ReoPro 2 mg. / Ml. 5 ml.

What is ReoPro is and what it is used
What is ReoPro?
The active ingredient, abciximab, is the "murine monoclonal antibody". Monoclonal antibodies are proteins that recognize and bind to other unique proteins. ReoPro belongs to a group of medicines known as antithrombotics and binds to proteins in your blood to help prevent blood clotting.

What is ReoPro?
ReoPro is used when you undergo an operation known as angioplasty (see "What is angioplasty operation?" Below) for the following purposes.
ReoPro is used (together with heparin and acetylsalicylic acid) to prevent the formation of blood clots in the heart during or after surgery - angioplasty;
ReoPro is also used (together with heparin and acetylsalicylic acid) to lower short-term risk of a heart attack before surgery - angioplasty, which is scheduled to take place in the next one month. This is for patients with chest pain due to poor blood supply to the heart (unstable angina), and do not meet the usual treatment.
What kind of surgery is angioplasty?
Operation - angioplasty aims to open a blocked artery on all sides of the heart. Doctor will carefully guide a special instrument through an artery (which is usually in the groin) to reduce or remove the blockage.

There are three types of operations - angioplasty where ReoPro can be used:
Using an inflatable balloon to cram an artery blockage (balloon angioplasty);
Use of device crowbar to open a blocked artery (atherectomy);
Inserting an expandable metal Shia to maintain the artery open (stent).

2. What you should know before using ReoPro
Do not use ReoPro:
Your doctor will review the history of your disease to see if you have an increased risk of any adverse effects associated with the administration of ReoPro.

To prevent risks of increased bleeding ReoPro should not be applied:
if you have internal bleeding;
if you had a stroke within the last 2 years;
if you have had surgery of the head, spine (or injury) or other major surgery within the last 2 months;
if you have a brain tumor;
If you have severe bleeding problems or have a low amount of platelets in the blood;
if you have untreated high blood pressure;
if you have an unusual bulge in one of the blood vessels (aneurysm);
if you have serious problems with your liver;
if you are on dialysis due to kidney failure.
ReoPro should not be given if you are allergic (hypersensitive):
to abciximab, to any of the other ingredients of ReoPro or to a group of medicines known as 'murine monoclonal antibodies';
to a protein called papain (or to the fruit of the papaya, containing papain). Papain is used in the production of ReoPro and very small amounts may be present.
If you think you fall into one of the categories described above, it is important to discuss it with your doctor. ReoPro should not be applied in these situations.

Warnings and Precautions
Talk to your doctor before using ReoPro:
if you are taking blood-thinning medicines or other drugs that affect coagulation or blood platelet (see. section "Taking other medicines");
if you have previously received ReoPro, as this may be associated with a higher risk for the reduction of blood platelets or allergic (hypersensitivity) reactions;
If you have severe kidney problems, since this may put you at risk of increased bleeding. In this case, your doctor may monitor your blood frequently;
if you are aged over 65 years (see. point "Adults over the age of 65 years").
If you think you fall into one of the categories described above, it is important to discuss it with your doctor.

Adults over 65 years of age
In patients who are aged 65 years ReoPro should be used with caution because of the risk of increased bleeding.

Other medicines and ReoPro
Please tell your doctor if you are taking blood-thinning medicines or other drugs that affect blood clotting ('anticoagulants') or platelets in the blood ("antiplatelet"). It is especially important to inform your doctor if you are taking 'thrombolytic' medicines to unclog your arteries. Administered with these drugs ReoPro may put you at risk of increased bleeding.
Tell your doctor if you are taking, have recently taken or might take any other medicines.

Pregnancy and lactation
ReoPro should not be used during pregnancy unless clearly necessary, since the effect of ReoPro on the pregnant woman and the unborn child is not known.
Breast-feeding should be discontinued before treatment with ReoPro, since it is not known whether ReoPro is secreted in human milk.

3. How to use ReoPro
Your nurse or doctor will inject ReoPro liquid from a syringe into one of your veins. This is known as a "bolus".
After the injection your nurse, doctor or pharmacist will give diluted ReoPro liquid into a bag connected via a tube with a needle that is inserted into one of your veins. This is known as "drip intravenous infusion" or "infusion".

