Part B SmartSet GMV Gentamicin Bone Cement SmartSet
Part ASmartSet GHV Gentamicin Bone CementSmartSet HV Bone Cement(Including pre-filled systems)Part BSmartSet GMV Gentamicin Bone CementSmartSet MV Bone CementDePuy International Ltd.T/A DePuy CMWCornford RoadBlackpool, FY4 4QQEnglandThe data contained in this document is confidential.It is not to be used or copied by unauthorised personnelFile Ref: CP / RF 497 / Tender / Feb 2009
Part A - Table of Contents1.0Introduction . 31.1Medical Rationale . 32.0Manufacturer’s Details . 43.0Product Codes . 54.0Product Classifications . 64.1Medicated Bone Cements . 64.2Unmedicated Bone Cements . 64.3Accessories . 65.0Product Composition . 76.0Description of the Devices . 86.1SmartSet GHV Gentamicin and SmartSet HV Bone Cements (standard packs). 86.2SmartMix Cemvac and Cemvac Mixing Systems . 97.0Indications / Contraindications . 117.1SmartSet GHV Gentamicin Bone Cement . 117.2SmartSet HV Bone Cement . 118.0Finished Product Specifications. 128.1SmartSet GHV Gentamicin and SmartSet HV Bone Cements . 128.2SmartMix Cemvac prefilled with SmartSet GHV Gentamicin and SmartSet HV BoneCements. 149.0Summary of Design Verification . 169.1Factors Affecting Choice of Combination . 169.2Gentamicin Elution Studies . 179.3Physicomechanical Properties . 199.4Fatigue Life . 209.5Creep Resistance . 229.6Product Shelf life . 2210.0Biocompatibility / Toxicology Data . 2311.0 Clinical Evidence . 2411.1 SmartSet GHV Gentamicin Bone Cement (and prefilled systems) . 2411.2 SmartSet HV Bone Cement (and prefilled systems). 2611.3 Undesirable effects. 2711.4 Conclusions . 2712.0References . 29AppendicesAppendix 1:Appendix 2:Certificates for SmartSet GHV Gentamicin Bone Cement and its prefilledsystemsCertificates for SmartSet HV Bone Cement and its prefilled systemsAppendix 3:Certificates for Empty SmartMix Cemvac and Empty Cemvac SystemsFile Ref: CP / RF 497 / Tender / Feb 2009
1.0Introduction1.1Medical RationaleThe clinical success of hip arthroplasties has been demonstrated over the years and totaljoint replacement is now commonplace. In a review of the literature, Charnley reported a96.4% success rate in patients followed not less than 5 years after replacement (1).Charnley and Cupic reported the 9 and 10-year follow-up results from replacement with asuccess rate of 92% (2). Wrobleski reported 15 to 21 year results with a clinical successrate of 96.5%. Most patients maintained good pain relief and function (3).Successful treatment of the arthritic hip using total replacement arthroplasty has led to thedevelopment and use of prosthesis designed for other affected joints particularly the knee,elbow and shoulder. It is well established that the fixation of components in total jointarthroplasty has a significant effect on the long-term survivorship of the prosthesis.Unmedicated bone cements have been available in the market for over 50 years. In morerecent times both high and medium viscosity cements have been developed andintroduced into the marketplace, also cements containing antibiotic which deal directlywith deep infection. Infection under such circumstances can result in surgical failure,demanding further surgical intervention and even removal of the implant. Such anoutcome for the patient, in terms of quality of life, is dismal.Both SmartSet GHV Gentamicin Bone Cement (medicated) and SmartSet HV BoneCement (unmedicated) are available from DePuy CMW either in pack, which can bemixed manually in a bowl or in a prefilled system i.e. a syringe that mixes under vacuum.Alternatively the product can be supplied in a pack, then prior to surgery be loaded andmixed in an empty vacuum mixing like Cemvac or SmartMix Cemvac. Full ranges ofproduct listings are available in Section 3.0.File Ref: CP / RF 497 / Tender / Feb 2009Page 3 of 28
2.0Manufacturer’s DetailsDePuy International Limited T/A DePuy CMWCornford RoadBlackpoolLancashireFY4 4QQUKFile Ref: CP / RF 497 / Tender / Feb 2009Page 4 of 28
3.0Product CodesTable 1 – Product CodesProduct DescriptionProduct Code/sShelf LifeSmartSet GHV Gentamicin Bone Cement309502030950402 years2 yearsSmartSet HV Bone Cement309202030920402 years2 yearsSmartMix Cemvac pre-filled with SmartSet GHVGentamicin Bone Cement81950608195080*81951002 years2 years2 yearsSmartMix Cemvac pre-filled with SmartSet HVBone Cement81920608192080*81921002 years2 years2 yearsSmartMix Cemvac Syringe (empty)8316152 yearsStandard Cemvac Syringe (Single)8312152 yearsStandard Cemvac Syringe (Double)8312202 yearsThe last 3 digits of the Product Code donate the unit size in gramsFor example xxxx020 20g product* Product not manufacturedFile Ref: CP / RF 497 / Tender / Feb 2009Page 5 of 28
4.0Product Classifications4.1Medicated Bone CementsThe following products have been determined to be a Class III device within the scope ofthe European Directive 93/42/EEC of 14th June 1993 concerning medical devices underRule 13, Annex IX for devices that incorporate a medicinal substance:SmartSet GHV Gentamicin Bone CementSmartMix Cemvac prefilled with SmartSet GHV Gentamicin Bone CementThe relevant certificates for the products listed above are available in Appendix 1.4.2Unmedicated Bone CementsThe following products have been determined to be a Class IIb device within the scope ofthe European Directive 93/42/EEC of 14th June 1993 concerning medical devices underRule 8, Annex IX for devices that are surgically invasive long term implantable devices.SmartSet HV Bone CementSmartMix Cemvac prefilled with SmartSet HV Bone CementThe relevant certificates for the products listed above are available in Appendix 2.4.3AccessoriesThe following products have been determined to be Class IIa devices within the scope ofthe European Directive 93/42/EEC of 14th 1993 concerning medical devices under Rule 6of Annex IX for devices that are surgically invasive intended for transient use.SmartMix Cemvac SyringeStandard Cemvac Syringe (single pack)Standard Cemvac Syringe (double pack)The relevant certificates for the products listed above are available in Appendix 3.File Ref: CP / RF 497 / Tender / Feb 2009Page 6 of 28
5.0Product CompositionThe qualitative and quantitative compositions of the SmartSet Bone Cements arespecified in the table below:Table 2 – Cement CompositionsSmartSetGHVGentamicinBone CementSmartSetHVBone CementSmartMix Cemvacprefilled with SmartSetGHV Gentamicin BoneCementSmartMix Cemvac prefilledwith SmartSet HV BoneCement4.22*80.4584.000.9614.371.0015.0097.50 2.507597.50 2.5075Bone Cement Powder:Gentamicin Sulphate (% w/w)Methyl Methacrylate /Methyl Acrylate Copolymer (% w/w)Benzoyl Peroxide (%w/w)Zirconium Dioxide (% w/w)Bone Cement LiquidMethyl Methacrylate (%w/w)N, N-Dimethyl -p-toluidine (%w/w)Hydroquinone (ppm)* Equivalent to 1.0g (1.0 M.I.U) Gentamicin base in a 40g unitFile Ref: CP / RF 497 / Tender / Feb 2009Page 7 of 28
6.0Description of the Devices6.1SmartSet GHV Gentamicin and SmartSet HV Bone Cements (standard packs)SmartSet GHV Gentamicin and SmartSet HV Bone Cements are high viscosity cementsintended for either digital or syringe application. The cements are self-curing,radiopaque, polymethyl methacrylate based cements, available as either medicated or unmedicated and are used for securing metal or polymeric prosthesis to living bone inarthroplasty procedures. The bone cements have no intrinsic adhesive properties, but relyinstead on close mechanical interlock between the irregular bone surface and theprosthesis.Each product is supplied as a two-component system, consisting of separate, sterile liquidand sterile powder components, which are mixed together at the point of use to producethe cement.The liquid component is a colourless, flammable liquid with a distinctive odour. Itsmajor component is the monomer methyl methacrylate. Hydroquinone is present in theliquid component as a stabiliser to prevent premature polymerisation following mixing ofthe liquid and powder components. The liquid component is sterilised by membranefiltration and aseptically filled into a sterile glass ampoule. The ampoule is containedwithin a sealed blister pack, which is sterilised using ethylene oxide.The powder component is a white, finely divided powder, composed of polymethylmethacrylate based polymer. Benzoyl peroxide is present in the powder component