DIFESAN+
Description
Class IIa medical device, useful for the treatment, maintenance and physiological control of the cervico-vaginal mucosa environment, to be used in all cases of temporary alteration of the vaginal microbial balance.
Vaginal tablets, indicated as an adjuvant for maintaining the physiological environment of the cervico-vaginal mucosa, useful for the prevention and treatment of cervico-vaginal infections and of alterations that may arise during pregnancy and that can cause premature rupture of membranes (PROM) and shortening of the cervix, and for the prevention of pre-term birth.
It may be useful:
- as an adjuvant in the prevention of miscarriage and pre-term birth;
- as an adjuvant in the prevention of the increased risk of miscarriage associated with invasive procedures such as amniocentesis or chorionic villus sampling;
- as an adjuvant treatment useful in the prevention of pre-term birth in the presence of reduced cervical length or cervical length not corresponding to the gestational period;
- as an adjuvant in the prevention and treatment of female infertility.
How to use
After washing your hands thoroughly, remove a single tablet from the blister. Gently insert the tablet into the vagina, as deeply as possible. To make insertion easier, lie on your back with your legs slightly bent. Treatment should ideally be started and completed in the intermenstrual period or as otherwise directed by a doctor.
- As a treatment for maintaining and controlling the physiological environment of the cervico-vaginal mucosa, and in particular for the prevention and treatment of cervico-vaginal infections: use 1 vaginal tablet a day, preferably in the evening before going to bed, for 7 consecutive days or as otherwise directed by a doctor.
- As an adjuvant in the prevention of miscarriage and pre-term birth: use 1 vaginal tablet a day, preferably in the evening before going to bed, for 7 consecutive days each month from the start of pregnancy until the thirty-seventh week, or as otherwise directed by a doctor.
- As an adjuvant in the prevention of the increased risk of miscarriage associated with invasive procedures such as amniocentesis or chorionic villus sampling: use 1 vaginal tablet on the day of the test and continue with subsequent applications every 12 hours until the pack is finished.
- As an adjuvant treatment useful for the prevention of pre-term birth in the presence of reduced cervical length or cervical length not corresponding to the gestational period: use 1 vaginal tablet a day, preferably in the evening before going to bed, for 21 consecutive days, repeatable, up to the fortieth week, or as otherwise directed by a doctor.
- As an adjuvant in the prevention and treatment of female infertility: use 1 vaginal tablet a day, preferably in the evening before going to bed, for 7 consecutive days in repeatable cycles, or as otherwise directed by a doctor.
Components
Lactoferrin (300 mg), microcrystalline cellulose, mannitol, croscarmellose sodium carboxymethylcellulose, vegetable magnesium stearate, HPMC, glycerol, silicon dioxide.
Warnings
For vaginal use only. Do not swallow. Do not use in case of hypersensitivity or incompatibility with any component of the product. May contain lactose. No studies are available on the use of the vaginal tablet in combination with local drug therapies. The product is not intended for paediatric use. Treatment should ideally be started and completed in the intermenstrual period or as otherwise directed by a doctor. The maximum duration of continuous treatment is 30 days. Prolonged use of the product, as with all topical products, may give rise to sensitisation or local irritation; if this occurs, stop treatment and consult your doctor or pharmacist. Do not use the product if the pack appears damaged or not perfectly intact when first opened. Use the product in accordance with the instructions for use. Keep out of the sight and reach of children.
Do not use the product after the expiry date shown on the pack.
Do not use in case of hypersensitivity or incompatibility with any component of the product. Tests carried out on the product to date have not shown sensitisation or other side effects. If persistent discomfort occurs, consult your doctor.
Storage
Store in a dry place away from light and heat sources. The expiry date refers to the product unopened and correctly stored.
Shelf life unopened: 36 months.
Format
Blister of 7 vaginal tablets of 0.9 g.
Net weight: 6.3 g.
