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Colpofix

Colpofix

Manufacturer:

Uriach

Distributor:

DKSH
Full Prescribing Info
Contents
Carboxymethyl beta-glucan, polycarbophil.
Description
Colpofix is an innovative preparation in terms of formulation and method of use. It is a gel with thixotropic characteristics that due to the force of mechanical compression, turns into a liquid when applied, and returns to gel form after application. The exclusive and ergonomic shape of the applicator allows a uniform and effective distribution of the mucoadhesive preparation directly, and in depth, on the cervico-vaginal mucosa, avoiding the spills.
COMPOSITION: Water, Sorbitol, Carboxymethyl beta-glucan, Crosslinked acrylic polymer (Polycarbophyl), Imidazolidinyl urea, Sodium dehydroacetate.
Each applicator is for single use. Fragance-free.
Colpofix is a Class IIa Medical Device in compliance with the requirements of Directive 93/42/EEC and subsequent updates.
Action
Pharmacology: Colpofix contains as functional substances: Polycarbophil and Carboxymethyl beta-glucan. Particularly, Colpofix is effective in the proposed indications by several mechanisms of action: Form a film protecting the cervico-vaginal mucosa from the deleterious action of external microbial agents, thanks to its capacity of bioadhesion.
Promote re-epithelialisation and regression of cervical lesions, thanks to the control of physiological conditions on the cervico-vaginal transformation zone by hydration.
Restore and maintain the vaginal microbiota thanks to the pH regulation and by a prebiotic effect.
Indications/Uses
Prevention and treatment of cervical lesions caused by Human Papillomavirus, thanks to the control of physiological conditions of the transformation zone of the cervico-vaginal mucosa.
Dosage/Direction for Use
POSOLOGY: It is advisable to carry out one application (5 deliveries) per day, for 10 days, in the evening before the night's rest. To renew according to the recommendations of the doctor.
1 bottle corresponds to 10 days of use.
Warnings
The colour of the gel may undergo variations due to the presence of the natural ingredients, this change is not altering the quality of the preparation. The product is for vaginal use. Do not swallow. Do not use the product without the recommendation of physician or pharmacist, in case of confirmed or presumed pregnancy or concomitant local pharmacological therapies. The product is not intended for paediatric use. Prolonged use of the product, as with all topical products, can give rise to phenomena of local sensitization or irritation; if this happens stop the treatment and consult the attending physician or pharmacist. Do not use the product if the package or the applicator is damaged, or not perfectly intact at time of first opening. Do not use the product after the expiry date. Use the product in accordance with the instructions for use. The cannula is disposable and should not be reused.
Side Effects
Do not use in case of hypersensitivity and incompatibility with any component of the product. The tests performed on the product to date have not shown any sensitisation phenomena or other side effects. In the event of persistent discomfort, consult a doctor.
Caution For Usage
Instructions For Use and Handling: This product should not be disposed of in waste water nor in household rubbish. Ask the pharmacist how to dispose of healthcare products that no longer in use. This will help to protect the environment.
Storage
Store in a dry place, below 25°C, away from light and heat sources.
Patient Counseling Information
INSTRUCTIONS FOR USE: Do not shake the product before use.
Remove a vaginal applicator from its protective cover. Remove the cap from the spray cover. Insert the applicator into the dispensing nozzle of the spray. Begin the application by depressing the vacuum dispenser button until the product appears. Insert the applicator deep into the vagina while lying on your back with your knees bent. Perform 5 sprays per application. Discard the applicator after use. Close the spray with cap.
MIMS Class
Preparations for Vaginal Conditions
ATC Classification
G02CX - Other gynecologicals ; Used in the management of gynecological conditions.
Presentation/Packing
Form
Colpofix vag gel
Packing/Price
(+ 10 disposable applicators) 20 mL x 1's
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/thailand/image/info/colpofix-vag-gel/20-ml?id=29d7ff6b-02d2-48aa-a3d7-b2b50082a45f
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