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Gynofem

Gynofem

Manufacturer:

NTC

Distributor:

DKSH
Full Prescribing Info
Contents
Ectoin 3%, hyaluronic acid.
Description
Composition: Aqua, Allantoin, Hydroxyacetophenone, Hydroxyethylcellulose, Sodium Hyaluronate, Ectoin, PEG-40 Hydrogenated Castor oil, Propylene Glycol, Polysorbate 20, Magnolol, Honokiol, Sodium Levulinate.
Action
Pharmacology: Ectoin is a low molecular weight amino acid derivative, with moisturizing and soothing activity, tissue protective and hydrating properties. Ectoin creates a protective shield of water around the membranes that are stabilized and naturally protected from irritations.
Hyaluronic acid is a highly soluble non-sulfated glycosaminoglycan with a very high molecular weight. Thanks to its muco-mimetic and viscoelastic properties it guarantees adequate lubrication of the vaginal mucosa.
The combination of Ectoin and hyaluronic acid can alleviate the symptoms of mild to moderate-severe vaginal atrophy, dryness and irritation at the time of application and in the long term.
Indications/Uses
Gynofem is a medical device with pH 4.5 to be used as adjuvant in the prevention and treatment of vaginal atrophy.
Allowing the maintenance of vaginal mucosa natural hydration, it alleviates the symptoms of vaginal atrophy, which include dryness, burning, itching and discomfort during sexual intercourse.
Dosage/Direction for Use
In case of moderate to severe vaginal atrophy, apply the product once a day for a maximum of 7 days; then, or in case of mild vaginal atrophy, apply the product once every 3 days or as needed.
Contraindications
Do not use in case of known hypersensitivity to the components.
Warnings
Do not use the product for purposes other than those indicated in this monograph.
Before application wash hands carefully.
Avoid contact with eyes. In case of contact immediately flush thoroughly with water.
After first opening the tube, use the product within 8 weeks.
Store at room temperature away from heat sources.
Do not freeze.
Topical use - not to be taken by mouth.
Do not use if package is opened or damaged.
After use, close the tube properly.
Stop treatment in the presence of abnormal skin reactions.
In case of prolonged use, consult the doctor.
The product has no spermicidal or contraceptive effect.
The product must be used by only one person.
The product is normally intended for continuous use for not more than 30 days; if the symptoms persists consult the doctor.
Side Effects
The use-especially if prolonged - can lead to sensitiveness events. If this is the case, stop the treatment and consult the doctor in order to start a proper therapy.
Caution For Usage
Compatibilities: Compatible with natural latex condoms.
Storage
Keep away from moisture and heat; this does affect its functionality and durability characteristics.
Patient Counseling Information
Instructions for Use: Wash your hands.
Unscrew the cap of the tube and turn on the other side pressing to puncture the foil seal (to be performed only for the first opening).
Screw the cannula applicator onto the tube instead of the cap.
Squeeze the tube to make the product come out into the cannula. Completely fill the cannula with the gel.
Unscrew from the tube.
Insert the cannula into your vagina and empty the cannula by pressing the piston.
Extract the cannula.
Throw the cannula after application: it's not reusable.
Close the tube after use.
MIMS Class
Preparations for Vaginal Conditions
ATC Classification
G02CX - Other gynecologicals ; Used in the management of gynecological conditions.
MEDICAL DEVICE - Healthcare Device
Presentation/Packing
Form
Gynofem vag gel
Packing/Price
(+7 disposable cannulas) 30 mL x 1's
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