toinitiate cement polymerisation when the powder and liquid components are mixed. Thepowder component contains the radiopaque agent zirconium dioxide. The powdercomponent is contained in a double paper / film pouch which is then sterilised byethylene oxide. The sterile powder component is supplied within an outer, protective,non-sterile, laminated foil pouch.The 20g unit consists of a double paper / film peelable pouch containing 20g of sterilebone cement powder and a glass ampoule containing 9.44g of bone cement liquid. The40g unit is consists of a double paper / film peelable pouch containing 40g of sterile bonecement powder, the glass ampoule contains 18.88g of bone cement liquidStandard packs of SmartSet GHVGentamicin Bone Cement and SmartSetHV Bone CementFile Ref: CP / RF 497 / Tender / Feb 2009Page 8 of 28
6.2SmartMix Cemvac and Cemvac Mixing SystemsThe surgical techniques of hip replacements, together with methods to reduce infectionhave been greatly enhanced with time. Additionally, there have been improvements inthe preparation techniques of bone cements.In total hip arthroplasty, fracture and subsequent premature loosening are directly relatedto the strength of the cement mantle serving as an interface between bone and prosthesis.The cement has been shown to be weakened by porosity, which enhances the formationof micro fractures that contribute to crack propagation (4).Potential sources of porosity are:Air initially surrounding the powdered polymer beads.Air trapped during the "wetting" of the powder.Air stirred into the liquid cement during spatulation.Air trapped during transfer to a non-vented cement gun or specimen mould.Monomer boiling during polymerisation of very thick specimens.Mixing under too high a vacuum, resulting in boiling of the liquid monomer.Vacuum mixing of bone cement has been shown to significantly reduce porosity andenhance the cement strength (4-14).The methyl methacrylate liquid monomer is known to be volatile, flammable and a potentrespiratory sensitiser to individuals working with it. A short-term (15 minutes) exposurelimit has been set at 100ppm (15). Hospitals should seek to comply with the Control ofSubstances Hazardous to Health Regulations, and adjust work practices as appropriate.Consequently, vacuum mixing systems are increasingly being employed so as to controlmonomer fumes during preparation of bone cement.SmartMix Cemvac can be prefilled with either SmartSet GHV Gentamicin Bone Cementor SmartSet HV Bone Cement. Unit sizes are either 60g or 80g. Product codes areavailable in section 3.0.Each prefilled SmartMix Cemvac system consists of a syringe barrel prefilled with either60g or 80g of sterile bone cement powder, 2 glass ampoules containing sterile bonecement liquid presented within an ampoule cartridge (60g 2 x 14.16g / 80g 2 x18.88g) and a sterile components pouch containing a disposable mixing stand, a vacuumtube adaptor, a central mixing rod and a vacuum hose with attached filter.See photographs overleaf.File Ref: CP / RF 497 / Tender / Feb 2009Page 9 of 28
Prefilled SmartMix Cemvac systemThe empty SmartMix Cemvac system consists of a syringe barrel assembly withdisposable funnel attached. The components consist of a disposable mixing stand, mixingrod, airline with filter attached and a vacuum tube adaptor all of which are sterile andpacked into a double peelable pouch.Empty SmartMix Cemvac syringe barrel assemblySmartMix Cemvac componentsThe Cemvac syringe is slightly smaller that the SmartMix Cemvac syringe. The Cemvacsyringe mixing system consists of a syringe barrel assembly with disposable funnelattached. The components consist of a disposable mixing stand, mixing rod, airline withfilter attached and a vacuum tube adaptor all of which are sterile and packed into a doublepeelable pouch. The Cemvac syringe systems are available as either a single or doubleunit. Refer to section 3.0 for details of product codes.Empty Cemvac syringe barrel and componentsFile Ref: CP / RF 497 / Tender / Feb 2009Page 10 of 28
