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CERAMENT G

CERAMENT with 17.5 mg gentamicin/mL paste.

CERAMENT|G is the first and only CE-marked gentamicin-eluting injectable synthetic bone substitute on the market today. It is ideal for use in indications where infection may be present or of concern, because it offers:

High local concentration of gentamicin, without high serum gentamicin levels

In vivo studies have shown that CERAMENT|G offers local gentamicin concentration levels 64-150 times higher than the minimum inhibitory concentration (MIC) for gentamicin-sensitive pathogens such as Staphylococcus aureus and Pseudomonas aeruginosa.

In patients with long bone osteomyelitis treated with up to 30 mL CERAMENT|G (mean volume of 11.6 mL injected), the highest reported serum concentration of gentamicin was < 2 mg/mL within 24 hours after surgery, well below the gentamicin serum toxicity threshold level of 12 mg/mL.

 

REFERENCES

Horstmann et al. ‘In vivo gentamicin concentrations in plasma and drain fluid after bone defect reconstruction using a gentamicin-eluting bone graft substitute’, BJJ, 2015; vol 97-B SUPP 16, 106

McNally et al. ‘A Prospective Evaluation of CERAMENT®|G Bone Void Filler with Gentamicin in the Treatment of Chronic Osteomyelitis with Cavitary Defects’ - PR 0356-01 en EU

SPC Gentamicin (Hospira): http://www.medicines.org.uk/emc/medicine/21665/SPC/Gentamicin+40+mg+ml+Injection/

http://www.drugs.com/monograph/gentamicin-sulfate.html - The American Society of Health-System Pharmacists

Stravinskas et al. Pharmacokinetics of gentamicin eluted from a regenerating bone graft substitute – In vitro and clinical release studies. Bone Joint Res 2016;5:427–435

Gentamicin elution with a high initial peak, that remains above the minimum inhibitory concentration (MIC) for gentamicin-sensitive Staphylococcus aureus and Pseudomonas aeruginosa for at least 28 days in in vitro tests

It is essential to have a high initial concentration of gentamicin to deliver the most effective bactericidal blow to the pathogens that could cause a bone infection and to maintain the gentamicin concentration above MIC levels for a clinically relevant period of time (>28 days).

In vitro studies have shown gentamicin elution from CERAMENT|G has a high initial peak (>1000µg/mL), and remains above MIC for at least 28 days. Importantly, these levels of gentamicin can be effective in biofilm prevention and eradication.

Studies of drain fluid in hip replacement and tumor patients have confirmed that CERAMENT|G mimics this elution pattern in vivo.

 

REFERENCES

S009/2012. Data on file BONESUPPORT AB, Sweden

Xiong et al. Adaptive resistance of Pseudomonas aeruginosa induced by aminoglycosides and killing kinetics in a rabbit endocarditis model. Antimicrob. Agents Chemother. 1997, 41:823-826

Tam et al. Comparative Pharmacodynamics of Gentamicin against Staphylococcus aureus and Pseudomonas aeruginosa. Antimicrob. Agents Chemother. August 2006, vol. 50, no. 8, 2626-2631. http://aac.asm.org/content/50/8/2626.long

http://www.netdoctor.co.uk/medicines/infections/a7919/genticin-injection-gentamicin/

http://www.globalrph.com/kinetics.htm

Andrews. Determination of minimum inhibitory concentrations. J. Antimicrob. Chemother. (2001) 48 (suppl 1): 5-16. doi: 10.1093/jac/48.suppl_1.5

S001/2012. Reference to European Committee on Antimicrobial Susceptibility Testing. Gentamicin: Rationale for the clinical breakpoints, version 1.2, 2009. http://www.eucast.org. Data on file BONESUPPORT AB, Sweden.

V0062-01. CERAMENT G Clinical evaluation. Data on file BONESUPPORT AB, Sweden

Stravinskas et al. Pharmacokinetics of gentamicin eluted from a regenerating bone graft substitute – In vitro and clinical release studies. Bone Joint Res 2016;5:427–435.

Butini et al. Activity of a gentamicin-loaded bone graft substitute against different bacterial biofilm by microcalorimetry. Presentation at EBJIS 35th Annual Meeting 2016, Oxford, UK

Gentamicin elution that is reliable and consistent

Irrespective of whether CERAMENT|G is injected or formed into beads, the elution profile of gentamicin is the same. The patented CERAMENT mixing and injecting device ensures a homogeneous distribution of antibiotic, whilst the material properties of CERAMENT mean that all of this antibiotic is made available for elution and delivered in a controlled fashion.

 

REFERENCES

S009/2010. Data on file, BONESUPPORT AB, Sweden

Lindberg et al. ‘Antibiotic elution and bone remodeling with a novel bone substitute impregnated with gentamicin’, Podium presentation at 31st Annual Meeting of the European Bone and Joint Infection Society 2012, Montreux, Switzerland

A neutral pH that doesn't interfere with antibiotic activity

CERAMENT|G paste has been designed to have a neutral pH (7.0 - 7.2), so it doesn't reduce antibiotic activity. Gentamicin effectiveness is reduced at pH 6.4 or lower.

 

REFERENCES

Young & Hewitt. Activity of five aminoglycoside antibiotics in vitro against gram-negative bacilli and Staphylococcus aureus. Antimicrob. Agents Chemother. December, 1973, vol. 4, no. 6, 617-625

S081/2011. Data on file, BONESUPPORT AB, Sweden

BONESUPPORT AB is funding a prospective, multi-centre randomised controlled trial to demonstrate the safety and effectiveness of CERAMENT™|G used in conjunction with standard-of-care treatment compared to standard-of-care treatment alone for patients with open fractures of the tibial diaphysis. Enrolment completion is anticipated in 2019. For more information about this trial, please click here.

REFERENCES

CERAMENT™|G product data sheet – PR 0283-02 en S009/2012.

Data on file BONESUPPORT AB, Sweden

Horstmann et al. ‘In vivo gentamicin concentrations in plasma and drain fluid after bone defect reconstruction using a gentamicin-eluting bone graft substitute’, BJJ, 2015; vol 97-B SUPP 16, 106

McNally et al. ‘A Prospective Evaluation of CERAMENT™|G Bone Void Filler with Gentamicin in the Treatment of Chronic Osteomyelitis with Cavitary Defects’ - PR 0356-01 en EU

Lindberg et al. ‘Antibiotic elution and bone remodeling with a novel bone substitute impregnated with gentamicin’, Podium presentation at 31st Annual Meeting of the European Bone and Joint Infection Society 2012, Montreux, Switzerland