Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS

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6.1.   List of excipients
Sorbitol
Lactic acid
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
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.



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6.3.    Shelf life

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

After dilution
Chemical and physical in-use stability of the drug product after dilution in the recommended solutions for infusion (see section 6.6) has been demonstrated for 6 hours at 25°C±2°C and for 24 hours at 2°C-8°C.
From a microbiological point of view, unless the methods of opening and dilution preclude the risk of microbial contamination, the product should be used immediately after dilution. If not used immediately, in-use storage times and conditions are the responsibility of the user.

6.4.    Special precautions for storage

Store below 25°C. Keep the vial in the outer carton in order to protect from light. Do not freeze.
For storage conditions after dilution of the medicinal product, see section 6.3.
6.5.    Nature and contents of container

Irinotecan HCl Seacross 20 mg/ml, concentrate for solution for infusion is supplied as either 40mg/2ml, 100mg/5ml, 300mg/15ml or 500mg/25ml Type I amber tubular glass vials with a teflon coated stopper with an aluminium sealed flip off cap.

Pack sizes
1 x 2 ml vial
1 x 5 ml vial
1x 15 ml vial
1 x 25ml vial

Not all pack sizes may be marketed.
Vials may be sheathed in appropriate sleeve.
6.6.    Special precautions for disposal and other handling

As with other antineoplastic agents, Irinotecan HCl Seacross 20 mg/ml must be prepared and handled with caution. The use of glasses, mask and gloves is required.

If Irinotecan HCl Seacross 20 mg/ml solution or infusion solution should come into contact with the skin, wash immediatelyand thoroughly with soap and water. If Irinotecan HCl Seacross 20 mg/ml solution or infusion solution should come into contact with the mucous membranes, wash immediately with water.

Preparation for the intravenous infusion administration:

As with any other injectable medicinal product, the Irinotecan HCl Seacross 20 mg/ml 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 HCl Seacross 20 mg/ml 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% glucose solution. The infusion should then be thoroughly mixed by manual rotation.
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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.

7.      MARKETING AUTHORISATION HOLDER

A.L.Medi-Market Ltd, 3 Hakatif street, Emek Hefer Industrial Park, 3877701