Pharmaceutical particulars : מידע רוקחי

6     PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Anhydrous glucose, (S)-lactic acid, sodium hydroxide solution (for pH adjustment),(S)- lactic acid solution (for pH adjustment), water for Injection.
6.2 Incompatibilities
Furosemide or bumetanide should not be administered in intravenous lines containing Milhardt since precipitation occurs on admixture.
Sodium Bicarbonate Intravenous infusion should not be used for dilution.
Other drugs should not be mixed with Milhardt until further compatibility data are available.
6.3 Shelf life
The expiry date of the product is indicated on the packaging materials.
After dilution: Chemical and physical in-use stability has been demonstrated for 48 hours at 5°C or ambient temperature (20-22 °C) when diluted with 0.45% sodium chloride infusion, 0.9% sodium chloride infusion or 5% glucose infusion.
From a microbiological point of view, the product should be used immediately. If not used immediately, in- use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
6.4 Special precautions for storage
Store below 25°C. Do not freeze. Store in the original package.
6.5 Nature and contents of container
Milhardt is presented in 10ml clear, neutral glass (Type I) ampoules. The ampoules are packed in a PVC tray and cardboard box in packs of 10.
6.6 Special precautions for disposal
Infusion solutions diluted as recommended with 0.45% saline, 0.9% saline or 5% glucose should be freshly prepared before use.
For single use. Discard any unused solution.

Parenteral drug products should be examined visually and should not be used if particulate matter or discolouration are present.