Projekt je sufinancirala Europska unija iz Europskog fonda za regionalni razvoj
Naziv projekta: Certifikacijom biljnih medicinskih proizvoda tvrtke Apiherbal d.o.o. do tržišta, oznaka KK.032.1.12.0082
Razdoblje provedbe Projekta: od 01.lipnja 2020. do 01.lipnja 2021. godine
BioapigynÒ pessaries are a medical device of risk class IIa based on the ingredients of the herbal origin. The product does not contain synthetic based preservatives, dyes or fragrances.
Composition: One pessary (3 grams) contains hydrogenated coco-glycerides (Whitepsol E75); beeswax (Cera alba); macerate of the plant species: marigold flowers (Calendula officinalis L.), broadleaf plantain leaves (Plantago major L.), chamomile flowers (Matricaria chamomilla L.), lavender flowers (Lavandula officinalis L.), aerial parts of yarrow (Achillea millefolium L.), sage leaves (Salvia officinalis L.), lady’s mantle leaves and steam (Alchemilla vulgaris L.); essential oils: Australian tea tree (Melaleuca alternifolia), thyme (Thymus vulgaris ct. Thymol), oregano (Origanum Vulgare).
Intended use: BioapigynÒ pessaries are intended for women over the age of 18, both in the reproductive age and those in menopause and post menopause to relieve the symptoms of vulvovaginal disorders (vaginal discharge with an unpleasant odor, vaginal dryness, painful intercourse, irritation, burning, itching and edema in the vulvo-vaginal area) caused by an increase in the vaginal pH due to one or more of the following conditions: estrogen deficiency, sperm alkalization of the vagina in case of unprotected sex, menstrual blood alkalinization of the vagina, antibiotic therapy that killing nonselectivelly both the pathogens and healthy lactobacilli responsible for maintaining vaginal pH in acidic area.
Mode of action: The complex mixture of the ingredients creates an acidic, viscous microenvironment with low water activity that prevents the growth, adhesion and replication of the pathogens and lowers the pH of the vagina to an optimal value in relation with the patient’s age. Furthermore, the coating, lubricating and emollient effect of the product results in the formation of a protective layer on the damaged mucosa, which promotes its rapid recovery, prevents further irritation, relieves vaginal and vulvar dryness and allows painless intercourse. Additionally, the combination of essential oils and herbal macerate removes the unpleasant odor of various pathological conditions.
Instructions for use: BioapigynÒ pessaries are intended for vaginal use only. Separate both sides of the foil at the top and remove the pessary from the package with clean hands. Use your finger to insert the pessary into the vagina. Use one pessary per day, preferably before bedtime 10 days continuously. The maximum permitted length of use is 20 days continuously.
Packaging: Each box contains 10 3 g pessaries in a blister strip.
Precautions: Do not use BioapigynÒ pessaries if you are pregnant or breast-feeding. Do not use in case of hypersensitivity to any of the product components. Do not use the product if the original packaging is damaged or open. Do not eat, do not swallow. In case of swallowing contact your doctor. Rinse with plenty of water in the case of accidental contact with eyes.
Storage instructions: Keep in a dark place, at temperature not exceeding 25oC, out of the reach of children.
Manufacturer: APIHERBAL d.o.o., Dubrava 124, 10040 Zagreb, Croatia
Summary of the clinical investigation results: Ten days of the treatment with Bioapigyn pessaries (one pessary per day) resulted with 89% decrease of self assessed symptoms of vulvo-vaginal disorders, 97% decrease in the signs/symptoms determined by the investigator, 11% of decrease in the vaginal pH with clinical cure rate of 87%. Moreover, the patients with disturbed balance of vaginal flora showed complete normalization and establishment of a healthy balance of the vaginal flora with prevailing lactobacilli in vaginal secretion following 10 days of application.
None of the patients experienced any adverse effect (worsening of the existing symptoms, appearance of new symptoms, irritation or allergic reaction) during the treatment and follow up period.
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