TISSEEL FIBRIN SEALANT VH S/D (FROZEN) [SIN14707P]

Product Info

TISSEEL FIBRIN SEALANT VH S/D (FROZEN)

[SIN14707P]

4.1 Therapeutic indications

Supportive treatment where standard surgical techniques appear insufficient (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• For improvement of hemostasis

• As a tissue glue to improve wound healing or to support sutures in vascular surgery and in gastrointestinal anastomoses.

• For tissue sealing, to improve adhesion of the separated tissue (e.g. tissue flaps, grafts, split skin grafts [mesh grafts], fixation of subcutaneously implanted lightweight mesh).

The efficacy in fully heparinized patients has been proven.

4.2 Posology and method of administration

TISSEEL is intended for Hospital Use Only by suitably experienced physicians or surgeons.

Posology:
The amount of TISSEEL to be applied and the frequency of application should always be oriented towards the underlying clinical needs of the patient.

The dose to be applied is governed by variables including the type of surgical intervention, the size of the affected area, and the mode of intended application, and the number of applications.

Application of the product must be individualized by the treating physician. In clinical trials, the individual dosages have typically ranged from 4 to 20 ml. For some procedures (e.g. liver traumata, or the sealing of large burned surfaces), larger volumes may be required.

The initial amount of the product to be applied at a chosen anatomic site or target surface area should be sufficient to entirely cover the intended application area. The application can be repeated, if necessary. However, avoid reapplication of TISSEEL to a pre-existing polymerized TISSEEL layer as TISSEEL will not adhere to a polymerized layer.

As a guideline for the gluing of surfaces, 1 pack of TISSEEL 2 ml (i.e. 1 ml Tisseel solution plus 1 ml thrombin solution) will be sufficient for an area of at least 10 cm².

When TISSEEL is applied by spray application the same quantity will be sufficient to coat considerably larger areas, depending on the specific indication and the individual case.

It is recommended that, to avoid the formation of excess granulation tissue and to ensure gradual absorption of the solidified fibrin sealant, as thin a layer as possible of TISSEEL should be applied.

Safety and efficacy of the product in pediatric patients have not been established.

Method of administration
For epilesional (topical) use.
In order to ensure optimal safe use of TISSEEL by spray application the following recommendations should be followed:

In open wound surgery – a pressure regulator device that delivers a maximum pressure of no more than 2.0 bar (28.5 psi) should be used.

In minimally invasive/laparoscopic procedures – a pressure regulator device that delivers a maximum pressure of no more than 1.5 bar (22 psi) and uses carbon dioxide gas only should be used.

Prior to applying TISSEEL the surface area of the wound needs to be dried by standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices). Do not use pressurized air or gas for drying the site.

TISSEEL must be sprayed only onto application sites that are visible.

TISSEEL should only be reconstituted and administered according to the instructions and with the devices recommended for this product (see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

For spray application, see sections 4.4 and 6.6 for specific recommendations on the required pressure and distance from tissue per surgical procedure and length of applicator tips – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

In surgical procedures that require the use of minimal volumes of fibrin sealant, it is recommended to expel and discard the first few drops of product.

4.3 Contraindications

TISSEEL alone is not indicated for the treatment of massive and brisk arterial or venous bleeding.

TISSEEL is not indicated to replace skin sutures intended to close surgical wound.

TISSEEL must never be applied intravascularly. Intravascular application may result in life-threatening thromboembolic events.

TISSEEL must not be applied in case of hypersensitivity to the active substances or to any of the excipients.

Injection into the nasal mucosa must be avoided, as thromboembolic complications may occur in the area of the arteria ophthalmica.