INTEGRILIN 0.75 MG/ML Infusion solution

Зміст інструкції

1. Integrilin 0.75 mg/ml solution for infusion
   1. What is Integrilin and what is it used for
   2. What you need to know before you are given Integrilin
   3. How to use Integrilin
   4. Possible side effects
   5. How to store Integrilin
   6. Package contents and other information
2. Integrilin 2 mg/ml injectable solution
   1. What is Integrilin and what is it used for
   2. What you need to know before you are given Integrilin
   3. How to use Integrilin
   4. POSSIBLE SIDE EFFECTS
   5. How to store Integrilin
   6. Package Contents and Other Information

Integrilin 0.75 mg/ml solution for infusion

eptifibatide

Read this leaflet carefully before you start to use this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, hospital pharmacist or nurse.
• If any side effects occur, including any not listed in this leaflet, tell your doctor, hospital pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Integrilin and what is it used for

Integrilin is a platelet aggregation inhibitor, this means that it helps to prevent the
formation of blood clots.
It is used in adults with severe coronary insufficiency definable as spontaneous and recent chest pain
associated with electrocardiographic abnormalities or biological changes. It is usually
administered together with aspirin and unfractionated heparin.

2. What you need to know before you are given Integrilin

Integrilin must not be given to you:

• if you are allergic to eptifibatide or any of the other ingredients of this medicine (listed in section 6);
• if you have had a recent episode of bleeding from the stomach, intestine, spleen or other organs, for example if you have seen abnormal blood loss in your urine or stools (except for menstrual blood) in the last 30 days;
• if you have had a stroke in the last 30 days or any hemorrhagic stroke (make sure your doctor is aware of this episode);
• if you have had a brain tumor or diseases that can affect the blood vessels of the brain;
• if you have undergone major surgery or suffered serious injuries in the 6 weeks prior;
• if you have had or have bleeding problems;
• if you have had or have difficulty with blood clotting or a low platelet count;
• if you have suffered or are suffering from severe hypertension (high blood pressure);
• if you have suffered or are suffering from severe kidney or liver problems;
• if you have already been treated with a medicine of the same type as Integrilin.

If you have any of these conditions, tell your doctor. If you have any doubts, ask
your doctor or hospital pharmacist or nurse.

Pay special attention:

• Integrilin is recommended only in adult patients hospitalized in coronary care units.
• Integrilin is not indicated in children or adolescents under the age of 18 years.
• Before and during treatment with Integrilin, blood samples may be taken as a precaution to limit the possibility of unexpected bleeding.
• During the use of Integrilin, you will be carefully monitored for any signs of unusual or unexpected bleeding.

Other medicines and Integrilin:
To avoid the possibility of interactions with other medicines, tell your doctor or hospital
pharmacist or nurse if you are taking, have recently taken or might take any other
medicines, including those available without a prescription. In particular:

• blood thinners (oral anticoagulants) or
• medicines that prevent the formation of blood clots such as warfarin, dipyridamole, ticlopidine, aspirin (except those given as part of treatment with Integrilin).

Pregnancy and breastfeeding
Integrilin is generally not recommended for use during pregnancy.
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor for advice. The doctor will assess the benefit of using Integrilin for
you during pregnancy compared to the risk to the baby.
If you are breastfeeding, breastfeeding must be stopped during the treatment period.

Integrilin contains sodium
This medicine contains 161 mg of sodium (the main component of table salt) in each
100 ml vial. This is equivalent to 8.1% of the maximum daily intake of sodium
recommended with the diet of an adult.

