0.75 mg / ml solution for infusion
eptifibatide
1. What Eptifibatide Accord is and what it is used for
Eptifibatide Accord is a platelet aggregation inhibitor. This means that it helps to prevent the platelets from clotting.
It is used in adults with signs of severe heart failure defined as spontaneous and recently experienced chest pain with ECG changes or biological changes. It is usually given together with acetylsalicylic acid and unfractionated heparin.
2. What you need to know before using 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 the stomach, intestines, bladder, or other organs, for example, if you have seen abnormal co-bleeding in the stool or urine (except menstrual bleeding) in the last 30 days
- if you have had a stroke in the last 30 days or some form of cerebral hemorrhage (also make sure your doctor knows if you have ever had a stroke)
- if you have had a brain tumor or any disease that affects the blood vessels in the brain
- if you have undergone major surgery or suffered a serious injury in the last 6 weeks
- if you have or have had bleeding problems
- if you have or have had coagulation disorders or a low 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.
Tell your doctor if you have had any of these conditions. If you have any further questions, ask your doctor, hospital pharmacist, or nurse.
Warnings and cautions
- Eptifibatide Accord is only recommended for use in adult inpatients in cardiology departments.
- Eptifibatide Accord is not intended for use in children or adolescents below 18 years.
- Before and during treatment with Eptifibatide Accord, blood tests will be taken as a precautionary measure to limit the risk of unexpected bleeding.
- When you receive Eptifibatide Accord, you will be closely monitored for signs of unusual or unexpected bleeding.
Talk to your doctor, hospital pharmacist, or nurse before using Eptifibatide Accord.
Other medicines and Eptifibatide Accord
To avoid the risk of interacting with other medicines, tell your doctor, hospital pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. Particularly:
- blood thinners (oral anticoagulants ) or
- medicines that prevent the blood from clotting, including warfarin, dipyridamole, ticlopidine, acetylsalicylic acid (except for those that you may receive as part of the Eptifibatide Accord treatment).
Pregnancy, breastfeeding, and fertility
Eptifibatide Accord is not usually recommended for use during pregnancy. Tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby. Your doctor will weigh the benefits for you against the risks to your baby when using Eptifibatide Accord during your pregnancy.
If you are breast-feeding, you should stop breastfeeding during the treatment period.
3. How to use Eptifibatide Accord
Eptifibatide Accord is given into a vein by direct injection followed by an infusion(drip solution). Dose one is calculated according to your body weight. The recommended dose is 180 micrograms/kg given as a bolus (rapid intravenous injection ), followed by an infusion (drip solution) of 2 micrograms/kg/minute for up to 72 hours. If you have any kidney disease, the dose may be reduced to 1 microgram/kg/minute.
If catheterization (PCI) procedures are performed during treatment with Eptifibatide Accord, the intravenous solution may be given for up to 96 hours.
You must also receive acetylsalicylic acid and heparin (unless contraindicated in your case).
If you have any further questions on the use of this product, ask your doctor, hospital pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
A very common side effect
Occurs in more than 1 in 10 individuals
- minor or major bleeding (eg blood in the urine, blood in the stool, blood in connection with vomiting or bleeding in connection with surgery)
- anemia (decreased number of red blood cells ).
Common side effect
Occurs in up to 1 in 10 individuals
- inflammation of blood vessels.
Uncommon side effect
Occurs in up to 1 in 100 individuals
- decreased platelet count ( blood cells needed for blood coagulation)
- reduced blood supply to the brain.
A very rare side effect
Occurs in up to 1 in 10,000 individuals
- severe bleeding (eg bleeding inside the abdomen, brain, or lungs)
- bleeding leading to death
- a sharp decrease in the number of platelets ( blood cells needed for blood coagulation)
- skin rash ( hives )
- sudden severe allergic reaction.
If you notice any signs of bleeding, contact your doctor, hospital pharmacist, or nurse immediately. In very rare cases, bleeding has become severe and even fatal. Precautions to prevent this from happening to include blood tests and close checks performed by the healthcare professional who cares for you.
If you get a severe allergic reaction or hives, contact your doctor, hospital pharmacist, or nurse immediately.
Other side effects that may occur in patients who require this type of treatment include those associated with the disease you are being treated for, such as rapid or irregular heartbeat, low blood pressure, shock, or cardiac arrest.
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 vial after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C).
Store the infusion bottle in the outer carton. Sensitive to light. However, the Eptifibatide Accord solution does not need to be protected from light during administration
The contents of the bottle should be checked before use.
Do not use this medicine if the solution contains particles or is discolored.
Any remaining medicine in the bottle should be discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your hospital pharmacist or 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 eptifibatide.Eptifibatide Accord 0.75 mg / ml: Each ml of solution for infusion contains 0.75 mg of eptifibatide. One 100 ml vial contains 75 mg of eptifibatide.
- The other ingredients are citric acid monohydrate, sodium hydroxide, and water for injections.
What the medicine looks like and the 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, colorless liquid is supplied in a 100 ml glass infusion bottle, which is closed with a butyl rubber stopper and sealed with a removable aluminum closure.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Accord Healthcare SLU
World Trade Center, Moll de Barcelona, s / n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain
Manufacturer:
Accord Healthcare Limited
Sage House
319, Pinner Road, Harrow
Middlesex HA1 4HF
UK
Wessling Hungary Kft
Foot out 56, Budapest 1047,
Hungary
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland