Idiomas disponibles
Idiomas disponibles
VACU-MIX PLUS PRE-PACKED WITH
DEPUY CMW 1 GENTAMICIN BONE CEMENT
VACU-MIX PLUS PRE-PACKED WITH
DEPUY CMW 3 GENTAMICIN BONE CEMENT
INSTRUCTION LEAFLET
FOR THE PERSONAL ATTENTION OF THE SURGEON
DEVICE DESCRIPTION
Vacu-Mix Plus is an in-syringe vacuum mixing system
pre-packed with bone cement powder. The device is for
single use only and controls monomer fumes during the
preparation of the bone cement.
DePuy CMW 1 Gentamicin and DePuy CMW 3
Gentamicin bone cements are self-curing, radiopaque,
polymethyl methacrylate based cements containing
antibiotic, used for securing metal or polymeric
prostheses to living bone in arthroplasty procedures.
Bone cements have no intrinsic adhesive properties, but
instead rely on close mechanical interlock between the
irregular bone surface and prosthesis.
Each unit pack contains the following:
•
Syringe filled with bone cement powder
•
Mixing cap with attached funnel
•
Delivery nozzle
•
Economiser rod
•
Spatula
•
Vacuum tube attached with carbon microbial filter
•
Ampoule(s) containing bone cement liquid.
The syringe pre-packed with bone cement powder and
the accessories are contained within a sterile double
peelable pouch. The bone cement liquid is contained
in a sterile ampoule within a sterile blister pack. (Two
ampoules are provided with the 80g unit, and one with
the 50g unit). The ampoule blister(s) is located on a non-
sterile cardboard holder. The components are packed
together within a non-sterile protective foil pouch.
The liquid component is sterilised by membrane filtration
and aseptically filled into sterile glass ampoules. The
ampoule is contained within a sealed blister pack,
which is sterilised using ethylene oxide. The syringe
pre-packed with bone cement powder, together with the
accessories is sealed within a double peelable pouch
and sterilised using gamma irradiation.
The bone cements have different chemical formulations,
resulting in antibiotic bone cements with different
handling and setting characteristics to suit preferred
clinical requirements and surgical techniques.
The qualitative and quantitative composition of the bone
cements is specified in the table below:
Bone Cement Powder:
Gentamicin Sulphate (%w/w)
Polymethyl Methacrylate (%w/w)
Benzoyl Peroxide (%w/w)
Barium Sulphate (%w/w)
DePuy
DePuy
CMW 1
CMW 3
Gentamicin
Gentamicin
4.22*
4.22*
84.73
83.88
1.95
1.90
9.10
10.00
Bone Cement Liquid:
Methyl Methacrylate (%w/w)
N,N-Dimethyl-p-toluidine (%w/w)
Hydroquinone (ppm)
Equivalent to 2.0g (2.0 M.I.U.) Gentamicin base in
80g unit and 1.25g (1.25 M.I.U.) in 50g unit.
Liquid Component
The liquid component is a colourless, flammable
liquid with a distinctive odour. Its major component is
the monomer methyl methacrylate. Hydroquinone is
present in the liquid component as a stabiliser to prevent
premature polymerisation, which may occur when the
liquid is exposed to heat or light. N,N-Dimethyl-p-toluidine
is added to promote cement polymerisation following the
mixing of the liquid and the powder components.
Powder Component
The powder component is a white, finely divided powder,
composed of polymethyl methacrylate polymer. The
powder contains gentamicin sulphate for an ancillary,
local antibiotic effect. Benzoyl peroxide is present in the
powder component to initiate cement polymerisation
when the powder and liquid components are mixed. The
powder component also contains the radiopaque agent
barium sulphate.
INDICATIONS
The antibiotic bone cements DePuy CMW 1 Gentamicin
and DePuy CMW 3 Gentamicin bone cements are
indicated for the fixation of prostheses to living bone in
arthroplasty procedures of joints in which infection by
gentamicin sensitive organisms is a potential risk.
The bone cements are indicated for use in children
only in the case of limb preservation where no other
procedure is likely to give a good chance of successful
treatment.
The bone cement should be used with an appropriate
prosthesis.
CONTRAINDICATIONS
The use of gentamicin bone cements is contraindicated in
the presence of the condition Myasthenia Gravis.
The use of gentamicin bone cements is contraindicated in
patients with hypersensitivity to gentamicin, or to any other
of the cement components.
WARNINGS
Follow carefully the supplied instructions for handling
and mixing gentamicin bone cements.
Patients should be carefully monitored for any change
in blood pressure during and immediately following
the application of bone cement. Adverse patient
reactions affecting the cardiovascular system have
been associated with the use of bone cements, these
include: hypotension, hypoxemia, cardiac arrhythmia,
bronchospasm, cardiac arrest, myocardial infarction,
pulmonary embolism, cerebrovascular accident and
possible death. Hypotensive reactions have occurred
between 10 and 165 seconds following application of
bone cement; they have lasted from 30 seconds to 5 or
more minutes. Some have progressed to cardiac arrest.
In addition, the over-pressurisation of the bone cement
should be avoided during the insertion of the bone cement
and the implant in order to minimise the occurrence of
pulmonary embolism.
2
98.50
97.50
≤
≤
1.50
2.50
75
75
