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 Baclofen Sintetica may be diluted under 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 incompatible due to a chemical reaction with baclofen).
The compatibility of Baclofen Sintetica 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 printed on the package materials.

6.4 Special precautions for storage
Store below 25°C. Do not refrigerate or freeze.
Store in the original package in order to protect from light.
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
Baclofen Sintetica 0.5 mg/5 ml
Type I clear colourless glass 20 ml ampoules.
Boxes of 1 ampoule or 5 ampoules containing 20 ml of solution.

Baclofen Sintetica 2 mg/ml
Type I clear colourless glass 5 ml ampoules
Box of 10 ampoules containing 5 ml of solution.
Type I clear colourless glass 20 ml ampoules
Box of 1 ampoule containing 20 ml of solution.
Not all pack sizes may be marketed.

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.