Indications - Codman AS 10 Manual Del Usuario

Indications

ENGLISH
IMPORTANT INFORMATION
Please Read Before Use
®
CODMAN Refill Kit (AS 10) for ARCHIMEDES
Become thoroughly familiar with the information contained in this user manual prior
to filling or refilling an ARCHIMEDES Implantable Infusion Pump. Failure to follow
these instructions can result in patient complications ranging from a failure of the
intended therapy to a drug under- or overdose.
For additional information, refer to the user manual packaged with the infusion pump.
Indications
The CODMAN Refill Kit (AS 10) is used only to fill, refill, or empty the drug reservoir of
an ARCHIMEDES Implantable Infusion Pump. The pumps are indicated for the intrathecal
infusion of the drugs listed below.
• For use with preservative-free morphine sulfate sterile solution (4.0–6.5 pH) in the
treatment of chronic pain
• For use with LIORESAL Intrathecal (baclofen) (5.0–7.0 pH) for relief of spasticity
®
Use a 0.9% solution of preservative-free sodium chloride injection (4.5–7.0 pH) to achieve
the physician-prescribed drug concentration.
WARNING: Use only the drugs and diluent listed above with the ARCHIMEDES pump.
Using incompatible or contaminated (out of specification) drug solutions can damage
the pump flow restrictor chip and cause an increase in flow rate. This can lead to serious
complications, including overdose and death.
Indications – 4
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WARNING: Refer to the appropriate drug labeling for a complete list of drug
indications, contraindications, warnings, precautions, adverse reactions, dosage
and administration information, screening procedures, and overdose procedures.
Physicians prescribing an ARCHIMEDES Implantable Infusion Pump for use with
®
Pumps
these drugs must be familiar with the drug stability information listed in Drug
Stability Information.
WARNING: Based on studies carried out by Codman that evaluated precipitation
of Morphine Sulfate for Intrathecal Injection at varying pH levels, the use
of preservative-free morphine sulfate solutions with pH levels above 6.5 is
not recommended for these pumps. In particular, we have found that higher
concentrations of morphine sulfate solutions (>10 mg/mL) might be more susceptible
to precipitation when the pH levels of the drug are at or near the upper pH limits
specified in USP requirements for this drug (i.e., at or near pH 6.5).
Precipitation of morphine could result in an accumulation of the precipitates in the
flow path causing possible slowing or stoppage of flow through the flow-restrictor
chip. This can lead to inadequate pain relief and/or the need to remove and replace
the pump.
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