Dobutamin hameln

Package Leaflet: Information for the User

Dobutamin Hameln 5 mg/ml Solution for Infusion

Dobutaminum

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or nurse. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Dobutamin Hameln and what is it used for

Dobutamin Hameln belongs to a group of medicines called catecholamine amines. It works by increasing the efficiency of the heart's work. It strengthens the heart's pumping action, increasing blood flow in the body and dilating veins and arteries.

Dobutamin 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 Dobutamin 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 Dobutamin Hameln

When not to use Dobutamin 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 prevents the heart from filling or pumping blood properly(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).

Dobutamin 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 Dobutamin Hameln, discuss it with your doctor.
Before starting treatment, 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

Increased heart rate and increased blood pressure occur more frequently and are more pronounced
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 young
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.

Dobutamin Hameln and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
It is essential to inform your doctor, as the following medicines may affect the action of Dobutamin 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 plan to have a child, consult your doctor or pharmacist before using this medicine.
Dobutamine should not be given to pregnant women unless medically justified. If the use of dobutamine during breastfeeding is necessary, it is recommended to interrupt breastfeeding during treatment.

Driving and using machines

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

Dobutamin Hameln contains sodium

The medicine contains 3.06 mg of sodiumper 1 ml.
A 50 ml vial contains 153 mg of sodium.This corresponds to 7.7% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Dobutamin Hameln

Dobutamin 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 the dose of dobutamine each patient receives and adjusts the infusion rate and duration.
Dosage in adults:
Most patients respond to a dose of 2.5–10 micrograms of dobutamine per kilogram of body weight per minute. A dose of up to 40 micrograms of dobutamine per kilogram of body weight per minute can be administered.
Dosage in children and adolescents:
In children and adolescents (from newborns to 18 years), 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 microgram/kg/min.
The dose should be determined taking into account the presumably 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 may occur:

Very common side effects (may affect more than 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 affect up to 1 in 10 people):

• increased or decreased blood pressure
• vessel constriction (vasoconstriction)
• irregular heartbeat (palpitations)
• fast heart rate (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 affect up to 1 in 100 people):

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

Rare side effects (may affect up to 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 conduction disorders
• 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 the 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 package leaflet, please inform your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Drug Monitoring of the Office for Registration 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 Dobutamin Hameln

• Store the medicine 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 vials 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 no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Dobutamin Hameln contains

The active substance is dobutamine
1 ml of solution contains 5 mg of dobutamine.
1 vial of 50 ml of Dobutamin Hameln contains 250 mg of dobutamine.
The other ingredients are: sodium metabisulfite, sodium chloride, hydrochloric acid 1N (to adjust pH) and water for injections

What Dobutamin Hameln looks like and contents of the pack

Dobutamin Hameln is a clear, colorless or slightly yellowish solution for infusion.
The immediate packaging is a vial made of colorless glass (type I) with a stopper (type I) made of bromobutyl rubber, with an aluminum cap with a plastic flip-off cap, containing 50 ml of Dobutamin Hameln. The cardboard box contains 1, 5 or 10 vials.
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.

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

Date of last revision of the package leaflet:08.02.2025
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Information intended for healthcare professionals only:

Guide to preparation of the medicine:

Dobutamin Hameln 5 mg/ml 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 Dobutamin Hameln should be adjusted individually.

The infusion rate depends on the patient's response to therapy 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 kilogram of body weight per minute. In individual cases, doses of up to 40 micrograms of dobutamine per kilogram of body weight per minute have been used.
Dosage in children and adolescents:
In children and adolescents (from newborns to 18 years), 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 microgram/kg/min.
It has been shown that the minimum effective dose in children is higher than in adults. When using higher doses, caution should be exercised, as 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 occurred after decreasing the infusion rate or discontinuing dobutamine.
Among children, there was a large variation in both the concentration of dobutamine in serum that elicited a hemodynamic response (threshold) and the rate of hemodynamic response to increased serum concentration, indicating that the required dose cannot be predetermined for children and the dose should be determined taking into account the presumably narrower therapeutic range in children.

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

Dosage using infusion pumps
1 vial of Dobutamin Hameln 5 mg/ml (250 mg in 50 ml) diluted to a final 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 vial of Dobutamin Hameln 5 mg/ml (250 mg in 50 ml) undiluted
(final concentration 5 mg/ml)

The selected infusion syringe pump must be suitable for the volume and infusion rate.
For detailed information on compatible diluents, see 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 may 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
For intravenous infusion only. If a syringe pump is used, dilution is not required.
Intravenous infusion of Dobutamin Hameln is also 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). (For detailed information on diluents, see section 6.6.) The 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 reduced.
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 a concentration of dobutamine from 0.5 to 1 mg/ml (maximum 5 mg/ml when fluid volume is limited). 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 volume of 50 ml of infusion solution. 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 in viability studies, dobutamine may 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 storage instructions for the medicinal product.
Do not freeze.
Store the vials in the outer packaging to protect from light.
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 method of opening/reconstitution/dilution excludes the risk of microbial contamination, the product should be used immediately.
If not used immediately, the in-use storage times and conditions are the responsibility of the user.