Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS

6.1    List of excipients
Disodium Hydrogen Orthophosphate
Sodium chloride
Potassium Dihydrogen Orthophosphate
Water for Injection

6.2    Incompatibilities

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 label and packaging.

6.4    Special precautions for storage

Store below 25°C, protect from light.
Zantac Injection should not be autoclaved.
6.5    Nature and contents of container

2 ml colourless Type I glass ampoules, Pack size: 5 ampoules.

6.6    Special precautions for disposal and other handling 
Zantac Injection has been shown to be compatible with the following intravenous infusion fluids:


0.9% Sodium Chloride BP
5% Dextrose BP
0.18% Sodium Chloride and 4% Dextrose BP
4.2% Sodium Bicarbonate BP
Hartmann's Solution.
All unused admixtures of Zantac Injection with infusion fluids should be discarded 24 hours after preparation.

Although compatibility studies have only been undertaken in polyvinyl chloride infusion bags (in glass for Sodium Bicarbonate BP) and a polyvinyl chloride administration set it is considered that adequate stability would be conferred by the use of a polyethylene infusion bag.