What Myocet contains:
- The active substance is liposome?encapsulated doxorubicin. This corresponds to 50 mg doxorubicin hydrochloride.
- The other ingredients are lactose (in the doxorubicin HCl vial), phosphatidylcholine, cholesterol, citric acid, sodium hydroxide and water for injections (in the liposomes vial), and sodium carbonate and water for injections (in the buffer vial).
What Myocet looks like and contents of the pack
Myocet consists of a powder and pre-admixtures for concentrate for liposomal dispersion for infusion. It is supplied as a three-vial system: Myocet doxorubicin HCl, Myocet liposomes and Myocet buffer.
Once the content of the vials has been mixed together the resulting liposomal dispersion is orange-red and opaque.
Myocet is available in cartons containing 2 sets of the three constituents.
Marketing Authorisation Holder
Cephalon Europe
5 Rue Charles Martigny
94700 Maisons Alfort
France
Manufacturer
GP-Pharm
Polígon Industrial Els Vinyets - Els Fogars,
Sector 2, Carretera Comarcal C244, km 22
08777 Sant Quintí de Mediona (Barcelona)
Spain
This leaflet was last approved in: {MM/YYYY}
The following information is intended for healthcare professionals only:
PREPARATION GUIDE
Myocet 50 mg powder and pre-admixtures for concentrate for liposomal dispersion for infusion Doxorubicin hydrochloride
It is important you read the entire contents of this guide prior to the preparation of this medicinal product.
1. PRESENTATION
Myocet is supplied as a three-vial system: (1) Myocet doxorubicin HCl, (2) Myocet liposomes, and (3) Myocet buffer. In addition to these three components, 0.9% (w/v) sodium chloride solution for injection will also be required for the reconstitution of the doxorubicin HCl. Myocet must be reconstituted prior to administration.
2. RECOMMENDATIONS FOR SAFE HANDLING
The normal procedures for proper handling and disposal of anti-tumour medicinal products should be adopted, namely:
- Personnel should be trained to reconstitute the medicinal product.
- Pregnant staff should be excluded from handling the medicinal product.
- Personnel handling this medicinal product during reconstitution should wear protective clothing including masks, goggles and gloves.
- All items for administration or cleaning, including gloves, should be placed in a high-risk, waste disposal bag for high-temperature incineration. Liquid waste may be flushed with large amounts of water.
- Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
3. PREPARATION FOR THE INTRAVENOUS ADMINISTRATION
Aseptic technique must be strictly observed throughout handling of Myocet since no preservative is present.
3.1 Preparation of Myocet
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 temperature set point by checking the thermometer.
(Please note that whilst the control settings on the water bath and heat block are set to different levels the temperature of the vial contents are in the same range (55°C-60°C)).
- Remove the carton of Myocet constituents from the refrigerator.
Step 2. Reconstitute doxorubicin HCl
- Withdraw 20 ml sodium chloride solution for injection (0.9%), (not provided in the package), and inject into each Myocet doxorubicin HCl, intended for preparation.
- Shake well in the inverted position to ensure doxorubicin is fully dissolved.
Step 3. Heat in water bath or dry heat block
- Heat the reconstituted Myocet doxorubicin HCl vial in the Techne DB-3 Dri Block heater with the thermometer in the block reading (75°C-76°C) for 10 minutes (not to exceed 15 minutes).
- If using the water bath heat the Myocet doxorubicin HCl vial with the thermometer temperature reading 55°C-60°C for 10 minutes (not to exceed 15 minutes).
- While heating proceed to step 4.
Step 4. Adjust pH of liposomes
- Withdraw 1.9 ml of Myocet liposomes. Inject into Myocet buffer vial to adjust the pH of liposomes. Pressure build-up may require venting.
- Shake well.
Step 5. Add pH-adjusted liposomes to doxorubicin
- Using a syringe, withdraw the entire vial contents of pH-adjusted liposomes from the Myocet buffer vial.
- Remove the reconstituted Myocet doxorubicin HCl vial from the water bath or dry heat block. SHAKE VIGOROUSLY. Carefully insert a pressure-venting device equipped with a hydrophobic filter. Then IMMEDIATELY (within 2 minutes) inject the pH-adjusted liposomes into the vial of heated reconstituted Myocet doxorubicin HCl. Remove venting device.
- SHAKE VIGOROUSLY.
- WAIT FOR A MINIMUM OF 10 MINUTES BEFORE USING, KEEPING THE MEDICINE AT ROOM TEMPERATURE.
The Techne DB-3 Dri Block Heater is fully validated for use in the constitution of Myocet. Three inserts, each with two 43.7mm openings per insert must be used. To ensure correct temperature control the use of a 35mm immersion thermometer is recommended.
The resulting reconstituted preparation of Myocet contains 50 mg of doxorubicin HCl/25 ml of concentrate for liposomal dispersion for infusion (2 mg/ml).
After reconstitution the finished product must be further diluted in 0.9% (w/v) sodium chloride solution for injection, or 5% (w/v) glucose solution for injection to a final volume of 40 ml to 120 ml per 50 mg reconstituted Myocet so that a final concentration of 0.4 mg/ml to 1.2 mg/ml doxorubicin is obtained.
Once constituted, the liposomal dispersion for infusion containing liposome encapsulated doxorubicin should be a red-orange opaque homogeneous dispersion. All parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration. Do not use the preparation if foreign particulate matter is present.
It has been demonstrated that once reconstituted Myocet has a chemical and physical in-use stability at room temperature for up to 8 hours or in a refrigerator (2 ?C-8 ?C) for up to 5 days.
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 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.
Myocet should be administered by intravenous infusion over a period of 1 hour. Warning: Myocet must not be administered by the intramuscular or subcutaneous route or as a bolus injection.
4. DISPOSAL
Any unused product or waste material should be disposed of in accordance with local requirements.
