y of male reproductive organs both in rats and dogs after multiple daily doses of 20 mg/kg and 0.4 mg/kg, respectively.These effects were reversible upon cessation of treatment.
6. Pharmaceutical particulars
6.1 List of excipients
Liposome forming lipids
1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC)
Cholesterol
N-(carbonyl-methoxypolyethylene glycol-2000)-1, 2-distearoly-sn-glycero-3-phosphoethanolamine (MPEG-2000-DSPE)
Other excipients
Sucrose octasulphate
2- [ 4- (2-Hydroxyethyl)piperazin-1-yl] ethanesulfonic acid (HEPES buffer)
Sodium chloride
Water for injections
6.2 Incompatibilities
ONIVYDE must not be mixed with other medicinal products except those mentioned in section 6.6.
6.3 Shelf life
Unopened vial
30 months.
After dilution
Chemical and physical stability for the diluted solution for infusion has been demonstrated at 15-25°C for up to 6 hours or in the refrigerator (2°C-8°C) for no more than 24 hours.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
6.4 Special precautions for storage
Store in a refrigerator (2°C-8°C).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
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 a grey chlorobutyl stopper and an aluminium seal with a flip-off cap, containing 10 ml of concentrate.
Each pack contains one vial.
6.6 Special precautions for disposal and other handling
ONIVYDE is a cytotoxic medicinal product, and caution should be exercised in handling it. The use of gloves, goggles and protective clothing when handling or administering ONIVYDE is recommended. If the solution contacts the skin, the skin should be washed immediately and thoroughly with soap and water. If the solution contacts mucous membranes, they should be flushed thoroughly with water. Pregnant staff should not handle ONIVYDE considering the cytotoxic nature of the medicinal product.
Preparation of the solution and administration
ONIVYDE is supplied as a sterile liposomal dispersion at a concentration of 5 mg/ml and must be diluted prior to administration. Dilute with 5% glucose solution for injection or sodium chloride 9 mg/ml (0.9%) solution for injection to prepare a solution of the appropriate dose of ONIVYDE diluted to a final volume of 500 ml. Mix the diluted solution by gentle inversion. The diluted solution is clear to slightly white to slightly opalescent and free from visible particles.
ONIVYDE should be administered before LV followed by 5-FU. ONIVYDE must not be administered as a bolus injection or an undiluted solution.
Aseptic techniques must be followed during the preparation of the infusion. ONIVYDE is for single use only.
Care should be taken to avoid extravasation, and the infusion site should be monitored for signs of inflammation. Should extravasation occur, flushing the site with sodium chloride 9 mg/ml (0.9%) solution for injection and/or sterile water and applications of ice are recommended.
Forstorage conditions after dilution of the medicinal product, see section 6.3.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorisation holder
Les Laboratoires Servier
50, rue Carnot
92284 Su |
