DOBUTAMINE HOSPIRA 12.5 mg/ml CONCENTRATE FOR INFUSION SOLUTION

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

Do not use Dobutamine Hospira 12.5 mg/ml

• If you are allergic to dobutamine, substances related to dobutamine, or any of the other componentsof this medicine (described in section 6)
• If your heart does not pump enough blood (decompensation) due to a disease in the heart muscle 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 a mechanical obstruction in 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 Dobutamine Hospira 12.5 mg/ml

• If your blood pressure or heart rate becomes too highor your heart rate becomes irregularduring use. Your doctor should temporarily stop treatment or reduce the dose.
• If you have a specific type of irregular heartbeat (atrial fibrillation with rapid ventricular response). The 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 artery disease.
• If you have had a recent heart attack(within 4-12 days),
• If you receive prolonged infusion(48-72 hours) of dobutamine. The effect of dobutamine may decrease, and you may need higher doses.
• If you experience cardiogenic 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 as rash, itching of the scalp, fever, and shortness of breath (bronchospasm). This may be due to a hypersensitivity reaction.
• If you are susceptible to sulfites. Dobutamine can cause a typical allergic reaction that ranges from mild asthmatic episodes to sometimes fatal anaphylactic shock.
• If you have a history of severe heart rhythm disorders. Your doctor should exercise extreme caution when starting therapy with dobutamine.

Children and adolescents

Special care should be taken when administering dobutamine to children under 1 year of age. They may react differently to adults.

Using Dobutamine Hospira 12.5 mg/ml with other medicines

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

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

Tell your doctorif you are using or have recently used other medicines, even those bought without a prescription.

Using Dobutamine Hospira 12.5 mg/ml with food and drinks

Food and drink do not affect the effects of dobutamine.

Pregnancy and breastfeeding

If you are pregnant, you should not use dobutamine. There is not enough data to assess the potential harmful effects of dobutamine administration 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 medicine.

Driving and using machines

There is no data on the influence of this product on the ability to drive and use machines. However, the effect is not predictable.

Important information about some of the ingredients of Dobutamine Hospira 12.5 mg/ml

Dobutamine contains sodium metabisulfite. Sulfites can rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to use Dobutamine Hospira 12.5 mg/ml

As a general rule, this medicine will 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.

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

The action of dobutamine starts 1-2 minutes after administration.

During administration, the colorless solution may acquire a pink color without affecting the activity.

If you are given more Dobutamine 12.5 mg/ml than you should:

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

• high blood pressure (severe hypertension)
• fast heart rate (tachycardia)

The effect of dobutamine is only short-term. To alleviate the mentioned symptoms, it is sufficient to temporarily pause the administration of dobutamine or reduce the infusion rate until it stabilizes.

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

4. Possible side effects

Like all medicines, dobutamine can have side effects, although not everybody gets them. If you experience any side effect, it is important that you inform your doctor before starting the next treatment.

The following side effects have been reported:

Very common (affects more than 1 in 10 patients)

• increased heart rate
• chest pain
• heart rhythm disorders

Common (affects up to 1 in 10 patients)

• increased or decreased blood pressure
• constriction of blood vessels (vasoconstriction)
• irregular heartbeat (palpitations)
• headache
• asthma-like symptoms (bronchospasm)
• shortness of breath
• increased white blood cell count (eosinophilia)
• inhibition of blood clot formation
• increased urine production (at high doses)
• feeling of discomfort (nausea)
• rash (exanthema)
• fever
• inflammation of the vein where the injection was made (phlebitis)
• rapid ventricular contractions (ventricular tachycardia)

Uncommon (affects up to 1 in 100 patients)

• uncontrolled ventricular contractions (ventricular fibrillation)
• heart attack (myocardial infarction)

Rare (affects up to 1 in 1,000 patients)

• slow heart rate (bradycardia)
• insufficient blood supply to the heart (myocardial ischemia)
• low potassium levels in the blood (hypokalemia)
• skin spots (petechiae)
• heart block
• constriction of the blood vessels that supply the heart (coronary vasospasm)
• skin necrosis
• cardiac arrest
• decompensation

Unknown frequency (cannot be estimated from the available data)

• restlessness
• tingling and cramps (paresthesia)
• tremors
• feeling of heat and anxiety
• muscle cramps (myoclonic spasm)
• decrease in pulmonary capillary pressure
• heart muscle problems (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 side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dobutamine Hospira 12.5 mg/ml

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 carton after EXP. The first two digits indicate the month and the last four digits indicate the year. The expiry date refers to the last day of the month stated.

Before dilution

Store in the original package 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).

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dobutamine Hospira 12.5 mg/ml

• The active substance 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 metabisulfite, hydrochloric acid, sodium hydroxide, and water for injection

Appearance and packaging

Dobutamine is a clear and colorless concentrate for solution for infusion packaged in transparent glass ampoules with a colored spot.

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

Dobutamine is available in packs of 1.5 or 10 ampoules of 20 ml.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

HOSPIRA INVICTA, S.A.

Avda. de Europa 20-B - Parque Empresarial La Moraleja

28108 Alcobendas, Madrid-Spain

Manufacturer

ANTIGEN PHARMACEUTICALS LTD.Roscrea (Roscrea, County Tipperary) - - - Ireland orSYNTHON 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 Area under the following names:

Netherlands: Dobutamine 12.5 mg/ml concentrate for infusion

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

Luxembourg: Dobutamine EG solution for infusion

Portugal: Dobutamine Genthon 12.5 mg/ml concentrate for solution for infusion

Date of last revision of this leaflet03/2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/