B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Eptifibatide Accord 0.75 mg/ml solution for infusion eptifibatide

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or hospital pharmacist or nurse.

• – If you get any side effects talk to your doctor or hospital pharmacist or nurse. This includes any

possible side effects not listed in this leaflet. See section 4.

What is in this leaflet :

• 1. What Eptifibatide Accord is and what it is used for

• 2. What you need to know before you are given Eptifibatide Accord

• 3. How to use Eptifibatide Accord

• 4. Possible side effects

• 5. How to store Eptifibatide Accord

• 6. Contents of the pack and other information

1. What Eptifibatide Accord is and what it is used for

Eptifibatide Accord is an inhibitor of platelet aggregation. This means that it helps to prevent blood clots from forming.

It is used in adults with manifestation of severe coronary insufficiency defined as spontaneous and recent chest pain with electrocardio­graphic abnormalities or biological changes. It is usually given with aspirin and unfractionated heparin.

2. What you need to know before you are given Eptifibatide Accord

Do not use Eptifibatide Accord:

• – if you are allergic to eptifibatide or any of the other ingredients of this medicine (listed in section 6).

• – if you have recently had bleeding from your stomach, intestines, bladder or other organs, for example if you have seen abnormal blood in your stool or urine (except from menstrual bleeding) in the past 30 days.

• – if you have had a stroke within the past 30 days or any haemorrhagic stroke (also, be sure your doctor knows if you ever had a stroke).

• – if you have had a brain tumour or a condition that affects the blood vessels around the brain.

• – if you had a major operation or severe injury during the past 6 weeks.

• – if you have or have had bleeding problems.

• – if you have or have had difficulty with your blood clotting or a low blood platelet count.

• – if you have or have had severe hypertension (high blood pressure).

• – if you have or have had severe kidney or liver problems.

• – if you have been treated with another medicine of the same type as Eptifibatide Accord.

Please tell your doctor if you have had any of these conditions. If you have any questions, ask your doctor or hospital pharmacist or nurse.

Warnings and precautions

• – Eptifibatide Accord is recommended for use only in adult, hospitalised patients in coronary care units.

• – Eptifibatide Accord is not intended for use in children or adolescents less than 18 years of age.

Before and during your treatment with Eptifibatide Accord, samples of your blood will be tested as a safety measure to limit the possibility of unexpected bleeding.

During use of Eptifibatide Accord, you will be checked carefully for any signs of unusual or unexpected bleeding.

Talk to your doctor or hospital pharmacist or nurse before using Eptifibatide Accord.

Other medicines and Eptifibatide Accord

To avoid the possibility of interactions with other medicines please tell your doctor or hospital pharmacist or nurse if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription. Particularly: blood thinners (oral anticoagulants) or medicines that prevent blood clots, including warfarin, dipyridamole, ticlopidine, aspirin (except those that you may be given as part of Eptifibatide Accord treatment).

Pregnancy, breast-feeding and fertility

Eptifibatide Accord is not usually recommended for use during pregnancy. Tell your doctor if you are pregnant, think you might be pregnant or are planning to have a baby. Your doctor will weigh up the benefit to you against the risk to your baby of using Eptifibatide Accord while you are pregnant.

If you are breast-feeding a baby, breast-feeding should be interrupted during the treatment period.

Eptifibatide Accord contains sodium

This medicine contains 172 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 8.6% of the recommended maximum daily dietary intake of sodium for an adult.

3. How to use Eptifibatide Accord

Eptifibatide Accord is given into the vein by direct injection followed by an infusion (drip solution). The dose given is based on your weight. The recommended dose is 180 microgram/kg administered as a bolus (rapid intravenous injection), followed by an infusion (drip solution) of

2 microgram/kg/mi­nute for up to 72 hours. If you have kidney disease, the infusion dose may be reduced to 1 microgram/kg/mi­nute.

If percutaneous coronary intervention (PCI) is performed during Eptifibatide Accord therapy, the intravenous solution may be continued for up to 96 hours.

You must also be given doses of aspirin and heparin (if not contraindicated in your case).

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common side effects

These may affect more than 1 in 10 people

• – minor or major bleeding, (for example, blood in urine, blood in stool, vomiting blood, or bleeding with surgical procedures).

• – anaemia (decreased number of red blood cells).

Common side effects

These may affect up to 1 in 10 people – inflammation of a vein.

Uncommon side effects

These may affect up to 1 in 100 people

• – reduction in the number of platelets (blood cells necessary for blood clotting).

• – reduced blood flow to the brain.

