Ketesse Caution For Usage

Instructions for use/handling: Tablet: No special requirements.
Solution for injection: When KETESSE solution for injection/infusion is administered intramuscularly or as intravenous bolus, the solution should be injected immediately after its removal from the coloured ampoule (see also Incompatibilities and Special precautions for disposal and other handling as follows).
For administration as intravenous infusion, the solution should be diluted aseptically and protected from natural daylight (see also Shelf-life under Storage and Special precautions for disposal and other handling as follows). For instructions on the dilution of the medicinal product before administration, see Special precautions for disposal and other handling as follows.
Incompatibilities: Tablet: Not applicable.
Solution for injection: KETESSE Solution for injection/infusion must not be mixed in a small volume (e.g. in a syringe) with solutions of dopamine, promethazine, pentazocine, pethidine or hydroxyzine, as this will result in a precipitation of the solution.
The diluted solutions for infusion obtained as stated in Special precautions for disposal and other handling as follows must not be mixed with promethazine or pentazocine.
This medicinal product must not be mixed with other medicinal products except those mentioned in Special precautions for disposal and other handling as follows.
Special precautions for disposal and other handling: Solution for injection: KETESSE Solution for injection/infusion has shown to be compatible when mixed in small volumes (e.g. in a syringe) with injectable solutions of heparin, lidocaine, morphine and theophylline.
For administration as intravenous infusion, the content of one ampoule (2 ml) of KETESSE Solution for injection/infusion should be diluted in a volume of 30 to 100 ml of normal saline, glucose or Ringer lactate solution. The solution should be diluted aseptically and protected from natural daylight (see also Shelf-life under Storage). The diluted solution is a clear solution.
KETESSE Solution for injection/infusion, diluted in a volume of 100 ml of normal saline or glucose solution has shown to be compatible with the following medicinal products: dopamine, heparin, hydroxyzine, lidocaine, morphine, pethidine and theophylline.
No sorption of the active ingredient has been found when diluted solutions of KETESSE Solution for injection/infusion have been stored in plastic bags or administration devices made of Ethyl Vinyl Acetate (EVA), Cellulose Propionate (CP), Low Density PolyEthylene (LDPE) and PolyVinyl Chloride (PVC).
KETESSE Solution for injection/infusion is for single use only and any unused solution should be discarded. Prior to administration, the solution should be inspected visually to make sure it is clear and colourless: it should not be used if particulate matter is observed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.