250 mg powder for concentrate for solution for injection / infusion
bivalirudin
1. What Bivalirudin Reig Jofre is and what it is used for
Bivalirudin Reig Jofre containing the substance bivalirudin, which is an anti-thrombosis. Anti- thrombosis is a drug that prevents the formation of blood clots ( thrombosis ).
Bivalirudin Reig Jofre is used in patients:
- with chest pain due to. heart disease ( acute coronary syndrome – AKS)
- undergoing surgery to treat narrowed blood vessels (vascular surgery and/or percutaneous coronary intervention – PCI).
Bivalirudin contained in Bivalirudin Reig Jofre may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.
What you need to know before you use Bivalirudin Reig Jofre
Do not use Bivalirudin Reig Jofre
- if you are allergic to bivalirudin or any of the other ingredients of this medicine (listed in section 6) or hirudins (other blood thinners).
- if you have or have recently had, bleeding from the stomach, intestines, bladderor other organs, for example, if you have seen abnormal blood in the stool or urine (with the exception of menstrual bleeding).
- if you have or have had, problems with blood coagulation (low platelet count ).
- if you have high blood pressure.
- if you have a heart infection.
- if you have severe kidney problems or if you need kidney dialysis.
Talk to your doctor if you are unsure.
Warnings and cautions
Talk to your doctor before using Bivalirudin Reig Jofre.
- if bleeding occurs (if this occurs, treatment with Bivalirudin Reig Jofre will be stopped). Your doctor will monitor you throughout the treatment period to detect any signs of bleeding.
- if you have previously been treated with medicines similar to Bivalirudin Reig Jofre (eg lepirudin).
- Before starting an injection or infusion, your doctor will inform you of any signs of an allergic reaction. Such a reaction is less common (affects 1 to 10 users in 1,000).
- if you are receiving radiation therapy in the blood vessel that supplies the heart with blood (a procedure called beta or gamma brachytherapy).
If you have been treated with Bivalirudin Reig Jofre after a cardiac event, you should stay in the hospital for at least 24 hours. There, you should be monitored for symptoms or signs that remind you of the symptoms you experienced during the cardiac event that resulted in you being hospitalized.
Children and young people
- if you are a child (under 18 years) this medicine is not suitable for you.
Other medicines and Bivalirudin Reig Jofre
Tell a doctor
- if you are taking, have recently taken, or might take any other medicines.
- if you are taking blood thinners or medicines that prevent blood clots (anticoagulants or antithrombotic agents, such as warfarin, dabigatran, apixaban, rivaroxaban, acetylsalicylic acid, clopidogrel, prasugrel, ticagrelor).
These drugs can increase the risk of side effects such as bleeding when given concomitantly with Bivalirudin Reig Jofre. The results of blood tests taken during warfarin treatment (INR test) may be affected by Bivalirudin Reig Jofre.
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 using this medicine.
Bivalirudin Reig Jofre should not be used during pregnancy unless it is very important that you get it. Your doctor will decide if the treatment is right for you or not. If you are breast-feeding, your doctor will decide if you should receive Bivalirudin Reig Jofre.
Driving and using machines
The effect of this drug is short-lived. Bivalirudin Reig Jofre is only given to patients in hospitals. It is therefore unlikely that your ability to drive or use machines will be affected.
Bivalirudin Reig Jofre contains sodium
Bivalirudin Reig Jofre contains less than 23 mg sodium per vial and can therefore be considered “sodium-free”.
How to use Bivalirudin Reig Jofre
Your treatment with Bivalirudin Reig Jofre will be carried out by a doctor. Your doctor will decide how much Bivalirudin Reig Jofre to take, and prepare the medicine.
The dose one is given depends on your body weight and the type of treatment you are receiving.
Dosage
For patients with acute coronary syndrome (ACS) who are receiving medical treatment, the recommended starting dose is:
- 0.1 mg/kg body weight as an intravenous injection accompanied by an infusion(“drip”) into a vein at 0.25 mg / kg body weight per hour for up to 72 hours.
If you subsequently need to undergo percutaneous coronary intervention therapy, dose one will be increased to:
- 0.5 mg/kg body weight as an intravenous injection, followed by an intravenous infusion of 1.75 mg/kg body weight per hour for at least the duration of PCI. This intravenous infusion can be continued for up to 4 hours.
- At the end of this treatment, you may return to an infusion of 0.25 mg/kg body weight per hour.
If you need to have a bypass operation on the coronary arteries, treatment with bivalirudin will either be stopped one hour before the operation or an additional dose of 0.5 mg/kg body weight will be given as an injection followed by an infusionof 1.75 mg/kg body weight per hour…
For patients starting percutaneous coronary intervention (PCI) , the recommended dose is:
- 0.75 mg/kg body weight as an injection immediately followed by an infusion of 1.75 mg/kg body weight per hour (the intravenous infusion can be continued for up to 4 hours).
If you have kidney problems, the dose of Bivalirudin Reig Jofre may need to be reduced.
In the elderly, the dose may need to be reduced if renal function is impaired.
Your doctor will decide how long you should be treated.
Bivalirudin Reig Jofre is given as an injection followed by an infusion (drip) into a vein (never into a muscle). This is performed and supervised by a physician experienced in the management of patients with heart disease.
If you take more Bivalirudin Reig Jofre than you should
Your doctor will take appropriate action, including stopping treatment with the medicine and monitoring you closely for signs of harmful effects.
If you have any further questions on the use of this product, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them. If you get any of the following side effects (which may be serious):
- while in hospital: tell your doctor or nurse immediately
- after leaving the hospital: contact your doctor immediately or go to the emergency department of the nearest hospital immediately
The most common ( affects less than 1 user in 10) , the most serious side effect with Bivalirudin Reig Jofre is major bleeding which may occur inside the body (eg stomach, digestive system (including blood in vomit or feces), abdomen, lungs, groin, bladder, heart, eyes, ear, nose or brain). They can rarely result in stroke or be fatal. Swollen groin or arm, or pain in the groin or arm, back pain, bruising, headache, blood in the cough, pink or red urine, sweating, feeling dizzy, nausea or dizziness due to low blood pressuremay be a sign of internal bleeding. Bleeding is more likely to occur when Bivalirudin Reig Jofre is used in combination with other anticoagulants or antithrombotic agents (see section 2 “Taking other medicines”).
- Bleeding and bruising at the injection site (after PCI) can be painful. In rare cases, surgery may be needed to repair the blood vessel in the groin ( fistula, pseudoaneurysm) (occurs in less than 1 in 1,000 users). A less common side effect(affects less than 1 user in 100) is a low platelet count, which may make bleeding worse. Bleeding in the gums (less common, occurs in less than 1 in 100 users) is usually not serious.
- Allergic reactions are less common (affects less than 1 in 100 people) and are usually not serious but can in some cases be serious and in rare cases fatal due to low blood pressure ( shock ). They can start with limited symptoms such as itching, redness, rash, or small lumps on the skin. Sometimes the reactions can be more severe with itching in the throat, feeling of tightness in the throat, swollen tongue, swollen face or swollen eyes or lips, wheezing, difficulty breathing or exhaling (wheezing).
- Thrombosis (blood clot) is a less common side effect (affects less than 1 in 100 people) that can lead to serious or fatal complications such as heart attack. Thrombosis includes arterial thrombosis (blood clots in the coronary artery s or in a stent that feel like a heart attack and can even be fatal) and / or thrombosis in the catheter, both of which are rare (less than 1 of 1 000).
If you get any of the following side effects (which may be less serious):
- while in hospital: tell your doctor or nurse immediately
- after leaving the hospital: first, consult your doctor. If you cannot reach your doctor, go to the emergency department of the nearest hospital immediately
Very common side effects (affects more than 1 user in 10):
- Minor bleeding
Common side effects (affects less than 1 user in 10):
- Anemia (low blood cell count )
- Hematoma (bruising)
Uncommon side effects (affects less than 1 user in 100):
- nausea and / or vomiting
Rare side effects (affects less than 1 user in 1,000):
- INR tests (results from blood tests taken during warfarin treatment) increased (see section 2, Other medicines and Bivalirudin Reig Jofre)
- Angina or chest pain
- Slow heartbeat
- Fast heartbeat
- Respiratory distress
- Reperfusion injury (no or slow reflow): impaired flow in the coronary artery ‘s when they have been reopened
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 Bivalirudin Reig Jofre
Because Bivalirudin Reig Jofre is a drug that is only administered in hospitals, healthcare professionals are responsible for storing Bivalirudin Reig Jofre.
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 the carton after “EXP”. The expiration date is the last day of the specified month.
Freeze-dried powder: No special storage instructions.
Prepared concentrate: Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8 ° C. Store in a refrigerator (2-8 ° C). Do not freeze.
Diluted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 25 ° C. Do not store above 25 ° C. Do not freeze.
From a microbiological perspective, the product should be used immediately, unless opening/preparation / dilution has taken place in a way that eliminates the risk of microbial contamination. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
The solution should be a clear or slightly opalescent, colorless to pale yellow solution. The doctor will inspect the solution and discard it if it contains particles or is discolored.
6. Contents of the packaging and other information
Content declaration
- The active substance is bivalirudin.
- Each bottle contains 250 mg of bivalirudin.
- 1 ml of reconstituted concentrate (5 ml of water for injections added to the vial to dissolve the powder) contains 50 mg of bivalirudin.
- After further dilution (mix 5 ml of the diluted solution in the infusion bag [50 ml total volume] with glucose solution or sodium chloride solution), 1 ml contains 5 mg of bivalirudin.
The other ingredients are mannitol and sodium hydroxide (for pH adjustment ).
What the medicine looks like and contents of the pack
Bivalirudin Reig Jofre is a powder for concentrate for solution for injection or infusion (powder for concentrate).
Bivalirudin Reig Jofre is a white to off-white powder in a glass vial.
Bivalirudin Reig Jofre is supplied in packs containing 2 or 10 vials.
Marketing Authorization Holder and Manufacturer
Laboratory Reig Jofre, SA
Grand Captain 10
08970 Sant Joan Despí- Barcelona
Spain
Local representative
Bioglan AB
Box 50310
202 13 Malmö
This medicinal product is authorized under the European Economic Area under the names:
| DK, FI, IS, NO, SE, UK | Bivalirudin Reig Jofre |
| ES | Bivalirudina Sala |