Web Page: http://www.rotapharm.co.uk/
Bioselac (Vaginal Capsules)
(Lactobacillus Rhamnosus)
CONTENT:
Capsules. 1 capsule contains Lactobacillus rhamnosus 573 rods - about 1010 (not less than108 CFU).
PHARMACOLOGICAL PROPERTIES:
Bioselac is manufactured in form of vaginal capsules containing lactobacilli of normal vaginal microflora and performing protective function.
Local or systemic treatment of vaginal infections with antibiotics and sulfanilamides, hormonal therapy and incorrect hygiene damage natural vaginal flora, increase the risk of relapse. Therapeutic effect of Bioselac is provided by means of introduction of active lactic-acid bacteria Lactobacillus rhamnosus 573 strain, lyophilized on a milk-saccharose carrier directly to vagina and what produced a rapid vaginal pH lowering to 4.0 - 4.7 and in active growth inhibition and pathogenic bacteria reproduction, in inherent vaginal microflora and vaginal physiological equation restoration.
In vitro studies confirmed that Lactobacillus rhamnosus 573 is resistant to cotrimoxasole and metronidasole. That is why Bioselac can be used during treatment with the drugs containing these medicines.
THERAPEUTIC INDICATIONS:
Bioselac is to be administered in order to restore or maintain normal vaginal microflora in the following cases:
- prophylaxis and treatment of specific and nonspecific vaginal infections;
- in complex vaginitis therapy, including vaginitis of bacterial etiology;
- prophylaxis of vulvovaginal candidosis;
- prophylaxis of vaginal dysbiosis of different etiology;
- during administration of different types of antibiotics, oral and vaginal contraceptives;
- before topical gynecological intervention;
- as prevention while using tampon, topical contraceptives in insufficient hygiene;
- at occurence of vaginal discharge.
CONTRAINDICATIONS:
- hypersensitivity to the drug components.
ADVERSE EFFECTS:
The drug is well tolerated.
In single cases local allergic reactions (pruritus, burning sensation, increase in vaginal secretion) are possible.
DOSAGE AND ADMINISTRATION:
For topical use (intravaginal).
Insert a capsule deep in the vagina, following all personal hygiene rules.
Use 1 to 2 capsules of Biosela? a day (one in the morning and one in the evening at bedtime) for 7 to 10 days.
Repeat treatment if necessary.
PREGNANCY AND LACTATION:
Can be administered during pregnancy and lactation by doctor recommendation.
OVERDOSAGE:
There were no reports on the drug overdosing.
Overdosing is not dangerous for patient's condition.
DRUG INTERACTION:
Bioselac should not be used by patients simultaneously with antibacterial, antitrichomonal or antifungal drugs (except for metronidasole and cotrimoxasole), and also one should refrain from vaginal syringing with antiseptic solutions as they may lower the drug efficiency.
WARNINGS AND PRECAUTIONS:
In case of serious immune system disorders Bioselac should be administered with caution
PHARMACEUTICAL FORM:
10 vaginal capsules in a vial.
1 vial with an enclosed leaflet in a carton box.