Pharmaceutical particulars : מידע רוקחי

6.        PHARMACEUTICAL PARTICULARS
6.1.      List of excipients

Sodium chloride, citric acid monohydrate, sodium citrate, water for injection.

6.2.      Incompatibilities
Zofran injection should not be administered in the same syringe or infusion as any other medication.

ZOF INJ API MAR22 V2.0                                                             UK PI 12Jan2022 Ondansetron injection should only be mixed with those infusion solutions that are recommended.

6.3.      Shelf life

The expiry date of the product is indicated on the packaging materials 
6.4.      Special precautions for storage

Protect from light. Store below 30ºC.
Dilutions of Zofran injection in compatible intravenous infusion fluids are stable under normal room lighting conditions or daylight for at least 24 hours, thus no protection from light is necessary while infusion takes place.

6.5.      Nature and contents of container

Type I clear glass one-point-cut ampoules.
5 ampoules are packed in a carton.

6.6.      Special precautions for disposal and other handling

Zofran Injection should not be autoclaved.
Compatibility with intravenous fluids

Zofran injection should only be mixed with those infusion solutions which are recommended: •      Sodium Chloride Intravenous Infusion BP 0.9% w/v
•      Glucose Intravenous Infusion BP 5% w/v
•      Mannitol Intravenous Infusion BP 10% w/v
•      Ringers Intravenous Infusion
•      Potassium Chloride 0.3% w/v and Sodium Chloride 0.9% w/v Intravenous Infusion BP •      Potassium Chloride 0.3% w/v and Glucose 5% w/v Intravenous Infusion BP 
In keeping with good pharmaceutical practice dilutions of Zofran injection in intravenous fluids should be prepared at the time of infusion or stored at 2-8°C for no more than 24 hours before the start of administration.

Compatibility studies have been undertaken in polyvinyl chloride infusion bags and polyvinyl chloride administration sets. It is considered that adequate stability would also be conferred by the use of polyethylene infusion bags or Type 1 glass bottles. Dilutions of Zofran in sodium chloride 0.9% w/v or in glucose 5% w/v have been demonstrated to be stable in polypropylene syringes. It is considered that Zofran injection diluted with other compatible infusion fluids would be stable in polypropylene syringes.

Compatibility with other drugs: Zofran may be administered by intravenous infusion at 1mg/hour, e.g. from an infusion bag or syringe pump. The following drugs may be administered via the Y-site of the Zofran giving set for ondansetron concentrations of 16 to 160 micrograms/mL (e.g. 8 mg/500 mL and 8 mg/50 mL respectively);

Cisplatin: Concentrations up to 0.48 mg/mL (e.g. 240 mg in 500 mL) administered over one to eight hours.


ZOF INJ API MAR22 V2.0                                                           UK PI 12Jan2022 5-Fluorouracil: Concentrations up to 0.8 mg/mL (e.g. 2.4 g in 3 litres or 400 mg in 500 mL) administered at a rate of at least 20 mL per hour (500 mL per 24 hours). Higher concentrations of 5- fluorouracil may cause precipitation of ondansetron. The 5-fluorouracil infusion may contain up to 0.045% w/v magnesium chloride in addition to other excipients shown to be compatible.

Carboplatin: Concentrations in the range 0.18 mg/mL to 9.9 mg/mL (e.g. 90 mg in 500 mL to 990 mg in 100 mL), administered over ten minutes to one hour.

Etoposide: Concentrations in the range 0.14 mg/mL to 0.25 mg/mL (e.g. 72 mg in 500 mL to 250 mg in 1 litre), administered over thirty minutes to one hour.

Ceftazidime: Doses in the range 250 mg to 2000 mg reconstituted with Water for Injections BP as recommended by the manufacturer (e.g. 2.5 mL for 250 mg and 10 mL for 2 g ceftazidime) and given as an intravenous bolus injection over approximately five minutes.

Cyclophosphamide: Doses in the range 100 mg to 1g, reconstituted with Water for Injections BP, 5 mL per 100 mg cyclophosphamide, as recommended by the manufacturer and given as an intravenous bolus injection over approximately five minutes.

Doxorubicin: Doses in the range 10-100 mg reconstituted with Water for Injections BP, 5 mL per 10 mg doxorubicin, as recommended by the manufacturer and given as an intravenous bolus injection over approximately 5 minutes.

Dexamethasone: Dexamethasone sodium phosphate 20 mg may be administered as a slow intravenous injection over 2-5 minutes via the Y-site of an infusion set delivering 8 or 16 mg of ondansetron diluted in 50-100 mL of a compatible infusion fluid over approximately 15 minutes.
Compatibility between dexamethasone sodium phosphate and ondansetron has been demonstrated supporting administration of these drugs through the same giving set resulting in concentrations in line of 32 microgram - 2.5 mg/ mL for dexamethasone sodium phosphate and 8 microgram – 1 mg/mL for ondansetron.


7.        Registration holder and importer and its address
Novartis Israel Ltd., P.O.B 7126, Tel-Aviv