Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients
Water for injection

6.2   Incompatibilities
As with all parenteral solutions compatibility of the additives with the solution must be assessed before addition. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. Those additives known to be incompatible should not be used.
See section 6.6 for further instructions on the use of the product with additives.

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.
6.5   Nature and contents of container
LDPE bottle:
100 ml, 250 ml, 500ml, 1000 ml

Not all pack sizes may be marketed.
6.6   Special precautions for disposal
Use only if the solution is clear, without visible particles and if the container is undamaged.
Administer immediately following the insertion of infusion set.
Before adding a drug, verify it is soluble and stable in water at the pH range of Sodium Chloride Vioser Solution 0.9%. Additives may be introduced before infusion through the injection site.
It is the responsibility of the physician to judge the incompatibility of an additive medication with Sodium Chloride Vioser Solution 0.9% by checking for eventual colour change and/or eventual precipitate, insoluble complexes or crystals apparition.
When additive is used, verify isotonicity prior to parenteral administration. Thorough and careful aseptic mixing of any additive is mandatory. Solutions containing additives should be used immediately and not stored.
Discard after single use.
Discard any unused portion.
Do not reconnect partially used containers.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


Instructions for use
• Check for minute leaks by squeezing container firmly. If leaks are found, discard solution, as sterility may be impaired.
• Check solution for limpidity and absence of foreign matter. If solution is not clear or contains foreign matter, discard the solution.
• Each plastic bottle has a protective cap. The protective ring is removed just before use with a simple pull and the infusion device is adjusted in the special elastic slot. Administer immediately following the insertion of infusion set.


Preparation for administration
Use sterile material for preparation and administration.
• Suspend container from eyelet support.
• Remove plastic protector from outlet port at bottom of container.
• Use an aseptic method to set up the infusion.
• Attach administration set. Refer to directions of the accompanying set for connection, priming of the set and administration of the solution.


Techniques for injection of additive medications
Warning: Additives may be incompatible (see section 6.2 "") .
To add medication before administration:
• Disinfect medication site.
• Using syringe with 19 gauge (1.10 mm) to 22 gauge (0.70 mm) needle, puncture medication port and inject.
• Mix solution and medication thoroughly.
Caution: Do not store bags containing added medications.