and contents of container
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. ...
6.6. Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Almirall Hermal GmbH, Scholtzstrasse 3, 21465 Reinbek, Germany
8. Marketing authorization number(s)
PL 33016/0015
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 03 June 2011 Date of latest renewal: 04 May 2016
10. Date of revision of the text
30 October 2020
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