Very rare side effects

These may affect up to 1 in 10,000 people

• – serious bleeding (for example, bleeding inside the abdomen, inside the brain, and into the lungs).

• – fatal bleeding.

• – severe reduction in the number of platelets (blood cells necessary for blood clotting).

• – skin rash (such as hives).

• – sudden, severe allergic reaction.

If you notice any signs of bleeding, notify your doctor or hospital pharmacist or nurse immediately. Very rarely, bleeding has become severe and even fatal. Safety measures to prevent this from happening include blood tests and careful checking by the healthcare professionals taking care of you.

If you develop severe allergic reaction or hives, notify your doctor or hospital pharmacist or nurse immediately.

Other events that may occur in patients, who require this type of treatment, include those that are related to the condition you are having treated, such as rapid or irregular heartbeat, low blood pressure, shock or cardiac arrest.

Reporting of side effects

If you get any side effects, talk to your doctor or hospital 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 By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Eptifibatide Accord

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 carton and the vial after (EXP). The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C).

Keep the vial in the outer package in order to protect from light. However, protection of Eptifibatide Accord solution from light is not necessary during administration.

Before using, the vial contents should be inspected.

Eptifibatide Accord should not be used if it is noticed that particulate matter or discoloration is present.

Any unused medicine after opening should be thrown away.

Do not throw away any medicines via wastewater or household waste. Ask your hospital pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Eptifibatide Accord contains

• – The active substance is eptifibatide.

Eptifibatide Accord 0.75 mg/ml: Each ml of solution for infusion contains 0.75 mg of eptifibatide. One vial of 100 ml of solution for infusion contains 75 mg of eptifibatide.

• – The other ingredients are citric acid monohydrate, sodium hydroxide and water for injections.

What Eptifibatide Accord looks like and contents of the pack

Eptifibatide Accord 0.75 mg/ml solution for infusion: 100 ml vial, pack of one vial.

Eptifibatide Accord 0.75 mg/ml: The clear, colourless solution is contained in a 100 ml glass vial, which is closed with a butyl rubber stopper and sealed with a flip-off aluminium seal.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est 6a planta,

08039 Barcelona,

Spain

Manufacturer:

Wessling Hungary Kft

Fôti ùt 56, Budapest 1047,

Hungary

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95–200 Pabianice, Poland

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

Detailed information on this medicine is available on the European Medicines Agency web site:

Package leaflet: Information for the patient

Eptifibatide Accord 2 mg/ml solution for injection eptifibatide

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or hospital pharmacist or nurse.

• – If you any get side effects talk to your doctor or hospital pharmacist or nurse. This includes any

possible side effects not listed in this leaflet. See section 4.

What is in this leaflet :

• 1. What Eptifibatide Accord is and what it is used for

• 2. What you need to know before you are given Eptifibatide Accord

• 3. How to use Eptifibatide Accord

• 4. Possible side effects

• 5. How to store Eptifibatide Accord

• 6. Contents of the pack and other information

1. What Eptifibatide Accord is and what it is used for

Eptifibatide Accord is an inhibitor of platelet aggregation. This means that it helps to prevent blood clots from forming.

It is used in adults with manifestation of severe coronary insufficiency defined as spontaneous and recent chest pain with electrocardio­graphic abnormalities or biological changes. It is usually given with aspirin and unfractionated heparin.

2. What you need to know before you are given Eptifibatide Accord

Do not use Eptifibatide Accord:

• – if you are allergic to eptifibatide or any of the other ingredients of this medicine (listed in section 6).

• – if you have recently had bleeding from your stomach, intestines, bladder or other organs, for example if you have seen abnormal blood in your stool or urine (except from menstrual bleeding) in the past 30 days.

• – if you have had a stroke within the past 30 days or any haemorrhagic stroke (also, be sure your doctor knows if you ever had a stroke).

• – if you have had a brain tumour or a condition that affects the blood vessels around the brain.

• – if you had a major operation or severe injury during the past 6 weeks.

• – if you have or have had bleeding problems.

• – if you have or have had difficulty with your blood clotting or a low blood platelet count.

• – if you have or have had severe hypertension (high blood pressure).

• – if you have or have had severe kidney or liver problems.

• – if you have been treated with another medicine of the same type as Eptifibatide Accord.

Please tell your doctor if you have had any of these conditions. If you have any questions, ask your doctor or hospital pharmacist or nurse.

Warnings and precautions

• – Eptifibatide Accord is recommended for use only in adult, hospitalised patients in coronary care units.

• – Eptifibatide Accord is not intended for use in children or adolescents less than 18 years of age.

