Aggreva 0,05 mg Solution

AGGREVA 0,05 mg/ml is used to help assist the blood flow to your heart and to help prevent chest pain and heart attacks. It works by preventing platelets, cells found in the blood, from forming blood clots. AGGREVA 0,05 mg/ml is intended for use with unfractionated heparin.

AGGREVA 0,05 mg/ml should not be administered to you:

• if you are hypersensitive (allergic) to tirofiban or to any other ingredients of AGGREVA 0,05 mg/ml (listed in section 6)
• if you are bleeding internally or have a history of bleeding internally within the last 30 days
• if you have a history of bleeding in the brain, brain tumour or abnormal blood vessels in the brain
• if you have a low blood platelet count (thrombocytopenia) or problems with blood clotting
• if you developed thrombocytopenia if you had received treatment with AGGREVA 0,05 mg/ml or another medicine in the same group of drugs previously
• if you have been seriously injured or had a major operation within the last month
• if you have a history of stroke within the last 30 days or any history of stroke with bleeding
• a history or symptoms of splitting of the aorta (aortic dissection)
• if you have severe uncontrolled high blood pressure (malignant hypertension)
• if you have an inflammation of the lining around your heart (pericarditis)
• if you have had a recent spinal procedure
• if you have kidney failure and receive haemodialysis
• if your blood takes longer to clot (prolonged INR).

Warnings and precautions:

Tell your doctor or healthcare provider before being given the injection: Special care should be taken with AGGREVA 0,05 mg/ml if:

• you had cardiopulmonary resuscitation (CPR), a biopsy, or a procedure to break up kidney stones within the last 2 weeks
• you have been seriously injured or had a major operation within the last 3 months
• you had an ulcer in the stomach or intestine (duodenum) within the last 3 months
• you had a recent bleeding disorder (within 1 year) such as bleeding in the stomach or intestine, or blood in your urine or stool
• you have uncontrolled high blood pressure (hypertension)
• you have an inflammation of the lining around your heart (pericarditis)
• you have an inflammation of the blood vessels (vasculitis)
• you have a tear in the inner layer of the large blood vessel branching off the heart (aorta)
• you have problems with the blood vessels in the back of your eye (retina)
• you are taking medicines that help to prevent or dissolve blood clots
• you have a special intravenous line inserted under your collar bone within the last 24 hours
• you have heart failure
• you have very low blood pressure due to a failing heart (cardiogenic shock)
• you have a liver disorder
• you have low blood platelet count
• you have low blood count or anaemia
• concurrent administration of ticlopidine, clopidogrel, adenosine, dipyridamole, sulfinpyrazone, and prostacyclin
• elderly, female patients and a low body weight, they have a higher incidence of bleeding and should be carefully monitored
• kidney problems.

Children:

AGGREVA 0,05 mg/ml should not be used in children.

Other medicines and AGGREVA 0,05 mg/ml:

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) It is especially important to tell your doctor if you are taking other medicines that help prevent your blood from clotting such as:

• warfarin
• aspirin
• clopidogrel.

Pregnancy, breastfeeding and fertility:

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before receiving AGGREVA 0,05 mg/ml. You should not receive AGGREVA 0,05 mg/ml if you are pregnant or breastfeeding your baby.

Do not share medicines prescribed for you with any other person. Your doctor will tell you how long your treatment with AGGREVA 0,05 mg/ml will last. If you have the impression that the effect of AGGREVA 0,05 mg/ml is too strong or too weak, tell your doctor or pharmacist. You will not be expected to give yourself AGGREVA 0,05 mg/ml. It will be given to you by a person who is qualified to do so. You have been given, or are about to be given, AGGREVA 0,05 mg/ml into a vein. Your doctor will decide on the appropriate dose, depending on your condition and your weight. The use of AGGREVA 0,05 mg/ml in children is not recommended.

If you use more AGGREVA 0,05 mg/ml than you should: Since a healthcare provider will administer AGGREVA 0,05 mg/ml, he/she will control the dosage. However, in the event of over dosage your doctor will manage the over dosage. The most frequently reported symptom of overdose is bleeding. If you notice bleeding, you should notify your healthcare provider immediately.

If you forget to use AGGREVA 0,05 mg/ml: Since a healthcare provider will administer AGGREVA 0,05 mg/ml, it is unlikely that the dose will be missed.

AGGREVA 0,05 mg/ml can have side effects. Not all side effects reported for AGGREVA 0,05 mg/ml are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving AGGREVA 0,05 mg/ml, please consult your doctor, pharmacist or other healthcare provider for advice. If any of the following happens, tell your doctor immediately as the administration of AGGREVA 0,05 mg/ml should be stopped:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching.

These are all very serious side effects. If you have them, you may have had a serious reaction to AGGREVA 0,05 mg/ml. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

Frequent side effects:

• signs of internal bleeding such as coughing up blood or blood in your urine or stool.

Frequency unknown:

• signs of bleeding in the skull such as pain in the head, sensory impairments (visual or hearing), difficulties in speech, numbness or problems with movement or balance.

These are serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

Frequent side effects:

• headache
• collection of blood outside of a blood vessel
• nose bleeds
• nausea
• bleeding in the gums and mouth, bleeding
• small red bruises on the skin
• fever
• bleeding after surgery
• bleeding from vessel puncture site
• invisible blood in urine or stool
• reduction in red blood cells (reduced haematocrit and haemoglobin)
• decreases in platelet count below 90 000/mm3.

Less frequent:

• bleeding in the stomach or intestines
• vomiting of blood
• decreased platelet count below 50 000/mm3.

Unknown frequency:

• acute and/or severe decreases in platelet counts below < 20 000/mm3
• haematoma in the spinal region
• accumulation of blood around the heart
• bleeding in the lung
• bleeding in the abdomen of the internal organs.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects:

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the 6.04 Adverse Drug Reaction Reporting Form, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of AGGREVA 0,05 mg/ml.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Store at or below 25 °C. Do not freeze. Keep container in foil over pouch to protect from light. Keep in original packaging until required for use. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets). From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. The AGGREVA 0,05 mg/ml solution should be clear and free of visible particles, if not, the solution should be discarded.