Bionect Start

CE 0373 medical device.
Fluid ointment for topical application containing hyaluronic acid sodium salt from bacterial fermentation, as the main component, and bacterial collagenase obtained from Vibrio alginolyticus as an incorporated medicinal substance. During the wound bed preparation phase, Bionect Start promotes the healing process and protects neoformed tissue thanks to the moisturizing action of hyaluronic acid. Indeed, the healing process of lesions occurs more quickly in a moist environment. Bacterial collagenase facilitates wound bed preparation.
Indicated for the local treatment of chronic ulcers with necrotic or fibrinous tissue (i.e., pressure sores, vascular leg ulcers, diabetic ulcers), promoting debridement. In particular, it is indicated to provide an optimal moist environment and wound bed preparation that facilitate the natural healing process.

Components
Main component: hyaluronic acid sodium salt 0.2%. Other components: collagenase (not less than 2.0 nkat/g of ointment¹), light liquid paraffin, white petrolatum.
1 - The katal (symbol kat) is the unit of measurement for the catalytic activity of an enzyme, included in the International System of Units (SI).

Instructions for use
Lesions should be cleaned and disinfected before application. To ensure treatment success, sufficient moisture must be present on the lesion area. Dry lesions should be moistened with physiological saline (0.9% NaCl) or with solutions well tolerated by the tissue, such as glucose solution. Hard eschar should be softened by applying a moist dressing. Apply a layer of about 2 mm of BIONECT® START to the wound once a day or as advised by healthcare personnel. Cover the treated area with a sterile bandage to ensure adequate contact.

Pregnancy and lactation
Bionect Start can be used during pregnancy and lactation as medically indicated.

Contraindications
Bionect Start should not be used in patients with known individual hypersensitivity to the product components.

Warnings and precautions
It is advisable not to prolong the use of the product beyond 30 days. In case of obvious signs of infection, consult a doctor for possible antibiotic treatment. Tetracyclines should not be used topically with Bionect Start. Do not use the product together with soaps/detergents, disinfectants based on quaternary ammonium salts, silver, and other heavy metals, which may reduce its action. If necessary, ask your pharmacist or doctor which products to use. Do not use on exposed cartilage and tendon tissue. Avoid contact with eyes and mucous membranes. In case of accidental ingestion or inhalation, consult a doctor immediately. Avoid direct contact of the container with the wound. Close the container after each application. Keep the product out of the reach of children.

Side effects
Local side effects such as pain, itching, burning, and erythema may occur. Systemic side effects cannot be excluded in patients with known hypersensitivity to the product components.

Storage
Store at a temperature not exceeding 30°C.
Do not use if the package is damaged. The product can be used for up to 36 months after the first opening of the tube. Do not use the product after the expiry date indicated on the package. The expiry date refers to the product stored correctly. After use, dispose of according to current national regulations.

Format
30 g tube.

Code 195800