Pharmaceutical particulars : מידע רוקחי

6     PHARMACEUTICAL PARTICULARS

6.1   List of excipients

Water for injections
Hydrochloric acid (for pH adjustment)

6.2   Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Erythrocyte concentrates must not be suspended in glucose solutions because of the risk of pseudo-agglutination. See also section 4.4.


6.3   Shelf life
Unopened
The expiry date of the product is indicated on the packaging materials.

After first opening the container
Not applicable, see section 6.6.

After reconstitution or dilution
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.
Observe the directions given by the manufacturer of the respective additive or drug to be diluted.


6.4   Special precautions for storage
Do not store above 25°C.


6.5   Nature and contents of container
Bottles of colourless low-density polyethylene,
contents: 500, 1000 ml.


6.6   Special precautions for disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Single-dose container. Discard containers and any unused contents after use.
Do not re-connect partially used containers.
Only to be used if the solution is clear and colourless or slightly yellowish and if the bottle and its closure are undamaged.

Administration should commence immediately after connecting the container to the giving set or infusion equipment.

Before addition of an additive or preparing a nutrient mixture, physical and chemical compatibility must be confirmed. Because glucose solutions have an acidic pH, incompatibilities can occur on mixing with other medicinal products. Information on compatibility can be requested from the manufacturer of the added drug.

When adding additives observe usual precautions of asepsis strictly.