TACHOSIL, MEDICATED SPONGE [SIN14441P]

Product Info

TACHOSIL, MEDICATED SPONGE

[SIN14441P]

INDICATIONS
TachoSil is indicated as an adjunct to haemostasis during surgery when control of bleeding by standard surgical techniques is ineffective or impractical.

DOSAGE AND ADMINISTRATION
The use of TachoSil is restricted to experienced surgeons.

TachoSil should not be used intravascularly (see ‘Contraindications’). For more information on situations where TachoSil should not be used, see ‘Precautions’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

The number of TachoSil sponges to be applied should always be determined by the underlying clinical need for the patient. The number of TachoSil sponges to be applied vary and should be appropriate to the size of the wound area.

Application of TachoSil must be patient-specific and accordingly determined by the treating surgeon. In clinical trials, the individual dosages have typically ranged from 1 to 2 sponges (9.5 cm × 4.8 cm), however application of up to 7 sponges has been reported. For smaller wounds, e.g. in minimal invasive surgery, the smaller sized sponges (4.8 cm × 4.8 cm or 3.0 cm × 2.5 cm) are recommended.

Instructions for use/handling
Preparation for Application:

• TachoSil comes ready to use in sterile packages and must be handled using sterile technique in aseptic conditions. Open or damaged packages should be discarded as resterilization is not possible.

• When in the operating room, the outer aluminium foil pouch may be opened in a non-sterile environment. The inner sterile blister must be opened in a sterile environment. TachoSil should be used immediately after opening the inner sterile cover.

• Remove TachoSil from the blister, which can be used as a container for pre-moistening of the sponge (patch), if needed. Determine the size of sponge(s) patch (es) to be applied to the bleeding surface. Select the appropriate TachoSil so that it extends 1 – 2 cm beyond the margins of the wound. The sponge (patch) can be cut to the correct size and shape if desired. If more than one sponge (patch) is used, overlap sponges (patches) by at least 1 cm.

• Prior to application, cleanse the area to be treated to remove blood, disinfectants and other fluids. The fibrinogen and thrombin proteins can be denatured by alcohol, iodine or heavy metal ions. If any of these substances have been used to clean the wound area, thoroughly irrigate the area before the application of TachoSil.

• Apply TachoSil directly to the bleeding area either wet or dry. If applied wet, pre-moisten TachoSil in 0.9% saline solution for no more than 1 minute and then apply immediately. In the case of a wet tissue surface (e.g., oozing or bleeding) TachoSil may be applied without pre-moistening.

• Use only undamaged packages.

Method of Application

• Cleanse surgical instruments, gloves and adjacent tissues with saline solution to reduce the adherence to TachoSil. The white, inactive side of TachoSil may also adhere to surgical instruments (e.g., forceps), gloves or adjacent tissues covered with blood due to the affinity of collagen to blood. It is important to note that failure to adequately clean adjacent tissues may cause adhesions (see ‘Precautions’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Apply the yellow, active side of the sponge (patch) to the bleeding area and hold in place with gentle pressure applied through moistened gloves or a moist pad for at least 3 minutes.

• To avoid pulling the patch loose, first place a clean surgical instrument at one end of the patch before relieving the pressure. Gentle irrigation may also aid in removing the premoistened pad or glove without removing TachoSil from the bleeding area.

• Leave TachoSil in place once it adheres to organ tissue. Only remove any unattached TachoSil or part of sponges (patches) and replace with new sponges (patches).

• TachoSil cannot be re-sterilized once removed from inner pouch. Discard unused, opened packages of human fibrinogen/human thrombin sponge (patch) at the end of the procedure.

• Record patient name and TachoSil batch number every time that TachoSil is administered to a patient.

Retreatment

If not satisfied with the placement of the sponge (patch), or if bleeding still occurs during or after the specified duration of compression, then repeat the application procedure as described above. Do not remove already applied and attached (partial) TachoSil.

Any unused product or waste material should be disposed of in accordance with local requirements.

CONTRAINDICATIONS
Hypersensitivity to the active ingredients or to any of the excipients.
Do not apply TachoSil intravascularly. Intravascular application of TachoSil may result in life-threatening thromboembolic events.