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.

Razdoblje provedbe Projekta: od 01.lipnja 2020. do 01.lipnja 2021. godine



Bioapifit® wound care ointment is a medical device of risk class IIa based on the ingredients of the herbal and honeybee origin. The product does not contain synthetic based preservatives, dyes or fragrances.

Composition: honey (certified organic), beeswax (Cera flava), glycerol, the macerates of the plant species: plantain leaves (Plantago major L.), aerial parts of yarrow (Achillea millefolium L.), oak bark (Quercus robur L.), sage leaves (Salvia officinalis L.), olive leaves (Olea europaea L.), aerial parts of knotweed (Polygonum aviculare L.), comfrey root (Symphytum officinale L.), marigold flowers (Calendula officinalis L.), chamomile flowers (Matricaria chamomilla L.); essential oils: Australian tea tree (Melaleuca alternifolia), thyme (Thymus vulgaris ct. Thymol), oregano (Origanum vulgare).                      

Intended use: BioapifitÒ wound care ointment is intended to be used by adult population of both genders in order to help relieve the symptoms of pressure ulcers, venous ulcers, diabetic wounds, surgical wounds, oncological wounds, as well as superficial wounds and burns.

Mode of action: The ointment promotes wound closure and manages wound infection in the following ways: by creating an acidic wound micro-environment due to the presence of honey and the oil macerates; by absorbing wound exudates due to high osmotic effect/high sugar content in honey; by creating an environment with low water activity, which is unsupportive of pathogen growth and multiplication due to the presence of honey and the macerates; by an astringent effect of the plant macerate which promotes wound shrinkage and creates surface wound coating; by isolating the wound from the microbial infection due to the creation of a protective wound coating, promoted by the presence of beeswax and the macerate; by creating a moist wound environment essential for healing due to the presence of glycerin.

Instructions for use: Clean the wound following the standard procedures, remove the slough and apply the ointment directly onto the wound, covering the wound surface area completely. Apply a bandage. Repeat the procedure twice a day. Duration of the treatment depends on the type of wound. The product may be used for 28 consecutive days.

Packaging: A tube containing 50 mL of the ointment in a cardboard box.

Precautions: Do not use BioapifitÒ wound care ointment during pregnancy and lactation. Do not use in case of hypersensitivity to any of the product ingredients. Avoid contact with eyes. Do not eat, do not swallow. In case of swallowing contact your doctor. In case of accidental contact with eyes rinse with plenty of water.

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: Treatment with Bioapifit wound care ointment resulted in complete closure of all pressure ulcers after 28 days reaching zero values of all wound healing parameters. Significant decrease of pH from 7.6±0.8 to 5.7±0.3 (25%) was also observed after seven days of the treatment while in the same times all the wound swabs were negative to Pseudomonas aeruginosa and Staphylococcus aureus.

The treatment of venous ulcers with Bioapifit wound care ointment resulted in 90.2% decrease of the total number, 99.3% decrease of ulcers surface area while the scores for quantity of exudate and type of tissue for decreased for 100% and 95%, respectivelly and wound pH for 20.1%. The clinical cure rate of the wounds treated with Bioapifit wound care ointment was 90.2%.

In the end of the treatment of neuropathic foot ulcers with Bioapifit wound care ointment 84% of the ulcers were completely closed which was also clinical cure rate. Compared to baseline, total surface area of the ulcers decreased for 96.8%. All the wounds were completely dry. The score for the type of tissue also dropped for 96.8% and wound pH for 18%. All the wounds were sterile.

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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