Pharmaceutical particulars : מידע רוקחי

6     PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Ketamin Sintetica 10mg/ml: Sodium chloride, water for injections 
Ketamin Sintetica 50mg/ml: water for injections

6.2   Incompatibilities
Ketamin Sintetica 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.

After dilution the solutions should be used immediately.

6.4   Special precautions for storage
Store below 25°C. Protect from light.
6.5   Nature and contents of container
Ketamin Sintetica Injection 10 mg/ml: 10ml clear colourless glass one point cut vial containing 10 ml of solution as 10 mg ketamine base per ml.

Ketamin Sintetica 50 mg/ml Injection: 2 ml clear colourless glass one point cut vial containing 2 ml of solution as 50 mg ketamine base per ml.

6.6   Instructions for use/handling
Ketamin Sintetica 50 mg/ml
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 5% dextrose injection, or sodium chloride (0.9%) for injection, and mix well. The resultant solution will contain 1 mg of ketamine per mL. A 1 mg/mL solution of ketamine in dextrose 5% or sodium chloride 0.9% is stable for 24 hours.

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,
ketamine can be added to a 250 mL infusion as described above to provide a ketamine concentration of 2 mg/mL.

Ketamin Sintetica 10 mg/ml
Ketamine vials in the 10 mg/mL concentration are not recommended for dilution.

7      Manufacturer:
SINTETICA SA , SWITZERLAND
VIA PENATE 5, CH-6850 MENDRISIO, SWITZERLAND