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 these solutions must be assessed before addition. It is the responsibility of the physician to judge the incompatibility of an additive medication with the corresponding sodium chloride and dextrose solution, by checking for eventual colour change and/or eventual precipitate, insoluble complexes or crystals apparition. The instructions for use of the medication to be added must be consulted. Before adding a drug, verify it is soluble and stable in water at the pH of the corresponding sodium chloride and dextrose solution.

When a compatible medication is added to the sodium chloride and dextrose solution, the solution must be administered immediately.

Those additives known to be incompatible should not be used.

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

The product should be used immediately after opening.

In-use shelf-life (Additives)
From a microbiological point of view, the diluted product must be used immediately unless dilution has taken place in controlled and validated aseptic conditions. If not used immediately, in-use storage times and conditions are the responsibility of the user.

6.4 Special precautions for storage
Store below 25oC.

6.5 Nature and contents of container
Dextrose 4.3 % and 0.18 % sodium chloride Vioser solution for infusion is available in low density polyethylene bottles (round and oval) of 500 ml and 1000 ml.
Each pack contains 10 bottles.
Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Use only if the solution is clear, without visible particles and if the container is undamaged.

Do not use the solution after its expiry date.

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.
Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is completed.

The solution should be administered with sterile equipment using an aseptic technique.

The equipment should be primed with the solution in order to prevent air entering the system.

Additives may be introduced before infusion or during infusion through the injection site.

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.

Adding other medications or using an incorrect administration technique might cause the appearance of fever reactions due to the possible introduction of pyrogens. In case of an adverse reaction, infusion must be stopped immediately.

Discard after single use.

Discard any unused portion. No special requirements for disposal.
Do not reconnect partially used containers.

Do not administer the content if: a) it is not clear and the bottle is not intact,
b) disinfection with 70% alcohol has not taken place:
-on the surface below the site of insertion of the infusion set.
-any other perforation site.