Pregyn

Pregyn

Manufacturer:

Stragen

Distributor:

MacroPhar
Full Prescribing Info
Contents
Alpha-glucan oligosaccharides, lactic acid, glycerol.
Description
Pregyn vaginal gel is specially designed to maintain the balance of the vaginal ecosystem. Available in boxes of 8 specially shaped tube applicators for single use. Each tube contains a single application quality of 5 ml. Gel appearance is homogenous with translucent white to light yellow color.
Free from hormones, antibiotics, perfume and parabens.
Ingredients: Aqua, Glycerol, Lactic Acid, Alpha-Glucan Oligosaccharides, Polyacrylamide, C13-14 isoparaffin, Sodium benzoate, Laureth-7, Potassium sorbate.
Action
Pregyn is a unique combination of glycerol, lactic acid and the innovative α-GOS prebiotic. α-GOS prebiotic is a specific substrate promoting the selective growth of Lactobacilli to the detriment of pathogens. The lactic acid supports this function by naturally decreasing the vaginal pH.
Pregyn relieves vaginal discomfort and odours by restoring a normal pH and vaginal flora.
Moreover, Pregyn provides an additional moisturizing and regenerating effect, thus protecting the vaginal epithelium from dehydration, thanks to the high water binding capacity of glycerol.
Indications/Uses
Pregyn is indicated for a rapid recovery of a normal vaginal ecosystem, mainly after antibiotics treating vaginal infections such as bacterial vaginosis. Pregyn relieves vaginal discomfort and odours by restoring a normal pH and vaginal flora. Pregyn also prevents bacterial vaginosis relapses.
Dosage/Direction for Use
After an "isolated" bacterial vaginosis episode, 1 dose (tube) per day is applied for 8 consecutive days, starting the day after the end of antibiotic treatment. The treatment should be repeated after the following menstruation.
In case of frequent relapses the previously mentioned protocol should be followed. Then 8-day treatments should be repeated every 6 months, starting the day after the end of menstruation.
Pregyn vaginal gel is inserted directly into the vagina. It is recommended to wash the hands before and after applying the product.
Directions for use of the single dose tube: A. Grip the applicator firmly by the thick end. Shake down 4 times to ensure that the content is at the thin end.
B. Bend thin pointed end of the applicator back and forth repeatedly. Break off the tip of the tube by twisting it.
Do not use scissors or tools to cut the applicator tip.
C. While sitting or lying on the back with knees bent, take the tube in the hand and gently insert the thin end of the applicator into the vagina.
D. Squeeze slightly the thick end of the applicator firmly 2-3 times to deposit the gel into the vagina.
E. Remove the applicator, still squeezing and discard in waste container.
Contraindications
Pregyn vaginal gel must not be used by young girls who have not reached puberty or by women with a known allergy to any of its ingredients.
Special Precautions
Clean conditions should be ensured (e.g. washed hands). Pregyn vaginal gel should not be used if the single dose container is not intact. Pregyn vaginal gel is intended for single application and must not be re-used. Pregyn vaginal gel should not be used during menstruation. Application should be avoided when pregnancy is desired, as the gel has a low pH value, which is a less favourable environment for sperm. Furthermore, glycerol contained in Pregyn may alleviate sperm motility. In case of virginity, treatment with Pregyn vaginal gel should only be started after having consulted a physician.
Use In Pregnancy & Lactation
Based on the composition and mode of action of Pregyn vaginal gel, the products are not absorbed systemically and thus, there is no risk to the infant. However, it is recommended to always consult the physician before taking any medication.
Side Effects
Side effects can include skin reactions such as erythema, swelling, burning sensation or itching at the area of application. The burning sensation may be due to the low pH-value of Pregyn vaginal gel leading to an increased sensitivity of the vagina. It may be slight or moderate in intensity and usually occurs after having started the application. It should disappear when the vaginal flora is restored. Very rarely, additional mild local reactions may also occur in response to certain ingredients of the gel (e.g. sodium benzoate).
A general practitioner should be consulted if the well-being is affected, symptoms become worse or do not improve within 7 days.
Drug Interactions
Condoms, latex membranes (diaphragms), spermicidal agents or other types of physical barrier contraceptives must not be used while using Pregyn vaginal gel due to a risk of rupture or ineffectiveness.
Storage
Do not store above 25°C. Store in dry place and protect from moisture.
ATC Classification
G02CX - Other gynecologicals ; Used in the management of gynecological conditions.
MEDICAL DEVICE - Healthcare Device
Presentation/Packing
Vag gel 5 mL x dose x 8's.
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