DOPAMINE BASI 40 mg/mL CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the Patient

Dopamine Basi 40 mg/ml Concentrate for Solution for Infusion EFG

dopamine hydrochloride

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What Dopamine Basi is and what it is used for
2. What you need to know before you are given Dopamine Basi
3. How Dopamine Basi is given
4. Possible side effects
   1. Storage of Dopamine Basi

1. Contents of the pack and further information

1. What Dopamine Basi is and what it is used for

Dopamine Basi is a sympathomimetic used in shock of any etiology: cardiogenic shock post-stroke, surgical shock, hypovolemic or hemorrhagic shock, septic shock, anaphylactic shock.

2. What you need to know before you are given Dopamine Basi

You should not be given Dopamine Basi

• if you are allergic to dopamine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• if you have a tumor that causes an increase in blood pressure.
• if you have irregular or rapid heartbeats.

If possible, inform your doctor if you have any of the above before using this medicine.

Warnings and precautions

Talk to your doctor or nurse before you start using Dopamine Basi.

You need to be especially careful with Dopamine Basi:

• if you have diabetes.
• if you have kidney or liver problems.
• if you have a history of blood circulation problems (you will be monitored to detect any changes in the color or temperature of your fingers or toes).
• if you have narrow-angle glaucoma.
• if you have benign prostatic hyperplasia with urinary retention.
• if you have an overactive thyroid gland.

If possible, inform your doctor if you have any of the above before using this medicine.

Other medicines and Dopamine Basi

You need to be especially careful if you are using other medicines, as some may interact with dopamine, for example:

• anesthetics (dopamine should not be used with cyclopropane and halogenated hydrocarbon anesthetics);
• alpha-blockers and beta-blockers, such as propranolol (medicines often used to treat blood pressure and heart disorders);
• monoamine oxidase inhibitors (antidepressant medicines);
• phenytoin (a medicine used to treat epilepsy);
• reserpine, cardiac glycosides, metoclopramide;
• thyroid hormones;
• antiarrhythmics;
• butyrophenones (such as haloperidol) and phenothiazines: these substances can suppress the mesenteric and renal vasodilation caused by the administration of dopamine at low doses.

Tell your doctor if you are using, have recently used, or might use any other medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Your doctor will only use this medicine if the expected benefits outweigh any potential risk to your baby.

Dopamine Basi contains sodium metabisulfite (E223)

This ingredient can rarely cause severe hypersensitivity reactions (severe allergy) and bronchospasm (breathing difficulties).

This medicine contains less than 1 mmol of sodium (23 mg) per ampoule; it is essentially "sodium-free".

3. How Dopamine Basi is given

This medicine will be diluted before it is given to you. It will be given as an infusion (drip) into a vein.

Dose

If your blood volume is low, you may be given a blood transfusion or a plasma expander before dopamine is given to you.

Your doctor will decide the correct dose of dopamine for you and how often it should be given. The dose will depend on your clinical condition and body weight.

The rate of administration will be carefully controlled and adjusted according to your response. During treatment, your heart rate, blood pressure, and urine output will be measured to check your response.

If you are given too much Dopamine Basi

This medicine will be given to you in a hospital, under the supervision of a doctor. It is unlikely that you will be given too much or too little, however, tell your doctor or nurse if you have any doubts.

4. Possible side effects

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

The most common reactions include:

• Headache, anxiety, tremor;
• Ectopic heartbeats, fast heart rate (tachycardia), angina-related pain (anginal pain), palpitations, low blood pressure (hypotension), and narrowing of small arteries (vasoconstriction);
• Difficulty breathing (dyspnea);
• Discomfort (nausea) and vomiting;
• Frequent urination (polyuria);
• Increased glucose levels in the blood and urea nitrogen levels in the blood (BUN).

Less common reactions include:

• Goosebumps (piloerection);
• Large pupil dilation (mydriasis);
• Abnormal heart conduction (irregular conduction), slow heart rate (bradycardia), elevated QRS (electrocardiogram), high blood pressure (hypertension), gangrene, and fatal ventricular arrhythmias (irregular heartbeat);
• Kidney failure (azotemia).

