Dobutamine tzf

Package leaflet: Information for the patient

DOBUTAMINE TZF, 250 mg, lyophilisate for preparation of infusion solution
Dobutamini hydrochloridum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

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

Dobutamine – the active substance in Dobutamine TZF – is a synthetic catecholamine. The medicine increases the force of contraction of the heart muscle, slightly accelerates heart rate and atrioventricular conduction.
Indications
Dobutamine is used in acute heart failure occurring during cardiogenic shock, myocardial infarction, and after cardiothoracic surgical procedures.
Children and adolescents
Dobutamine TZF is indicated in children and adolescents (from newborns up to 18 years of age) when positive inotropic support is required in patients with reduced cardiac output due to hypoperfusion resulting from decompensated heart failure after cardiothoracic surgery, cardiomyopathy, cardiogenic shock, or septic shock.

2. Important information before using Dobutamine TZF

When not to use Dobutamine TZF

• If the patient is allergic to dobutamine or any of the other ingredients of this medicine (listed in section 6).
• If the patient has hypertrophic cardiomyopathy with left ventricular outflow tract obstruction.
• If the patient has a condition called hypertrophic aortic valve stenosis.

Warnings and precautions
Dobutamine TZF is administered only as an intravenous infusion by appropriately trained medical personnel. During intravenous infusion of dobutamine, medical staff monitor heart rate and rhythm, arterial blood pressure, ECG, urine output, and infusion rate.
Dobutamine may increase heart rate, raise systolic blood pressure, or worsen arrhythmias. In such cases, the physician should reduce the dose or temporarily discontinue dobutamine administration.
Dobutamine may exacerbate ventricular extrasystoles; however, ventricular tachycardia or ventricular fibrillation rarely occur. Since dobutamine facilitates atrioventricular conduction, patients with atrial flutter or fibrillation may develop rapid ventricular response.
Particular caution is required when administering dobutamine to patients with myocardial infarction. Significant increase in heart rate or elevation of arterial blood pressure may aggravate myocardial ischemia, cause angina pectoris, and lead to ST-segment elevation on the electrocardiogram.
Inotropic agents, including dobutamine, do not improve hemodynamics in most patients with mechanical obstruction impairing ventricular filling or (and) outflow. This applies to patients with cardiac tamponade, aortic valve stenosis, or idiopathic hypertrophic subaortic stenosis.
Peripheral vasoconstriction may occur in patients who have previously received β-adrenergic blocking agents.
The use of dobutamine as an alternative to exercise testing is not recommended in patients with unstable angina pectoris, bundle branch block, valvular heart disease, aortic outflow obstruction, or other cardiac conditions that would make dobutamine stress testing inappropriate.
A potential complication following myocardial infarction is cardiac rupture. Risk factors for cardiac rupture (including septal and free wall rupture) include infarct location and timing.
Occasionally, a drop in blood pressure may be observed during dobutamine infusion. In such cases, reducing the dose or stopping the infusion usually results in a rapid return of blood pressure to baseline levels. However, in rare instances, more significant medical intervention may be required, and blood pressure normalization may not be immediate.
Dobutamine should be administered with great caution to patients with severely low blood pressure due to cardiogenic shock (mean arterial pressure below 70 mm Hg).
In patients with reduced circulating blood volume, blood volume should be restored prior to initiating treatment.
Persistent low arterial pressure or ongoing hypotension during dobutamine administration, despite adequate right ventricular filling pressure and cardiac output, may indicate the need for administration of peripheral vasoconstricting agents such as dopamine or noradrenaline.
Patients with renal impairment should inform their physician before receiving this medicine.

Children
Tachycardia and increased arterial blood pressure occur more frequently and are more pronounced in children than in adults. There are reports of reduced cardiovascular system sensitivity to dobutamine in neonates, and hypotensive effects (low blood pressure) appear to be observed more often in adults than in young children.
Therefore, administration of dobutamine in children requires careful monitoring.
Consult a physician, even if the above warnings relate to conditions that occurred in the past.

Dobutamine TZF with other medicines
Inform your doctor about all medicines currently used, recently used, or planned for use.
Some medicines may interact with dobutamine, potentially reducing the effectiveness of concomitant therapy or causing dangerous adverse reactions. These include:

• halogenated general anesthetics;
• entacapone (a medicine used in patients with Parkinson's disease and motor fluctuations);
• β-adrenolytics (a group of drugs acting as antagonists at β1- and β2-adrenergic receptors, used, among others, in hypertension, ischemic heart disease, cardiac arrhythmias, hyperthyroidism, glaucoma, and anxiety disorders).

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she might be pregnant, or plans to become pregnant, she should consult her doctor before using this medicine.
Dobutamine TZF may be used during pregnancy only if the benefit to the mother outweighs the potential risk to the fetus.

Driving and operating machinery
Not applicable.

3. How to use Dobutamine TZF

Dobutamine TZF is intended exclusively for use in a hospital setting under strict medical supervision.
Dobutamine should be administered only as an intravenous infusion.
The medicine may be administered only by qualified medical personnel.

Recommended dose
Adults
The usual dose ranges from 2.5 micrograms/kg body weight/minute to 10 micrograms/kg body weight/minute. In some patients, a dose of 0.5 microgram/kg body weight/minute may be sufficient. The need for higher doses of dobutamine, occasionally up to 40 micrograms/kg body weight/minute, is very rare.

Use in children and adolescents
In children and adolescents (from newborns to 18 years of age), an initial dose of 5 micrograms/kg body weight/minute is recommended, adjusted according to clinical response within the range of 2 to 20 micrograms/kg body weight/minute. Occasionally, a clinical response may be achieved with a low dose of 0.5 to 1.0 microgram/kg body weight/minute. The required dose for children cannot be determined in advance. It should be calculated taking into account the presumed narrower therapeutic window compared to adults.

If you feel that the medicine's effect is too strong or too weak, consult your doctor.

The prepared dobutamine solution should be used within 24 hours.
The method of administration and preparation of the solution is described at the end of this leaflet, under the section "Information intended exclusively for healthcare professionals."

Overdose of Dobutamine TZF
Symptoms of dobutamine overdose are rarely observed.
Overdose may cause the following symptoms: loss of appetite, nausea, vomiting, muscle tremors, severe anxiety, palpitations, headache, shallow breathing, and angina-like or atypical chest pain. Additionally, dobutamine may cause increased blood pressure and cardiac arrhythmias (including ventricular tachyarrhythmias, up to ventricular fibrillation). A decrease in blood pressure may also occur.
If any of the above symptoms occur, the medicine should be discontinued immediately and medical advice should be sought.

Missed dose of Dobutamine TZF
Since the medicine is administered in a hospital, missing a dose at the scheduled time is highly unlikely.

4. Possible adverse reactions

Like all medicines, Dobutamine TZF can cause adverse reactions, although not everyone will experience them.
In patients receiving dobutamine infusion for more than 72 hours, tolerance to the drug may develop. To maintain the same level of dobutamine effect, gradual dose escalation may be necessary.

Very common (occurring in more than 1 out of 10 patients)

• increased heart rate
• chest pain
• heart rhythm disturbances.

Common (occurring in 1 to 10 out of 100 patients)

• headache
• increase or decrease in blood pressure
• narrowing of blood vessels (vasoconstriction)
• angina pain
• irregular heartbeat (palpitations)
• asthma-like symptoms (bronchospasm), shortness of breath
• dyspnea
• increased number of white blood cells (eosinophilia)
• inhibition of blood clot formation
• skin rash
• elevated body temperature
• phlebitis (at the injection site).

Uncommon (occurring in 1 to 10 out of 1,000 patients)

• accelerated ventricular contractions (ventricular tachycardia)
• contractions of heart ventricles and atria (ventricular fibrillation, atrial fibrillation)
• heart attack (myocardial infarction).

Very rare (occurring in less than 1 out of 10,000 patients)

• slowed heart rate (bradycardia)
• cardiac arrest
• insufficient blood supply to the heart (myocardial ischemia)
• low potassium levels (hypokalemia); in some cases, the physician may consider monitoring potassium levels
• skin spots (petechiae), skin necrosis at the site of intravenous dobutamine administration
• narrowing of blood vessels supplying the heart (coronary artery constriction).

Frequency not known – frequency cannot be determined from available data

• chest pain caused by stress (stress-induced cardiomyopathy)
• allergic reactions (hypersensitivity reactions), including rash, fever, increased number of white blood cells (eosinophilia), and asthma-like symptoms (bronchospasm)
• muscle spasms (clonic seizures) in patients receiving dobutamine with severe renal failure
• ectopic rhythm (a type of cardiac arrhythmia)
• abnormal cardiac function test results (ST segment elevation in ECG)
• myocarditis (eosinophilic myocarditis) in heart transplant patients
• heart block (left ventricular outflow tract obstruction)
• cardiac rupture
• anxiety
• nausea
• tingling (paresthesia)
• tremor
• increased need to urinate
• sensation of warmth
• brief, rapid muscle jerks (myoclonic jerks)
• disturbances in heart muscle function (stress cardiomyopathy, also known as takotsubo syndrome), manifesting as chest pain, dyspnea, dizziness, fainting, and irregular heartbeat, occurring during dobutamine administration in stress echocardiography.

Impaired left ventricular outflow has been observed during stress echocardiography.
In very rare cases, cardiac rupture resulting in death has been observed during dobutamine stress testing.
Eosinophilic myocarditis has been observed in patients with transplanted hearts who had received multiple drugs such as dobutamine or other inotropic agents (drugs modulating cardiac contractility) prior to transplantation.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Dobutamine TZF

Keep this medicine out of the sight and reach of children.
Store below 25 °C. Keep in the original packaging to protect from light.
Do not use this medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Dobutamine TZF contains
The active substance is dobutamine in the form of dobutamine hydrochloride.
One vial contains 250 mg of dobutamine as dobutamine hydrochloride.
The other ingredient is: mannitol.
To adjust to the appropriate pH value, 0.1 mol/l HCl solution is used.

What Dobutamine TZF looks like and contents of the pack
White or almost white lyophilisate in the form of a disc or fragments of varying size.

Pack
1 or 25 vials in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga 2
03-176 Warsaw
Telephone number: (22) 811-18-14
For more detailed information, please contact the Marketing Authorisation Holder.

Information intended exclusively for medical professionals

Administration method
Dobutamine is administered only as a continuous intravenous infusion using precision infusion devices.
The infusion rate and duration of treatment should be adjusted according to the patient's heart rate and rhythm, taking into account hemodynamic parameters (arterial pressure, ventricular filling pressure, central venous pressure, pulmonary artery wedge pressure, stroke volume or cardiac output, diuresis).

Administration in children
To administer the medicinal product as a continuous infusion using an infusion pump, the solution should be diluted with 5% glucose solution or 0.9% sodium chloride solution to achieve a dobutamine concentration of 0.5 to 1 mg/ml (up to a maximum of 5 mg/ml when fluid volume must be limited).
Administration of solutions with higher concentrations is permitted only via central venous access.
Dobutamine infusion solution is incompatible with solutions containing bicarbonates and other strongly alkaline solutions.

Use in neonates under intensive care conditions
Dilute a dose of 30 mg/kg body weight to a final volume of 50 ml of infusion solution. An infusion rate of 0.5 ml per hour delivers a dose of 5 micrograms/kg body weight/minute.
Dobutamine should be discontinued gradually. A gradual reduction in the intravenous infusion rate is recommended. During dose tapering, the patient's condition and hemodynamic parameters should be closely monitored.

Preparation of the solution
To the vial containing 250 mg of dobutamine, add 20 ml of water for injections or 20 ml of 5% glucose solution. After shaking, the resulting solution should be diluted by transferring it into 250 ml or 500 ml of one of the following infusion fluids: 5% glucose solution, 0.9% sodium chloride solution, or 5% glucose solution in 0.9% sodium chloride solution (1:1 ratio). The resulting concentrations of the prepared solution, depending on the diluent volume used, are as follows:

• 250 ml infusion solution – 1000 micrograms of dobutamine per 1 ml
• 500 ml infusion solution – 500 micrograms of dobutamine per 1 ml

Dobutamine solutions may be stored for 24 hours at a temperature of 2°C to 8°C (refrigerator). They also maintain physicochemical stability for 24 hours at room temperature.

Note: A slight change in color of the solution stored at room temperature to pale pink does not affect the physicochemical stability of the drug.

Pharmaceutical incompatibilities
Dobutamine solution should not be mixed with other medicinal products.
Do not add 5% sodium bicarbonate solution or other strongly alkaline solutions to dobutamine solutions.
Dobutamine hydrochloride must not be mixed with substances or solutions containing ethanol or sodium metabisulfite.