Dobutamin hameln

Leaflet attached to the packaging: information for the user

Dobutamine hameln 12.5 mg/ml concentrate for solution for infusion

Dobutamine

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Dobutamine hameln and what is it used for
• 2. Important information before using Dobutamine hameln
• 3. How to use Dobutamine hameln
• 4. Possible side effects
• 5. How to store Dobutamine hameln
• 6. Contents of the packaging and other information

1. What is Dobutamine hameln and what is it used for

Dobutamine hameln belongs to a group of medicines called catecholamine amines. It works by increasing the effectiveness of heart function. It strengthens the pumping action of the heart, increasing blood flow in the body and dilating veins and arteries.

Dobutamine hameln is used:

• to treat heart failure (decompensated heart failure), if the heart does not beat strongly enough (reduced contractility),
• for heart failure with very low blood pressure (hypotension),
• to detect poor blood flow to the heart (cardiac stress tests).

Children and adolescents
The use of Dobutamine hameln is indicated in children and adolescents (from newborns to 18 years),
when it is necessary to achieve a positive inotropic effect in patients with reduced cardiac output in hypoperfusion states due to uncompensated heart failure after cardiac surgery, in the course of cardiomyopathy, in cardiogenic or septic shock.

2. Important information before using Dobutamine hameln

When not to use Dobutamine hameln:

• if the patient is allergic(hypersensitive) to dobutamineor any of the other ingredients of this medicine(listed in section 6). Symptoms of an allergic reaction may include: rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue. If the patient has experienced such symptoms before.
• if the patient has narrowing of the aortic valve or blood vessels that prevent the heart from filling or ejecting blood properly(will be diagnosed by a doctor).
• if the patient has too little blood volume(hypovolemia).
• if the patient has high blood pressure due to a tumor near the kidney (phaeochromocytoma).

Dobutamine hameln should not be used to detect poor blood flow to the heart, if the patient has certain heart or blood vessel diseases.

Warnings and precautions

Before starting treatment with Dobutamine hameln, you should discuss it with your doctor.
Before starting treatment, you should discuss with your doctor if:

• the patient has asthma and is allergic to sulfites
• the patient has severe coronary heart disease,
• the patient has acute (sudden) heart failure.

Children
Tachycardia and increased blood pressure occur more frequently and are more severe
in children than in adults. There are reports of lower sensitivity of the newborn's circulatory system to dobutamine and it seems that the hypotensive effect is observed more frequently in adults than in small children. Therefore, the doctor will carefully monitor the use of dobutamine in children.
Caution should be exercised in children when administering high doses of dobutamine.
The doctor will carefully adjust the required dose for the child.

Dobutamine hameln and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
You must inform your doctor, as the following medicines may affect the action of Dobutamine hameln:

• beta-adrenergic blockers (medicines used to treat high blood pressure and irregular heart rhythm),
• alpha-adrenergic blockers (medicines used to treat high blood pressure and prostate enlargement),
• vasodilators (medicines that dilate blood vessels in the treatment of angina pectoris or severe heart failure);
• antidiabetic medicines (medicines used in diabetes)
• ACE inhibitors (medicines used to treat high blood pressure and heart failure),
• dopamine (used to accelerate heart rate and increase blood pressure),
• inhalation anesthetics,
• entacapone (a medicine used to treat Parkinson's disease). The doctor will decide whether the administration of dobutamine is beneficial for the patient.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Dobutamine should not be given to pregnant women unless it is medically justified. If the use of dobutamine during breastfeeding is necessary, it is recommended to stop breastfeeding during treatment.

Driving and using machines

In case of any doubts, consult your doctor or pharmacist.
Dobutamine hameln contains sodium metabisulfite (E223). The medicine can rarely cause severe hypersensitivity reactions and bronchospasm.

Dobutamine hameln contains sodium

The medicine contains less than 1 mmol of sodiumper (23 mg) per 1 ml, i.e. the medicine is considered "sodium-free".