Other adverse reactions include:

• Allergic reactions (hypersensitivity);
• Bluish skin discoloration (cyanosis);
• Breathing difficulties (bronchospasm);
• Localized death of skin tissue (necrosis).

This medicine can also cause biochemical changes in your blood, such as:

• Decreased prolactin levels in the blood;
• Decreased somatotropin levels in the blood;
• Decreased thyrotropin levels in the blood;
• Abnormal thyroid function test results.

Your doctor may take blood samples to monitor these changes.

Severe or potentially fatal reactions:

Gangrene of the limbs has occurred after higher doses and at lower doses in patients with pre-existing vascular disease.

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dopamine Basi

Do not store above 30°C.

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 label and carton after EXP. The expiry date is the last day of the month stated.

Parenteral medicines should be inspected visually before administration for signs of particulate matter and discoloration. Do not use if the injection has a color darker than slightly yellow or any other type of discoloration.

6. Contents of the pack and further information

Composition of Dopamine Basi

• The active ingredient is dopamine hydrochloride. Each ml of solution contains 40 mg of dopamine hydrochloride.
• The other ingredients are sodium metabisulfite (E223), sodium hydroxide and/or hydrochloric acid (for pH adjustment), and water for injections.

Appearance and packaging

Concentrate for solution for infusion, for intravenous administration.

Dopamine Basi is a clear and colorless solution, packaged in type I glass ampoules, one-point-cut (OPC), with a capacity of 5 ml, containing 5 ml of solution.

Package sizes: 6, 10, or 50 ampoules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratórios Basi - Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, lote 15

3450-232 Mortágua

Portugal

Tel: + 351 231 920 250

Fax: + 351 231 921 055

Email: [email protected]

Manufacturer

Laboratórios Basi – Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, lotes 8, 15 e 16

3450-232 Mortágua

Portugal

You can request more information about this medicine from the local representative of the marketing authorization holder:

LAPHYSAN, S.A.U.

Anabel Segura 11, Edificio A, Planta 4, Puerta D,

28108 Alcobendas - Madrid

Spain

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

Portugal Dopamina Isab

Spain Dopamina Basi 40 mg/ml concentrate for solution for infusion EFG

Date of last revision of this leaflet: January 2025

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

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This information is intended only for healthcare professionals:

Incompatibilities

Dopamine Basi concentrate for solution for infusion should not be added to any alkaline intravenous solution, i.e., sodium bicarbonate. No solution that presents physical or chemical incompatibility due to color change or precipitate should be administered.

It is recommended to avoid mixtures containing gentamicin sulfate, cefalotin sodium, cefalotin sodium neutral, or oxacillin sodium, unless all other viable alternatives have been exhausted.

Mixtures of ampicillin and dopamine in 5% glucose solution are alkaline and incompatible, causing the decomposition of both drugs. They should not be mixed.

Mixtures of dopamine and amphotericin B in 5% glucose solution are incompatible, as a precipitate forms immediately after mixing.

Special precautions for disposal and other handling

For single use.

Disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.

Parenteral medicines should be inspected visually before administration for signs of particulate matter and discoloration. Do not use if the injection has a color darker than slightly yellow or any other type of discoloration.

Preparation of Solutions for Infusion

Suggested Dilution

Transfer the sterile concentrate for solution for infusion aseptically to the intravenous solution as indicated in the following table:

Dopamine Basi can be diluted with:

• Sodium chloride 0.9% injection
• Glucose 5% injection
• Glucose 5% and sodium chloride 0.9% injection
• Sodium chloride 0.45% solution
• Glucose 5% and sodium chloride 0.45% solution
• Glucose 5% and Ringer lactate solution
• Sodium lactate 1/6 molar injection
• Ringer lactate injection

Expiry after dilution:

Use immediately after dilution.