BalanceActiv

BalanceActiv

Manufacturer:

Exeltis

Distributor:

DKLL

Marketer:

Exeltis
Full Prescribing Info
Contents
Lactic acid, glycogen.
Description
Vaginal gel formulated to physiological vaginal pH.
Excipients/Inactive Ingredients: Purified water, propylene glycol, hydroxypropyl methyl cellulose, sodium lactate, lactic acid, glycogen.
Action
BalanceActiv contains lactic acid, which acidifies and keeps the vagina within an acidic pH 3.8 and 4.5 providing an ideal environment for growing off "good" bacteria (lactobacilli). It also contains glycogen which provides nutrients for lactobacilli. Due to this rapid restore in the vaginal flora balance, BalanceActiv normalize and rapidly treats unpleasant odour, irritation and excessive discharge.
Bacterial vaginosis: The micro-organisms that colonize the vagina are collectively referred as the vaginal flora. The primary colonizing bacteria of a healthy woman are Lactobacillus ("good" bacteria). The amount and type of bacteria present have significant implications for a woman's overall health. The pH of the vagina is normally acidic (pH 3.8-4.5). This is maintained by the metabolism of glycogen which is transformed by lactobacilli into lactic acid. A normal vaginal flora aids in the prevention of vaginal infections by maintaining an acidic pH (<4.5) that is unfavourable for the growth of "bad" bacteria.
Bacterial vaginosis (BV) is an infection caused when too much of certain bacteria change the normal balance of bacteria in the vagina.
There are number of condition that may upset the natural acidity of the vagina such as: fluctuation of hormone levels during menstrual cycle, pregnancy and menopause.
Other influencing factors include antibiotics, sexual intercourse (semen is alkaline), intrauterine devices (the coil), douching (rinsing inside the vagina) or using vaginal washes or deodorants and smoking. An imbalance in the environment of the vagina may lead to infection such as bacterial vaginosis, and candidiasis. The most common cause of recurring vaginal infection is bacterial vaginosis.
Indications/Uses
BalanceActiv is designed for restoring the vaginal pH in situations where this has become raised above the normal range of pH 3.8-4.5. The change of this normal pH range can result in, or be caused by a change in the natural balance of the vaginal flora. The use of BalanceActiv returns the vaginal pH to its normal range, thereby facilitating the normalisation of the vaginal flora. BalanceActiv is a vaginal gel with lactic acid and glycogen indicated to: Restore and maintain the natural acidity of the vagina creating a suitable environment for lactobacilli to grow; relieves abnormal vaginal discharge and odour; treat bacterial vaginosis symptoms; and prevent bacterial vaginosis recurrence.
Dosage/Direction for Use
Recommended posology: For symptomatic treatment: Use one single tube (5 mL) per day at bedtime during 7 days.
For prevention: Use one single tube (5 mL) for 2 or 3 days at bedtime after menstruation.
Method of use: BalanceActiv should be used at bedtime when lying down to minimise any potential leakage. In the event of a small leak a panty liner may be useful. This does not mean that BalanceActiv is not working.
Each applicator is sealed and contains a single dose of gel, which is squeezed into the vagina.
1. Remove the cap.
2. Insert the entire neck of the tube into the vagina.
3. Squeeze out the gel and maintain a constant pressure in the tube while withdrawing it.
4. Discard appropriately.
Warnings
BalanceActiv is intended for its use by adult women only. If there is no symptomatic improvement within the first three days, the patient should consult a doctor. The patient should also see a doctor if she thinks she has a vaginal infection during pregnancy. BalanceActiv is free of hormones and can be use with latex condoms. BalanceActiv is not a contraceptive, but it should not be used during the ovulation if patient is trying to conceive, as it lows vaginal pH making a less suitable environment for sperm. Tell a doctor or pharmacist if patient is using, has recently used or might use any other barrier contraceptive method such as cervical caps, diaphragms, or contraceptive sponges with spermicide.
Do not use BalanceActiv if patient has ever had an allergic reaction to any of its ingredients. If patient experiences such reactions, stop use immediately and consult a health care provider.
Do not use this product and contact the customer service if the package is damaged.
Special Precautions
What would I notice If I had bacterial vaginosis?: An abnormal vaginal discharge which may be: smelly - sometimes described as 'fishy' and often worse after sex; Thin and either white or pale grey in colour discharge.
Bacterial vaginosis is not associated with soreness, itching or irritation unless there is another condition such as thrush as well.
However, many women with bacterial vaginosis do not notice anything wrong.
Bacterial vaginosis is often confused with other vaginal infections. Simple test carried out by healthcare professional can diagnose the presence of bacterial vaginosis.
Can BalanceActiv be used safely with condoms?: Yes. Because BalanceActiv is not oil-based, it does not affect the latex integrity and will not alter latex condom effectiveness.
Use In Pregnancy & Lactation
BalanceActiv can be used during pregnancy. However, the patient should see her doctor if the patient thinks she may have any vaginal infection during pregnancy.
Side Effects
When BalanceActiv is applied a minor burning sensation and/or itching, which subsides soon. In the event of persistent discomfort or irritation, the patient is advised to discontinue the use of the product and consult a physician.
Irritation of the mucous membrane of the vagina may also occur if the patient is predisposed to such condition, or especially if the mucous lining was damaged by improper care/hygiene. Do not use this gel under such conditions.
Caution For Usage
The applicator tube is for a single use only. Do not reuse as it may cause infections.
Call a doctor if patient apply the gel as directed and symptoms persist.
BalanceActiv contains no preservatives.
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
BalanceActiv vag gel
Packing/Price
5 mL x 7 × 1's
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