Pharmaceutical particulars : מידע רוקחי

6. Pharmaceutical particulars
6.1 List of excipients
Sodium chloride; water for injections

6.2 Incompatibilities
If alternative baclofen concentrations are required Baclofene Bioindustria L.I.M. 10 mg/5 ml may be dilutedunder aseptic conditions with sterile preservative-free sodium chloride for injections. The ampoules should not be mixed with other solutions for injection or infusion (dextrose has proved to be incompatibledue to a chemical reaction with baclofen).
The compatibility of Baclofene Bioindustria L.I.M. 10 mg/5 ml with the components of the infusion pump (including the chemical stability of baclofen in the reservoir) and the presence of an in-line bacterial retentive filter should be confirmed with the pump manufacturer prior to use.

6.3 Shelf life
The expiry date of the product is indicated on the packaging materials.

6.4 Special precautions for storage
Store below 25°C.
After opening: the product must be used immediately. Any remaining product not administered to the pump must be disposed of.
Medicines should be kept out of the reach and sight of children.

6.5 Nature and contents of container
Type I neutral glass 5 mL ampoules
Box of 5 ampoules containing 5 ml of solution.

6.6 Special precautions for disposal and other handling
Each ampoule is intended for single use only, and any unused solution not administered to the pump should be discarded. Ampoules should not be autoclaved.