GEM S.r.l.

info@gemitaly.it

Glubran Tiss - Technical card

Composition:

NBCA (n- butil 2 cyanoacrilate)
OCA (2- octil cyanoacrilate)

SPECIFICATIONS

GLUBRAN TISS skin adhesive is a class-II medical device for topical use that fulfils the requirements of EU Directive 93/42 EEC. GLUBRAN TISS is a sterile, ready-for-use cyanoacrylate adhesive to be used on the skin. It is an amber liquid that, when in contact with the tissues, quickly polymerises into a thin, elastic waterproof film, which has high tensile strength and firmly adheres to the tissues. Once set, the adhesive looses its adhesive effect. Once polymerised, the adhesive acts as an effective antimicrobial barrier against the most common infectious bacteria.

HOW TO USE

Open the blister pack and take out one sterile single-dose vial. Before using the product, check the adhesive is fluid and transparent. If the product looks thick and/or turbid, do not use it. Use the product immediately after opening the single-dose vial. Never apply the adhesive into a wound, but only on to the skin after opposing the edges of the wound, which will have been preliminarily cleaned and dried. Keep the edges of the wound close together until the adhesive has dried, approximately 1 minute. Once the adhesive has polymerised, the result cannot be corrected. The adhesive will naturally slough off within approximately 3-5 days of its application.

1. Ensure the vial is in the vertical position, with the cap turned up.

2. Let the adhesive flow down from the neck of the vial to ensure no accidental leakage.

3. Screw the dispenser tip onto the neck of the vial and make sure it is securely fastened before applying the adhesive. Exercise care while doing this operation, as excessive pressure on the body of the ampoule will cause leakage of the adhesive through the dispenser tip.

4. Overturn the vial and gently press the body of the vial so as to let a tiny amount of adhesive flow out onto the padded dispenser tip.

5. Apply a thin film of adhesive onto the wound without pressing too hard on the body of the vial. Application of an excessive amount of product would result in a longer polymerisation time which would reduce the tensile strength of the adhesive on the site of application and would prevent the correct healing of the wound.

CONTRAINDICATIONS

Never apply the adhesive inside the edges of the wound but only on the skin after opposing the edges of the wound, which will have been preliminarily cleaned and dried.

Never use the adhesive on hypersensitive patients.

Do not apply on infected or chronic wounds.

PRECAUTIONS

Always apply a tiny amount of adhesive. A second film of adhesive may be applied over the first one only after the first layer has polymerised. Any excess product can be removed with a dry tampon within 5-6 seconds of its application.
Avoid contact with the eyes. In case of accidental contact, immediately rinse with water. If the product has polymerised, it will naturally slough off after about 2-3 days.
If the adhesive comes into contact with surgical instruments, remove with acetone.

WARNING

Only physicians experienced in the use of the product must use the adhesive. The user is responsible for the proper use of the product.
Do not use the adhesive if thick and/or turbid.
The adhesive is disposable.
Any unused adhesive must be disposed of.
After application, some minor, local inflammatory reaction may very rarely occur. The exothermic reaction that occurs during the polymerisation process, although always below 45°C, could sometimes cause a slight burning sensation in hypersensitive patients (such as children or elderly people) on the site of application.

STORAGE

The product must be stored at 0°C to +4°C.

EXPIRY DATE

The product, if properly stored, lasts two years from the date of manufacture. Do not use the product after the expiry date.

STERILITY

The product is sterile.

PACK

One pack contains no. 10 0.50-ml single-dose vials (Ref. G-NBOC)
One pack contains no. 10 0.25-ml single-dose vials (Ref. G-NBOC-25)

PRODUCT CODE

G-NBOC
G-NBOC-25