7.0Indications / Contraindications7.1SmartSet GHV Gentamicin Bone Cement7.1.1 IndicationsSmartSet GHV Gentamicin Bone Cement is indicated for the fixation of prostheses toliving bone in arthroplasty procedures of joints in which infection by Gentamicinsensitive organisms is a potential risk.7.1.2 ContraindicationsSmartSet GHV Gentamicin Bone Cement is contraindicated in the presence of thecondition Myasthenia Gravis. SmartSet GHV Gentamicin Bone Cement iscontraindicated in patients with hypersensitivity to Gentamicin or to any other of thecement components.7.2SmartSet HV Bone Cement7.2.1 IndicationsSmartSet HV Bone Cement is indicated for the fixation of prostheses to living bone inorthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis,traumatic arthritis, osteoporosis avascular necrosis, collagen disease, severe jointdestruction secondary to trauma or other conditions, and revision of previous arthroplasty.7.2.2 ContraindicationsSmartSet HV Bone Cement is contraindicated in the presence of active or incompletelytreated infection, which could involve the site where the cement is applied. SmartSet HVBone Cement is contraindicated in patients with hypersensitivity to any of the cementcomponents.File Ref: CP / RF 497 / Tender / Feb 2009Page 11 of 28
8.0Finished Product Specifications8.1SmartSet GHV Gentamicin and SmartSet HV Bone CementsTable 3 – Powder Component, finished product specificationsPOWDERCOMPONENTAppearanceSmartSet GHVGentamicin Bone CementSmartSet HVBone CementA fine to off white free flowing powder in sealed paper / poly pouches20.0g unit: /- 0.5g20.0g unit: /- 0.5gTarget weight /40.0g unit: /- 1.0g40.0g unit: /- 1.0guniformity of fillIdentification:PositiveNot applicableGentamicin crylate copolymerPositivePositiveZirconium DioxideThe precision of the assay is suchGentamicin Assaythat the fiducial limits of error ofthe assay (P 0.95) are not less thanNot applicable95% and not greater that 105% ofthe estimated potency.Calculated from assays havingRelease limits (1)acceptable fiducial limits, the lowerfiducial limit is not less than 95%Not applicableand the upper fiducial limit is notmore than 120% of the statedcontent.(2)Calculated from assays havingControl limitsacceptable fiducial limits, the lowerfiducial limit is not less than 120%Not applicableand the upper fiducial limit is notless than 95% of the stated content.AssayBenzoyl Peroxide0.76 to 1.50 (%w/w)0.76 to 1.50 (%w/w)Release limit (1)(2)Control limit0.60 to 1.50 (%w/w)0.60 to 1.50 (%w/w)Complies with the European & United StatesSterility of finalMedical Device requirements for sterility.packsEthylene Oxide25 ppmResiduals(1) Release limits apply at the time of manufacture(2) Control limits apply over shelf life of the productFile Ref: CP / RF 497 / Tender / Feb 2009Page 12 of 28
Table 4 – Liquid Component, finished product specificationsLIQUIDCOMPONENTAppearanceTarget weight /uniformity of methyl-ptoluidineLiquidStabilitySterility of finalpacksSmartSet GHVGentamicin Bone CementSmartSet HVBone CementA clear mobile liquid with a characteristic odour contained in a sealedamber neutral glass ampoule.20.0g unit: 9.44g /- 0.46g40.0g unit: 18.88 /- 0.94g20.0g unit: 9.44g /- 0.46g40.0g unit: 18.88 /- 0.94gPositivePositive2.50 maximum (%w/w)2.50 maximum (%w/w)The flow time shall not increase by The flow time shall not increase bymore than 10% at 60 C 2 C formore than 10% at 60 C 2 C for72 h 2 hours72 h 2 hoursComplies with the European & United StatesMedical Device requirements for sterility.Table 5 – Constituted Cement, finished product specificationsCONSTITUTEDCEMENTSmartSet GHVGentamicin Bone CementAppearancePhysicalProperties:Dough timeRelease Limit (1)Control Limit (2)Setting TimeRelease Limit (1)Control Limit (2)ExothermTemperature (oC)Setting timeCompressivestrength (MPa)Bending modulus(MPa)Bending strength(MPa)Sterility of finalpacksSmartSet HVBone CementA dough setting to an off white solid*1:00*1:30*1:00*1:30*9:00 to *11:00*8:00 to *12:30*9:00 to *11:00*8:00 to *12:3090 maximum*7:00 to *12.:007090 maximum*7:00 to *12:0070180018005050Complies with the European & United StatesMedical Device requirements for sterility.*Minutes: seconds(1) Release limits apply at the time of manufacture(2) Control limits apply over shelf life of the productFile Ref: CP / RF 497 / Tender / Feb 2009Page 13 of 28
