Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS

6.1    List of excipients
Albumin
L-Arginin-hydrochloride.
Collagen
Sodium Chloride
Sodium Citrate
Riboflavine

6.2    Incompatibilities

Not applicable
6.3    Shelf life

The expiry date of the product is indicated on the packaging materials.
Once the foil sachet is opened, Tachosil must be used immediately.

6.4    Special precautions for storage
Store below 25 °C.

6.5    Nature and contents of container

Each sealant matrix is packed in a PET-GAG blister sealed with a coated PE foil. The blister is packed in an aluminium-bonded foil sachet with a desiccant bag included and packed in a folding carton.
Pack sizes:
Package with 1 matrix of 9.5 cm x 4.8 cm
Package with 2 matrix of 4.8 cm x 4.8 cm
Package with 1 matrix of 3.0 cm x 2.5 cm
Package with 5 matrix of 3.0 cm x 2.5 cm

Not all pack sizes may be marketed.

6.6   Instructions for use and handling and disposal
TachoSil comes ready to use in sterile packages and must be handled accordingly. Use only undamaged packages.
Once the package is opened, post-sterilisation is not possible. The outer aluminium foil sachet may be opened in a non-sterile operating area. The inner sterile blister must be opened in a sterile operating room area. TachoSil should be used immediately after opening the inner sterile cover.

TachoSil is used under sterile conditions. Prior to application the wound area should be cleansed, e.g. from blood, disinfectants and other fluids. After removal of conventional, flat TachoSil from the sterile package it should be pre- moistened in saline solution and then applied immediately. The yellow, active side of the matrix is applied to the bleeding/leaking surface and held against it with a gentle pressure for 3-5 minutes. This procedure enables an easy adhesion of TachoSil to the wound surface.

Pressure is applied with moistened gloves or a moist pad. Due to the strong affinity of collagen to blood, TachoSil may also stick to surgical instruments, gloves or adjacent tissues covered with blood. This can be avoided by cleansing surgical instruments, and gloves and adjacent tissues before application. It is important to note that failure to adequately clean adjacent tissues may cause adhesions (see section 4.4). After pressing TachoSil to the wound, the glove or the pad must be removed carefully. To avoid TachoSil from being pulled loose it may be held in place at one end, e.g. with a pair of forceps.

Alternatively, e.g. in case of stronger bleeding, TachoSil may be applied without pre-moistening, while also pressing gently to the wound for 3-5 minutes.

The active side of TachoSil should be applied so that it extends 1-2 cm beyond the margins of the wound. If more than one matrix is used they should overlap. TachoSil can be cut to the correct size and shaped if too large.

In neurosurgery, TachoSil should be applied on top of the primary dura closure.

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