3. How to use Integrilin

Integrilin is injected into a vein for direct injection, followed by an infusion (drip solution).
The administered dose is based on body weight. The recommended dose is 180 micrograms/Kg
administered as a bolus (rapid intravenous injection), followed by an infusion (drip solution) of 2 micrograms/Kg/minute for up to 72 hours. In case of renal impairment, the infusion dose
must be reduced to 1 microgram/Kg/minute.
If percutaneous coronary intervention (PCI) is performed during therapy with Integrilin,
the intravenous infusion may be continued for up to 96 hours.
You will also be treated with aspirin and heparin (if not contraindicated in your case).
If you have any further questions about the use of this medicine, consult your doctor or hospital pharmacist
or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Very common side effects

May affect more than 1 in 10 people

• bleeding of minor or major severity (e.g., blood in the urine, blood in the stool, blood in the vomit, or bleeding following surgical procedures);
• anemia (reduced number of red blood cells in the blood)

Common side effects

May affect up to 1 in 10 people

• inflammation of a vein

Uncommon side effects

May affect up to 1 in 100 people

• reduction in the number of platelets (blood cells necessary for coagulation)
• reduced blood flow to the brain

Very rare side effects

May affect up to 1 in 10,000 people

• severe bleeding (for example, internal bleeding in the abdomen, brain, or lungs)
• fatal bleeding
• severe reduction in the number of platelets (blood cells necessary for coagulation)
• skin rash (such as hives)
• sudden and severe allergic reactions

If you notice any signs of bleeding, inform your doctor, hospital pharmacist, or nurse immediately.
Very rarely, bleeding has had serious and even fatal consequences. Safety measures to prevent these events include blood tests and careful
monitoring by the healthcare professionals caring for you.
If you experience a severe allergic reaction or hives, inform your doctor, hospital pharmacist, or nurse immediately.
Other side effects that may occur in patients who require this type of therapy include those related to the conditions for which they are being treated, such as rapid or
irregular heartbeat, low blood pressure, shock, or cardiac arrest.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor, hospital pharmacist, or nurse. You can also report side effects
directly through the national reporting system as detailed in Annex V * .
By reporting side effects, you can help provide more information on the safety
of this medicine.

5. How to store Integrilin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (Exp.) stated on the packaging and on the
vial. The expiry date refers to the last day of the month.
Store in a refrigerator (2°C - 8°C).
Keep the vial in the outer packaging to protect it from light. Nevertheless, it is
not necessary to protect the solution from light during administration.
Before use, the contents of the vial must be visually inspected.
Do not use Integrilin if you notice particulate matter or discoloration of the solution.
Any unused content after opening must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Integrilin contains

• The active substance is eptifibatide. Each ml of solution for infusion contains 0.75 mg of eptifibatide. One 100 ml vial of solution for infusion contains 75 mg of eptifibatide.
• The other ingredients are citric acid monohydrate, sodium hydroxide and water for injections.

Description of the appearance of Integrilin and contents of the pack
Integrilin solution for infusion: 100 ml vial, pack of one vial.
The clear, colourless solution is contained in a 100 ml vial fitted with a butyl rubber stopper and an aluminium crimp seal.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
and Manufacturer:
GlaxoSmithKline (Ireland) Limited,
12 Riverwalk,
Citywest Business Campus,
Dublin 24,
Ireland
GlaxoSmithKline Manufacturing S.P.A.
Strada Provinciale Asolana No. 90
San Polo di Torrile 43056,
Parma
Italy
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder.

België/Belgique/Belgien
GlaxoSmithKline Pharmaceuticals s.a./n.v.
Tél/Tel: + 32 (0)10 85 52 00

Lietuva
GlaxoSmithKline Lietuva UAB
Tel: + 370 5 264 90 00
[email protected]

България
ГлаксоСмитКлайн ЕООД
Тел. + 359 2 953 10 34

Luxembourg/Luxemburg
GlaxoSmithKline Pharmaceuticals s.a./n.v.
Belgique/BelgienTél/Tel: + 32 (0) 10 85 52 00

Česká republika
GlaxoSmithKline s.r.o.
Tel: + 420 222 001 111
[email protected]

Magyarország
GlaxoSmithKline Kft.
Tel.: + 36 1 225 5300

Danmark
GlaxoSmithKline Pharma A/S
Tlf: + 45 36 35 91 00
[email protected]

Malta
GlaxoSmithKline (Malta) Limited
Tel: + 356 21 238131

Deutschland
GlaxoSmithKline GmbH & Co. KG
Tel.: + 49 (0)89 36044 8701
[email protected]

