Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Sodium chloride, Sodium hydroxide, Water for injections.
6.2    Incompatibilities

It must be ensured that the pH value of the reconstituted solution for injection is in the weak alkaline to neutral range (pH value not less than 7). Acidic solutions must not be used, as the active ingredient may precipitate.
Solutions for injection with an acidic or weakly acidic reaction and having a marked buffer capacity in the acidic range may not be mixed with Furosemide. In such mixtures, the pH value is displaced into the acid range and the slightly soluble furosemide precipitates out as crystalline precipitate.

6.3    Special precautions for storage

Store below 25°C.
Keep the ampules in the outer carton in order to protect from light.
For single use only. Once opened the product should be used immediately.
6.4    Nature and contents of container

Amber glass ampoule of hydrolytic class I.
5 x 2 ml, 10 x 2 ml, 50 x 2 ml, 100 x 2 ml.
Not all pack sizes may be marketed.

6.5   Special precautions for disposal and other handling
Furosemide can be mixed or diluted with 0.9% sodium chloride or Ringer's lactate solutions.
After dilution, chemical and physical in-use stability has been demonstrated for 24 hours at 25°C protected from light.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.