1. NAME OF DRUG TRANSVERCID 3.62mg/6mm protectors for local use. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Salicylic acid: .62 mg Each protector has a diameter of 6mm and weighs 96.94mg on a polyester bands covered with a polyethylene film. To see a complete list of dilutants, see section 6.1. 3. PHARMACEUTICAL FORM Protector for local application. 4. CLINICAL DATA 4.1. Therapeutic Indications Local treatment for verrucas, notably multiple and/or large verrucas. 4.2. Dosage and how to use Before going to bed and after taking a warm bath, lightly rub the verruca with a soft file then clean it with warm water and soap. Open the sachet on one side. Take off the borders, gently tear off the stripy and stick and apply to the verruca. The part in contact with the strip is put onto the skin and the blue protective film is the top part of the patch. Keep the protector in place with the adhesive bands: leave to work throughout the night (minimum 8 hours) and take it off in the morning. Do this every evening with a clean protector until the verruca has disappeared. Duration is capped at 1 month. 4.3. Contraindications · allergy to one of its components, 4.4. Special warnings and side effects Those suffering from arthritis, diabetes and neuropathy must use verruca treatments with precaution. If treatment does work or verrucas come back, treatment needs to be re-evaluated. In case of pain, irritation, ulcers or bleeding, treatment must be stopped. Apply the protector onto the verruca to be treated, avoiding contact with uninfected skin and/or mucous membranes. 4.5. Interactions with other drugs The current data available does not suggest any clinical interactions. 4.6. Pregnancy and breast feeding This medication is not for pregnant women. Pregnant and breast feeding women should use salicylic acid with caution due to lack of clinical data. 4.7. Effects on the ability to drive and operate machinery Not applicable. 4.8. Side effects Possible local reaction around the verruca when treatment has stopped. Risk of pain, irritation, ulcers and bleeding. Declaration of suspected side effects The declaration of suspected side effects after drug authorisation is important. It allows continuous observation into the benefits/risks of the drug. Health professionals declare all suspected side effects via the national system of declaration: The ANSM and the network of Regional Centres of Pharmacovigilance- website www.ansm.sante.fr. 4.9. Overdose Risk of burning in case of an overdose. 5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmaco-dynamic properties Pharmaco-therapeutic class: KERATOLYTIC. (D: Dermatology) 5.2. Pharmacokinetics properties Not known. 5.3. Preclinical safety data Not known. 6. PHARMACEUTICAL DATA 6.1. List of dilutants Sterculia gum, propyleneglycol, macrogol 300, N-(3-chloroallyl) hexaminium chloride (QUATERNIUM 15). Removable protective film in polyethylene, blue colour. Removable protective support in polyester. Plasterin polyethylene and adhesive acrylic. 6.2. Incompatibilities Not applicable. 6.3. Shelf life 3 years. 6.4. Storage precautions Store in a place below 25°C. 6.5. Nature and contents of outside packaging 8 plasters in a sachet (paper/PE/aluminium). Box of 1 + 10 plasters. 6.6. Precautions for handling and disposal No specific requirements. 7. THE MARKETING AUTHORISATION HOLDER LABORATOIRES DERMATOLOGIQUES DUCRAY 45, place Abel Gance 92100 Boulogne 8. NUMBER OF THE MARKETING AUTHORSATION HOLDER 3400935941299: 8 protectors in a sachet + 10 plasters. 9. START/RENEWEL DATE OF AUTHORISATION [To be completed by holder] 10. DATE OF UPDATE OF TEXT [To be completed by holder] 11. DOSIMETRY Not applicable. 12. INSTRUCTIONS FOR RADIOPHARMACEUTICAL PREPARATION Not applicable. PRESCRIPTION AND DELIVERY CONDITIONS Drug not subjected to prescription.
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