Nederland
GlaxoSmithKline BV
Tel: + 31 (0)33 2081100

Eesti
GlaxoSmithKline Eesti OÜ
Tel: + 372 6676 900
[email protected]

Norge
GlaxoSmithKline AS
Tlf: + 47 22 70 20 00

Ελλάδα
GlaxoSmithKline Μονοπρόσωπη A.E.B.E.
Τηλ: + 30 210 68 82 100

Österreich
GlaxoSmithKline Pharma GmbH
Tel: + 43 (0)1 97075 0
[email protected]

España
GlaxoSmithKline, S.A.
Tel: + 34 900 202 700
[email protected]

Polska
GSK Services Sp. z o.o.
Tel.: + 48 (0)22 576 9000

France
Laboratoire GlaxoSmithKline
Tél.: + 33 (0)1 39 17 84 44
[email protected]

Portugal
GlaxoSmithKline – Produtos Farmacêuticos, Lda
Tel: + 351 21 412 95 00
[email protected]

Hrvatska
GlaxoSmithKline d.o.o.
Tel: + 385 1 6051 999

România
GlaxoSmithKline (GSK) S.R.L.
Tel: + 4021 3028 208

Ireland
GlaxoSmithKline (Ireland) Limited
Tel: + 353 (0)1 4955000

Slovenija
GlaxoSmithKline d.o.o.
Tel: + 386 (0)1 280 25 00
[email protected]

Ísland
Vistor hf.
Sími: + 354 535 7000

Slovenská republika
GlaxoSmithKline Slovakia s. r. o.
Tel: + 421 (0)2 48 26 11 11
[email protected]

Italia
GlaxoSmithKline S.p.A.
Tel: + 39 (0)45 7741 111

Suomi/Finland
GlaxoSmithKline Oy
Puh/Tel: + 358 (0)10 30 30 30
[email protected]

Κύπρος
GlaxoSmithKline (Cyprus) Ltd
Τηλ: + 357 22 39 70 00
[email protected]

Sverige
GlaxoSmithKline AB
Tel: + 46 (0)8 638 93 00
[email protected]

Latvija
GlaxoSmithKline Latvia SIA
Tel: + 371 67312687
[email protected]

United Kingdom
GlaxoSmithKline UK Ltd
Tel: + 44 (0)800 221441
[email protected]

This leaflet was last updated on
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu

Integrilin 2 mg/ml injectable solution

eptifibatide

Read this leaflet carefully before you start to use the medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, hospital pharmacist or nurse.
• If any side effect occurs, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Integrilin and what is it used for

Integrilin is a platelet aggregation inhibitor, this means that it helps to prevent the
formation of blood clots.
It is used in adults with severe coronary insufficiency definable as spontaneous and recent chest pain
associated with electrocardiographic abnormalities or biological changes. It is usually
administered together with aspirin and unfractionated heparin.

2. What you need to know before you are given Integrilin

Integrilin must not be given to you:

• if you are allergic to eptifibatide or any of the other ingredients of this medicine (listed in section 6);
• if you have had a recent episode of bleeding from the stomach, intestine, spleen or other organs, for example if you have seen abnormal blood losses in your urine or stools (except for menstrual blood) in the last 30 days;
• if you have had a stroke in the last 30 days or any episode of hemorrhagic stroke (make sure your doctor is aware of this episode);
• if you have been affected by a brain tumor or diseases that can affect the blood vessels of the brain;
• if you have undergone major surgery or suffered serious injuries in the 6 weeks prior;
• if you have had or have bleeding problems;
• if you have had or have difficulty with blood clotting or a low platelet count;
• if you have suffered or are suffering from severe hypertension (high blood pressure);
• if you have suffered or are suffering from severe kidney or liver problems;
• if you have already been treated with a medicine of the same type as Integrilin.

If you have any of these conditions, tell your doctor. If you have any doubts, ask
your doctor or hospital pharmacist or nurse for advice.

