Pharmaceutical particulars : מידע רוקחי

6     PHARMACEUTICAL PARTICULARS
6.1   List of excipients
Acetylcysteine
Citric acid monohydrate (for pH-adjustment)
Water for injections

6.2   Incompatibilities
Aminoplasmal B. Braun 10% E may only be mixed with other nutrients such as carbohy- drates, lipids, vitamins and trace elements for which compatibility has been documented.
Compatibility data for different additives (e.g. electrolytes, trace elements, vitamins) and the corresponding shelf life of such admixtures are available from the manufacturer on request.
See also section 6.6.


6.3   Shelf life

Unopened
The expiry date of the product is indicated on the packaging materials 
After first opening
The medicinal product should be used immediately after first opening.

After admixture of additives
Do not refrigerate.
From a microbiological point of view, unless the method of opening and mixing precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

6.4   Special precautions for storage
Do not store above 25 °C.
Keep the bottle in the outer carton in order to protect from light.
Do not freeze. Cool storage of the solution, below 15 °C, may lead to the formation of crys- tals that can, however, be easily and completely dissolved by gentle warming at 25 °C.
Shake container gently to ensure homogeneity.
For storage conditions after mixing with additives, see section 6.3.

6.5   Nature and content of container
Bottles of colourless glass (type II), sealed with chlorobutyl-rubber stoppers.
Contents:    250 ml, available in packs of 10 bottles
500 ml, available in packs of 10 bottles
1000 ml, available in packs of 6 bottles
Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling
No special requirements for disposal.
For single use only. Discard container and any unused contents after the infusion.

The solution should only be used if the closure of the container is not damaged and if the so- lution is clear, colourless or faintly straw-coloured solution, free from particles.


Use a sterile infusion set for administration.

If, in the setting of complete parenteral nutrition, it is necessary to add other nutrients such as carbohydrates, lipids, vitamins, electrolytes or trace elements to this medicinal product, admixing must be performed under strict aseptic conditions. Mix well after admixture of any additive. Pay special attention to compatibility.