Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Benzethonium chloride, water for injections.

6.2   Incompatibilities

Ketamine-hameln is chemically incompatible with barbiturates and diazepam because of precipitate formation. Therefore, these should not be mixed in the same syringe or infusion fluid.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
For single use only. Discard any unused product at the end of each operating session.
Shelf-life after first opening: 28 days at < 250 C.
Shelf life after reconstitution: after dilution in sodium chloride 0.9% or glucose 5 or ringer lactate solution a chemical and physical in-use stability has been demonstrated for up to 72 hours at 20-25°C. From a microbiological point of view, the product should be used immediately.
6.4   Special precautions for storage
Store below 30°C. Protect from light. For single use only. Discard any unused product.


6.5   Nature and contents of container
10 ml neutral clear glass vial with rubber closure and aluminium flip-off cap containing 10 ml of solution as 50 mg ketamine base per ml.

Ketamine-hameln 50 mg/ml Injection is available in the following pack sizes: 10 vials with 10 ml solution for injection each.

6.6   Instructions for use/handling
Do not use this medicinal product after the expiry date which is stated on the carton and label.

Use only clear and colourless solution.

Dilution: To prepare a dilute solution containing 1 mg of ketamine per ml, aseptically transfer 10 ml (50 mg/ml vial) to 500 ml of sodium chloride 0.9%, or glucose 5%, or ringer lactate solution, and mix well. The resultant solution will contain 1 mg of ketamine per ml. A 1 mg/ml solution of ketamine in sodium chloride 0.9%, or glucose 5%, or ringer lactate solution has been demonstrated for up to 72 hours at 20-       250 C. From a microbiological point of view, the product should be used immediately.

The fluid requirements of the patient and duration of anaesthesia must be considered when selecting the appropriate dilution of ketamine. If fluid restriction is required, ketamine can be added to a 250 ml infusion as described above to provide a ketamine concentration of 2 mg/ml.