Pharmaceutical particulars : מידע רוקחי

6     PHARMACEUTICAL PARTICULARS

6.1   List of excipients

Sodium chloride, Hydrochloric acid, Sodium hydroxide, Water for injections 
6.2   Incompatibilities

Ketamine G.L.10 mg/ml is chemically incompatible with barbiturates and diazepam because of precipitate formation. Therefore, these should not be mixed in the same syringe or infusion fluid.

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

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.
After dilution to 1 mg/ml:

Chemical and physical stability has been demonstrated for 48 hours at 25°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 12 hours at 2-8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.

For further information see section 6.6.

6.4   Special precautions for storage
Do not store above 30°C. Do not freeze.
Store in the original package in order to protect from light.

For storage conditions after dilution of the medicinal product, see section 6.3.

6.5   Nature and contents of container

Clear glass ampoules (type I) with OPC (one-point-cut).
Packs of 2, 5, or 10 mL ampoules in boxes of 1, 5, 10.

Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling
Dilution: To prepare a dilute solution containing 1 mg of ketamine per mL, aseptically transfer 50 mL of Ketamine G.L.10 mg/mL (=500 mg Ketamine) to 450 mL of one of the below mentioned diluents, and mix well. The resulting solution will contain 1 mg of ketamine per mL.

The fluid requirements of the patient and duration of anesthesia must be considered when selecting the appropriate dilution of ketamine. If fluid restriction is required, 50 mL of ketamine G.L.10 mg/mL (=500 mg Ketamine) can be diluted in 200 mL of one of the below mentioned diluents to provide a ketamine concentration of 2 mg/mL.


If required, Ketamine G.L.10 mg/ml can be diluted with
-      sodium chloride 0.9% solution for injection
-     sodium chloride and dextrose solution for injection (sodium chloride 0.18% w/v and dextrose 4% w/v)
-      Ringer’s solution for injection
-      Lactated Ringer’s solution for injection


No evidence of incompatibility was observed between Ketamine G.L.10 mg/ml and representative brands of injectable forms of the following drugs when stored over a 48 hour period at ambient temperature using sodium chloride 0.9% solution for injection as diluent:
-      morphine hydrochloride
-      oxycodone hydrochloride
-      hydromorphone hydrochloride


Use only if the solution is clear and colourless and without precipitate.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.