Instructions for Use¹

Composition
Collatamp G is a sterile fully absorbable haemostatic device for implantation. It is composed of bovine collagen incorporating gentamicin sulfate at a locally effective dose. The product is available in three different sizes.

Indications
Collatamp G is used for local haemostasis of capillary, parenchymatous and seeping haemorrhages in areas with a high risk of infection (determined by the surgeon on a case-by-case basis, including patient-related, surgery-related, and physiological factors). 

After implantation of Collatamp G, systemic gentamicin plasma amounts may temporarily reach therapeutic levels. 

Contraindications
Do not use Collatamp G if: 

• a protein allergy is known; 
• any signs of hypersensitivity (severe allergy) to gentamicin has been observed or the patient is allergic to other aminoglycosides; 
• the patient is suffering from myasthenia gravis. 

Collatamp G should not be used in the paediatric population due to a lack of data on safety. 

Undesireable effects
Serious adverse reactions including neurotoxicity (vertigo, tinnitus), ototoxicity (potential hearing loss, deafness, balance loss) and nephrotoxicity have occurred primarily in patients receiving systemic gentamicin therapy. However, systemic absorption following implantation of Collatamp G is unlikely to constitute a comparable risk. 

Rare / very rare incidents (maximum 1 incident by sales volume of 10,000 qty.) potentially associated with Collatamp G use include delayed/impaired wound healing, local infection / secretion, haematoma, seroma, elevated creatinine levels, sensitisation/hypersensitivity reactions, and thrombosis. Categories and ranges have been calculated based on `probability of occurrence’ estimates using the manufacturer’s risk management rating system. As a reference parameter, the probability of occurrence of an ´event per patient´ is used, which is based on product sales numbers. 

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
The implant procedure should be performed by an appropriately trained surgeon under aseptic conditions. Avoid any unsterile handling of the product before or during application to avoid contamination. 

Collatamp G is administrated as follows: 

a) Before surgery 

• Read the instruction for use carefully. 
• Check the integrity of packaging. 
• The product must be used as soon as the sterile package component has been opened. 
• Do not use if the packaging is damaged. 

b) During surgery 

• Gloves and instruments should be wetted to prevent Collatamp G from adhering to them. Collatamp G can be cut to size to fit the area to be treated. 
• Place a dry Collatamp G on the area to be treated, which should be as dry as possible, and light pressure applied for about a few minutes to achieve better adhesion. 
• Up to 3 large Collatamp G sponges (10 × 10 × 0.5 or 5 × 20 × 0.5 cm) can be used, depending on the size of the area requiring haemostasis. However, the patient’s body weight should be taken into account. The number and size of the implants should be selected so that a total dose of 9 mg gentamicin sulfate per kg body weight is not exceeded. 

c) After surgery 

• Collatamp G is completely absorbed. 
• Timelines for complete absorption depend on the site of surgical implantation. 

Storage Conditions
Store in original package. 
Store between +4°C and +25°C. 
Store in a clean, dry place. 

Verify the integrity of all aspects of the sterile packaging. DO NOT use if open or damaged. 
Do not use after the expiry date. 

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 completely absorbed (estimated that in the overwhelming majority of cases, Collatamp G is completely or predominantly degraded within 4-8 weeks, regardless of the site of implantation).
The gentamicin included in Collatamp G helps to prevent infections that might occur at the site of implantation caused by gentamicin-sensitive bacteria The administration of Collatamp G might not prevent an infection with gentamicin-resistant bacteria. The risk of infection is based on individual/combination of factors.