Pharmaceutical particulars : מידע רוקחי

6      PHARMACEUTICAL PARTICULARS


6.1    List of excipients
Glucose monohydrate;
Disodium edetate;
Water for injections;
Sodium hydroxide and hydrochloric acid (for pH adjustment).



6.2    Incompatibilities

Labetalol injection has been shown to be incompatible with Sodium Bicarbonate injection BP 4.2% w/v. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.


6.3    Shelf life


After first opening:
The expiry date of the product is indicated on the packaging materials.


Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C, 30°C and 40°C.
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 - 8 °C.
After dilution:

In case of dilution, the product is stable for 24 hours at 2-8°C or at 25°C, but from a microbial point of view, the product should be used immediately after dilution.



6.4    Special precautions for storage

Store below 25ºC. Store in the original package to protect the product from light.
6.5    Nature and contents of container


Colorless, Type I glass ampoule.

Pack of 5x20 ml

6.6    Special precautions for disposal and other handling

Labetalol should be diluted only with compatible I.V. infusion fluids under aseptic condition.

LABETALOL S.A.L.F. 5 MG/ML is compatible with the following intravenous infusion solutions:


•      5% Dextrose BP.
•      0.18% Sodium Chloride and 4% Dextrose BP.
•      0.3% Potassium Chloride and 5% Dextrose BP.
•      Compound Sodium Lactate BP (Ringer Lactate).