3. How to use Dobutamine hameln

Dobutamine hameln can only be administered by qualified medical personnel in a setting with emergency equipment available.

Dosage

The required infusion rate depends on the patient's response to treatment and the occurrence of side effects. The doctor determines what dose of dobutamine each patient should receive and adjusts the infusion rate and duration.
Dosage in adults:
Most patients respond to a dose of 2.5–10 micrograms of dobutamine per kg of body weight per minute. A dose of up to 40 micrograms of dobutamine per kg of body weight per minute can be administered.
Dosage in children and adolescents:
In children and adolescents (from newborns to 18 years of age), the initial dose of 5 micrograms/kg/min is recommended, adjusted to clinical response in the range of 2 to 20 micrograms/kg/min. Occasionally, a response is obtained after administration of a small dose, ranging from 0.5 to 1.0 micrograms/kg/min.
The minimum effective dose in children is higher than in adults. When using higher doses, particular caution should be exercised, as it has been shown that the maximum tolerated dose in the treatment of children is lower than the doses used in adults. Most side effects (especially tachycardia) were observed after administration of dobutamine at a dose of 7.5 micrograms/kg/min or higher, but rapid resolution of side effects occurs after decreasing the infusion rate or discontinuing dobutamine infusion.
Among children, there is a large variability in both the plasma dobutamine concentration that elicits a hemodynamic response (threshold) and the rate of hemodynamic response to increased plasma concentration, indicating that the required dose cannot be predetermined for children and the dose should be adjusted taking into account the presumed narrower therapeutic range in children.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects are possible:

Very common side effects (may occur more often than in 1 in 10 people):

• increased heart rate
• chest pain
• heart rhythm disturbances
• abnormal electrocardiogram (ST segment elevation) during dobutamine stress test

Common side effects (may occur less often than in 1 in 10 people):

• increased or decreased blood pressure
• vasoconstriction (vasoconstriction)
• irregular heartbeat (palpitations)
• rapid heartbeat (ventricular tachycardia)
• headache
• asthma-like symptoms (bronchospasm)
• shortness of breath
• increased white blood cell count (eosinophilia)
• inhibition of blood clotting
• increased need to urinate (at high doses)
• nausea (nausea)
• rash (rash)
• fever
• inflammation of the vein at the injection site (phlebitis)
• allergic reactions (hypersensitivity reactions), including rash symptoms
• inflammation of the heart muscle (eosinophilic myocarditis)

Uncommon side effects (may occur less often than in 1 in 100 people):

• uncontrolled ventricular contractions (ventricular flutter)
• heart attack (myocardial infarction)
• uncontrolled atrial contractions (atrial flutter)
• obstruction of left ventricular outflow during dobutamine stress test
• severe allergic reactions (anaphylactic reactions) and severe, life-threatening asthma episodes, likely due to hypersensitivity to sodium metabisulfite (see section 2).

Rare side effects (may occur less often than in 1 in 10,000 people):

• slow heart rate (bradycardia)
• insufficient blood flow to the heart (myocardial ischemia)
• low potassium levels (hypokalemia)
• skin spots (purpura)
• heart block
• constriction of blood vessels supplying the heart (coronary vasospasm)
• black spots on the skin (necrosis)
• muscle spasms (myoclonus) in patients with severe renal impairment receiving dobutamine
• fatal heart rupture during dobutamine stress test

Frequency not known (cannot be estimated from available data):

• chest pain caused by stress (stress cardiomyopathy)
• heart function disorders (decreased pulmonary capillary pressure)
• heart muscle function disorders (stress cardiomyopathy, also known as takotsubo syndrome), characterized by chest pain, shortness of breath, dizziness, fainting, irregular heartbeat, occurring during dobutamine stress echocardiography

Other observed side effects:

• anxiety
• tingling (paresthesia)
• involuntary muscle contractions (tremor)
• feeling of heat and anxiety
• muscle cramps

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dobutamine hameln

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging after EXP:. The expiry date refers to the last day of the month.
• Do not use this medicine if you notice that the solution is not clear and free of particles or if the packaging is damaged.
• This medicine does not require any special storage conditions.
• Store the ampoules in the original packaging to protect from light.
• Do not freeze. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Dobutamine hameln contains

The active substance of the medicine is dobutamine.
1 ml of concentrate contains 12.5 mg of dobutamine.
1 ampoule of 20 ml of Dobutamine hameln contains 250 mg of dobutamine.
The other ingredients are: sodium metabisulfite, hydrochloric acid 1N (to adjust pH) and water for injections

What Dobutamine hameln looks like and contents of the pack

Dobutamine hameln is a clear, colorless or yellowish concentrate for solution for infusion.
The immediate packaging is an ampoule made of colorless glass (type I) containing 20 ml of Dobutamine hameln. The cardboard box contains 1, 5 or 10 ampoules.
Not all pack sizes may be marketed.

Marketing authorization holder

hameln pharma gmbh
Inselstraße 1
31787 Hameln
Germany
Tel.: +49 171 766 2789

Manufacturer

Siegfried Hameln GmbH
Langes Feld 13
31789 Hameln
Germany
hameln rds s.r.o.
Horná 36
90001 Modra
Slovakia

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: 08.02.2025

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Information intended for healthcare professionals only:

Guide to preparation of the medicine:

Dobutamine hameln 12.5 mg/ml concentrate for solution for infusion

Full information on indications and other information can be found in the Summary of Product Characteristics.

1. Dosage and administration

The dose of Dobutamine hameln should be adjusted individually.

The required infusion rate depends on the patient's response to treatment and the occurrence of side effects.

Dosage

Dosage in adults:
Experience has shown that most patients respond to doses of 2.5–10 micrograms of dobutamine per kg of body weight per minute. In individual cases, doses of up to 40 micrograms of dobutamine per kg of body weight per minute have been used.
Dosage in children and adolescents:
In children and adolescents (from newborns to 18 years of age), the initial dose of 5 micrograms/kg/min is recommended, adjusted to clinical response in the range of 2 to 20 micrograms/kg/min. Occasionally, a response is obtained after administration of a small dose, ranging from 0.5 to 1.0 micrograms/kg/min.
It has been shown that the minimum effective dose in children is higher than in adults. When using higher doses, particular caution should be exercised, as it has been shown that the maximum tolerated dose in the treatment of children is lower than the doses used in adults. Most side effects (especially tachycardia) were observed after administration of dobutamine at a dose of 7.5 micrograms/kg/min or higher, but rapid resolution of side effects occurs after decreasing the infusion rate or discontinuing dobutamine infusion.
Among children, there is a large variability in both the plasma dobutamine concentration that elicits a hemodynamic response (threshold) and the rate of hemodynamic response to increased plasma concentration, indicating that the required dose cannot be predetermined for children and the dose should be adjusted taking into account the presumed narrower therapeutic range in children.

The following tables show the relationship between infusion rate and initial concentration for different doses of the medicinal product.

Infusion using infusion pumps
1 ampoule of Dobutamine hameln 12.5 mg/ml (250 mg in 20 ml) diluted to a solution volume of 500 ml (final concentration 0.5 mg/ml)

* When using twice the concentration, i.e. 500 mg of dobutamine added to 500 ml, or 250 mg added to 250 ml of solution, the infusion rate should be reduced by half.
Administration using infusion syringe pumps
1 ampoule of Dobutamine hameln 12.5 mg/ml (250 mg in 20 ml) diluted to a solution volume of 50 ml (final concentration 5 mg/ml)

The selected infusion syringe pump must be suitable for the volume and infusion rate.
Detailed information on suitable diluents can be found in section 6.6 of the Summary of Product Characteristics.

Dobutamine stress echocardiography (only adult population)

Administration during stress echocardiography involves gradual increase of dobutamine infusion.
The most commonly used dosing regimen starts with a dose of 5 micrograms/kg/min of dobutamine, increased every 3 minutes to 10, 20, 30, 40 micrograms/kg/min, until a diagnostic endpoint is reached (see method and duration of administration).
If the endpoint is not reached, atropine sulfate can be administered in a dose of 0.5 to 2 mg in divided doses of 0.25-0.5 mg at 1-minute intervals to increase heart rate. Alternatively, the dobutamine infusion rate can be increased to 50 micrograms/kg/min.
The use of dobutamine in children and adolescents is limited to the treatment of patients requiring positive inotropic effect.
Method of administration

The concentrate for solution for infusion should be diluted before administration.

Only for intravenous infusion. Must be diluted to a volume of 50 ml or more.
Intravenous infusion of dobutamine is possible after dilution with compatible infusion solutions, such as: 5% glucose solution (50 mg/ml), 0.9% sodium chloride solution (9 mg/ml) or 0.45% sodium chloride solution (4.5 mg/ml) in 5% glucose solution (50 mg/ml).
Infusion solutions should be prepared immediately before use.
Due to the short half-life of dobutamine, it must be administered as a continuous intravenous infusion.
When discontinuing treatment, the dose of dobutamine should be gradually decreased.
The duration of treatment depends on clinical requirements and should be as short as possible.
If dobutamine is administered continuously for more than 72 hours, tolerance may occur, requiring an increase in dose.
During dobutamine administration, heart rate, heart rhythm, blood pressure, diuresis, and infusion rate should be closely monitored. If possible, cardiac output, central venous pressure (CVP), and pulmonary capillary pressure (PCP) should be monitored.
Children and adolescents: To administer the medicinal product as a continuous infusion using an infusion pump, the solution should be diluted with 5% glucose solution (50 mg/ml) or 0.9% sodium chloride solution (9 mg/ml) to achieve a dobutamine concentration of 0.5 to 1 mg/ml (maximum 5 mg/ml with restriction of fluid volume). Administration of solutions with higher concentrations is only allowed through central venous access. The dobutamine infusion solution is incompatible with solutions containing bicarbonates and other strongly alkaline solutions.
Use in newborns in intensive care: Dilute 30 mg/kg body weight to a final infusion solution volume of 50 ml. Infusion at a rate of 0.5 ml per hour provides a dose of 5 micrograms/kg/min.
Dobutamine stress echocardiography (only adult population)
To detect myocardial ischemia and viability, dobutamine can only be administered by a doctor with sufficient experience in performing cardiac stress tests. Continuous monitoring of all areas of the heart using echocardiography and ECG, as well as blood pressure control, is necessary.
Monitoring equipment and life-saving medicines (e.g. defibrillator, intravenous beta-blockers, nitrates, etc.) and personnel trained in resuscitation should be available.
Instructions for dilution of the medicinal product before administration, see section 6.6 of the Summary of Product Characteristics.

2. Incompatibilities

To find out which solutions are incompatible with dobutamine and sodium metabisulfite, see section 6.2 of the Summary of Product Characteristics.
This medicinal product must not be mixed with other medicinal products, except for those for which compatibility has been confirmed.

3. Storage

There are no special recommendations for the storage temperature of the medicinal product.
Ampoules should be stored in the outer packaging to protect from light.
Do not freeze.
After dilution:
The ready-to-use infusion solution shows chemical and physical stability for 24 hours at a temperature up to 25°C.
From a microbiological point of view, unless the opening/reconstitution/dilution method precludes the risk of microbial contamination, the product should be used immediately.
If not used immediately, the user is responsible for the storage time and conditions during use.
The medicinal product should be used immediately after opening.
Any unused solution should be discarded.