Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients

Sodium chloride
Water for injections
6.2   Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.


6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
Once prepared and diluted, Evoltra should be used straight away or within 24 hours if stored in a refrigerator (at 2 to 8°C).


6.4     Special precautions for storage
Store below 25°C. Do not freeze.

For storage conditions after dilution of the medicinal product, see section 6.3.


6.5   Nature and contents of container

Type I glass vial with bromobutyl rubber stopper, polypropylene flip-off cap and aluminium overseal.
The vial contains 20 ml concentrate for solution for infusion and is packaged in a box. Each box contains 1, 3, 4, 10 or 20 vials.

Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling
Special precautions for administration

Evoltra 1 mg/ml concentrate for solution for infusion must be diluted prior to administration. It should be filtered through a sterile 0.2 micrometre syringe filter and then diluted with sodium chloride 9 mg/ml (0.9%) intravenous infusion, to produce a total volume according to the examples given in the table below. However, the final dilution volume may vary depending on the patient’s clinical status and physician discretion. If the use of a 0.2 micrometre syringe filter is not feasible, the concentrate should be pre-filtered with a 5 micrometre filter, diluted and then administered through a 0.22 micrometre in-line filter.

Suggested dilution schedule based on the recommended dosage of 52 mg/m2/day clofarabine Body surface area (m2)                Concentrate (ml)*              Total diluted volume ≤ 1.44                             ≤ 74.9                           100 ml 1.45 to 2.40                       75.4 to 124.8                       150 ml            2.41 to 2.50                      125.3 to 130.0                       200 ml
*Each ml of concentrate contains 1 mg of clofarabine. Each 20 ml vial contains 20 mg of clofarabine. Therefore, for patients with a body surface area ≤ 0.38 m2, the partial contents of a single vial will be required to produce the recommended daily dosage of clofarabine. However, for patients with a body surface area > 0.38 m2, the contents of between 1 to 7 vials will be required to produce the recommended daily dosage of clofarabine.

The diluted concentrate should be a clear, colourless solution. It should be visually inspected for particulate matter and discolouration prior to administration.


Instructions for handling
Procedures for proper handling of antineoplastic agents should be observed. Cytotoxic medicinal products should be handled with caution.

The use of disposable gloves and protective garments is recommended when handling Evoltra. If the product comes into contact with eyes, skin or mucous membranes, rinse immediately with copious amounts of water.

Evoltra should not be handled by pregnant women.

Disposal
Evoltra is for single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.