Doxorubicin(Myocet) 50mg powder, dispersion and solvent for concentrate for dispersion for infusion(七)
tabolite of doxorubicin, doxorubicinol, is formed via aldo-keto-reductase. The peak levels of doxorubicinol occur in the plasma later with Myocet than with conventional doxorubicin.
The pharmacokinetics of Myocet have not been specifically studied in patients with renal insufficiency. Doxorubicin is known to be eliminated in large part by the liver. A dose reduction of Myocet has been shown to be appropriate in patients with impaired hepatic function (see section 4.2 for dosage recommendations).
Substances that inhibit P-glycoprotein (P-Gp) have been shown to alter the disposition of doxorubicin and doxorubicinol (see also section 4.5).
5.3 Preclinical safety data
Studies of genotoxicity, carcinogenicity and reproductive toxicity of Myocet have not been performed but doxorubicin is known to be both mutagenic and carcinogenic and may cause toxicity to reproduction.
6. Pharmaceutical particulars
6.1 List of excipients
Myocet doxorubicin HCl
• lactose
Myocet liposomes
• phosphatidylcholine
• cholesterol
• citric acid
• sodium hydroxide
• water for injections
Myocet buffer
• sodium carbonate
• 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
18 months
Chemical and physical in-use stability after reconstitution has been demonstrated for up to 8 hours at 25°C, and for up to 5 days at 2°C – 8°C.
From a microbiological point of view, the medicinal 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 would normally not be longer than 24 hours at 2°C – 8°C, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
6.4 Special precautions for storage
Store in a refrigerator (2°C – 8°C).
For storage conditions after reconstitution of the medicinal product, see section 6.3.
6.5 Nature and contents of container
Myocet is available in cartons containing 1 set or 2 sets of the three constituents. Not all pack-sizes may be marketed.
Myocet doxorubicin HCl
Type I glass vials sealed with grey butyl rubber stoppers and orange flip-off aluminium seals, containing 50 mg of doxorubicin HCl lyophilised powder.
Myocet liposomes
Type I flint glass tubing vials sealed with siliconised grey stopper and green flip-off aluminium seals, containing not less than 1.9 ml of liposomes.
Myocet buffer
Glass vials sealed with siliconised grey stopper and blue aluminium flip-off seals, containing not less than 3 ml of buffer.
6.6 Special precautions for disposal and other handling
Preparation of Myocet
Aseptic technique must be strictly observed throughout handling of Myocet since no preservative is present.
Caution should be exercised in the handling and preparation of Myocet. The use of gloves is required
Step 1. Set up
Two alternative heating methods can be used : a Techne DB-3 Dri Block heater or a water bath:
• Turn on the Techne DB-3 Dri Block heater and set the controller to 75°C-76°C. Verify the temperature set point by checking the thermometer(s) on each heat block insert.
• If using a water bath, turn on the water bath and allow it to equilibrate at 58°C (55°C-60°C). Verify the temperatu |
