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
BIOAPIFIT® ANTI HEMORRHOIDAL OINTMENT
BioapifitÒ anti hemorrhoidal 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 Achilea millefolium L., oil macerate of Plantago major L., oil macerate of Quercus robur L., oil macerate of Salvia officinalis L. oil macerate of Olea europaea L., oil macerate of Polygonum aviculare L., oil macerate of Calendula officinalis L., oil macerate of Matricaria chamomilla L.; essential oils: Melaleuca alternifolia, Thymus vulgaris ct. Thymol, Origanum vulgare.
Intended use. BioapifitÒ anti hemorrhoidal ointment is CE-marked as a Class IIa medical device intended for the alleviation of the symptoms of hemorrhoids, fissures, pruritus ani and other non-infective ano-rectal conditions including: rectal bleeding, anal itching and irritation, anal swelling, pain, painful defecation.
Mode of action. The ointment creates a protective layer on the damaged mucosa which allows it to recover faster and prevents further irritation. Furthermore, the ointment prevents wound infection by creating an acidic, viscous environment with low water activity that does not support the growth, adhesion, and multiplication of pathogens. The product relieves pain and discomfort during defecation due to its lubricating effect. The astringent effect of the product stops bleeding, shrinking wound surface and accelerates its healing.
Instructions for use: In order to relieve the symptoms of external hemorrhoids, apply the ointment 3-4 times daily for ten days to the clean and dry perianal area, and spread it gently. For rectal administration, screw the attached applicator onto the tube as presented in the picture, insert the applicator into the rectum and squeeze the tube in order to evenly apply the ointment onto the painful area. After use, remove the applicator immediately from the tube and close the tube with a stopper. Clean the applicator thoroughly with water and a detergent and close it with a special cap.
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, rectal applicator and instruction for use paced in secondary carton box.
Summary of the clinical investigation results: Following ten days of perianal (three times a day) and rectal (once a day) treatment there was no bleeding while pain was reduced for 96%, defecation discomfort for 94.2%, anal itching severity for 95.7% and overall subjective discomfort for 96.2% with clinical cure rate of 85%.
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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