Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - myocet

Document Subject

Generated Narrative: MedicinalProductDefinition mp0c5e12e3bf77e98e54b67519ddda8471

identifier: http://ema.europa.eu/identifier/EU/1/00/141/001-002

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Myocet liposomal 50 mg powder, dispersion and solvent for concentrate for dispersion for infusion.

type: Full name

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part: nan

type: Invented name part

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part: nan

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-0c5e12e3bf77e98e54b67519ddda8471

identifier: http://ema.europa.eu/identifier/EU/1/00/141/001-002

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - myocet

Attesters

What is in this leaflet

1. What Myocet liposomal is and what it is used for
2. What you need to know before you are given Myocet liposomal
3. How Myocet liposomal is given
4. Possible side effects
5. How to store Myocet liposomal
6. Contents of the pack and other information

Myocet liposomal contains a medicine called doxorubicin , which damages tumour cells. This type of medicine is called chemotherapy . The medicine is contained inside very small droplets of fat called liposomes .

Myocet liposomal is used in adult women for the first-line treatment of breast cancer that has spread ( metastatic breast cancer ). It is used with another medicine called cyclophosphamide . Please also read the patient information leaflet carefully that comes with that medicine.

Do not have Myocet liposomal: if you are allergic to doxorubicin or any of the other ingredients of this medicine (listed in section 6). Do not have Myocet liposomal if this applies to you. If you are not sure, talk to your doctor or nurse before having Myocet liposomal.

Warning and precautions Talk to your doctor or nurse before having Myocet liposomal.

Check with your doctor or nurse before having your medicine if: you have ever had heart problems such as a heart attack, heart failure or you have had high blood pressure for a long time you have liver problems. If any of the above apply to you (or you are not sure), talk to your doctor or nurse before having Myocet liposomal.

Tests Your doctor will do tests during your treatment to check that the medicine is working properly. They will also look out for any side effects such as blood problems or heart problems.

Radiation therapy If you have already had radiation therapy, this may react with Myocet liposomal. You may get painful, red or dry skin. This can happen straight away or later on in your treatment.

Other medicines and Myocet liposomal Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Myocet liposomal can affect the way some other medicines work. Also some other medicines can affect the way Myocet liposomal works.

In particular tell your doctor or nurse if you are taking any of the following medicines:

• phenobarbital or phenytoin for epilepsy
• warfarin for thinning the blood
• streptozotocin for cancer of the pancreas
• cyclosporine for changing your immune system. If any of the above apply to you (or you are not sure), please talk to your doctor or nurse before having Myocet liposomal.

Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before having Myocet liposomal.

• Myocet liposomal should not be used during pregnancy unless clearly necessary.
• Women having Myocet liposomal should not breast-feed.
• Women who could get pregnant should use effective contraception during treatment with Myocet liposomal and for 6.5 months after treatment.
• Women desiring to have children following completion of therapy are recommended to obtain genetic counselling and advice on fertility preservation before treatment.

Driving and using machines You may feel dizzy after having Myocet liposomal. If you feel dizzy or are not sure how you feel, do not drive or use any tools or machines.

Myocet liposomal contains sodium
Myocet liposomal is available in cartons containing 1 set or 2 sets of 3 vials (not all pack-sizes may be marketed). When the 3 vials have been mixed together, your medicine contains about 108 mg sodium (main component of cooking/table salt). This is equivalent to 5.4 % of the recommended maximum daily dietary intake of sodium for an adult.

This medicine is normally given by a doctor or nurse. It is given as a drip (infusion) into a vein.

How much you will be given Your doctor will work out exactly how much you need. This is based on the size of your body (measured in square metres or m2 ).

The recommended dose is between 60 and 75 mg of the medicine for each square meter of your body:

• this is given once every 3 weeks
• the medicine cyclophosphamide is given on the same day. The doctor may give you a lower dose if they think you need it.

