Pharmaceutical particulars : מידע רוקחי

6       PHARMACEUTICAL PARTICULARS

6.1     List of excipients
Sodium chloride, water for injections.

6.2     Incompatibilities

Ketamine Propharm 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 dilution

After dilution the solutions should be used immediately.
Chemical and physical in-use stability has been demonstrated for 48 hours at 25°C.
However, 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 30°C.

6.5     Nature and contents of container
5 ml sealed glass ampoules type I containing 5 ml of solution as 10 mg ketamine base per ml. Each pack contains 10 ampoules.

6.6     Instructions for use/handling
I.V. infusion
Dilution: To prepare a dilute solution containing 1 mg of ketamine per mL, aseptically transfer 500 mg ketamine to 500 mL of 5% dextrose injection, or sodium chloride (0.9%) for injection, and mix well. The resultant solution will contain 1 mg of ketamine per mL. For shelf life after dilution please refer to section 6.3.

The fluid requirements of the patient and duration of anesthesia must be considered when selecting the appropriate dilution of ketamine.