10 U powder and solvent for solution for injection
reteplase
What Rapilysin is and what it is used for
Rapilysin contains the active substance reteplase (a recombinant plasminogen activator ) a thrombolytic medicine used to dissolve blood clots that have formed in certain blood vessels and to restore the blood flow in these clogged blood vessels (= thrombolysis).
Rapilysin is used after an acute heart attack (heart attack) to dissolve the blood clot that has caused the heart attack. It should be given within 12 hours after the first symptoms.
What you need to know before you use Rapilysin
Do not use Rapilysin
Your doctor will ask you questions before taking Rapilysin to see if you are at increased risk of bleeding.
Do not use Rapilysin:
- if you are allergic to reteplase or any of the other ingredients of this medicine (listed in section 6).
- if you have a bleeding disorder.
- if you are taking medicines for blood thinning (oral anticoagulants, such as warfarin ).
- if you have a brain tumor or blood vessel malformation or vascular wall dilation ( aneurysm ) in the brain.
- if you have other tumors you may have an increased risk of bleeding.
- if you have had a stroke.
- if you have had a topical heart massage in the last 10 days.
- if you have severe uncontrolled high blood pressure ( hypertension ).
- if you have stomach ulcers or small bowel ulcers.
- if you have enlarged blood vessels in the esophagus (esophagus) (often caused by liver disease).
- if you have severe liver or kidney disease.
- if you have acute inflammation of the pancreas or pericardium (the sac that surrounds the heart) or an infection of the heart muscle (bacterial endocarditis ).
- if you have had severe bleeding, extensive damage, or extensive surgery (eg coronary bypass surgery, surgery, or injury to the head or spine) in the last 3 months, given birth, or undergone a tissue biopsy or other medical/surgical procedure.
Warnings and cautions
Bleeding
The most common side effect of Rapilysin is bleeding. Therefore, Rapilysin should only be given in the presence and under the instructions of a doctor.
Pay close attention to any bleeding sites (eg injection sites). Heparin, co-administered with Rapilysin, may also cause increased bleeding.
The risks of Rapilysin treatment may increase if you have any of the following conditions:
- diseases of the blood vessels of the brain
- systolic blood pressure higher than 160 mmHg
- gastrointestinal bleeding, bleeding in the urinary or genital tract during the last 10 days
- high probability of blood clots in the heart (eg as a result of narrowing of a heart valve or atrial fibrillation )
- bacterial inflammation in vein with blood clot ( septic thrombophlebitis ) or blocked blood vessels in the infected area
- is over 75 years old
- other conditions where bleeding can be particularly dangerous or can occur in areas where it can be difficult to control
There are currently little data on the use of Rapilysin in patients with diastolic blood pressure above 100 mmHg.
Abnormal heart rate ( arrhythmias )
Thrombolytic therapy can cause the heart to beat irregularly. Therefore, tell your medical staff immediately if you
- feel palpitations or irregular heartbeats
Repeated use
There is currently no experience with repeated use of Rapilysin. Therefore, repeated use is not recommended. The formation of antibodies to the reteplase molecule has not been observed.
Children
The safety and efficacy of Rapilysin in children have not been established. Treatment of children with Rapilysin is not recommended.
Other medicines and Rapilysin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Heparin and other blood thinners ( anticoagulants ) and acetylsalicylic acid (a substance found in many painkillers and antipyretics) may increase the risk of bleeding.
For information on medicines that should not be physically mixed with Rapilysin liquid for injection, see section 3.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Pregnancy
There is no experience with Rapilysin in pregnant women. Therefore, it should not be used except in life-threatening situations. You must tell your doctor if you are pregnant or think you may be pregnant. Your doctor may tell you about the risks and benefits of using Rapilysin during pregnancy.
Breast-feeding
You should not breastfeed your baby during Rapilysin treatment as it is not known if Rapilysin is excreted in human milk. Breast milk should be discarded for the first 24 hours after thrombolytic therapy. Discuss with your doctor when you can start breastfeeding again.
How to use Rapilysin
Rapilysin is usually given in a hospital. The medicine is supplied in vials as a lyophilized powder for injection. Before use, the powder for injection must be dissolved in water for injection into the pre-filled syringe provided in the package. Do not add any other medicines. The finished solution must be used immediately. The solution must be examined to ensure that only clear, colorless solutions are injected. If the solution is not clear and colorless, discard it.
Treatment with Rapilysin 10 U should be started as soon as possible after the onset of symptoms of a heart attack.