8.2SmartMix Cemvac prefilled with SmartSet GHV Gentamicin and SmartSet HVBone CementsTable 6 – Prefilled system, powder component, finished product specificationsPOWDERCOMPONENTSmartMix Cemvac prefilled withSmartSet GHVGentamicin Bone CementSmartMix Cemvac prefilled withSmartSet HV Bone CementAppearanceA fine to off white free flowing powder presented in a close syringe barrel60.0g unit: /- 1.5g60.0g unit: /- 1.5gTarget weight /80.0g unit: /- 2.0g80.0g unit: /- 2.0guniformity of fillIdentification:PositiveNot applicableGentamicin crylate copolymerPositivePositiveZirconium DioxideThe precision of the assay is suchGentamicin Assaythat the fiducial limits of error ofthe assay (P 0.95) are not less thanNot applicable95% and not greater that 105% ofthe estimated potency.Calculated from assays havingRelease limits (1)acceptable fiducial limits, the lowerfiducial limit is not less than 95%Not applicableand the upper fiducial limit is notmore than 120% of the statedcontent.(2)Calculated from assays havingControl limitsacceptable fiducial limits, the lowerfiducial limit is not less than 120%Not applicableand the upper fiducial limit is notless than 95% of the stated content.AssayBenzoyl Peroxide0.76 – 1.50 (%w/w)0.76 – 1.50 (%w/w)Release limit (1)(2)Control limit0.60 – 1.50 (%w/w)0.60 – 1.50 (%w/w)Complies with the European & United StatesSterility of finalMedical Device requirements for sterility.packsEthylene Oxide25 ppmResiduals(1) Release limits apply at the time of manufacture(2) Control limits apply over shelf life of the productFile Ref: CP / RF 497 / Tender / Feb 2009Page 14 of 28
Table 7 – Prefilled systems, liquid Component, finished product specificationsLIQUIDCOMPONENTSmartMix Cemvac prefilled withSmartSet GHVGentamicin Bone CementSmartMix Cemvac prefilled withSmartSet HV Bone CementAppearanceA clear mobile liquid with a characteristic odour contained in a sealedamber neutral glass ampoule.Target weight /uniformity of methyl-ptoluidineLiquidStability60.0g unit: 2 x 14.16g /- 0.70g80.0g unit: 2 x 18.88 /- 0.94g60.0g unit: 2 x 14.16g /- 0.70g80.0g unit: 2 x 18.88 /- 0.94gPositivePositive2.50 maximum (%w/w)2.50 maximum (%w/w)SterilityThe flow time shall not increase by The flow time shall not increase bymore than 10% at 60 C 2 C formore than 10% at 60 C 2 C for72 h 2 hours72 h 2 hoursComplies with the European & United StatesMedical Device requirements for sterility.Table 8 – Prefilled systems, constituted cement, finished product specificationsCONSTITUTEDCEMENTAppearanceSmartMix Cemvac prefilled withSmartMix Cemvac withSmartSet GHVSmartSet HV Bone CementGentamicin Bone CementA syringe-able dough setting to an off white solidPhysicalPropertiesSetting TimeRelease Limit (1)Control Limit (2)ExothermTemperature (oC)Setting timeCompressivestrength (MPa)Bending modulus(MPa)Bending strength(Mpa)Sterility*7:30 - *10:30*7:00 - *12:30*7:30 - *10:30*7:00 - *12:30907:30 - 11:3070907:30 - 11:3070180018005050Complies with the European & United StatesMedical Device requirements for sterility.*Minutes: seconds(1) Release limits apply at the time of manufacture(2) Control limits apply over shelf life of the productFile Ref: CP / RF 497 / Tender / Feb 2009Page 15 of 28
9.0Summary of Design VerificationSmartSet GHV Gentamicin Bone Cement is a high viscosity bone cement with thesimilar physicomechanical and gentamicin elution properties to the original DePuyCMW 1 Gentamicin and Palacos R40 Gentamicin bone cements.The data used to support SmartSet GHV Gentamicin Bone Cement can be extrapolated tosupport SmartSet HV Bone Cement; the unmedicated version which is an equivalentcement apart from the absence of the gentamicin.Data to support these similarities, demonstrating the safety and efficacy of SmartSetGHV Gentamicin Bone Cement follows below.9.1Factors Affecting Choice of Combination9.1.1 General Properties of GentamicinGentamicin is an amino glycoside antibiotic derived from Micromonospora purpurea. Itis commercially available as a pharmacopoeial material (BP, Ph.Eur), which is comprisedof a complex mixture of