CONDYLINE Cutaneous solution (2020)
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Περιεχόμενα
1. Name of the medicinal product
Condyline 5 mg/ml Cutaneous Solution.
2. Qualitative and quantitative composition
Condyline contains 5 mg/ml podophyllotoxin in vials of 3.5 ml. For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Cutaneous Solution. Each pack of Condyline consists of a 3.5 ml amber glass vial containing 5 mg/ml podophyllotoxin in a clear, colourless alcoholic solution.
4.1. Therapeutic indications
For the topical treatment of condylomata acuminata (warts) affecting the penis or the female external genitalia.
4.2. Posology and method of administration
For topical administration. Adults and the elderly Apply twice daily for three days directly to the warts. Allow to dry after treatment. Use the applicator provided, applying not more than 50 applicators-full ...
4.3. Contraindications
Condyline is contraindicated in patients with the following conditions/diseases: hypersensitivity to podophyllotoxin or to any of the other ingredients (see section 6.1); inflamed or bleeding lesions; ...
4.4. Special warnings and precautions for use
Avoid contact with healthy skin. Lesions in the female and lesions greater than 4cm² in the male should be treated under direct medical supervision. The risk of toxicity is increased during simultaneous ...
4.5. Interaction with other medicinal products and other forms of interaction
None known.
4.6. Pregnancy and lactation
Condyline is not recommended for use during pregnancy or during breast feeding.
4.7. Effects on ability to drive and use machines
Condyline does not interfere with the ability to drive or use machines.
4.8. Undesirable effects
<u>Disorders of the reproductive system and breast:</u> Balanoposthitis <u>Skin and subcutaneous tissue disorders:</u> Local irritations (of the mucous membrane), usually mild, may include itching, burning, ...
4.9. Overdose
Symptoms The risk of systemic toxicity after topical application is increased by the treatment of large areas with excessive amounts for prolonged periods, by the treatment of friable, bleeding, or recently ...
5.1. Pharmacodynamic properties
Podophyllotoxin is an anti-mitotic agent, with a topical action against warts. It is applied locally to the lesion (e.g. wart) and causes destruction of the tissues locally. Podophyllotoxin and its derivatives ...
5.2. Pharmacokinetic properties
Absorption After topical application, podophyllotoxin is absorbed through the skin or mucous membranes. The extent of absorption depends on the concentration used. Topical application of 0.1 ml of 5 mg/ml ...
5.3. Preclinical safety data
Podophyllotoxin toxicity in animals is related to its cytotoxic activity. As a cytotoxic agent it has teratogenic potential and in reproductive toxicity studies has been associated with intrauterine deaths ...
6.1. List of excipients
Lactic acid Sodium lactate 60% solution Ethanol 96%
6.2. Incompatibilities
None stated.
6.3. Shelf life
The shelf life of the unopened vial is 2 years from the date of manufacture. Once opened, the product has a shelf life of 6 weeks.
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
Each pack of Condyline consists of a 3.5ml amber glass vial fitted with a child resistant closure. The pack also includes a suitable quantity of special applicators.
6.6. Special precautions for disposal and other handling
Condyline is flammable and should be kept away from naked flames. A patient information leaflet is provided with the product giving details on the use and handling of the product.
7. Marketing authorization holder
Takeda UK Limited, 1 Kingdom Street, London, W2 6BD, United Kingdom
8. Marketing authorization number(s)
PL 16189/0037
9. Date of first authorization / renewal of the authorization
23 January 2009
10. Date of revision of the text
21 April 2020
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