AILACTA
AILACTA is a single use medical device in the form of vaginal tablets with smooth surface, light color with yellow dots. To be used in all cases of temporary alteration of the balance of the vaginal microflora of women. AILACTA helps to recover normal vaginal microflora.
In normal conditions, the vaginal ecosystem is inhabited by Lactobacilli which maintain the local pH to values of 4-4.5 through the production of lactic acid. The acidity of the vaginal environment is an important and effective natural protection against bacterial infections. However, conditions which alter the vaginal ecosystem and it’s acidity can frequently occur. In these cases, there is a high risk of bacterial infections, associated with burning and itching, and increased vaginal discharge (leucorrhoea).
Ingredients: One vaginal tablet contains: Lactobacillus acidophilus 500,000,000 CFU (*), lactic acid (60%) 15 mg, soya bean (Glycine max, seeds) standardised dry extract to 40% in isoflavones in the aglycone form 18 mg. Excipients: mannitol, starch, sodium croscarmellose E468, glyceryl behenate, silicon dioxide.
(*) CFU: Colony-Forming Unit
How AILACTA works: One tablet of AILACTA contains Lactobacillus acidophilus La-14, lactic acid and soy isoflavone aglycones. After being inserted in the vagina, it is formulated to dissolve a few minutes releasing its active ingredients. The ingredients of AILACTA help acidify the vaginal environment by lowering the pH to values of 4-4.5 to counter attacks and growth of pathogenic microorganisms, help to restore vaginal microflora and physiological balance in the vagina and to improve the health and elasticity of the vaginal walls.
Method of use: Method of administration and duration of treatment: One vagina tablet AILACTA shall be administered deep intravaginal in the evening before going to bed, for 14 consecutive days of treatment, respecting intimate hygiene. Begin treatment immediately after the monthly period, or as your doctor recommended. Do not extend the treatment beyond 20 days without first consulting your gynaecologist. Each tablet must be used only once and immediately after removing it from the blister. Pay particular attention when removing the tablet from the blister: apply gentle pressure to the end of the blister bubble, without pressing on the centre, to avoid the tablet breaking. Alternatively, score the aluminium on the back of the blister and open it from that side to remove the tablet. The entire tablet must be inserted all the way into the vagina, to help it dissolve fully and quickly.
Warnings: Do not use AILACTA together with other devices or drugs for vaginal use without consulting your gynaecologist. The product is not for use by patients below age of 14. AILACTA has not demonstrated any local irritation, but if you experience hypersensitivity to the product, consult your doctor immediately. Occasionally, especially in the first days of treatment, itching can appear; however, it tends to disappear in 2-3 days.
Age: AILACTA is recommended for women from age of 14 years.
*Full version of SmPC and PIL will be placed after obtaining the Marketing Authorization.
Marketing Authorisation Holder: Aicore Life Sciences B.V.
Boxbergerweg 119, 7431 PM Diepenveen, the Netherlands
Tel.: +31611923166, e-mail: info@aicorelifesciences.nl
Manufacturer: Mithra Pharmaceuticals CDMO S.A.
Zoning de l’Arbre Saint-Michel, Rue de l’Expansion, 57, 4400 Flemalle, Belgium
In normal conditions, the vaginal ecosystem is inhabited by Lactobacilli which maintain the local pH to values of 4-4.5 through the production of lactic acid. The acidity of the vaginal environment is an important and effective natural protection against bacterial infections. However, conditions which alter the vaginal ecosystem and it’s acidity can frequently occur. In these cases, there is a high risk of bacterial infections, associated with burning and itching, and increased vaginal discharge (leucorrhoea).
Ingredients: One vaginal tablet contains: Lactobacillus acidophilus 500,000,000 CFU (*), lactic acid (60%) 15 mg, soya bean (Glycine max, seeds) standardised dry extract to 40% in isoflavones in the aglycone form 18 mg. Excipients: mannitol, starch, sodium croscarmellose E468, glyceryl behenate, silicon dioxide.
(*) CFU: Colony-Forming Unit
How AILACTA works: One tablet of AILACTA contains Lactobacillus acidophilus La-14, lactic acid and soy isoflavone aglycones. After being inserted in the vagina, it is formulated to dissolve a few minutes releasing its active ingredients. The ingredients of AILACTA help acidify the vaginal environment by lowering the pH to values of 4-4.5 to counter attacks and growth of pathogenic microorganisms, help to restore vaginal microflora and physiological balance in the vagina and to improve the health and elasticity of the vaginal walls.
Method of use: Method of administration and duration of treatment: One vagina tablet AILACTA shall be administered deep intravaginal in the evening before going to bed, for 14 consecutive days of treatment, respecting intimate hygiene. Begin treatment immediately after the monthly period, or as your doctor recommended. Do not extend the treatment beyond 20 days without first consulting your gynaecologist. Each tablet must be used only once and immediately after removing it from the blister. Pay particular attention when removing the tablet from the blister: apply gentle pressure to the end of the blister bubble, without pressing on the centre, to avoid the tablet breaking. Alternatively, score the aluminium on the back of the blister and open it from that side to remove the tablet. The entire tablet must be inserted all the way into the vagina, to help it dissolve fully and quickly.
Warnings: Do not use AILACTA together with other devices or drugs for vaginal use without consulting your gynaecologist. The product is not for use by patients below age of 14. AILACTA has not demonstrated any local irritation, but if you experience hypersensitivity to the product, consult your doctor immediately. Occasionally, especially in the first days of treatment, itching can appear; however, it tends to disappear in 2-3 days.
Age: AILACTA is recommended for women from age of 14 years.
*Full version of SmPC and PIL will be placed after obtaining the Marketing Authorization.
Marketing Authorisation Holder: Aicore Life Sciences B.V.
Boxbergerweg 119, 7431 PM Diepenveen, the Netherlands
Tel.: +31611923166, e-mail: info@aicorelifesciences.nl
Manufacturer: Mithra Pharmaceuticals CDMO S.A.
Zoning de l’Arbre Saint-Michel, Rue de l’Expansion, 57, 4400 Flemalle, Belgium
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