• – Before and during your treatment with Eptifibatide Accord, samples of your blood will be tested

as a safety measure to limit the possibility of unexpected bleeding.

• – During use of Eptifibatide Accord, you will be checked carefully for any signs of unusual or

unexpected bleeding.

Talk to your doctor or hospital pharmacist or nurse before using Eptifibatide Accord.

Other medicines and Eptifibatide Accord

To avoid the possibility of interactions with other medicines please tell your doctor or hospital pharmacist or nurse if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription. Particularly:

• – blood thinners (oral anticoagulants) or

• – medicines that prevent blood clots, including warfarin, dipyridamole, ticlopidine, aspirin (except those that you may be given as part of Eptifibatide Accord treatment).

Pregnancy, breast-feeding and fertility

Eptifibatide Accord is not usually recommended for use during pregnancy. Tell your doctor if you are pregnant, think you might be pregnant or are planning to have a baby. Your doctor will weigh up the benefit to you against the risk to your baby of using Eptifibatide Accord while you are pregnant.

If you are breast-feeding a baby, breast-feeding should be interrupted during the treatment period.

Eptifibatide Accord contains sodium

This medicine contains 34.5 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 1.7% of the recommended maximum daily dietary intake of sodium for an adult.

3. How to use Eptifibatide Accord

Eptifibatide Accord is given into the vein by direct injection followed by an infusion (drip solution). The dose given is based on your weight. The recommended dose is 180 microgram/kg administered as a bolus (rapid intravenous injection), followed by an infusion (drip solution) of 2 microgram/kg/mi­nute for up to 72 hours. If you have kidney disease, the infusion dose may be reduced to 1 microgram/kg/mi­nute.

If percutaneous coronary intervention (PCI) is performed during Eptifibatide Accord therapy, the intravenous solution may be continued for up to 96 hours.

You must also be given doses of aspirin and heparin (if not contraindicated in your case).

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common side effects

These may affect more than 1 in 10 people

• – minor or major bleeding, (for example, blood in urine, blood in stool, vomiting blood, or bleeding with surgical procedures).

• – anaemia (decreased number of red blood cells).

Common side effects

These may affect up to 1 in 10 people

• – inflammation of a vein.

Uncommon side effects

These may affect up to 1 in 100 people

• – reduction in the number of platelets (blood cells necessary for blood clotting).

• – reduced blood flow to the brain.

Very rare side effects

These may affect up to 1 in 10,000 people

• – serious bleeding (for example, bleeding inside the abdomen, inside the brain, and into the lungs)

• – fatal bleeding.

• – severe reduction in the number of platelets (blood cells necessary for blood clotting).

• – skin rash (such as hives).

• – sudden, severe allergic reaction.

5. How to store Eptifibatide Accord

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 carton and the vial after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C - 8°C).

Keep the vial in the outer package in order to protect from light. However, protection of Eptifibatide Accord solution from light is not necessary during administration.

Before using, the vial contents should be inspected.

Eptifibatide Accord should not be used if it is noticed that particulate matter or discoloration is present.

Any unused medicine after opening should be thrown away.

Do not throw away any medicines via wastewater or household waste. Ask your hospital pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Eptifibatide Accord contains

The active substance is eptifibatide.

Eptifibatide Accord 2 mg/ml: Each ml of solution for injection contains 2 mg of eptifibatide. One vial of 10 ml solution for injection contains 20 mg of eptifibatide.

The other ingredients are citric acid monohydrate, sodium hydroxide and water for injections.

What Eptifibatide Accord looks like and contents of the pack

Eptifibatide Accord 0.75 mg/ml solution for infusion: 100 ml vial, pack of one vial.

Eptifibatide Accord 0.75 mg/ml: The clear, colourless solution is contained in a 100 ml glass vial, which is closed with a butyl rubber stopper and sealed with a flip-off aluminium seal.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est 6a planta,

08039 Barcelona,

Spain

Manufacturer:

Wessling Hungary Kft

Fôti ùt 56, Budapest 1047,

Hungary

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95–200 Pabianice, Poland

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

Detailed information on this medicine is available on the European Medicines Agency web site:

Package leaflet: Information for the patient

Eptifibatide Accord 2 mg/ml solution for injection eptifibatide

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or hospital pharmacist or nurse.

• – If you any get side effects talk to your doctor or hospital pharmacist or nurse. This includes any

possible side effects not listed in this leaflet. See section 4.

