Active ingredients: Salicylic acid
TRANS-VER-SAL 3.75 mg / 6 mm TRANSDERMAL PATCHES
TRANS-VER-SAL 13.5 mg / 12 mm TRANSDERMAL PATCHES
TRANS-VER-SAL 36.3 mg / 20 mm TRANSDERMAL PATCHES
Why is Trans-Ver-Sal used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY: Preparation for corns and warts.
THERAPEUTIC INDICATIONS: For the treatment of common warts, calluses and calluses.
Contraindications When Trans-Ver-Sal should not be used
Hypersensitivity to the active substance or to any of the excipients. The product should not be used in case of diabetes or circulatory insufficiency. Like all products with a high salicylic acid content, it should not be applied to the face, anogenital area and mucous membranes.
The transdermal patch should not be applied to nevi, seborrheic warts and warts.
Precautions for use What you need to know before taking Trans-Ver-Sal
The product is for external use only. The use, especially prolonged, of products for topical use can give rise to sensitization phenomena, in this case interrupt the treatment and institute a suitable therapy.
Interactions Which drugs or foods can modify the effect of Trans-Ver-Sal
Avoid the simultaneous use of other keratolytics in order not to increase the caustic action of the active substance.
Warnings It is important to know that:
Do not use for prolonged treatments, after a short period of treatment without appreciable results, consult your doctor.
Avoid applying to healthy skin surrounding the affected area.
Keep out of reach of children.
Avoid contact with eyes and mucous membranes.
Do not use the product on irritated, infected or reddened skin.
Do not swallow. In case of accidental ingestion, consult your doctor immediately.
The product should not be used to prevent the formation of warts.
Dose, Method and Time of Administration How to use Trans-Ver-Sal: Posology
Apply a transdermal patch to the affected area in the evening and remove it the next morning. Repeat the application every 24 hours, until the wart is eliminated. Do not exceed the recommended dose.
- Preparation of the area to be treated. Clean the skin until the surface of the wart is softened with the emery file supplied with the package.
- Preparation of the medicated transdermal patch. Remove a transdermal patch from the clear backing, leaving the plastic film on top. If the transdermal patch is larger than the wart, it should be reduced to a size large enough to cover only the surface of the wart. It is important that the transdermal patch is cut precisely so that it does not come in contact with the normal skin around the wart.
- Humidification of the wart. Apply a drop of warm water to the wart, keeping the surrounding skin dry.
- Apply the medicated transdermal patch at bedtime, making sure the sticky part adheres.
- Fixation of the transdermal patch. Use a patch to secure the transdermal patch once applied.
The TRANS-VER-SAL® transdermal patch should be left on overnight and discarded in the morning. Repeat the application every 24 hours, until the wart is eliminated.
Side Effects What are the side effects of Trans-Ver-Sal
In some cases, intolerance (burning or irritation) may occur, however without consequences, which does not require modification of the treatment. The patient must inform his doctor or pharmacist of any undesirable effect not described in the package leaflet.
Expiry and Retention
Do not use the medicine after the expiry date indicated on the package.
Do not use the product if the package shows visible signs of deterioration.
Do not dispose of the container in the environment after use.
KEEP OUT OF REACH OF CHILDREN
Deadline "> Other information
COMPOSITION:
Each transdermal patch contains:
Active ingredient: salicylic acid
Excipients: Karaya Gum, Propylene Glycol, Polyethylene Glycol 300, Quaternium-15
PHARMACEUTICAL FORM:
transdermal patches of Ø 6-12-20 mm.
Each pack contains 20-16-10 transdermal patches, 24-18-10 fixation patches and a file respectively.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
TRANS-VER-SAL
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
03.0 PHARMACEUTICAL FORM -
Transdermal patches.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
For the treatment of common warts, calluses and calluses.
04.2 Posology and method of administration -
Apply a transdermal patch to the affected area in the evening and remove it the next morning. Repeat the application every 24 hours, until the wart is eliminated. Do not exceed the recommended dose.
04.3 Contraindications -
Hypersensitivity to the active substance or to any of the excipients.
The product should not be used in case of diabetes or circulatory insufficiency.
Like all products with a high salicylic acid content, it should not be applied to the face, anogenital area and mucous membranes.
The transdermal patch should not be applied to nevi, seborrheic warts and warts.
