Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Sorbitol
Lactic Acid
Sodium Hydroxide (to adjust to pH 3.5)
Hydrochloric Acid (to adjust to pH 3.5)
Water for injections

6.2   Incompatibilities

None known.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3   Shelf life

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

After dilution
Irinotecan Teva concentrate for solution for infusion is intended for intravenous infusion only after diluting prior to administration in the recommended diluents: 0.9 % Sodium chloride solution for infusion or 5 % Dextrose solution for infusion.

The physicochemical and microbiological stability of the drug product after dilution in the recommended solutions for infusion has been demonstrated for 24 hours at 30°C and for 48 hours at 2-8°C. From microbiological point of view, unless the methods of opening and dilution preclude the risk of microbial contamination, the product must be used immediately after dilution.
If not used immediately, other in-use time periods and other on-use storage conditions are the responsibility of the user.

6.4   Special precautions for storage

For storage conditions after dilution of the medicinal product, see section 6.3.
Store below 30°C.
Store in the original package in order to protect from light.
Do not freeze.


6.5   Nature and contents of container
Brown glass vial (type I) with bromobutylic rubber stopper and metallic cap (aluminium) with polypropylene disk. Vials may or may not be sheathed in protective sleeve.
Vials contain 100 mg /5 ml; 300 mg /15 ml or 500 mg /25 ml of solution.

Pack sizes:
1 vial per carton.

Not all pack sizes may be marketed.
6.6   Special precautions for disposal and other handling

As with all antineoplastic agents, Irinotecan Teva must be prepared and handled with caution.
The use of glasses, mask and gloves is required.

If Irinotecan Teva solution or infusion solution should come into contact with the skin, wash immediately and thoroughly with soap and water. If Irinotecan Teva solution or infusion solution should come into contact with the mucous membranes, wash immediately with water.

Preparation for the intravenous infusion administration:
Irinotecan Teva concentrate for solution for infusion is intended for intravenous infusion only after diluting prior to administration in the recommended diluents, either 0.9 % Sodium chloride solution for infusion or 5 % Dextrose solution for infusion.

As with any other injectable medicinal product, the Irinotecan Teva solution must be prepared aseptically (see section 6.3)

If any precipitate is observed in the vials or after dilution , the product should be discarded according to standard procedures for cytotoxic agents.

Aseptically withdraw the required amount of Irinotecan Teva concentrate for solution from the vial with a calibrated syringe and inject into a 250 ml infusion bag or bottle containing either 0.9% sodium chloride solution or 5% Dextrose solution. The infusion should be thoroughly mixed by manual rotation.

Disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

All materials used for dilution and administration should be disposed of according to hospital standard procedures applicable to cytotoxic agents.