Betadine BV gel

Betadine BV gel

Manufacturer:

Mundipharma

Distributor:

DKSH
Full Prescribing Info
Contents
Astodrimer sodium.
Description
BETADINE BV Gel contains astodrimer sodium 10mg/g (1%).
Excipients/Inactive Ingredients: BETADINE BV Gel also contains purified water, carbomer homopolymer type A, sodium hydroxide, glycerine, propylene glycol, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate and edetate disodium dihydrate.
Action
BETADINE BV Gel, which contains astodrimer sodium 10mg/g (1%), a patented dendrimer, works by creating a physical barrier that targets the BV-causing bad bacteria. This barrier prevents the bad bacteria from attaching to the vaginal lining, reducing its opportunity to grow whilst allowing the good bacteria to replenish, helping to normalise the vaginal pH, and relieves unpleasant odour and discharge. This product is not an antibiotic.
BETADINE BV Gel is not absorbed into the body following vaginal application.
Bacterial Vaginosis, also known as BV, is an imbalance in the naturally occurring vaginal bacteria and is associated with symptoms including a strong 'fishy' vaginal odour, which can be worse after sex, and an abnormal greyish-white, thin vaginal discharge, which can cause discomfort. BV can have a high rate of recurrence in some women.
Indications/Uses
BETADINE BV Gel is a clear gel intended to be applied into the vagina and has been clinically tested and shown to: Treats bacterial vaginosis (BV).
Prevents recurrent BV.
Provides rapid relief of vaginal discomforts such as unpleasant odour and discharge.
Restores normal vaginal flora balance.
Well tolerated as is not absorbed into the blood stream.
When to use: BETADINE BV Gel is a clear gel intended to be applied into the vagina and has been clinically tested and shown to: Treat BV, restore vaginal flora balance, and normalise vaginal pH.
Provide rapid resolution of symptoms including fishy vaginal odour and discharge.
Prevent recurrent BV and its symptoms.
Dosage/Direction for Use
For vaginal use only.
Treatment: One applicator full (5g), applied vaginally once daily, preferably at bedtime. It is important to complete all 7 applications within 7 days of opening, even if the symptoms go away.
Prevention: One applicator full (5g), applied vaginally once every second day, preferably at bedtime. It is important to complete all 7 applications within 14 days of opening.
BETADINE BV Gel can be used when the patient is having her period. It is recommended to apply BETADINE BV Gel after any sexual activity if the patient is using the product at bedtime.
Contraindications
Do not use BETADINE BV Gel: In girls before the onset of puberty.
If the patient has a history of sensitivity to astodrimer sodium, hydroxybenzoates or any other ingredients in the formulation.
If the applicator wrapper is not present or torn, or if the metal tube seal has been punctured.
Special Precautions
See a doctor or pharmacist if: The patient may be at risk of a Sexually Transmitted Infection (STI); symptoms persist or recur, or patient's condition worsens; irritation occurs following use of the product; pregnant or plan to become pregnant or breastfeeding or plan to breastfeed. Do not share the applicator with anyone. Dispose of the applicator responsibly into a waste container after completing all doses.
Use In Pregnancy & Lactation
See a doctor or pharmacist if: Pregnant or plan to become pregnant or breastfeeding or plan to breastfeed.
Side Effects
The majority of women will likely not experience side effects. However a small percentage reported headache, itching or burning around the vaginal area, abdominal pain, urinary tract infection and yeast infection.
Drug Interactions
BETADINE BV Gel is not expected to interfere with medications because astodrimer sodium in the product is not absorbed into the bloodstream following vaginal application.
Due to incompatibility, use of other vaginal products containing polyquaterniums, which are found in some personal lubricants, should be avoided while using BETADINE BV Gel.
BETADINE BV Gel can be used with condoms; however, it is recommended to apply BETADINE BV Gel after any sexual activity if the patient is using the product at bedtime.
Caution For Usage
Directions for the Multi-dose Tube and Disposable Applicator: A single dose of BETADINE BV Gel (5g) is to be filled into the applicator. Follow the steps as follows to prepare the applicator for use: 1. Remove cap from tube and puncture metal seal on tube with the pointed tip of cap.
2. Remove one applicator from the wrapper and screw the threaded end onto the tube.
3. Slowly squeeze the tube from the bottom to fill the applicator with gel until the plunger stops moving. The applicator now contains the correct amount of gel.
4. Once filled, unscrew the applicator from the tube and replace the tube cap. The filled applicator is now ready to be used.
5. In a sitting or standing position, hold the applicator barrel between the thumb and middle finger, and gently insert the applicator as far as comfortably possible into the vagina.
6. Hold the applicator in place and slowly push the plunger until it stops dispersing the gel into the vagina.
7. Carefully remove the applicator, keeping the plunger depressed.
8. Dispose of the used applicator responsibly into a waste container. Do not flush into the toilet.
Disposal:
Dispose responsibly into a waste container. Do not flush into the toilet.
Storage
Store BETADINE BV Gel below 30°C.
Do not refrigerate or freeze.
ATC Classification
G02CX - Other gynecologicals ; Used in the management of gynecological conditions.
Presentation/Packing
Vag gel 40 g.
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