Projekt je sufinancirala Europska unija iz Europskog fonda za regionalni razvoj
Naziv projekta: Certifikacijom proizvoda tvrtke Apiherbal d.o.o. do tržišta
Razdoblje provedbe Projekta: od 16.srpnja 2018. do 02.studednog 2019. godine
BIOAPIGYN® VAGINAL OINTMENT
BioapigynÒ vaginal ointment is medical device based on the ingredients of herbal and honeybees origin containing no synthetic preservatives, colorants or fragrances.
Composition: honey, Cera flava, glycerin, oil macerate of Calendula officinalis L., oil macerate of Plantago major L., oil macerate of Matricaria chamomilla L., oil macerate of Lavandula officinalis L., oil macerate of Achilea millefolium L., oil macerate of Salvia officinalis L., oil macerate of Alchemilla vulgaris L.; essential oils: Melaleuca alternifolia, Thymus vulgaris ct. Thymol, Origanum vulgare.
Intended use. BioapigynÒ vaginal ointment is intended to relieve the symptoms of vulvovaginal disorders caused by an increase in the vaginal pH, characterized by vaginal discharge, vaginal dryness, dyspareunia, abnormal vaginal odour, irritation, burning, itching, and oedema in the vaginal and vulvar area.
Mode of action. BioapigynÒ vaginal ointment is class IIa medical device intended for women over 18 years of age, both of reproductive age and those in menopause / postmenopause, to relieve the symptoms of vulvo-vaginal disorders (vaginal discharge, vaginal dryness, painful intercourse, irritation, burning, itching and edema in the vulvo-vaginal area) caused by an increase in vaginal pH due to estrogen deficiency, unprotected sex due to the alkaline value of sperm, during menstruation due to the alkaline value of menstrual blood and after therapy with antibiotics that kill lactobacilli responsible for maintaining normal acidic vaginal pH.
The complex mixture of ingredients creates an acidic, viscous environment with low water activity that prevents the growth, adhesion and replication of pathogens and lowers the pH of the vagina to the optimal acidic values. The coating, lubricating and emollient effect of the product results in the formation of a protective layer on the damaged mucosa, which enables its recovery and prevents further irritation, alleviates vaginal dryness and painful intercourse. Moreover, the combination of essential oils and herbal macerate removes the unpleasant odor accompanying various pathological conditions.
Instructions for use. BioapigynÒ vaginal ointment is intended for internal and external use on the mucous membranes of the genital tract. Use before bedtime. Insert 2.5 mL of the ointment deep into the vagina using the applicator. After each use, separate the applicator plunger from its body and clean the parts using warm water and a detergent. Having washed your hands, use your finger to apply a thin layer of the ointment to the external genitalia.
Precautions and storage condition: The device must not be use during the pregnancy and breast-feeding or in the case of hypersensitivity to any component of the product. The device must be stored in dark please out of reach of children at temperature below 25 0C.
Packaging: 50 mL ointment in aluminum tube, vaginal applicator (dosing pipette) and instruction for use paced in secondary carton box.
Summary of the clinical investigation results: Ten days of the treatment with BioapigynÒ vaginal ointment (2.5 mL per day) resulted with 85% decrease of self assessed symptoms of vulvo-vaginal disorders, 94% decrease in the signs/symptoms determined by the investigator, 14.4% 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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