Depending on your condition ReoPro will be applied as follows:
If you have an operation - angioplasty, your doctor will give you the bolus injection 10 to 60 minutes before the start of treatment. After bolus injection, your doctor will start the infusion. The infusion will continue for 12 hours after completion of the operation;
If you have unstable angina (chest pain due to poor blood supply to the heart) and are scheduled for surgery - angioplasty, your doctor will give you the bolus injection up to 24 hours before the planned operation. After bolus injection, your doctor will start the infusion. The infusion will continue for 12 hours after completion of surgery.
Dosage
Your doctor will calculate the dose of ReoPro, which will be administered as follows:
Dose bolus injection will be determined based on your body weight. The dose is 0,25 mg per kg of body weight;
Dose intravenous infusion will be determined based on your body weight. The dose is 0,125 micrograms per kilogram per minute to a maximum of 10 micrograms per minute.
After the operation,
After surgery - Angioplasty Your doctor or nurse will gently press on the artery bandage to stop the bleeding. The patient is complete bed rest and leg, which is made angioplasty must remain in an upright position for at least 6 to 8 hours. You will be also closely monitored by your doctor and nurse and your blood pressure and pulse will be measured several times. Routine blood tests will also be carried out to control the number of your blood cells.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although everybody gets them. Cases of fatal bleeding have been reported rarely.

Please tell your doctor immediately if you notice any of these side effects, as it will need to take immediate action and suspend your treatment:
Common (may affect up to 1 in 10 people):
Bleeding from the stomach or intestines. Signs include vomiting blood, blood in the stool or black stools.
Uncommon (may affect up to 1 in 100 people):
Bleeding in the skull. Signs may be pain in the head; difficulties in speech, sight or hearing; numbness or loss of feeling; mobility problems or problems with balance.
Rare (may affect up to 1 in 1000 people):
Allergic reactions (including hypersensitivity and anaphylactic reactions). The signs may be a skin rash; itchy and swollen skin; difficulty breathing; dizziness;
Accumulation of blood around the heart. Signs may have rapid heart beat, chest pain, shortness of breath, sweating or fatigue;
Serious limitation in respiratory capacity: Signs may have shortness of breath, rapid and shallow breathing;
Bleeding in the lungs. The signs may include cough with blood, wheezing, rapid breathing, airway obstruction.
Please also tell your doctor if you notice any of the following side effects:
Common (may affect up to 1 in 10 people):
Low number of platelets in the blood. Signs may be easy bruising or excessive bruising, bleeding under the skin, bleeding from nose or gums;
Headache;
Slow heartbeat;
Bleeding (may include bruising, purple-colored skin rash, nose bleeding, vaginal bleeding, blood in urine or faeces);
Swelling of the hands and feet;
Nausea or vomiting;
Back pain;
Chest pain;
Temperature;
Pain at the injection site;
Abdominal pain.
Rare (may affect up to 1 in 1000 people):
Very low blood pressure. Signs may be dizziness or pronounced weakness (loss of consciousness).
Adverse event reporting
If you get any side effects, tell your doctor or pharmacist.
This includes any possible effects not listed in this leaflet. You can also report adverse events directly through the national reporting system referred to in Annex V. As reported adverse reactions, you can do your bit to get more information on the safety of this medicine.

5. How to store ReoPro
Your doctor or other health care professionals will pay attention to handling and storing ReoPro according to the following instructions:
Keep this medicine out of the reach and sight of children.
Store in a refrigerator (2 ° C - 8 ° C).
Do not freeze.
Do not shake.
Do not use this medicine after the expiry date which is stated on the carton and vial label after "EXP". The expiry date refers to the last day of that month.
Do not use this medicine if you notice discoloration of the liquid or particulate matter in the liquid.

6. Contents of the pack and other information
What ReoPro
ReoPro 2 mg / ml is supplied by injection / infusion solution comprising 10 milligrams of abciximab (active ingredient) dissolved in 5 ml of water for injections.
Other ingredients are: disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, sodium chloride, and polysorbate 80.

ReoPro looks like and contents of the pack
Container ReoPro 2 mg / ml glass vial with a label filled with colorless and transparent liquid ReoPro.