Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients

α-(2-[1,2-distearoyl-sn-glycero(3)phosphooxy]ethylcarbamoyl)-ω-methoxypoly(oxyethylen)- 40 sodium salt (MPEG-DSPE)
fully hydrogenated soy phosphatidylcholine (HSPC)
cholesterol
ammonium sulphate
sucrose
histidine
water for injections
hydrochloric acid (for pH-adjustment)
sodium hydroxide (for pH-adjustment)

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.

After dilution:
- Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C.
- From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C to 8°C.
- Partially used vials must be discarded.

6.4 Special precautions for storage

Store in a refrigerator (2°C - 8°C).
Do not freeze.
For storage conditions of the diluted medicinal product, see section 6.3.
6.5 Nature and contents of container

Type I glass vials, each with a siliconised grey bromobutyl stopper, and an aluminium seal, with a deliverable volume of 10 ml (20 mg) or 25 ml (50 mg).
Caelyx liposomal is supplied as a single pack.

6.6 Special precautions for disposal and other handling

Do not use material that shows evidence of precipitation or any other particulate matter.
Caution must be exercised in handling Caelyx liposomal solution. The use of gloves is required. If Caelyx liposomal comes into contact with skin or mucosa, wash immediately and thoroughly with soap and water. Caelyx liposomal must be handled and disposed of in a manner consistent with that of other anticancer medicinal products in accordance with local requirements.

Determine the dose of Caelyx liposomal to be administered (based upon the recommended dose and the patient’s body surface area).
Take the appropriate volume of Caelyx liposomal up into a sterile syringe. Aseptic technique must be strictly observed since no preservative or bacteriostatic agent is present in Caelyx liposomal . The appropriate dose of Caelyx liposomal must be diluted in 5 % (50 mg/ml) glucose solution for infusion prior to administration. For doses < 90 mg, dilute Caelyx liposomal in 250 ml, and for doses ≥ 90 mg, dilute Caelyx liposomal in 500 ml. This can be infused over 60 or 90 minutes as detailed in 4.2.

The use of any diluent other than 5 % (50 mg/ml) glucose solution for infusion, or the presence o f any bacteriostatic agent such as benzyl alcohol may cause precipitation of Caelyx liposomal .

It is recommended that the Caelyx liposomal infusion line be connected through the side port of an intravenous infusion of 5 % (50 mg/ml) glucose. Infusion may be given through a peripheral vein. Do not use with in-line filters.


7. MARKETING AUTHORISATION HOLDER
J-C Health Care Ltd.
Kibbitz Shefayim
6099000
Israel