10 mg/ml concentrate for solution for injection landiolol
hydrochloride
What Rapibloc concentrate is and what it is used for
Rapibloc concentrate contains the active substance landiolol hydrochloride. It belongs to a group of medicines called beta-blockers. Rapibloc concentrate normalizes irregular or fast heart rate ( pulse ).
This drug is used in adults to treat too fast heart rate.
It is used during or immediately after surgery or in other situations where the heart rate needs to be controlled.
Landiolol contained in Rapibloc concentrate may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you get Rapibloc concentrate
Your doctor will NOT give Rapibloc concentrate to you:
- if you are allergic to landiolol or any of the other ingredients of this medicine (listed in section 6)
- if you have a very low heart rate (less than 50 beats per minute)
- if you have fast or alternating fast and slow heart rate (so-called sick sinus syndrome)
- if you have severe heart block. Heart block is a problem with the electrical impulses that control your heart rate.
- if you have problems with the heart’s blood supply (so-called cardiogenic shock )
- if you have very low blood pressure
- if you have symptoms of severe heart failure
- if you have high blood pressure in the lungs ( pulmonary hypertension )
- if you have an untreated glandular disease called pheochromocytoma. Pheochromocytoma occurs in the adrenal glands and can cause a sudden increase in blood pressure, severe headache, sweating, and increased heart rate.
- if you have asthma symptoms that get worse quickly
- if you have very high acid levels in your body (severe metabolic acidosis ) that can not be treated.
You will not receive Rapibloc concentrate if any of the above apply to you. If you are not sure if you have any of these conditions, talk to your doctor or nurse before taking this medicine.
Warnings and cautions
- Talk to your doctor or nurse before receiving this medicine.
- Rapibloc concentrate must be diluted by your doctor or nurse before using.
- Normally, your heart rate, blood pressure, and electrical activity of your heart will be monitored continuously while you are being treated with this medicine.
- Rapibloc concentrate contains ethanol (alcohol). Your doctor will pay special attention to this
- if you suffer from alcoholism
- if you are pregnant or breastfeeding
- if you have liver disease or epilepsy.
If any of the following apply to you (or you are not sure), talk to your doctor or nurse before taking this medicine.
Your doctor will take special precautions with this medicine:
- if you have diabetes or low blood sugar. Landiolol can mask the symptoms of low blood sugar.
- if you have low blood pressure
- if you have a problem called preexcitation syndrome combined with irregular and fast heart rate ( atrial fibrillation )
- if you have problems with the electrical impulses that control your heart rate (heart block)
- if you have problems with the propagation of electrical impulses in the heart and receive any of the medicines verapamil or diltiazem
- if you have a specific type of angina (chest pain) called Prinzmetal’s angina
- if you have or have had heart problems (eg congestive heart failure ). Your doctor will monitor you very closely for heart symptoms. If necessary, treatment will be discontinued, the dose reduced, or special treatment measures are taken.
- if you have a certain type of heart rhythm disorder called supraventricular arrhythmia and you:
- have other heart problems or
- taking other heart medicines
- if you have kidney problems
- if you have a glandular disease called pheochromocytoma that has been treated with a medicine called alpha-receptor blocking agent
- if you have narrow airways or wheezing such as asthma
- if you have blood circulation problems such as whitening fingers (Raynaud’s syndrome) or if you feel pain, fatigue and sometimes burning pain in your legs
- if you have any allergies or risk of anaphylactic reactions (severe allergic reactions). Rapibloc concentrate can increase the severity of allergies and make them more difficult to treat.
Other medicines and Rapibloc concentrate
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines, including herbal medicines and natural products. Your doctor will check that none of the medicines you are taking affect the function of Rapibloc concentrate.
In particular, tell your doctor or nurse if you are taking any of the following:
- medicines used to treat heart rhythm problems (eg diltiazem, verapamil, propafenone, disopyramide, amiodarone, digoxin, digitalis ) and high blood pressure (eg nifedipine)
- medicines used to treat diabetes, including insulin and oral medicines
- drugs used as muscle relaxants (eg suxamethonium), usually during surgery, or drugs used to counteract the effects of muscle relaxants (cholinesterase inhibitors such as neostigmine, distigmine, edrophone). Your doctor will also take special precautions if you receive Rapibloc concentrate during surgeries when you will also receive anesthetics and other treatments.
