2.5 mg / ml concentrate for solution for infusion
levosimendan
What Simdax is and what it is used for
Simdax is a concentrated form of medicine that must be diluted before it is given to you as an intravenous infusion (drip).
Simdax both strengthens the pumping power of the heart and dilates blood vessels. Simdax means that the blood clotting in your lungs will be reduced and the blood and oxygen transport to the organs will be facilitated. Treatment with Simdax helps reduce the shortness of breath that occurs in severe heart failure.
Simdax is used to treat heart failure in people who still have difficulty breathing, despite receiving other medications to get rid of water accumulation in the body.
What you need to know before using Simdax
Do not use Simdax
- if you are allergic (hypersensitive) to levosimendan or any of the other ingredients of this medicine (listed in section 6).
- if you have very low blood pressure or an abnormally fast heartbeat
- if you have severe kidney or liver disease
- in cases of heart disease that makes it difficult to fill or empty the heart
- if you have had a heart rhythm disorder called Torsades de Pointes.
Warnings and cautions
Talk to your doctor before using Simdax.
- if you have any kidney or liver disease
- in case of anemia and concomitant chest pain
- If you have abnormally fast heartbeats, abnormal heart rhythms, or if you have atrial fibrillation, or an abnormally low level of potassium in your blood, your doctor will be extra careful when using Simdax.
Children and young people
Simdax should not be used in children and adolescents under 18 years of age.
Other medicines and Simdax
Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
If you have been given other heart medications by drip, your blood pressure may drop if you receive Simdax.
Pregnancy, breastfeeding, and fertility
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. It is not known if Simdax affects the fetus during pregnancy. Your doctor will determine if the benefit to you outweighs the potential risk to your child.
There are indications that Simdax passes into breast milk. You should not breastfeed while using Simdax to avoid possible cardiovascular side effects in your baby.
Driving and using machines
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Simdax contains alcohol
This medicine contains 3,925 mg of alcohol (anhydrous ethanol ) per 5 ml vial, corresponding to about 98% by volume. The amount in a 5 ml vial of this medicine corresponds to 99.2 ml of beer or 41.3 ml of wine.
The alcohol in this medicine may affect the ability to drive and use machines. This is because your judgment and ability to react may be affected.
If you have epilepsy or liver problems, consult your doctor or pharmacist before using this medicine.
The alcohol in this medicine may affect the effectiveness of other medicines. Tell your doctor or pharmacist if you are taking other medicines.
If you are pregnant or breastfeeding, talk to your doctor or pharmacist before taking this medicine.
If you are or have been addicted to alcohol, consult your doctor or pharmacist before using this medicine.
The effects of alcohol may be reduced as this medicine is usually given slowly over 24 hours.
How to use Simdax
Simdax will be given to you as a drip and is therefore given at the hospital where the doctor can monitor you. Your doctor will adjust the dose individually for you. Your doctor will monitor how you react to Simdax (eg by measuring your heart rate, blood pressure, ECG, and feeling). If necessary, your doctor may change the dose one. Your doctor may monitor you for up to 4-5 days after stopping the Simdax infusion.
You will usually receive a rapid infusion over 10 minutes followed by a slower infusion for up to 24 hours.
Your doctor should continuously monitor how you react to Simdax. Your doctor may reduce the infusion rate if your blood pressure drops, if your heart beats too fast or if you do not feel well. Tell your doctor or healthcare professional if you experience palpitations, if you feel dizzy or if you feel that the effect of Simdax is too weak or too strong.
If your doctor thinks you need more Simdax and you do not have any side effects, the speed of your infusion may be increased.
Your doctor will give you your Simdax infusion for as long as you need it to support your heart. Usually, this is for 24 hours.
The effect on the heart lasts for at least 24 hours after the end of Simdax infusion and can last up to 7-10 days.
If you take more Simdax than you should
Too high a dose of Simdax can cause your blood pressure to drop and your heart rate to increase. Your doctor will assess how you should be treated based on your general condition.
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):
Abnormally fast heartbeat
Headache
Drop in blood pressure.
Common (may affect up to 1 in 10 people):
Low potassium in the blood
Sleeping problems
Dizziness
A type of heart rhythm disorder called atrial fibrillation (part of the heart stands and flutters instead of beating properly)
Extra stroke
Heart failure
Your heart is not getting enough oxygen
Nausea
Constipation
Diarrhea
Vomiting
Low blood levels.
A type of heart rhythm disorder called ventricular fibrillation (part of the heart is fluttering instead of beating properly) has been reported in patients receiving Simdax.
Tell your doctor immediately if you get any side effects. Your doctor may reduce the drip rate or stop the drip.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
How to store Simdax
Keep out of sight and reach of children.
Store in a refrigerator (2 ° C – 8 ° C).
Do not freeze.
Do not use this medicine after the expiry date which is stated on the carton.
The prepared solution is used within 24 hours after dilution.
Contents of the packaging and other information
Content declaration
The active substance is levosimendan 2.5 mg / ml.
For further information on this medicine, please contact your local representative: Orion Pharma AB, Danderyd, medinfo@orionpharma.comr levosimendan 2.5 mg/ml.
The other ingredients are povidone, citric acid, and ethanol.
Marketing Authorization Holder and Manufacturer
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation
PO Box 65
FI-02101 Espoo
Finland