Correvio FR

Infusion solution 50 micrograms / ml 
(Clear colorless solution)

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

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

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Aggrastat is and what it is used for 
2. What you need to know before you use Aggrastat 
3. How to use Aggrastat 
4. Possible side effects 
5. How to store Aggrastat 
6. Contents of the packaging and other information 

1. What Aggrastat is and what it is used for

Aggrastat is used to facilitate the blood supply to the heart and helps prevent chest pain and heart attack. It works by preventing the formation of blood clots. This medicine can also be used by patients who have had dilation of the heart’s vessels by balloon rupture ( percutaneous coronary intervention, PCI). This procedure is usually performed with the help of an implant of a small tube to facilitate blood flow to the heart.

Aggrastat is intended for use with acetylsalicylic acid and unfractionated heparin.

2. What you need to know before using Aggrastat

Do not use Aggrastat

  • if you are allergic (hypersensitive) to tirofiban or to any of the other ingredients of Aggrastat ( listed in section 6 “Content declaration”).
  • if you are currently having internal bleeding or if you have had internal bleeding within the last 30 days.
  • if you have a history of a cerebral hemorrhage, brain tumor, or abnormal blood vessels in the brain.
  • if you have uncontrolled, severe hypertension ( malignant hypertension )
  • if you have low platelet counts ( thrombocytopenia ) or problems with your blood’s ability to coagulate.
  • if you have used Aggrastat or any other similar medicine and have developed thrombocytopenia in the past.
  • if you have had a stroke within the last 30 days or a stroke that involved bleeding in the past.
  • if you have been seriously injured or undergone major surgery within the last 6 weeks.
  • if you have severe liver disease. Your doctor will review your medical history to determine if you are at increased risk of any side effects associated with this medicine.

Warnings and cautions

Talk to your doctor before using Aggrastat if you have or have had:

  • some medical problems
  • any allergies you
  • have undergone cardiopulmonary resuscitation, had tissue samples were taken ( biopsy), or if you have had surgery or another procedure for kidney stones within the last two weeks.
  • seriously injured or undergone major surgery in the last 3 months.
  • gastric or intestinal ulcers during the last 3 months
  • bleeding in the stomach or intestines, or blood in urine or feces recently (within 1 year)
  • recently underwent spinal cord surgery
  • have had or have symptoms of cracking in the carotid artery
  • uncontrolled high blood pressure ( hypertension )
  • inflammation of the pericardium (pericarditis)
  • inflammation of the blood vessels ( vasculitis )
  • problems with the blood vessels in the back of the eyes (retina)
  • treated with drugs that prevent or dissolve blood clots
  • kidney problems
  • a special intravenous entry into the collarbone during the last 24 hours
  • heart failure
  • very low blood pressure due to heart failure
  • liver disease
  • low blood cell counts or anemia

Other medicines and Aggrastat

Aggrastat can generally be used with other medicines. Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription, as some medicines may affect each other. It is especially important to tell your doctor if you are taking other medicines that prevent the blood from clotting, such as warfarin.

Aggrastat with food and drink

Intake of food and drink does not affect this medicine.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

Due to your medical condition, you should not drive or use machines while using Aggrastat.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Aggrastat contains sodium

This medicine contains approximately 917 mg sodium per 250 ml of infusion bag. This should be considered by patients on a low-salt diet.

3. How to use Aggrastat

Aggrastat should be prescribed by a qualified doctor who has experience in treating heart attacks.

You have been given, or will be given, Aggrastat intravenously. Your doctor will decide on the appropriate dose, based on your general condition and your weight.

Use for children

Use in children is not recommended.

If you forget to use Aggrastat

Your doctor will decide when a dose should be given.

If you stop using Aggrastat

Your doctor will decide when to stop treatment. However, if you want to end treatment earlier, you should discuss other options with your doctor.

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

4. Possible side effects

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

Bleeding is the most common side effect during treatment with Aggrastat and can occur throughout the body. This can be serious, and in rare cases lead to a fatal outcome.

If side effects occur, medical attention may be needed. If you get any of the following symptoms while using Aggrastat, contact your doctor immediately:

  • signs of bleeding in the skull, such as pain in the head, impaired vision or hearing, speech difficulties, numbness or movement, or balance problems.
  • signs of internal bleeding such as coughing up blood or blood in urine or feces
  • signs of a severe allergic reaction such as breathing problems or dizziness.
    The following is a list of side effects that have occurred in some patients after treatment with Aggrastat. The side effects are listed by descending frequency:
    Very common (may affect more than 1 user in 10)
  • Bleeding after surgery
  • Bleeding under the skin at the injection site, or in a muscle causes swelling.
  • Small red bruises
  • Invisible blood in urine or feces
  • Feeling sick
  • Headache
    Common (may affect up to 1 in 10 people)
  • Blood in the urine
  • Blood in vomit
  • Nasal blood
  • Bleeding in the gums and mouth
  • Bleeding from a punctured vessel
  • Decreased red blood cell count (decreased hematocrit and hemoglobin )
  • Reduced platelet count, below 90,000 / mm 3
  • Fever
    Uncommon (may affect up to 1 in 100 people )
  • Bleeding in the stomach or intestines
  • Bloody vomiting
  • Decreased platelet count, below 50,000 / mm 3
    Has been reported (occurs in an unknown number of users)
  • Bleeding in the skull
  • Local hemorrhage (hematoma) that presses on the spinal cord
  • Bleeding in internal organs of the abdomen
  • Pulmonary hemorrhage
  • Acute and/or sharp decrease in the number of platelets, below 20,000 / mm 3
  • Severe allergic reaction with a feeling of pressure over the chest, rash or hives, as well as reactions that cause difficulty breathing and dizziness.

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Aggrastat

Your doctor and pharmacist know how to store and take care of Aggrastat after use.

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 bag after EXP.

The expiration date is the last day of the specified month.

Do not freeze.

Store in the original package (250 ml infusion bag in foil bag). Sensitive to light.

Do not use this medicine if you notice that there are visible particles or that the solution is discolored before use.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is tirofiban.

1 ml solution for infusion contains 56 micrograms tirofiban hydrochloride monohydrate, equivalent to 50 micrograms tirofiban.

The other ingredients are Sodium chloride, sodium citrate dihydrate, anhydrous citric acid, water for injections, hydrochloric acid, and/or sodium hydroxide (for adjustment ).

What the medicine looks like and the contents of the pack

Aggrastat is a clear, colorless solution available as follows:

250 ml Freeflex® infusion bag  (not PVC plastic), colorless, multilayer polyolefin film with polyolefin sealed bag with an injection port. It is packed in a pre-printed foil bag.

Pack sizes: 1 or 3 infusion bags of 250 ml solution for infusion. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Correvio

15 rue du Bicentenaire

92800 Puteaux

France

Manufacturer

Arvato Distribution GmbH,

Gottlieb Daimler Straße 1,

33428 Harsewinkel,

Germany

This leaflet was last modified on 27 May 2019

Other sources of information

The following information is intended for healthcare professionals only:

This product is only intended for use in hospitals by specialists accustomed to treating acute heart disease.

Aggrastate should be co-administered with unfractionated heparin and oral platelet aggregation inhibitors, including acetylsalicylic acid (ASA).

Dosage and route of administration

In patients treated with an early invasive strategy for NSTE-ACS but who are not expected to undergo angiography for at least 4 hours and up to 48 hours after diagnosis, Aggrastat is given intravenously at an initial infusion rate of 0.4 micrograms/kg/min for 30 minutes. . After the initial infusion, treatment with Aggrastat should be continued with a maintenance infusion at a rate of 0.1 micrograms/kg/min. Aggrastat should be given with unfractionated heparin(usually an intravenous bolus dose)of 50-60 units (E) / kg at the start of treatment with Aggrastat and thereafter approximately 1,000 U / h titrated based on the activated partial thromboplastin time (APT time), which should be approximately twice the normal value, and oral treatment with platelet aggregation inhibitors, including but not exclusively ASA unless contraindicated.

In NSTE-ACS patients scheduled to be treated with PCI within 4 hours of diagnosis or in patients with acute myocardial infarction scheduled for primary PCI, Aggrastat should be administered with an initial bolus dose of 25 micrograms/kg administered over 3 minutes followed by a maintenance infusion of 0, 15 micrograms/kg/min for 12-24 hours and up to 48 hours.

Aggrastat should be given in combination with unfractionated heparin ( dosing as above) and oral platelet aggregation inhibitors, including but not limited to ASA unless contraindicated.

No dose adjustment is required for the elderly.

Patients with severe renal failure

In severe renal failure ( creatinine clearance <30 mL/min), Aggrastat dose a is reduced by

50%.

Pediatric population

The safety and efficacy of Aggrastat in children have not been established.

No data are available.

Start and treatment time with Aggrastat

In patients treated with an early invasive strategy for NSTE-ACS but who are not expected to undergo angiography for at least 4 hours and up to 48 hours after diagnosis, Aggrastat should be administered intravenously at an initial infusion rate of 0.4 micrograms/kg/min after diagnosis. . The recommended time for the maintenance dose is at least 48 hours. Infusion of Aggrastat and unfractionated heparin may continue during coronary angiography and should be maintained for at least 12 hours, but not more than 24 hours after angioplasty/atherectomy. When a patient is clinically stable and no coronary surgery is planned by the treating physician, the infusion should be given one is interrupted. The total treatment time should not exceed 108 hours.

If a patient who has been diagnosed with NSTE-ACS and treated with an invasive approach then undergoes angiography within 4 hours of diagnosis, Aggrastat should be given with a bolus dose of 25 micrograms/kg intravenously at the start of PCI with continuous infusion for 12-24 hours and up to 48 hours. In patients with acute myocardial infarction planned for primary PCI, the bolus infusion should be started as soon as possible after diagnosis.

Concomitant treatment (unfractionated heparin, oral antithrombocyte aggregation inhibitors, including ASA)

Treatment with unfractionated heparin begins with an intravenous bolus dose of 50-60 U / kg and then continues with a maintenance dose of 1,000 U per hour. The heparin dose is titrated to maintain an APT time of approximately twice the normal value.

