Pharmaceutical particulars : מידע רוקחי

6     PHARMACEUTICAL PARTICULARS
6.1   List of excipients
Sodium Nitrite Solution for Injection
Water for Injections
Sodium Thiosulfate Solution for Injection
Boric Acid
Potassium Chloride
Water for Injections
Sodium Hydroxide and/or Boric Acid for pH Adjustment



6.2   Incompatibilities
Chemical incompatibility has been reported between Nithiodote and hydroxocobalamin and these drugs should not be administered simultaneously through the same IV line. No chemical incompatibility has been reported between sodium thiosulfate and sodium nitrite, when administered sequentially through the same IV line.

6.3   Shelf life
The expiry date of the product is indicated on the packaging materials 
6.4   Special precautions for storage
Store below 25°C.
Store in the original package in order to protect from light.

6.5   Nature and contents of container
Each Nithiodote carton consists of one 10 mL glass vial of sodium nitrite 30 mg/mL solution for injection (containing 300 mg of sodium nitrite) and one 50 mL glass vial of sodium thiosulfate 250 mg/mL solution for injection (containing 12.5 g of sodium thiosulfate).

6.6   Special precautions for disposal
No special requirements for disposal.

Registration number:
159-47-34947-00