What is in this leaflet :

• 1. What Eptifibatide Accord is and what it is used for

• 2. What you need to know before you are given Eptifibatide Accord

• 3. How to use Eptifibatide Accord

• 4. Possible side effects

• 5. How to store Eptifibatide Accord

• 6. Contents of the pack and other information

1. What Eptifibatide Accord is and what it is used for

Eptifibatide Accord is an inhibitor of platelet aggregation. This means that it helps to prevent blood clots from forming.

It is used in adults with manifestation of severe coronary insufficiency defined as spontaneous and recent chest pain with electrocardio­graphic abnormalities or biological changes. It is usually given with aspirin and unfractionated heparin.

2. What you need to know before you are given Eptifibatide Accord

Do not use Eptifibatide Accord:

• – if you are allergic to eptifibatide or any of the other ingredients of this medicine (listed in section 6).

• – if you have recently had bleeding from your stomach, intestines, bladder or other organs, for example if you have seen abnormal blood in your stool or urine (except from menstrual bleeding) in the past 30 days.

• – if you have had a stroke within the past 30 days or any haemorrhagic stroke (also, be sure your doctor knows if you ever had a stroke).

• – if you have had a brain tumour or a condition that affects the blood vessels around the brain.

• – if you had a major operation or severe injury during the past 6 weeks.

• – if you have or have had bleeding problems.

• – if you have or have had difficulty with your blood clotting or a low blood platelet count.

• – if you have or have had severe hypertension (high blood pressure).

• – if you have or have had severe kidney or liver problems.

• – if you have been treated with another medicine of the same type as Eptifibatide Accord.

Please tell your doctor if you have had any of these conditions. If you have any questions, ask your doctor or hospital pharmacist or nurse.

Warnings and precautions

• – Eptifibatide Accord is recommended for use only in adult, hospitalised patients in coronary care units.

• – Eptifibatide Accord is not intended for use in children or adolescents less than 18 years of age.

• – Before and during your treatment with Eptifibatide Accord, samples of your blood will be tested

as a safety measure to limit the possibility of unexpected bleeding.

• – During use of Eptifibatide Accord, you will be checked carefully for any signs of unusual or

unexpected bleeding.

Talk to your doctor or hospital pharmacist or nurse before using Eptifibatide Accord.

Other medicines and Eptifibatide Accord

To avoid the possibility of interactions with other medicines please tell your doctor or hospital pharmacist or nurse if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription. Particularly:

• – blood thinners (oral anticoagulants) or

• – medicines that prevent blood clots, including warfarin, dipyridamole, ticlopidine, aspirin (except those that you may be given as part of Eptifibatide Accord treatment).

Pregnancy, breast-feeding and fertility

Eptifibatide Accord is not usually recommended for use during pregnancy. Tell your doctor if you are pregnant, think you might be pregnant or are planning to have a baby. Your doctor will weigh up the benefit to you against the risk to your baby of using Eptifibatide Accord while you are pregnant.

If you are breast-feeding a baby, breast-feeding should be interrupted during the treatment period.

Eptifibatide Accord contains sodium

This medicine contains 34.5 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 1.7% of the recommended maximum daily dietary intake of sodium for an adult.

3. How to use Eptifibatide Accord

Eptifibatide Accord is given into the vein by direct injection followed by an infusion (drip solution). The dose given is based on your weight. The recommended dose is 180 microgram/kg administered as a bolus (rapid intravenous injection), followed by an infusion (drip solution) of 2 microgram/kg/mi­nute for up to 72 hours. If you have kidney disease, the infusion dose may be reduced to 1 microgram/kg/mi­nute.

If percutaneous coronary intervention (PCI) is performed during Eptifibatide Accord therapy, the intravenous solution may be continued for up to 96 hours.

You must also be given doses of aspirin and heparin (if not contraindicated in your case).

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common side effects

These may affect more than 1 in 10 people

• – minor or major bleeding, (for example, blood in urine, blood in stool, vomiting blood, or bleeding with surgical procedures).

• – anaemia (decreased number of red blood cells).

Common side effects

These may affect up to 1 in 10 people

• – inflammation of a vein.

Uncommon side effects

These may affect up to 1 in 100 people

• – reduction in the number of platelets (blood cells necessary for blood clotting).

• – reduced blood flow to the brain.

Very rare side effects

These may affect up to 1 in 10,000 people

• – serious bleeding (for example, bleeding inside the abdomen, inside the brain, and into the lungs)

• – fatal bleeding.

• – severe reduction in the number of platelets (blood cells necessary for blood clotting).

• – skin rash (such as hives).

• – sudden, severe allergic reaction.