Pharmaceutical particulars : מידע רוקחי

6.   PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Benzethonium chloride, water for injection, nitrogen
6.2 Incompatibilities
Ketamine Hydrochloride Injection should not be mixed with barbiturates or diazepam for injection or dilution, as physical or chemical incompatibilities result in precipitation or turbidity.
Use only glucose solutions (5%) and isotonic sodium chloride solutions for preparing the solution for infusion.

6.3 Shelf life
The expiry date of the product is indicated on the packaging materials After first opening can be used within 4 weeks, below 25℃, protected from light.
Shelf life of prepared solutions for infusion:
The chemical and physical stability of the drug product diluted in 5% glucose or isotonic sodium chloride solution at a concentration of 1mg/ml, has been demonstrated for 24 hours at 25℃.

From the microbiological point of view, the reconstituted solution should be used immediately, unless the dilution method eliminates the risk of microbial contamination. If the reconstituted solution is not used immediately, the user is responsible for storage times and conditions. Use only clear and colorless solutions.

6.4 Special precautions for storage
Store below 30°C. Protect from light in the original pack.
For storage, conditions after reconstitution/dilution of the medicinal product see section 6.3.

6.5 Nature and contents of container
Packaging: vials of 10 ml solution for injection in boxes of 25 vials.

6.6. Instructions for use/handling
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 at 25℃.

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.

7.   Manufacturer:
Panpharma GmbH, Germany
Bunsenstrasse 4, D-22946, Trittau, Germany

8.   Importer and License Holder:
Pharmalogic Ltd.
P.O.B 3838, Petah-Tikva 49511