Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS

6.1    List of excipients
Mannitol, Water for Injection.

6.2    Incompatibilities

This medicinal product should not be mixed with other medical products except those mentioned under section 4.2 “Dilution” and section 6.4.
This product should not be used with aluminium-containing infusion assemblies, syringes and injection needles. The antineoplastic activity can be reduced.

6.3    Shelf life

The expiry date of the product is indicated on the packaging materials.
After first opening
Immediate and single use.

After dilution

Carboplatin Teva EM 12/2023 Notification
From a microbiological point of view, unless the method of opening/dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
When diluted as directed, carboplatin solutions should be used within 12 hours when stored at room temperature (15 - 25°C) protected from light or within 24 hours when stored at 2 - 8°C if dilution is carried out under validated aseptic conditions.
Since no antibacterial preservatives are contained in the formulation, it is recommended that any carboplatin solution be discarded 12 hours after dilution if stored at room temperature protected from light or after 24 hours, if stored under refrigeration. This product is for single dose use only.

6.4    Special precautions for storage

Store below 25°C. Do not refrigerate. Keep in the original package in order to protect from light.
For storage conditions of the diluted medicinal product, see section 6.3.
Dilution: The product may be diluted with 5% Glucose for Injection, or 0.9% Sodium Chloride for Injection, to concentrations as low as 0.5 mg/ml (500 micrograms/ml).

6.5    Nature and contents of container

Amber coloured glass vials, type I with chlorobutyl, teflon-coated stoppers and aluminium caps.
Pack sizes:
5 ml vials:                         1 vial
15 ml vials:                        1 vial
45 ml vials:                        1 vial
60 ml vials:                        1 vial

Not all pack sizes may be marketed.

6.6    Special precautions for disposal
The solution for infusion must be visually inspected for particulate matter before use.

Guidelines for the safe handling of antineoplastic agents:

1. Trained personnel should handle the drug.
2. This should be performed in a designated area.

3. Adequate protective gloves should be worn.

4. Precautions should be taken to avoid the drug accidentally coming into contact with the eyes. In the event of contact with the eyes, wash with water and/or saline.
5. The cytotoxic preparation should not be handled by pregnant staff.

6. Adequate care and precautions should be taken in the disposal of items (syringes, needles, etc.) used to reconstitute cytotoxic drugs. Excess material and body waste may be disposed of by placing in double sealed polythene bags and incinerating at a temperature of 1,000°C. Liquid waste may be flushed with copious amounts of water.

Dilution:

7. The work surface should be covered with disposable plastic-backed absorbent paper.
Carboplatin Teva EM 12/2023 Notification
8. Use Luer-Lock fittings on all syringes and sets. Large-bore needles are recommended to minimise pressure and the possible formation of aerosols. The latter may also be reduced by the use of a venting needle.



7.     LICENCE HOLDER AND MANUFACTURER

Licence Holder and manufacturer:
Teva Israel Ltd.,
124 Dvora HaNevi'a St., Tel Aviv 6944020.