If not contraindicated, all patients should receive treatment with oral platelet aggregation inhibitors before starting treatment with Aggrastat. This medication should be continued at least as long as the infusion of Aggrastat is ongoing.

Most studies examining the administration of Aggrastat as an adjuvant to PCI have used ASA in combination with clopidogrel as an oral platelet aggregation inhibitor. The efficacy of Aggrastat in combination with either prasugrel or ticagrelor has not been established in randomized controlled trials. 

If angioplasty (PCI) is required, heparin delivery should be discontinued after PCI and the catheter should be removed as soon as coagulation has returned to normal, ie when activated clotting time (ACT) is less than 180 seconds (usually 2-6 hours after heparin release ).

Incompatibilities

Incompatibility has been observed with diazepam. Therefore, Aggrastat and diazepam should not be administered via the same intravenous line.

No incompatibilities have been observed with Aggrastat and the following intravenous preparations: atropine sulfate, dobutamine, dopamine, adrenaline hydrochloride, furosemide, heparin, lidocaine, midazolam hydrochloride, morphine sulfate, glyceryl trinitrate, potassium chloride, propranolol hydrochloride, and injection.

Instructions for handling

Check the expiration date.

Do not draw the solution directly from the infusion bag with a syringe.

To open: Pull the notch in the dustproof foil or plastic bag (250 ml solution for infusion ) and remove the infusion bag. Check for leaks by squeezing the bag tightly. If leakage is detected, the solution should be discarded as sterility may have been compromised.

Do not use unless the solution is clear and the seal is intact.

Do not add additional medicines or draw solution directly from the infusion bag with a syringe.

NOTE: Do not connect in series. Such use may result in air embolism due to residual air from an emptied bag being drawn in by liquid from another bag.

Preparation for delivery

1. Identify the blue infusion port.
2. Break off the blue warranty sealed port cover from the Freeflex® infusion port. The membrane under the protection is sterile – disinfection of the membrane is not necessary!
3. Close the roller clamp. Slide the tip into the door until the blue plastic ring comes in contact with the shaft of the tip. Use a non-ventilated unit or close the vent valve.

4. Hang the bag in the infusion stand. Press the drip chamber to get the liquid level. Fill the infusion line and prime it free of air bubbles. Connect and adjust the flow rate.

Used according to the dose calculation given below.

The following table can be used as a guide for dose adjustment based on body weight:


0.4 micrograms / kg / min Dose adjustmentMost patients 0.4 micrograms / kg / min Dose adjustmentSevere renal failure 25 micrograms/kg bolus adjustment most patients 25 micrograms / kg bolus adjustmentSevere renal failure
Bodyweight (kg) 30 minute initialinfusion rate (ml / hour) Infusion rate during maintenance treatment 
(ml / hour)
30 minute initial infusion rate 
(ml / hour)
Infusion rate during maintenance treatment 
(ml / hour)
Bolus(ml) Infusion rate during maintenance treatment 
(ml / hour)
Bolus(ml) Infusion rate during maintenance treatment 
(ml / hour)
30-37 16 4 8 2 17 6 8 3
38-45 20 5 10 3 21 7 10 4
46-54 24 6 12 3 25 9 13 5
55-62 28 7 14 4 29 11 15 5
63-70 32 8 16 4 33 12 17 6
71-79 36 9 18 5 38 14 19 7
80-87 40 10 20 5 42 15 21 8
88-95 44 11 22 6 46 16 23 8
96-104 48 12 24 6 50 18 25 9
105-112 52 13 26 7 54 20 27 10
113-120 56 14 28 7 58 21 29 10
121-128 60 15 30 8 62 22 31 11
129-137 64 16 32 8 67 24 33 12
138-145 68 17 34 9 71 25 35 13
146-153 72 18 36 9 75 27 37 13
  • When the solution and packaging allow, parenteral drugs should be inspected for visible particles and discoloration before use.
  • Aggrastat should only be given intravenously and can be given through the same infusion needle as unfractionated heparin.
  • It is recommended that Aggrastat be given with a calibrated infusion set and with sterile equipment.
  • It is important to ensure that the infusion of the initial dose is not prolonged and that incorrect calculations of the infusion rate for the maintenance dose based on the patient’s weight are avoided.

Special storage instructions

Do not use this medicine after the expiry date which is stated on the label and outer carton after EXP. The expiration date is the last day of the specified month.

Do not freeze.

What the medicine looks like and the contents of the pack

Aggrastat is a clear, colorless solution available as follows:

250 ml Freeflex® TM (not PVC plastic), colorless, 3-layer polyolefin film with polyolefin sealed bag with an injection port. It is packed in a pre-printed foil bag.

Pack sizes: 1 or 3 infusion bags of 250 ml solution for infusion. Not all pack sizes may be available.

Special instructions for destruction and handling

Any unused product or waste material should be disposed of in accordance with local requirements.

Muhammad Nadeem

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