12.5 mg / mL concentrate for infusion solution
dobutamine
1. What Dobutamine Hameln is and what it is used for
Dobutamine Hameln belongs to the group of drugs catecholamines. This allows the heart to work more efficiently. It works by stimulating the heart’s pumping power, increasing blood flow in the body, and by dilating your veins and arteries.
Dobutamine Hameln is used:
- to treat heart failure ( heart failure ) if the heart does not beat hard enough (decreased contractility ),
- in heart failure with severe hypotension ( hypotension ),
- to detect poor blood supply to the heart (in a working ECG ).
Pediatric population
Dobutamine is indicated for all pediatric age groups (from newborns to 18 years) as inotropic support in conditions of decreased cardiac output with hypoperfusion caused by decompensated heart failure, after cardiac surgery, cardiomyopathy and in cardiogenic or septic shock.
Dobutamine contained in Dobutamine Hameln may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before you use Dobutamine Hameln
Do not use Dobutamine Hameln if:
- you are allergic (hypersensitive) to Dobutamine or any of the other ingredients (see content declaration in section 6). An allergic reaction may include rash, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue. You may have experienced this before.
- there is a narrowing in the heart or the blood vessels which prevents the heart from filling up or pumping out the blood properly (your doctor will know if this is the case.)
- the circulating blood volume is insufficient ( hypovolemia ).
If you have any problems with your heart or blood vessels, Dobutamine Hameln should not be used to detect poor blood supply to the heart.
Warnings and cautions
Tell your doctor if you have any of the following conditions:
– asthma and is allergic to sulfites,
– severe coronary heart disease,
– acute (sudden) heart failure.
Children
Increased heart rate and increased blood pressure appear to be more frequent and intense in children than in adults.
The cardiovascular system in newborns has been reported to be less sensitive to dobutamine and hypotonic (blood pressure lowering) effects appear to be observed more often in adult patients than in young children. The use of dobutamine in children should therefore be closely monitored.
Caution should be exercised when high dose you dobutamine given to children. Your doctor will carefully adjust the required dose for your child.
Other medicines and Dobutamine Hameln
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important with the following medicines as they may interact with DobutamineHameln:
- beta-blockers (treatment for high blood pressure and irregular heartbeat),
- alpha-blockers (treatment for high blood pressure and prostate enlargement),
- vasodilators ( vasodilators, used to treat angina or severe heart failure ),
- diabetes drugs (treatment for diabetes ),
- ACE inhibitors (treatment for high blood pressure and heart failure ),
- dopamine (used to increase heart rate and blood pressure ),
- inhalation anesthetics
It is still possible that you may be treated with Dobutamine Hameln and your doctor will be able to determine what is right for you.
Pregnancy and breastfeeding
Dobutamine Hamelin should not be given to pregnant women unless medically justified. It is recommended that you stop breast-feeding during treatment with Dobutamine Hameln. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Discuss with your doctor if you are unsure.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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. Therefore, learn all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Dobutamine Hameln contains sodium metabisulfite
(E223) which in rare cases may cause severe hypersensitivity reactions and convulsions in the trachea.
Dobutamine contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per 1 ml, ie essentially ‘sodium-free’.
3. How to use Dobutamine Hameln
Dobutamine Hameln is administered by specially trained healthcare professionals at a location where emergency equipment is available.
Dosage
The required infusion rate depends on how you respond to the treatment and any side effects. Your doctor will decide how many doses of Dobutamine Hameln you will receive and adjust the flow rate and duration of the infusion.
Dosage for adults:
Most patients respond to doses of 2.5–10 micrograms of dobutamine per kg body weight per minute. Doses of up to 40 micrograms of dobutamine per kg body weight per minute have been administered.
Dosage for children:
A starting dose of 5 micrograms/kg/minute, adjusted according to the clinical response to 2-20 micrograms/kg/minute, is recommended for all pediatric age groups (newborns up to 18 years). Occasionally, a response of the dose is induced down to 0.5-1.0 micrograms/kg/minute.
The required dose for children should be titrated given the probably narrower “therapeutic window” for children.
4. Possible side effects
Like all medicines, Dobutamine Hameln can cause side effects, although not everybody gets them.
The following side effects have been reported:
Very common (in more than 1 in 10 patients)
- increased heart rate
- chest pain
- heart rhythm disorders
Common (in less than 1 in 10, but more than 1 in 100 patients)
- increase in blood pressure or drop in blood pressure
- vasoconstriction ( vasoconstriction )
- irregular heartbeat ( palpitation )
- headache
- bronchospasm / asthma-like symptoms ( bronchospasm )
- shortness of breath
- increased white blood cell count ( eosinophilia )
- inhibited ability of the blood to clot
- increased need to urinate (at high doses )
- nausea (nausea)
- skin rash (exanthema)
- fever
- inflammation of the vein at the injection site ( phlebitis )
Uncommon (in less than 1 in 100, but more than 1 in 1,000 patients)
- rapid contractions in the heart chambers
- uncontrolled contractions of the heart chambers ( ventricular tachycardia )
- heart attack (heart attack)
Very rare (in less than 1 in 10,000, including isolated cases)
- slow heartbeat ( bradycardia )
- insufficient blood supply to the heart (myocardial ischemia)
- low potassium ( hypokalaemia )
- spots on the skin (petechial hemorrhage)
- heart block
- contraction of vessels one that supplies the heart with blood (coronary spasm)
- restlessness
- tingling and numbness ( paresthesia )
- tremor
- feeling hot and worry / anxiety
- muscle spasm (myoclonic spasm )
No known frequency (cannot be calculated from the available data)
- takotsubosyndrome / stress-induced cardiomyopathy (SIC)
5. How to store Dobutamine Hameln
- Your doctor or pharmacist is responsible for storing Dobutamin Hameln. They are also responsible for ensuring that unused medicines are discarded according to current instructions.
- 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 outer carton after EXP. dat. and on ampoule one after EXP. The expiration date is the last day of the specified month.
- Do not use Dobutamine Hameln if the solution is cloudy or contains particles or if the container is damaged.
- Keep the vial are in the outer carton. Sensitive to light.
- Store in a cool place or do not freeze.
6. Contents of the packaging and other information
Content declaration
The active substance is dobutamine hydrochloride.
1 ml solution contains 12.5 mg dobutamine.
Each 20 ml ampoule of Dobutamine Hameln contains dobutamine hydrochloride equivalent to 250 mg dobutamine .
The other ingredients are sodium metabisulfite (E223), hydrochloric acid, and water for injections.
What the medicine looks like and the contents of the pack
Dobutamine Hameln is a clear, colorless, or almost colorless concentrate for a solution for infusion.
Dobutamine Hameln is supplied in 20 ml clear glass ampoules. It is available in original packaging containing 1, 5, or 50 ampoules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
hameln pharma gmbh
Inselstraße 1
31787 Hameln
Germany
Siegfried Hameln GmbH
Langes Feld 13
31789 Hameln
Germany
This medicinal product is authorized under the European Economic Area under the names:
| THE | Dobutamine hameln 12.5 mg / ml |
| FI | Dobutamine Hameln 12.5 mg / ml infusion concentrate, liuosta varten |
| NL | Dobutamine Hameln 12.5 mg / ml sterile concentrate, concentrate for solution for infusion |
| NO | Dobutamine Hameln 12.5 mg / ml concentrate for solution for infusion |
| SEE | Dobutamine Hameln 12.5 mg / mL concentrate for infusionsolution |
| UK | Dobutamine 12.5 mg / ml concentrate for solution for infusion |