- so-called ganglion blocking drugs (eg trimethadione)
- drugs used for pain relief, e.g. non-steroidal anti-inflammatory drugs, called NSAIDs
- floctafenine which is a painkiller
- amisulpride used to treat mental health problems
- tricyclic antidepressant drugs (eg imipramine and amitriptyline)
- barbiturates (eg phenobarbital used to treat epilepsy )
- phenothiazines (eg chlorpromazine used to treat mental disorders)
- drugs used to treat asthma
- medicines used to treat colds or nasal congestion, so-called nasal decongestants
- medicines that can lower blood pressure (eg reserpine and clonidine )
- adrenaline used to treat allergic reactions
- heparin is used to thin the blood.
If you are not sure if any of the above applies to you, talk to your doctor or nurse before taking Rapibloc concentrate.
Pregnancy and breastfeeding
If you are pregnant or think you may be pregnant, ask your doctor for advice before taking this medicine. There are no data available on the use of Rapibloc concentrate during pregnancy. Due to the lack of experience, it is not recommended to use this medicine during pregnancy.
Tell your doctor if you are breastfeeding. Rapibloc concentrate can pass into breast milk. You should not receive this medicine if you are breastfeeding.
Your doctor will also consider that this medicine contains alcohol (see section 2 “Rapibloc concentrate contains alcohol, potassium, and sodium”).
Rapibloc concentrate contains alcohol, potassium, and sodium
This medicine contains up to 672 mg of alcohol ( ethanol ) per dose (calculated for a patient weighing 70 kg). The amount in a dose of this medicine corresponds to less than 17 ml of beer or 7 ml of wine. The low amount of alcohol in this medicine does not produce any noticeable effects.
This medicine contains less than 1 mmol (23 mg) sodium and less than 1 mmol (39 mg) potassium per ampoule, ie essentially ‘sodium- and potassium-free’.
How to get Rapibloc concentrate
- Rapibloc concentrate must be diluted before administration and it will be given to you by a doctor or nurse. It is given to you as an injection via a needle into a vein.
- The usual dose is 0.1-0.3 mg per kg body weight. Your doctor may give you 5-15 doses per day.
- Your doctor will decide how much medicine you need. While receiving Rapibloc concentrate, your heart rate, blood pressure, and electrical activity will be monitored.
Dose adjustment is usually not necessary if you are older.
If you have kidney problems, your doctor will take appropriate precautions.
Hepatic impairment
If you have liver problems, your doctor will start your treatment with a lower dose.
Your doctor will consider that this medicine contains alcohol (see section 2 “Rapibloc concentrate contains alcohol, potassium, and sodium”).
Use for children and adolescents
The drug contains alcohol and should therefore not be used in children and adolescents.
If you take more Rapibloc concentrate than you should
If you suspect that you have been given too much Rapibloc concentrate, tell your doctor or nurse immediately. Your doctor will take appropriate action (your treatment may be stopped immediately and you may receive supportive care).
The following symptoms may occur if you have taken too much of this medicine:
- severe drop in blood pressure (you may feel dizzy or dizzy)
- very low heart rate
- impaired cardiac function
- shock as a result of impaired cardiac function
- breathing problems
- unconsciousness or even coma
- convulsions (convulsions)
- nausea
- vomiting
- low blood sugar
- high potassium levels in the blood (hyperkalemia).
If you have ingested too much medicine or if e.g. If a child has ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice.
If you have any further questions on the use of this product, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects disappear within 30 minutes after stopping treatment with Rapibloc concentrate. Tell your doctor or nurse immediately if you notice any of the following side effects, which may be serious.
Infusion one may need to be stopped if your doctor observes severe changes in:
- your heart rate
- your blood pressure
- the electrical activity of your heart.
Common (may affect up to 1 in 10 people):
- low heart rate
- low blood pressure.
Uncommon (may affect up to 1 in 100 people):
- pneumonia _ _ _
- low levels of sodium in the blood ( hyponatremia )
- decreased blood flow to the brain, headache
- inability to circulate blood normally (cardiac arrest), fast heart rate
- high blood pressure
- accumulation of fluid in the lungs
- vomiting, nausea
- liver disease
- abnormalities in examinations of the heart ( ECG, ultrasound)
- altered blood levels
- abnormalities in urine samples ( protein in the urine).