Heparin and Rapilysin can not be mixed in the same solution. Other drugs are also not as miscible as Rapilysin. No other drugs may be added to the solution for injection (see below). Rapilysin should preferably be injected through an intravenous infusion used only for injection of Rapilysin. No other drug should be injected through the reserved entrance of Rapilysin, either concomitantly, before, or after injection of Rapilysin. This applies to all medicines, including heparin and acetylsalicylic acid, which are given before and after Rapilysin to reduce the risk of new blood clots.
If the same inlet must be used, this inlet (including the Y-tube inlet) must be rinsed thoroughly with 0.9% sodium chloride solution or 5% glucose solution before and after injection of Rapilysin.
Dosage of Rapilysin
Rapilysin is given as a 10 U injection followed by a second 10 U injection 30 minutes later (double bolus injection).
Each injection should be given slowly within 2 minutes. Injection should not be accidentally given outside the vein. Therefore, inform your medical staff if you experience pain during injection.
Heparin and acetylsalicylic acid are given before and after Rapilysin to reduce the formation of new blood clots.
Dosage of Heparin
The recommended dose of heparin is 5000 IU as a single injection before Rapilysin. This is accompanied by an infusion of 1000 IU per hour starting after the second Rapilysin injection. Heparin should be given for at least 24 hours, preferably for 48-72 hours, to keep aPTT levels 1.5 to 2 times normal.
Dosage of Acetylsalicylic acid
One dose of acetylsalicylic acid given before Rapilysin should be at least 250 mg-350 mg and should be accompanied by 75-150 mg/day, at least until discharge from the hospital.
If you use more Rapilysin than you should
In case of overdose, there may be an increased risk of bleeding.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 user in 10):
- Bleeding at the injection site, eg bleeding (hematoma)
- Chest pain/angina, low blood pressure, and heart failure/shortness of breath may occur
- Burning sensation when Rapilysin is injected
Common (may affect up to 1 in 10 people):
- Bleeding from the gastrointestinal tract (eg bloody or black vomiting or feces), from the gums, or from the urogenital organs
- Abnormal heart rate ( arrhythmia ), cardiac arrest, circulatory collapse, or another heart attack may occur
Uncommon (may affect up to 1 in 100 people):
- Bleeding around the heart, abdomen, brain or eyes, under the skin, from the nose, or bloody cough
- Damage to the heart or heart valves, or blood clots in the lungs, brain, or another part of the body can occur
- Hypersensitivity (eg allergic reactions)
Very rare (may affect up to 1 in 10,000 people):
- Events related to the nervous system (eg epileptic seizures, convulsions, speech disorders, delirium, agitation, confusion, depression, psychosis )
- The severe allergic reaction that causes shock or collapse
Adverse reactions that have been reported (occurring in an unknown number of users):
- Blockage of blood vessels due to cholesterol (fat)
Side effects related to the heart and blood vessels can be life-threatening or fatal.
Patients with systolic blood pressure above 160 mm Hg have a higher risk of a cerebral hemorrhage. The risk of intracranial hemorrhage or fatal intracranial hemorrhage increases with increasing age. Blood transfusions were rarely required. Death or permanent disability is not uncommon in patients with stroke (including cerebral hemorrhage) or other severe bleeding problems.
Notify hospital staff immediately if any of these symptoms occur.
How to store Rapilysin
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 the vial label after EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Keep the vial in the outer carton. Sensitive to light.
After reconstitution (“when dissolved”), the solution must be used immediately.
Contents of the pack and other information
Content declaration
- The active substance is reteplase 10 U / 10 ml after reconstitution.
- Other ingredients are:
Powder: Tranexamic acid dipotassium hydrogen phosphate phosphoric acidsucrosepolysorbate 80
Solvent:10 ml water for injections (pre-filled syringe )
What the medicine looks like and the contents of the pack
Rapilysin consists of a powder and a solvent for injection (2 sets of 0.56 g of powder in a vial, 10 ml of solvent in a pre-filled syringe, a needle tip for transfer, and a needle).
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Actavis Group PTC EHF.
Reykjavikurvegur 76-78
IS-220 Hafnarfjordur
Iceland
Manufacturer
Actavis Italy SpA
Nerviano Plant
Via Pasteur 10
20014 Nerviano (Milano)
Italy
Cenex
52, Rue Marcel and Jacques Gaucher
FR-94120 Fontenay-Sous-Bois
France