the sulphates of Gentamicin C1, Gentamicin C1A, Gentamicin C2and, to a lesser extent, Gentamicin C2A. The Gentamicins are characterised by 4, 6substitution on a central 2-deoxystreptamine ring with cyclic amino-sugars attached byglycosidic linkages; they are broad-spectrum, basic, heat stable, water soluble antibioticswhich may be sterilised by ethylene oxide.The Gentamicin complex is bactericidal and is thought to interfere with bacterial proteinsynthesis by binding irreversibly to the 30S subunit of the bacterial ribosome. It iseffective against many strains of Gram-negative bacteria including species ofEscherichia, Enterobacter, Klebsiella, Salmonella, Serratia, Shigella, Proteus andPseudomonas aeruginosa. Although less active against Gram-positive bacteria,Staphylococcus aureus is highly sensitive; Bacillus, Clostridium and Corynebacteriumspecies and Listeria monocytogenes may also be susceptible. Gentamicin is also activeagainst some strains of Mycobacteria, and Mycoplasmas have been reported to besensitive; fungi are resistant.9.1.2 Mode of Action of Bone CementEach unit of bone cement consists of a polymeric powder component and a monomericliquid component. The powder contains benzoyl peroxide (BPO) and the liquid containsN, N-dimethyl-ρ-toluidine (DMpT). When the liquid is added to the powder and mixedin accordance to the instructions for use, a cement of doughy consistency is formed.The BPO from the powder and DMpT from the liquid react to generate free radicals bymeans of a redox reaction. The free radicals react with the monomeric liquid causingpolymerisation and hardening of the cement.The surgeon applies the cement either digitally or by a syringe applicator, inserting theprosthesis into the cement when it is in a doughy state. The cement dough polymerisesexothermally in-situ and secures the prosthesis in place.File Ref: CP / RF 497 / Tender / Feb 2009Page 16 of 28
For SmartSet GHV Gentamicin Bone Cements the gentamicin will elute directly from thecured bone cement into the surrounding body fluids.9.2Gentamicin Elution StudiesElution studies were conducted on SmartSet GHV to confirm the level of gentamicinincorporated into the product (i.e. 1.0g as base per 40g powder and 0.5g base per 20gpowder). The results are shown below in graph 1.Graph 1 - Summary of SmartSet GHV v Palacos Gentamicin Bone CementsGentamicin Eluted (mg)2.01.81.61.41.2SMARTSET GHV1.0PALACOS R40G0.80.60.40.20.00 days0.04 Days1 Days2 Days3 Days7 DaysTimepoint (days)The elution profile in graph 1 shows the amount of gentamicin eluting from bothSmartSet GHV Gentamicin Bone Cement and alternative commercially available cementPalacos R40 with gentamicin. The tests were conducted at zero time point, again at 1hour time point (0.04 days) then at 1 day through to 7 days. The results confirm that theelution profile of SmartSet GHV Gentamicin Bone Cement is comparable to PalacosR40G.9.2.1 Independent Elution TestingDr Frommeld, an antibiotics and microbiology expert at the Endoklinik in Hamburg hasconducted independent elution studies for DePuy CMW. The study compared cumulativeelution (graph 2) and maximum elution (graph 3) rates of SmartSet GHV GentamicinBone Cement (referred to as GHV), DePuy CMW 1 Gentamicin (referred to as CMW1G) and Palacos R Gentamicin from 2 different manufacturers (Merck Biomet andSchering Plough).File Ref: CP / RF 497 / Tender / Feb 2009Page 17 of 28
Graph 2 - Cumulative Elution of Gentamicin containing Acrylic Bone CementsGraph 2 clearly shows that the results of this testing show cumulative elution of SmartSetGHV Gentamicin Bone Cement to be equivalent to Palacos R Gentamicin (MerckBiomet) and greater than both DePuy CMW 1 Gentamicin and Palacos R Gentamicin(Schering Plough).Graph 3: Maximum Elution Rate for Gentamicin Containing Acrylic Bone CementsGraph 3 shows the maximum elution rates of SmartSet GHV Gentamicin Bone Cementwere slightly greater than DePuy CMW 1 Gentamicin Bone Cement. A bigger differencein maximum elution rate is seen between SmartSet GHV Gentamicin Bone Cement andboth of the Palacos brands.File Ref: CP / RF 497 / Tender / Feb 2009Page 18 of 28