Rare (may affect up to 1 in 1,000 people):
- inflammation of the space between the alveoli (mediastinitis)
- abnormal platelet count ( platelets )
- high blood sugar
- stroke, seizures
- heart attack, heart rhythm disturbances, impaired heart function, and certain types of heart rate problems (eg short break in normal heart activity or missed heartbeat; heartbeat awareness (palpitations))
- shock, hot flashes
- respiratory problems (including shortness of breath), lung disease, abnormally low oxygen levels in the blood
- stomach upset, secretions from the mouth, bad breath
- abnormally high levels of bilirubin (a dye produced when red blood cells are broken down) in the blood
- reddening of the skin, cold sweats
- muscle cramps
- kidney failure, kidney damage, decreased urine volume
- fever, chills, chest discomfort, injection site pain
- increased pressure in the pulmonary vessels
- sugar ( glucose ) in the urine.
Has been reported (occurs in an unknown number of users):
- skin changes at the injection site, pressure sensation at the injection site.
How to store Rapibloc concentrate
- 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).
- For single use only.
- Rapibloc concentrate must be diluted before use.
- Do not use this medicine if there are visible particles or if the solution is discolored.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is landiolol hydrochloride. One milliliter of concentrate contains 10 mg of landiolol hydrochloride equivalent to 9.35 mg of landiolol. One ampoule of 2 ml concentrate for solution for injection contains 20 mg landiolol hydrochloride equivalent to 18.7 mg landiolol.
The other ingredients are hydroxypropyl betadex, macrogol 300, ethanol 96%, sodium chloride, potassium chloride, disodium phosphate, potassium dihydrogen phosphate, and water for injections.
What the medicine looks like and the contents of the pack
Rapibloc concentrate is a concentrated solution for injection. It is a clear, colorless yellowish solution with no visible particles.
Pack size: 5 ampoules with a volume of 3 ml, each containing 2 ml of Rapibloc concentrate.
Marketing Authorisation Holder
Amed Pharma GmbH
Leopold-Ungar-Platz 2
1190 Vienna
Austria
Manufacturer
AOP Orphan Pharmaceuticals GmbH
Leopold-Ungar-Platz 2
1190 Vienna
Austria
This medicinal product is authorized under the European Economic Area under the names:
| Austria: | Rapibloc 20 mg / 2 ml concentrate for the preparation of an injection solution |
| Bulgaria: | Rapibloc 20 mg / 2 ml Concentrate for Injection Injection |
| Croatia: | Rapibloc 20 mg / 2 ml otopinu concentrate for injection |
| Cyprus: | Rapibloc 20 mg / 2 ml single-dose fluid therapy device |
| Czech Republic: | Rapibloc 20 mg / 2 ml concentrate for injection |
| Denmark: | Rapibloc 20 mg / 2 ml concentrate for solution for injection |
| Estonia: | Raploc 20 mg / 2 ml süstelahuse concentrate |
| Germany: | Rapibloc 20 mg / 2 ml concentrate for the preparation of an injection solution |
| Greece: | Rapibloc 20 mg / 2 ml single-dose fluid therapy device |
| Finland: | Rapibloc 20 mg / 2 ml injection concentrate, lyuosta varten |
| France: | Rapibloc 20 mg / 2 ml solution for injectable dilution |
| Hungary: | Rapibloc 20 mg / 2 ml concentrate for injection injatcióhoz |
| Iceland: | Rapibloc 20 mg / 2 ml concentrate for solution for injection |
| Italy: | Landiobloc |
| Lithuania: | Raploc 20 mg / 2 ml concentrate for injection injections |
| Latvia: | Raploc 20 mg / 2 ml Concentrated Injection Remedies |
| Malta: | Rapibloc 20 mg / 2 ml concentrate for solution for injection |
| Netherlands: | Rapibloc 20 mg / 2 ml concentrate for solution for injection |
| Norway: | Raploch |
| Poland: | Runrapiq |
| Romania: | Rapibloc 20 mg / 2 ml concentrate for injectable solution |
| Slovakia: | Rapibloc 20 mg / 2 ml injectable concentrate |
| Slovenia: | Rapibloc 20 mg / 2 ml concentrate for injection for injection |
| Sweden: | Rapibloc |