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Colpofix

Colpofix

Manufacturer:

Favorex

Distributor:

DKSH
Full Prescribing Info
Contents
Water, sorbitol, carboxymethyl beta-glucan, crosslinked acrylic polymer (polycarbophil), imidazolidinyl urea, sodium dehydroacetate.
Description
Composition: Water, Sorbitol, Carboxymethyl beta-glucan, Crosslinked acrylic polymer (Polycarbophil), Imidazolidinyl urea, Sodium dehydroacetate.
Action
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.
Indications/Uses
Colpofix contains as functional substances: Polycarbophil and Carboxymethyl beta-glucan. Particularly, thanks to the following mechanisms of actions, Colpofix can: Form a film protecting the cervical-vaginal mucosa from the deleterious action of external microbial agents, thanks to its capacity of bioadhesion; Promote re-epithelialisation, thanks to the control of physiological conditions on the cervical-vaginal transformation zone by hydration; Restore and maintain the vaginal microbiota, thanks to the pH regulation and by a prebiotic effect.
Dosage/Direction for Use
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. Patients must be advised not to swallow. Patients must be advised not to use the product without the physician or pharmacist recommendation, 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, patients must be advised to stop the treatment and consult the attending physician or pharmacist. Patients must be advised not to use the product if the package or the applicator is damaged, or not perfectly intact at time of first opening. Use the product in accordance with the instructions for use. The cannula is disposable and should not be reused.
Side Effects
Patients must be advised not to 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, patients must be advised to consult a doctor.
Caution For Usage
This product should not be disposed of in waste water nor in household rubbish. Ask the pharmacist how to dispose of healthcare products that is no longer used. This will help to protect the environment.
Storage
Store in a dry place, 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 spray gel
Packing/Price
(+ 10 disposable applicators) 20 mL x 1's
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