Fleurstat BV Gel 45g – Astodrimer Sodium (S3)

Fleurstat BVgel is a non-antibiotic bacterial vaginosis (BV) treatment that works to relieve BV symptoms and prevent recurrent BV.

Fleurstat BVgel is for the TREATMENT of BV and relief of symptoms including abnormal vaginal odour and discharge, helping to normalise vaginal pH and restore the normal vaginal flora balance.

If you experience recurrent BV (typically 3 or more episodes in a 12-month period), you can use Fleurstat BVgel when you don’t have symptoms to help PREVENT recurrent BV.
Suitable For: Suitable for females of all ages, after the onset of puberty. For TREATMENT and relief of bacterial vaginosis (BV) and PREVENTION of recurrent BV.

Boxed Contents: The carton contains: One (1) sealed multi-dose aluminium tube containing 45 grams of Fleurstat BVgel sufficent for seven (7) doses. Seven (7) disposable vaginal applicators. One (1) instructions for use leaflet.

Size: 45g

KEY FEATURES

• For treatment and relief of bacterial vaginosis and its symptoms including abnormal vaginal odour and discharge.
• Fleurstat BVgel helps to normalise vaginal pH and restore the normal vaginal flora balance.
• Fleurstat BVgel prevents recurrent BV by forming a physical barrier that blocks the attachment of BV-causing bacteria to the vaginal lining.
• No prescription required.
• Fleurstat BVgel is not an antibiotic.

Active Ingredients: Fleurstat BVgel contains astodrimer sodium (VivaGel ®) at a concentration of 10 mg/g (1% w /w) in a gel consisting of purified water, carbomer homopolymer type A, glycerol, propylene glycol, methyl hydroxybenzoate and propyl hydroxybenzoate (preservatives) and disodium edetate.
Active ingredient: 1% w/w astodrimer sodium (VivaGel®)

Contains: Fleurstat BVgel contains astodrimer sodium (VivaGel ®) at a concentration of 10 mg/g (1% w /w) in a gel consisting of purified water, carbomer homopolymer type A, glycerol, propylene glycol, methyl hydroxybenzoate and propyl hydroxybenzoate (preservatives) and disodium edetate.

Directions for the multi-dose tube and disposable applicators.

A single dose of Fleurstat BVgel (5g) is to be filled into the disposable applicator. Follow the steps below 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 an applicator from the wrapper and screw end of applicator onto tube.
3. Slowly squeeze the tube from the bottom to fill the applicator with gel; the plunger will move as the applicator fills and will stop moving when the applicator contains the correct amount of gel.
4. Once filled, unscrew the applicator from the tube and replace the tube cap.
5. The filled applicator is now ready to be applied.
6. The applicator is inserted in the same way you would use a tampon applicator, so you may sit or stand depending on how you feel most comfortable.
7. Hold the applicator barrel between the thumb and middle finger and gently insert the applicator as far as comfortably possible into the vagina.
8. Holding the applicator in place, slowly push the plunger until it stops, dispersing the gel into the vagina.
9. Carefully remove the applicator, keeping the plunger depressed.
10. Discard used applicator into a suitable waste container.
TREATMENT: The recommended dose is one applicator full (equivalent to 5g) vaginally once daily, preferably at bedtime, for 7 days. It is important to complete all 7 doses, even if your symptoms go away.
PREVENTION: The recommended dose is one applicator full (equivalent to 5g) vaginally once every second day, preferably at bedtime.
Directions for the multi-dose tube and disposable applicators
A single dose of Fleurstat BVgel (5g) is to be filled into the disposable applicator. Follow the steps below 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 an applicator from the wrapper and screw end of applicator onto tube.
3. Slowly squeeze the tube from the bottom to fill the applicator with gel; the plunger will move as the applicator fills and will stop moving when the applicator contains the correct amount of gel.
4. Once filled, unscrew the applicator from the tube and replace the tube cap.
5. The filled applicator is now ready to be applied.
6. The applicator is inserted in the same way you would use a tampon applicator, so you may sit or stand depending on how you feel most comfortable.
7. Hold the applicator barrel between the thumb and middle finger and gently insert the applicator as far as comfortably possible into the vagina.
8. Holding the applicator in place, slowly push the plunger until it stops, dispersing the gel into the vagina.
9. Carefully remove the applicator, keeping the plunger depressed.
10. Discard used applicator into a suitable waste container.

• For vaginal use only.
• Keep out of reach of children.
• Do not use the product if the applicators are unwrapped or the wrapper is torn.
• Do not use the product if the container/tube is broken or dirty or appears to be tampered with.
• Only use the recommended dose as specified in these instructions.
• Do not use Fleurstat BVgel if you have a history of sensitivity to any ingredient of the formulation.
• See a doctor if you are pregnant or diabetic. See a doctor if you plan to become pregnant, or are breastfeeding or plan to breastfeed.
• Do not use for more than 7 days unless a doctor has told you to.
• See a doctor before using Fleurstat BVgel for the prevention of recurrent BV.
• Use of Fleurstat BVgel beyond 16 weeks is not recommended without medical supervision.
• When using the product for the treatment of BV consult a doctor if no better after 7 days, or if symptoms recur within two weeks of completing the course.
• See your healthcare provider if you consider that you may be at risk of a Sexually Transmitted Infection (STI).
• Laboratory-based studies of Fleurstat BVgel have not demonstrated a risk to the foetus, but there are no adequate and well-controlled clinical studies in pregnant or breastfeeding women and the effects on an unborn child have not been fully investigated.
• Fleurstat BVgel should not be used by girls before the onset of puberty.
• Delay administering the normal dose of Fleurstat BVgel when you anticipate sexual activity will occur around bedtime. Administer the normal dose of Fleurstat BVgel after any sexual activity is complete.
• Avoid use of this product with personal / medicinal products containing polyquaterniums.
• Do not share your vaginal applicators with anyone. Dispose of each applicator after dosing.
• Store Fleurstat BVgel below 30°C. Do not refrigerate or freeze.