The number of times you have the drip depends on:

• the stage of your breast cancer
• how well your body responds to the medicine. Treatment usually lasts for about 3 to 6 months. If you get Myocet liposomal on your skin Tell your doctor or nurse straight away if any medicine leaks from the drip (infusion) onto your skin. This is because Myocet liposomal can damage your skin. The drip will be stopped straight away. Ice will be put on the affected area for 30 minutes. Then the drip will be started in another vein.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.

Tell your doctor or nurse straight away if you notice any of the following side effects. These are signs of an allergic reaction and your drip (infusion) may have to be stopped: feeling breathless or a tight chest or throat headache or back pain fever or chills swollen or flushed face feeling tired, dizzy or light-headed. If you notice any of the side effects listed above, tell your doctor or nurse straight away.

Other side effects

Very common (may affect more than 1 in 10 people): hair loss
fever, chills, pain loss of appetite, diarrhoea, feeling or being sick (nausea or vomiting) reduced levels of certain blood cells your doctor will regularly check your blood for this and decide if any treatment is required. Signs may include:

• increased bruising
• sore mouth, throat or mouth ulcers
• reduced resistance to infection or fever
• feeling tired or dizzy, having a lack of energy.

Common (may affect up to 1 in 10 people): muscle aches, back pain, headache difficulty breathing, chest pains
feeling thirsty, pain or swelling of your food pipe
shortness of breath, swollen ankles, muscle cramps. These may be signs of heart failure, uneven heart beat or a low potassium level in your blood liver function tests abnormal difficulty sleeping
nose bleeds, hot flushes
constipation, weight loss
skin rash and nail problems.

Uncommon (may affect up to 1 in 100 people): coughing up blood
feeling agitated, feeling sleepy low blood pressure, feeling unwell a change in how you walk, speech problems stomach pains which may be a sign of a stomach ulcer forming muscle weakness itchy, dry skin or swollen areas around hair roots swollen, red and blistering skin around where the drip was given
high blood glucose level (your doctor will see this in a blood test) yellow skin or eyes. These may be signs of a liver problem called jaundice change in how often you pass water (urine), pain on passing water or blood in your urine.

Not Known: frequency cannot be estimated from the available data: Redness and pain on the hands and feet.

Myocet liposomal may cause some side effects that are related to how fast the drip is given. These include flushing, fever, chills, headaches and back pain. These side effects may stop if the drip is given more slowly over a longer period of time.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the label and carton.
• Store in a refrigerator (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 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.
• Do not use this medicine if you notice that it shows evidence of discoloration, precipitation or any other particulate matter.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Myocet liposomal 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 liposomal looks like and contents of the pack
Myocet liposomal consists of a powder, dispersion and solvent for concentrate for dispersion for infusion. It is supplied as a three-vial system: doxorubicin HCl, liposomes and buffer.

Once the content of the vials has been mixed together the resulting liposomal dispersion is orange-red and opaque.

Myocet liposomal is available in cartons containing 1 set or 2 sets of the three constituents. Not all pack-sizes may be marketed.

Marketing Authorisation Holder Teva B.V. Swensweg 5 2031 GA Haarlem Netherlands

Manufacturer GP-Pharm Pol gon Industrial Els Vinyets - Els Fogars, Sector 2, Carretera Comarcal C244, km 08777 Sant Quint de Mediona (Barcelona) Spain

This leaflet was last revised in {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

The following information is intended for healthcare professionals only:

PREPARATION GUIDE

Myocet liposomal 50 mg powder, dispersion and solvent for concentrate for dispersion for infusion
Liposomal doxorubicin hydrochloride

It is important you read the entire contents of this guide prior to the preparation of this medicinal product.

1. PRESENTATION

Myocet liposomal is supplied as a three-vial system: (1) doxorubicin HCl, (2) liposomes, and (3) 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 liposomal 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 liposomal since no preservative is present.

3.1 Preparation of Myocet liposomal

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 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 vial of 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 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 a water bath, heat the 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 liposomes. Inject into the 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 buffer vial.
• Remove the reconstituted 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 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 liposomal. 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 liposomal 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 liposomal 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 liposomal 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 liposomal should be administered by intravenous infusion over a period of 1 hour.
Warning: Myocet liposomal 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.