Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Water for injection

6.2 Incompatibilities

Mannitol / VIOSER solution for infusion 20% should not be administered simultaneously with, before, or after administration of blood through the same infusion equipment, due to risk of pseudoagglutination.
Concomitant blood transfusion requires concomitant administration of sodium chloride (see section 4.5 Interaction with other medicinal products and other forms of interaction).

Incompatibility of the medicinal product to be added to the mannitol solution must be assessed before addition.

Before adding a medicinal product, verify it is soluble and stable in water at the pH of the mannitol solution (4.5 to 7.0).

As an example, cefepime, imipenem, cilastin and filgrastim are incompatible with mannitol solutions. The addition of potassium chloride or sodium chloride to 20% mannitol solutions may cause precipitation of mannitol.

6.3 Shelf life

The expiry date of the product is indicated on the packaging materials. After opening the container, use the solution immediately.

6.4 Special precautions for storage
Store below 25°C.

6.5 Nature and contents of container
Polyethylene plastic bottle of 250 ml.

6.6 Special precautions for disposal and other handling

Do not use the product after its expiry date. Any unused solution should be disposed of.
Do not use the content if: a) it is not clear, it is not without visible particles and the bottle is not intact b) disinfection with 70% alcohol has not taken place at
- the surface around the site of insertion of the set
- any other perforation site.
In cooler temperatures mannitol may form crystals.
The crystals can be redissolved before use by warming in a water bath (at a temperature of approximately 60°C), agitating the solution vigorously periodically. Cool the solution to body temperature (37°C) before infusion.