GEM S.r.l.

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Glubran 2 - Technical Card

Composition:

NBCA — MS Co-monomer

CHARACTERISTCS

GLUBRAN 2 Surgical Glue is a class III medical-surgical product (for internal and external surgical use) which fulfils the requirements of the European Directive on Medical Devices 93/42/EEC and subsequent amendments. GLUBRAN 2 is a synthetic cyanoacrylic surgical glue modified by addition of a monomer synthesized by the manufacturer. GLUBRAN 2 surgical glue has outstanding haemostatic and adhesive properties, and once set (solidified), the glue produces an effective antiseptic barrier against infectious agents or pathogens commonly found in surgical settings. It is a pale yellow, transparent liquid ready for use. It polymerises rapidly in contact with living tissue and in moist environments, to create a thin elastic film of high tensile strength that ensures firm adherence to tissues. The film conforms naturally to the anatomy of the tissue on which it has been applied, it is waterproof and is not impaired by blood or organic fluids. Once set, the film may be easily perforated by a suture needle as the product polymerization does not generate glass-like aggregates. The polymerization time depends on the type of tissue with which the glue comes into contact, the nature of the fluids present and the amount of product applied. When applied properly, the glue starts to set after 1-2 seconds and completes its setting reaction after about 60-90 seconds. The glue reaches its maximum mechanical strength on completion of this reaction. Once set, the glue no longer possesses adhesive properties so that tissues or surgical gauzes may be placed in contact with it without any risk of unwanted adhesion. In normal surgical procedures, the film of glue is eliminated by hydrolytic breakdown, a process whose duration varies according to tissue type and quantity of glue applied. In embolization procedures, the glue remains for a longer period of time. The polymerization reaction generates a temperature of approximately 45°C.

METHOD OF USE

Surgical Applications

Open the blister and pour the sterile single-dose vial directly on the surgical table in a sterile field. Before opening the single-dose vial, check transparency and fluidity of the glue. If the product appears cloudy and/or thickened, it should not be used. Draw the glue out of the single –dose vial with a sterile 4-5 cm needle luer lock insulin syringe. The glue can be directly applied a drop at a time using the same syringe with an insulin needle (approximately one drop per sq.cm). Whenever possible, clean the area to be treated before applying the glue. The glue applied at in minimum amount will form, with polymerization, a thin adhesive film. For this purpose, it is essential not to apply more than one drop in the same spot. Any second layer of glue may be applied over the first only when this has already polymerized. Any excess product may be removed with a dry swab within the first 5-6 seconds after its application. After application and until the polymerization reaction is complete, do not touch the glue as it may detach or not produce the effect desired. After polymerization, the amount of product in excess may lead to detachment of the adhesive film and/or give rise to the formation of small fragments which tend to become detached from the tissues and which should always be removed. Moreover, an excessive amount of product, in addition to prolonging setting time, can prevent adherence. The glue can be sprayed; in this case it is advisable to protect the areas surrounding those to be treated.

Skin Closure Applications

The glue can be used in a sterile environment on the skin. The glue must not be applied into the wound but only on the skin after having made sure that the wound is perfectly clean and the two damaged sides of the tissue perfectly fit together. The edges of the wound must be kept firmly joined for about one minute. When polymerization occurs no other modifications are possible. After application, carefully check that the treated edges of the wound properly stick together. The glue will spontaneously detach after 5-8 days after application.

CONTRAINDICATIONS

Do not apply the glue directly to cerebral tissue.

Do not apply the glue inside a vessel lumen, except in the case of treatments during digestive tract endoscopy, interventional radiology and vascular neuroradiology.

When used in skin closure applications, the glue should never be applied inside wound margins, but only to the skin surface, after the margins of the wound have been joined perfectly and previously cleaned thoroughly.

Do not use the glue in particularly sensitive subjects or pregnant women.

Do not use the glue on bleeding varices caused by juvenile liver cyrrhosis of unknown origin.

Do not use the glue for anastomoses of peripheral nerves.

PRECAUTIONS

The viscosity of the glue is only slightly greater than that of water, so the glue should be applied very carefully to prevent its spread to unwanted areas; when necessary, apply gauzes to the protect surrounding areas. The glue should always be applied in minimal amounts, i.e. approximately one drop per square centimetre, avoiding the application of more than one drop in any given spot. A second layer of glue can be applied over the first only after its full polymerization.

Any excess product can be removed with a dry swab within 5-6 seconds after application.

After polymerization, any excess product may lead to detachment of the adhesive film and/or give rise to the formation of small fragments which tend to become detached from the tissues and which should always be removed. An excessive amount of product prolongs setting time and can prevent adherence.

Avoid contact with the eyes. In case of accidental contact, immediately wash with water. If the product has polymerized, it will detach spontaneously after about 2-3 days.

Should the glue come into contact with surgical instruments or other materials, it can be removed with acetone.

WARNING

The glue must be used only by qualified physicians who have experience in using this product. The manufacturer shall not be liable for damages caused by any uses other than those outlined in this technical data sheet.

The glue is a disposable product.

Do not reuse the device after the first opening. The reusing involves substantial risk of infection to the patient for lack of content sterility, fault of adhesive properties and of product efficacy by its contact with air.

The glue is ready for use.

The glue is not meant to be diluted or mixed with other substances, except for substances used to make it radio-opaque. However, such mixing shall proportionally change polymerization times.

Do not use the glue with instruments or accessories containing silicone or polycarbonate. Always make sure that instruments and accessories are sterile and compatible with the product to prevent any induction of polymerization or breakdown of the glue.

Do not use if thickened and/or cloudy.

Any glue remaining in the single-dose vial should not be re-used and should be discarded.

The glue cannot be re-sterilised.

In rare cases, after application, a temporary local inflammatory reaction may occur.

When used for skin applications, the exothermal reaction during polymerization, though not exceeding 45°C, may sometimes cause a slight sensation of heat in particularly sensitive patients (e.g. children and elderly subjects) at the glue application site.

STORAGE

The product should be stored at temperatures between 0°C and +4°C.

SHELF LIFE

When properly stored, the product has a shelf life of 2 years from the date of manufacture. The product should not be used after its expiration date.

STERILITY

The glue is sterile.

PACKAGING

One package contains 6 1-ml single-dose vials.

PRODUCT AND PRODUCT CODES

REF	PACKAGING	VOLUME	GMDN
G-NB-2	6 vials/box	1 ml	34164
G-NB2-50	10 vials/box	0.50 ml	34164
G-NB2S-25	10 vials/box	0.25 ml	34164