Pay special attention to:

• Integrilin is recommended only in adult patients hospitalized in coronary care units.
• Integrilin is not indicated in children or adolescents under the age of 18 years.
• Before and during treatment with Integrilin, blood samples may be taken as a precautionary measure to limit the possibility of unexpected bleeding.
• During the use of Integrilin, you will be carefully monitored to check for any signs of unusual or unexpected bleeding.

Other medicines and Integrilin:
To avoid the possibility of interactions with other medicines, tell your doctor or hospital
pharmacist or nurse if you are taking, have recently taken or might take any other
medicines, including those available without a prescription. In particular:

• blood thinners (oral anticoagulants) or
• medicines that prevent the formation of blood clots such as warfarin, dipyridamole, ticlopidine, aspirin (except those administered as part of treatment with Integrilin).

Pregnancy and breastfeeding
Integrilin is generally not recommended for use during pregnancy.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor for advice. The doctor will assess the benefit of using Integrilin for
you during pregnancy compared to the risk to the baby.
If you are breastfeeding, breastfeeding must be stopped during the treatment period.

Integrilin contains sodium
This medicine contains 13.8 mg of sodium (the main component of table salt) in each
10 ml vial. This is equivalent to 0.69% of the maximum recommended daily intake of sodium
with the diet of an adult.

3. How to use Integrilin

Integrilin is injected into a vein by direct injection, followed by an infusion (drip solution).
The administered dose is based on body weight. The recommended dose is 180 micrograms/Kg
administered as a bolus (rapid intravenous injection), followed by an infusion (drip solution) of 2 micrograms/Kg/minute for up to 72 hours. In case of renal impairment, the infusion dose
must be reduced to 1 microgram/Kg/minute.
If percutaneous coronary intervention (PCI) is performed during therapy with Integrilin,
the intravenous infusion may be continued for up to 96 hours.
You will also be treated with aspirin and heparin (if not contraindicated in your case).
If you have any further questions about the use of this medicine, consult 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

May affect more than 1 in 10 people

• bleeding of minor or major intensity (for example, blood in the urine, blood in the stool, blood in the vomit, or bleeding following surgical procedures);
• anemia (reduced number of red blood cells in the blood)

Common side effects

May affect up to 1 in 10 people

• inflammation of a vein

Uncommon side effects

May affect up to 1 in 100 people

• reduction in the number of platelets (blood cells necessary for coagulation)
• reduced blood flow to the brain

Very rare side effects

May affect up to 1 in 10,000 people

• severe bleeding (for example, internal bleeding in the abdomen, brain, lung)
• fatal bleeding
• severe reduction in the number of platelets (blood cells necessary for coagulation)
• skin rash (such as hives)
• sudden and severe allergic reactions

If you notice any signs of bleeding, immediately inform your doctor or hospital pharmacist or nurse.
Very rarely, bleeding has had serious and even fatal consequences. Safety measures
to prevent these events include blood tests and careful monitoring by the
healthcare professionals caring for you.
If you develop a severe allergic reaction or hives, immediately inform your doctor or
hospital pharmacist or nurse.
Other side effects that may occur in patients who need this type of therapy,
include those related to the conditions for which they are being 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, hospital pharmacist or nurse. You can also report side effects
directly through the national reporting system as described in Annex V * .
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Integrilin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (Exp.) stated on the packaging and the
vial. The expiry date refers to the last day of the month.
Store in a refrigerator (2°C - 8°C).
Keep the vial in the outer packaging to protect it from light. However, it is not
necessary to protect the solution from light during administration.
Before use, the contents of the vial must be visually inspected.
Do not use Integrilin if particulate matter or signs of a change in the colour of the
solution are present.
Any unused solution after opening must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Integrilin contains

• The active ingredient is eptifibatide. Each ml of injectable solution contains 2 mg of eptifibatide. One 10 ml vial of solution for injection contains 20 mg of eptifibatide.
• The other ingredients are citric acid monohydrate, sodium hydroxide and water for injections.