These results support the elution work carried out at DePuy CMW on SmartSet GHVGentamicin Bone Cement and provide further evidence of the in-vitro similarities ofSmartSet GHV Gentamicin Bone Cement and other commercially available bonecements.9.3Physicomechanical PropertiesThe physicomechanical properties SmartSet GHV Gentamicin and SmartSet HV BoneCements were evaluated and compared with the commercially available bone cementPalacos R40 Gentamicin. Refer to the table 9.Table 9 – Comparison of Physicomechanical PropertiesSmartSetHV BoneCement 2Palacos 1290 C max.71.976.977.5CMW chanicalPropertiesISO 5833:2002SpecificationSmartSetGHVGentamicinBone Cement1Dough Time(Min: sec)Setting Time(Min: sec)ExothermicTemperature ( C)Exothermic SettingTime(Min: sec)CompressiveStrength (MPa)(graph 4)Flexural Strength(MPa) (graph 4)Flexural Modulus(MPa) (graph 4)CMW specifications1:004: 1:305CMW specifications9:30 – 11:004, 8:00-9:00570 minimum50 minimum1800 minimum(1) Taken from report R744, on file at DePuy CMW(2) Taken from report R743, on file at DePuy CMW(3) Taken from report R064, on file at DePuy CMW (Palacos specifications unknown)(4) SmartSet GHV Gentamicin Bone Cement Specification(5) CMW 1 Gentamicin Bone Cement SpecificationThe results of the testing (summarised in Table 9) show that the physicomechanicalproperties of SmartSet GHV Gentamicin and SmartSet HV Bone Cements are equivalentto those of other commercially available bone cements and comply with the requirementsof the international standard for acrylic bone cements, ISO 5833:2002. The data forcompressive strength, flexural strength and flexural modulus has also been depicted ingraphical format for ease of viewing. Refer to graph 4 shown overleaf.File Ref: CP / RF 497 / Tender / Feb 2009Page 19 of 28
Graph 4: Compressive, Flexural Strength and Flexural modulusSMARTSET (G)HV vs. Palacos: Mechanical Strength(Refer to x axis for u
SmartSet GHV Gentamicin Bone Cement SmartSet HV Bone Cement (Including pre-filled systems) Part B SmartSet GMV Gentamicin Bone Cement SmartSet MV Bone Cement DePuy International Ltd. T/A DePuy CMW Cornford Road Blackpool, FY4 4QQ England The data contained in this document is confidential.
caused by the bone void fillers was compared to that caused by particles of SmartSet GMV PMMA bone cement (DePuy Synthes, IN, USA). The surface damage from Stimulan was below the resolution of the analysis technique used; SmartSet GMV caused 0.19scratches/mm with a mean lip heig
Gentamicin 120mg iv/im single dose vi) removal- post prostatic surgery YES D UTI, bacteraemia *Gentamicin 120mg iv/im single dose vii) removal- all other indications NO. Unless Staphylococcus aureus in urine or meatal sample D Bacteraemia *Gentamicin 120mg iv/im
3 Salesforce Shopping Index 2 Salesforce Shopping Index 1Monthly active users 1 In the UK GMV rose 62% YoY based on a strong app performance, while credit loss rates remained steady at well below 1% of GMV. Global credit losses remain in line with expectations at 0.6% of GMV, down 20bps from Q4 21while in our growth
The occurrence of positive patch test reactions to amino-glycosides increases with age in patients with chronic dermatosis [19]. Highest frequencies of sensitization to gentamicin have been found among patients with chronic otitis externa [20]. However, gentamicin has been regarded as less allergenic than neomycin [21]. It has been found
APHL RFP: Establishing a Quality Control Range for Gentamicin Susceptibility Testing of Neisseria gonorrhoeae. Please send the Letter of Intent (Due 5/0 3/19) and completed application (Due 5/31/19) to Anne Gaynor, an
bladder irrigation? Gentamicin is an antibiotic medicine that is used to treat or prevent urinary tract infections (UTIs). It can be given directly into the bladder through a catheter. This is called bladder irrigation. It is used to treat UTIs that are
Gentamicin Bladder Irrigation : 4 of 5 18. Place the 30 mL of medication into the piston syringe through the tip of the syringe : If the dose is 50 mL: 19. Using the same 30 mL syringe and 19-gauge needle, draw up the remainin
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