griego - Heraeus Medical: Bone Cement

EN
PALACOS ® R+G
Properties
PALACOS ® R+G is a fast-curing, radiopaque, poly(methyl
methacrylate)-based bone cement. It contains the
aminoglycoside antibiotic gentamicin to protect the cured
cement and contiguous tissue against contamination by
microbes sensitive to gentamicin.
PALACOS ® R+G contains the X-ray contrast medium zirconium
dioxide. To improve visibility in the surgical field
PALACOS ® R+G has been coloured with chlorophyll (E141).
The bone cement is prepared directly before use by mixing
a polymer powder component with a liquid monomer
component. A ductile dough forms which cures within a
few minutes.
Composition
A pack of PALACOS ® R+G contains one/two bag/s of
gentamicin-containing cement powder (polymer powder)
and one/two amber glass ampoule/s (monomer liquid).
Polymer powder ingredients:
Gentamicin (in the form of gentamicin sulphate),
poly(methylacrylate, methyl methacrylate), zirconium
dioxide, benzoyl peroxide and colorant E141.
Gentamicin content
Pack size 10 20 40 60
Gentamicin base 0.13 g 0.25 g 0.5 g 0.75 g
Monomer liquid ingredients:
Methyl methacrylate, N,N-dimethyl-p-toluidine, hydroquinone
and colorant E141.
The cement powder is doubly packed under sterile conditions.
The outer, non-sterile protective aluminium pouch
(no pure coating) contains a polyethylene-paper bag. Its
content, a polyethylene-paper bag of cement powder, is
sterilised with ethylene oxide.
The amber glass ampoule containing the monomer liquid
sterilised by filtration has been packed, again under sterile
conditions, in an individual blister pack sterilised with
ethylene oxide.
Indication
PALACOS ® R+G is indicated for
• Stable attachment of total or partial joint endoprostheses
in bone
• Filling and stabilising bone defects within the scope of
internal fixation treatment or for endoprosthesis revision
surgery
• Primary and secondary coverage of skull bone defects
8
Contraindication
PALACOS ® R+G must not be used
• if it is known or supposed that the patient is hypersensitive
to ingredients of the bone cement
• during pregnancy or breast-feeding
• in cases of serious renal insufficiency
• in the presence of an active or incompletely treated
infection at the bone site caused by gentamicin nonsensitive
strains
Side effects
Rarely there is a temporary drop in blood pressure after
preparation of the prosthesis bed or directly after the
implantation of PMMA bone cements and the endoprosthesis.
In single cases serious complications can occur
such as severe allergic reactions which are associated with
cardiac arrest, anaphylactic shock or even sudden death.
In order to avoid pulmocardiovascular complications such
as pulmonary embolism and cardiac arrest it is recommended
that the implantation site be irrigated thoroughly
with an isotonic solution (pulse lavage application) before
the prosthesis is introduced.
In the event of pulmonary or cardiovascular events it is
necessary to monitor blood volume and possibly increase
it. In the case of acute respiratory insufficiency anaesthesiological
measures should be taken.
The following adverse effects have been observed when
using poly(methyl methacrylate) bone cements: thrombophlebitis,
haemorrhage, trochanteric bursitis.
Other side effects observed: myocardial infarction, brief
cardiac arrhythmia, cerebrovascular incident.
Owing to the addition of gentamicin the side effects
typical of this antibiotic can occur. Occurrence of these
side effects is unlikely on account of the very low serum
levels reached. It is important to bear in mind that
gentamicin has neuromuscular blocking properties. Therefore
great care is required in patients with a history of
neuromuscular disease (e. g. myasthenia gravis).
Moreover, complications are possible that can occur
during any surgical procedure.
Interactions
Owing to the administration of muscle relaxants and ether
the neuromuscular blocking properties of gentamicin may
be intensified. However, this is unlikely on account of the
very low serum levels reached.
Precautions
Use by operating staff
Before using PALACOS ® R+G the user should be wellacquainted
with its properties, handling and application.
The user is advised to practise the entire procedure of
mixing, handling and introducing PALACOS ® R+G before