04.4 Special warnings and appropriate precautions for use -
The use, especially prolonged, of products for topical use can give rise to sensitization phenomena, in this case interrupt the treatment and institute a suitable therapy.
Do not use for prolonged treatments, after a short period of treatment without appreciable results, consult your doctor.
Avoid applying to healthy skin surrounding the affected area.
Keep out of reach of children.
Avoid contact with eyes and mucous membranes.
Do not use the product on irritated, infected or reddened skin.
Do not swallow. In case of accidental ingestion, consult your doctor immediately.
The product should not be used to prevent the formation of warts.
04.5 Interactions with other medicinal products and other forms of interaction -
Avoid the simultaneous use of other keratolytics in order not to increase the caustic action of the active substance.
04.6 Pregnancy and breastfeeding -
There are no restrictions on use.
04.7 Effects on ability to drive and use machines -
Nobody.
04.8 Undesirable effects -
In some cases, intolerance (burning or irritation) may occur, however without consequences, which does not require modification of the treatment.
04.9 Overdose -
Following the directions for use above, there is no possibility of overdose.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Salicylic acid is an irritating drug for gastric mucosa and tissues and can only be used topically.
It is an effective keratolytic, widely used, which produces desquamation and destruction of the epithelium by solubilizing the intercellular cement of the stratum corneum. It also has fungicidal properties.
05.2 "Pharmacokinetic properties -
It is a preparation for topical use, to be used on skin surfaces of extremely limited size. It has been experimentally shown that Trans-ver-sal® does not cause any systemic side effects. Baseline salicilemia values do not change during the course of treatment. In some cases of incorrect application, modest erythema of the periwound skin occurred in the area to be treated. The erythematous skin, returned to intact with topical moisturizing and emollient treatment, no longer determined any side effect after the resumption of treatment.
05.3 Preclinical safety data -
For salicylic acid, the LD50 in rabbits is 1.3 g / kg per os. The minimum lethal dose is 15 g.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Karaya gum; propylene glycol; polyethylene glycol 300 quaternium 15
06.2 Incompatibility "-
Salicylic acid is incompatible with iron salts, ethyl nitrite in alcoholic solution, lead acetate, iodine.
06.3 Period of validity "-
The product has a validity period of 3 years from the date of production when the packaging is intact
06.4 Special precautions for storage -
None.
06.5 Nature of the immediate packaging and contents of the package -
Trans-ver-sal® transdermal patches are placed on a polyester base, covered with a polythene film and closed in laminate plates.
06.6 Instructions for use and handling -
Apply a transdermal patch to the affected area in the evening and remove it the next morning. Repeat the application every 24 hours, until the wart is eliminated.
Do not exceed the recommended dose.
Preparation of the area to be treated:
Clean the skin until the surface of the wart is softened with the emery file supplied with the package.
Preparation of the medicated transdermal patch:
Remove a transdermal patch from the clear backing, leaving the plastic film on top. If the transdermal patch is larger than the wart, it should be reduced to a size large enough to cover only the surface of the wart. It is important that the transdermal patch is cut precisely so that it does not come in contact with the normal skin around the wart.
Humidification of the wart.
Apply a drop of warm water to the wart, keeping the surrounding skin dry.
Apply the medicated transdermal patch at bedtime, making sure the sticky part adheres.
Fixation of the transdermal patch.
Use a patch to secure the transdermal patch once applied.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
Difa Cooper S.p.A. - Via Milano 160 - 21042 Caronno Pertusella (VA)
Production Plant: Bradley Pharmaceuticals Inc., Fairfield, NJ, USA
Terminal Packaging: Istituto Biochimico Pavese Pharma S.p.A. - Pavia; Fulton Medicinali S.p.A. - Arese (MI); Toll Manufacturing Services, S.L. - Alcobendas Madrid
08.0 MARKETING AUTHORIZATION NUMBER -
A.I.C. No.
034674010 box containing 20 transdermal patches Ø 6 mm - 24 fixation patches and a file
034674022 box containing 16 transdermal patches Ø 12 mm - 18 fixing patches and a file
034674034 box containing 10 transdermal patches Ø 20 mm - 10 fixation patches and a file
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
28/01/2000
10.0 DATE OF REVISION OF THE TEXT -
20/06/2005