Description of the appearance of Integrilin and package contents
Integrilin injectable solution: 10 ml vial, pack of one vial.
The clear, colourless solution is contained in a 10 ml vial fitted with a butyl rubber stopper
and an aluminium crimp seal.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
and Manufacturer:
GlaxoSmithKline (Ireland) Limited,
12 Riverwalk,
Citywest Business Campus,
Dublin 24,
Ireland
Glaxo Operations UK Ltd.
(Trading as Glaxo Wellcome Operations)
Harmire Road
Barnard Castle
Co. Durham,
DL12 8DT,
United Kingdom
GlaxoSmithKline Manufacturing S.p.A.
Strada Provinciale Asolana No. 90
San Polo di Torrile 43056,
Parma
Italy
For further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder.

België/Belgique/Belgien
GlaxoSmithKline Pharmaceuticals s.a./n.v.
Tél/Tel: + 32 (0) 10 85 52 00

Lietuva
GlaxoSmithKline Lietuva UAB
Tel: + 370 5 264 90 00
[email protected]

България
ГлаксоСмитКлайн ЕООД
Тел. + 359 2 953 10 34

Luxembourg/Luxemburg
GlaxoSmithKline Pharmaceuticals s.a./n.v.
Belgique/Belgien
Tél/Tel: + 32 (0) 10 85 52 00

Česká republika
GlaxoSmithKline s.r.o.
Tel: + 420 222 001 111
[email protected]

Magyarország
GlaxoSmithKline Kft.
Tel.: + 36 1 225 5300

Danmark
GlaxoSmithKline Pharma A/S
Tlf: + 45 36 35 91 00
[email protected]

Malta
GlaxoSmithKline (Malta) Limited
Tel: + 356 21 238131

Deutschland
GlaxoSmithKline GmbH & Co. KG
Tel.: + 49 (0)89 36044 8701
[email protected]

Nederland
GlaxoSmithKline BV
Tel: + 31 (0)33 2081100

Eesti
GlaxoSmithKline Eesti OÜ
Tel: + 372 6676 900
[email protected]

Norge
GlaxoSmithKline AS
Tlf: + 47 22 70 20 00

Ελλάδα
GlaxoSmithKline Μονοπρόσωπη A.E.B.E.
Τηλ: + 30 210 68 82 100

Österreich
GlaxoSmithKline Pharma GmbH
Tel: + 43 (0)1 97075 0
[email protected]

España
GlaxoSmithKline, S.A.
Tel: + 34 900 202 700
[email protected]

Polska
GSK Services Sp. z o.o.
Tel.: + 48 (0)22 576 9000

France
Laboratoire GlaxoSmithKline
Tél.: + 33 (0)1 39 17 84 44
[email protected]

Portugal
GlaxoSmithKline – Produtos Farmacêuticos, Lda
Tel: + 351 21 412 95 00

Hrvatska
GlaxoSmithKline d.o.o.
Tel: + 385 1 6051 999

România
GlaxoSmithKline (GSK) S.R.L.
Tel: + 4021 3028 208

Ireland
GlaxoSmithKline (Ireland) Limited
Tel: + 353 (0)1 4955000

Slovenija
GlaxoSmithKline d.o.o.
Tel: + 386 (0)1 280 25 00
[email protected]

ÍslandSlovenská republika
GlaxoSmithKline Slovakia s. r. o.
Tel: + 421 (0)2 48 26 11 11
[email protected]
Vistor hf.
Sími: + 354 535 7000

Italia
GlaxoSmithKline S.p.A.
Tel: + 39 (0)45 7741 111

Suomi/Finland
GlaxoSmithKline Oy
Puh/Tel: + 358 (0)10 30 30 30
[email protected]

Κύπρος
GlaxoSmithKline (Cyprus) Ltd
Τηλ: + 357 22 39 70 00
[email protected]

Sverige
GlaxoSmithKline AB
Tel: + 46 (0)8 638 93 00
[email protected]

Latvija
GlaxoSmithKline Latvia SIA
Tel: + 371 67312687
[email protected]

United Kingdom
GlaxoSmithKline UK Ltd
Tel: + 44 (0)800 221441
[email protected]

This leaflet was last updated on
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu