Leaflet: information for the user

Leaflet: information for the user

DOBUTAMINA HOSPIRA 12.5 mg/ml

Concentrate for infusion solution EFG

Dobutamine

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

- Keep this leaflet, as you may need to read it again.

- If you have any questions, consult your doctor, pharmacist or nurse.

- This medicine has been prescribed for you only and should not be given to other people, even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What is Dobutamine Hospira 12.5 mg/ml and what it is used for

2. What you need to know before using Dobutamine Hospira 12.5 mg/ml

3. How to use Dobutamine Hospira 12.5 mg/ml

4. Possible side effects

5. Storage of Dobutamine Hospira 12.5 mg/ml

6. Contents of the pack and additional information.

Dobutamina belongs to a group of medications that increase the heart's contraction force.

Dobutamina is used in patients who need a stronger heart beat due to a decrease in their cardiac function, which is caused by a heart disease or operation. By direct action on the heart, dobutamina gives the heart more contraction power.

Dobutamina may be used to detect a poor blood supply to the heart (cardiac stress test).

Do not use Dobutamina Hospira 12.5 mg/ml

• If you are allergic to dobutamine, related substances to dobutamine, or any of the other components of this medication (described in section 6)of this medication
• If theheart is not pumping enough blood (decompensation) due to a heart muscle disease that causes the heart to be enlarged(hypertrophic cardiomyopathy).
• If you are allergic (hypersensitive) to sulfite antioxidants: specifically, asthmatic patients may experience reactionssuch as shortness of breath (bronchospasm) and an allergic reaction (anaphylactic shock).
• If you have amechanical obstruction in the blood flow to or from the heart, especially in the case of the following heart diseases: obstructive cardiomyopathy, aortic stenosis, or constrictive pericarditis.

If you have certain blood vessel or heart disorders, dobutamine should not be used to detect poor blood supply to the heart.

Warnings and precautions

Be especially careful with Dobutamina Hospira 12.5 mg/ml

• Ifblood pressure or heart rate becomes very highor theheart rate becomes irregularduring use. Your doctor should temporarily suspend treatment or reduce the dose.
• If you have a specific type of irregular heart rhythm (atrial fibrillation with rapid ventricular response). Your doctor should give you a medicine that increases the heart's pumping power (digitalis glycosides) before starting treatment with dobutamine.
• If you have severe coronary disease.
• If you have had arecent myocardial infarction(in 4-12 days),
• If you receive aprolonged perfusion(48-72 hours) of dobutamine. The effect of dobutamine may decrease and you may need higher doses.
• If you experiencecardiac shock with a decrease in blood volumebefore starting treatment with dobutamine. Your doctor needs to correct your blood volume before starting treatment with dobutamine.
• If you experience symptoms such asskin rash, pruritus, fever, and shortness of breath (bronchospasm). This may be due to an allergic reaction.
• If you aresusceptible to sulfites. Dobutamine may cause a typical allergic reaction that varies from mild asthma episodes to sometimes fatal anaphylactic shock.
• If you have ahistory of severe arrhythmias. Your doctor should exercise extreme caution when starting treatment with dobutamine.

Children and adolescents

Special care should be taken in the administration of dobutamine to childrenunder 1 year.They may react differently than adults.

Use of Dobutamina Hospira 12.5 mg/ml with other medications

Other medications may be affected by dobutamine. They, in turn, may affect dobutamine. Dobutamine may interact with:

• Certain medications used to treat high blood pressure (beta-blockers). These medications reduce the effect of dobutamine
• Certain medications for thecontrol of blood pressure, to improve blood flow, or for the control of sudden chest pain(nitroprusside and glyceryl trinitrate). These medications increase the effect of dobutamine.
• Inhalation anesthetics. These may increase the risk of arrhythmias (ventricular arrhythmias).
• Vitamin B1 (thiamine). Dobutamine may decrease vitamin B1 levels in the body.
• Atropine.There is a higher risk of adverse reactions when dobutamine is administered simultaneously withatropine(used in the detection of poor blood supply to the heart, cardiac stress test).

Inform your doctorif you are using or have recently used other medications, even those purchased without a prescription.

Use of Dobutamina Hospira 12.5 mg/ml with food and beverages

Foods and beverages do not affect the effects of dobutamine.

Pregnancy and lactation

If you are pregnant, you should not use dobutamine. There is not enough data to evaluate the possible harmful effects of administering dobutamine during pregnancy.

If you are breastfeeding, you should interrupt it during the duration of treatment with dobutamine.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

There is no data on the influence of this product on the ability to drive and operate machinery. However, the effect is unpredictable.

Important information about one of the components of Dobutamina Hospira 12.5 mg/ml

Dobutamine contains sodium metabisulfite. Sulfites may cause severe allergic reactions and bronchospasm.

This medication will generally be administered by a doctor or healthcare professional.

The dose (infusion rate and treatment duration) may be different for each patient and will be determined by the doctor.

Dobutamina must be added to an infusion bag using a sterile syringe with a glucose or saline solution.

The action of dobutamina begins 1-2 minutes after administration.

During administration, the colorless solution may turn pink without affecting its activity.

If you are administered more Dobutamina 12.5 mg/ml than you should:

The following symptoms may indicate that you have received more dobutamina than you should:

• Severe high blood pressure (hypertension)
• Fast heart rate (tachycardia)

The effect of dobutamina is of short duration. To alleviate the mentioned symptoms, a temporary pause in dobutamina administration or a reduction in infusion rate until stabilization is sufficient.

Consult with your doctor or pharmacist about any questions you have regarding your treatment.

Like all medications, dobutamine may have side effects, although not everyone will experience them. If you experience any side effect, it is essential to inform your doctor before starting the next treatment.

The following side effects have been described:

Very common (affect more than 1 in 10 patients)

• Increased heart rate
• Chest pain
• Abnormal heart rhythm

Common (affect up to 1 in 10 patients);

• Increased or decreased blood pressure
• Constriction of blood vessels (vasoconstriction)
• Irregular heart rhythm (palpitations)
• Headache
• Symptoms similar to asthma (bronchospasm)
• Labored breathing
• Increased white blood cell count (eosinophilia)
• Inhibition of blood clot formation
• Increased urine output (at high doses)
• Unpleasant sensation (nausea)
• Rash (exanthema)
• Fever
• Inflammation of the vein where the injection was administered (phlebitis)
• Fast contractions of the heart's ventricles (ventricular tachycardia)

Rare (affect up to 1 in 100 patients);

• Uncontrolled contractions of the heart's ventricles (ventricular fibrillation)
• Heart attack (myocardial infarction)

Very rare (affect up to 1 in 10,000 patients);

• Slow heart rate (bradycardia)
• Insufficient blood supply to the heart (myocardial ischemia)
• Low potassium levels in the blood (hypokalemia)
• Spots on the skin (petechiae)
• Cardiac arrest
• Constriction of blood vessels that supply the heart (coronary vasoconstriction)
• Skin necrosis
• Cardiac arrest
• Decompensation

Unknown (cannot be estimated from available data).

• Anxiety
• Pins and needles (paresthesia)
• Tremors
• Sensation of heat and anxiety
• Muscle cramps (myoclonic spasm)
• Decreased pulmonary capillary pressure
• Problems with the heart muscle (stress cardiomyopathy, also known as Takotsubo syndrome) that cause chest pain, difficulty breathing, dizziness, fainting, and irregular heartbeats when dobutamine is used for a stress echocardiogram

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children

Do not use this medication afterthe expiration date that appears on the box after CAD. The first number indicates the month and the last four numbers indicate the year. The expiration date refers to the last day of the month indicated.

Before dilution

Store in its original packaging between 2 – 30°C. Do not freeze.

Diluted product

If the dilution is performed under strict aseptic conditions, the diluted product is stable for 24 hours at 15-25°C (room temperature).

If the dilution is not performed under strict aseptic conditions, the diluted product is stable for a maximum of 24 hours at 2-8°C (in the refrigerator), or 12 hours at 15-25°C (room temperature).

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Dobutamina Hospira 12.5 mg/ml

• The active ingredient is dobutamine, 12.5 mg/ml. Dobutamine is present as dobutamine hydrochloride (14 mg/ml), which corresponds to 12.5 mg/ml of dobutamine
• The other ingredients are sodium metabisulphite, hydrochloric acid, sodium hydroxide, and water for injection

Appearance of the product and contents of the container

Dobutamine is aclear and colorless concentrated solution for perfusion conditioned in transparent glass vials with a colored point.

The slightly pink color of the solution may intensify over time, without affecting the activity of the solution.

Dobutamine is available in boxes of 1.5 or 10 vials of 20 ml.

Not all container sizes may be marketed.

Holder of the marketing authorization and manufacturer

Holder of the marketing authorization:

HOSPIRA INVICTA, S.A.

Avenida de Europa 20-B - Parque Empresarial La Moraleja

28108 Alcobendas, Madrid-Spain

Responsible for manufacturing

ANTIGEN PHARMACEUTICALS LTD.
Roscrea (Roscrea, County Tipperary) - - - Ireland or


SYNTHON HISPANIA, S.L.
Castello 1, Poligono Las Salinas. (Sant Boi de Llobregat (Barcelona)) - 08830 – Spain

Local Representative:

PFIZER S.L.

Avenida de Europa, 20 B – Parque Empresarial La Moraleja

28108,Alcobendas (Madrid)-Spain

This medicine is authorized in the member states of the European Economic Space with the following names:

Netherlands:Dobutamine 12.5 mg/ml concentrate for infusion

Belgium:Dobutamine EG 250 mg/20 ml concentrate for intravenous infusion

Luxembourg:Dobutamine EG solution for perfusion

Portugal:Dobutamina Genthon 12.5 mg/ml concentrated solution for perfusion

Last review date of this leaflet03/2022

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/