Instruction for Use1

Composition
Renatured bovine collagen, Gentamicin sulphate.
Collatamp G contains, per cm²: 2.8 mg collagen.
2.0 mg gentamicin sulphate (equivalent to 1.3 mg gentamicin base).

Indications
Collatamp G is used for local haemostasis of capillary, parenchymatous and seeping haemorrhages in areas with a high risk of infection.
This product contains gentamicin sulphate at a locally effective dose. Systemically effective therapeutic blood or plasma levels are not generally achieved.

Contraindications
Collatamp G should not be used if a protein allergy is known or intolerability towards gentamicin has been observed.
No experience has been gained in use during pregnancy and breast-feeding. For this reason, the indication should be strictly established during pregnancy and breast-feeding. The indication for Collatamp G should also be strictly established in patients with impaired renal function.

Side effects
No side effects have been reported to date. If the recommended maximum dose is exceeded, gentamicin-specific side effects cannot be ruled out completely, especially in the case of renal failure.

Interaction with other substances
No interactions have been reported to date. If adjuvant systemic treatment with gentamicin, other aminoglycoside antibiotics or other ototoxic or nephrotoxic drugs is necessary, the cumulative effects should be taken into account.

Dosage and method of administration
If not otherwise prescribed, Collatamp G is administrated as follows:
Collatamp G can be cut to size to fit the area to be treated. Up to 3 Collatamp G implants (10 x 10 cm) can be used, depending on the size of the area requiring haemostasis. However, the patient’s body weight and the total amount of gentamicin should be taken into account. In general, the number and size of the implants should be selected so that a total dose of 9 mg gentamicin sulphate per kg body weight is not exceeded.
A dry Collatamp G is placed on the area to be treated, which should be as dry as possible, and light pressure applied for about 3 minutes to achieve better adhesion. Gloves and instruments should be wetted to prevent Collatamp G from adhering to them.

Storage and shelf-life
Once opened, single packs of Collatamp G may not be kept for later use or re-sterilised.
Collatamp G should be stored between 4°C and 25°C.
Collatamp G must not be used after the expiry date.

Do not use if the sterile packaging is open or damaged.
Keep this product out of the reach of children.

Packaging size
Collatamp G 5 cm x 5 cm x 0.5 cm (Pack containing 1 piece)
Collatamp G 5 cm x 20 cm x 0.5 cm (Pack containing 1 piece)
Collatamp G 10 cm x 10 cm x 0.5 cm (Pack containing 1 piece)

Properties
Haemostasis is triggered when blood comes into contact with released tissue factors and exposed endogenous collagen fibrils or renatured collagen fibrils like those in Collatamp G. The adhesion and aggregation of platelets is induced on the renatured collagen fibrils of Collatamp G and the plasmatic coagulation process is accelerated.
The sponge-like structure of Collatamp G stabilises the wound clot, Collatamp G taking up a certain amount of blood. Collagen also promotes granulation and epithelialisation.
Collatamp G is absorbed quickly and completely. Gentamicin is added to help prevent any infections that might occur at the site of implantation.

Legal Manufacturer
Syntacoll GmbH
Donaustrasse 24
93342 Saal/Donau
Germany

Distributor
SERB SA
Avenue Louise 480
1050 Brussels
Belgium

UK Responsible Person:
Highbridge Pharma Services Ltd
International House
24 Holborn Viaduct
London
EC1A 2BN
Tel: +44 (0)789-5890-767

References:
1. Instruction for use, Feb. 2016