Project Description
GENTAFIX®3 & 3MV
PMMA acrylic cement with antibiotic
GENTAFIX 3 & 3 MV® is a PMMA acrylic bone cement loaded with gentamicin for fastening prostheses to the bone during orthopaedic surgery.
GENTAFIX 3® is a low viscosity, self-hardening cement recommended for application using a syringe.
GENTAFIX3 MV® is a ready-to-use, medium viscosity cement, specifically developed for the latest medical cementation techniques.
GENTAFIX 3 & 3 MV® contains an aminoglycoside antibiotic, gentamicin. Its wide spectrum of activity makes it effective against the majority of bacteria responsible for infections associated with orthopaedic surgery.
It comes in the form of an ampoule of sterile liquid monomer and a sachet of sterile polymer powder.
The product complies with the ISO 5833 Standard.
ADVANTAGES
- Significant salt release
- Easy mixing
- Reduced infection
- Suitable viscosity
- Long application time
- Optimal waiting time
The maximum temperature of 68°C reached during the polymerisation of GENTAFIX3 & 3 MV® lies well below that required by the ISO 5833 Standard, thus reducing the danger of bone necrosis.
Physical properties
The physical properties of GENTAFIX3 & 3 MV® cement largely exceed the requirements of the ISO 5833 Standard, ensuring perfect long-term physical integrity.
In-vitro release rates
GENTAFIX3 & 3 MV® contains 1g of gentamicin base, a quantity optimised to ensure prolonged release over time and thus prevent post-operative infections. Starting from the hours immediately after the operation, the period in which the risk of infection is greatest, there is a sizeable and rapid release of gentamicin.
Description | Reference |
Non-sterile bowl and spatula x 10 | T060404 |
Long cannula syringe | T060405 |
Oblong cannula syringe | T060402 |
VACUUKIT® | T060416 |
References
Description | Reference |
---|---|
GENTAFIX 3® 40g | T040340G |
GENTAFIX3® MV 40g | T040341G |
Certifications
CE 2797
Class: III