PROSPECTO: INFORMATION FOR THE USER

Noradrenaline B. Braun 0.5mg/ml Concentrate for Solution for Infusion

L-Norepinephrine

Noradrenalina B. Braunbelongs to a group of medicines called “adrenergic and dopaminergic agents”, which act by increasing blood pressure.

Noradrenalina B. Braunis used for the treatment of acute drops in blood pressure (acute hypotension).

Do not use Noradrenalina B. Braun:

• If you are allergic to noradrenaline bitartrate or any of the other components of this medication (listed in section 6).
• As the only therapy if you have low blood pressure (hypotension) due to a decrease in blood volume (hypovolemia).
• In lower extremities of elderly patients and with occlusive diseases, due to a possible decrease in blood vessel diameter (vasoconstriction).
• If you are to be administered other medications during anesthesia such as halothane or cyclopropane.
• If you have gastrointestinal ulcers or bleeding.

In patients who do not tolerate sulfites

Warnings and precautions:

Consult your doctor before starting to use Noradrenalina B. Braun.

Report any allergy or medical problem you have or have had, especially if:

• You are diabetic.
• You have an excess of thyroid hormone production (hyperthyroidism).
• You are lacking oxygen.
• You have any occlusive disease such as hardening of the arteries (arteriosclerosis) or inflammation of a vein with formation of a blood clot (Buerger's disease).
• You have had a blood clot in the interior of a blood vessel (thrombosis).
• You have high levels of carbon dioxide in the blood
• You have low oxygen levels in the blood.

Use of Noradrenalina with other medications:

Inform your doctor or pharmacist if you are using, or have recently used other medications, even those acquired without a prescription.

Certain medications may interact with Noradrenalina B. Braun. These should be administered with caution, sometimes modifying their dose (and/or that of Noradrenalina B. Braun).

It is essential to inform your doctor if you are using or have recently used any of the following medications:

• Organic anesthetics (particularly cyclopropane and halothane)
• Antidepressants: tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs) or maprotiline
• Digitalis glycosides
• Ergoloid mesylates or ergotamine
• Levodopa
• Cocaine
• Chlorpheniramine hydrochloride, tripelennamine hydrochloride, and desipramine
• Medications for allergy treatment: antihistamines
• Amphetamines
• Doxapram
• Mazindol
• Mecamilamine or methyldopa
• Methyphenidate
• Rauwolfia alkaloids
• Other sympathomimetics
• Thyroid hormones
• Dihydroergotamine, ergometrine, methylergometrine, or metisergide
• Medications for hypertension (such as guanadrel and guanethidine) or to increase urine elimination (diuretics)
• Desmopressin, lisopressin, or vasopressin
• β-adrenergic blockers
• Lithium

Pregnancy and lactation

Pregnancy:

Consult your doctor or pharmacist before using any medication. Before Noradrenalina B. Braun is administered to you, inform your doctor if you are pregnant or trying to become pregnant, as there may be risks for the unborn child.

Lactation:

Consult your doctor or pharmacist before using any medication. It is unknown whether it is excreted in breast milk, so your doctor will assess the need for its administration.

Noradrenalina B. Braun contains sodium and sodium metabisulfite (E-223):

10 ml ampoules:

This medication contains 34.24 mg of sodium (main component of table salt/for cooking) in each 10 ml ampoule. This is equivalent to 1.71% of the maximum daily sodium intake recommended for an adult.

50 ml vial:

This medication contains 171.2 mg of sodium (main component of table salt/for cooking) in each 50 ml vial. This is equivalent to 8.56% of the maximum daily sodium intake recommended for an adult.

This medication may cause severe allergic reactions and bronchospasm (sudden feeling of choking) because it contains sodium metabisulfite (E-223).

Noradrenalina B. Braun is administered via intravenous route.

This medication will always be administered by healthcare personnel.

Your doctor will decide the dose and frequency at which you will be administered the medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor again.

If you use more Noradrenalina B. Braun than you should:

In case of overdose or accidental ingestion, consult the Toxicological Information Service (phone: 91.562 04 20) or consult your doctor or pharmacist. Bring this leaflet with you.

This is unlikely to happen, as your doctor will determine your daily doses. However, if you receive more Noradrenalina B. Braun than you should, this could cause:

A severe increase in blood pressure with intense headache, photophobia, acute chest pain, throat pain, pallor, intense sweating, and vomiting.

If this happens, your doctor must immediately stop treatment and, depending on the severity of the situation, administer:

• an appropriate fluid and electrolyte replacement therapy
• an intravenous medication to lower blood pressure (antihypertensive), if necessary, to counteract the effects of the increased blood pressure.

If you have any other questions about the use of this product, ask your doctor or nurse.

Like all medicines, Noradrenalina B. Braun may cause side effects, although not everyone will experience them.

The leakage of liquid from the vein to the outside may destroy the tissue surrounding it.

It may cause a decrease in heart rate.

Prolonged use may decrease heart output.

Prolonged administration of noradrenalina may cause a loss of blood volume, which, if not corrected, may cause a relapse in blood pressure upon discontinuation of treatment.

Severe narrowing of the veins may occur. This would decrease blood flow and tissue perfusion, resulting in a lack of oxygen in these tissues, increased blood acidity, and damage due to poor blood supply.

During its application, the following side effects may occur, which require medical attention:

Rare (affecting between 1 and 10 of every 10,000 patients):

Dermatological and subcutaneous tissue disorders:

Pallor of the skin along the injection vein, skin scarring, blue discoloration, flushing or redness of the skin, skin rash, urticaria or pruritus.

Cardiac disorders:

Irregular heartbeats, decrease in heart rate.

Respiratory system disorders:

Wheezing or difficulty breathing.

General disorders and administration site conditions:

Severe dizziness or feeling of fainting.

Very rare (affecting less than 1 of every 10,000 patients):

Dermatological and subcutaneous tissue disorders:

Pallor.

Cardiac disorders:

Palpitations.

Nervous system disorders:

Anxiety or restlessness, sleep problems, tremors, headache.

General disorders and administration site conditions:

Dizziness, swelling in the neck.

In sensitive individuals, for example, individuals with nervous system diseases or hyperthyroidism, it produces:

Chest, thoracic, and mediastinal disorders:

Fear, anxiety, pulsating headache, and difficulty breathing.

Cardiac disorders:

Pallor, tachycardia, palpitations, slight elevation of blood pressure.

If you consider that any of the side effects you are experiencing is severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or nurse.

Reporting of side effects

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

Keep out of the sight and reach of children.

No special storage conditions are required.

Store in the original packaging to protect it from light.

Do not use this medication after the expiration date shown on the packaging (after CAD:). The expiration date is the last day of the month indicated.

The contents of the ampoules must be used immediately after opening. Once the packaging is opened, discard any unused portion of the solution.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

Composition of Noradrenalina B. Braun

The active principle is L-noradrenaline.

Each ml of solution contains 0.5 mg of L-norepinephrine base (equivalent to 1 mg of L-norepinephrine bitartrate).

Each ampoule of 10 ml contains 5 mg of L-norepinephrine base (equivalent to 10 mg of L-norepinephrine bitartrate).

Each vial of 50 ml contains 25 mg of L-norepinephrine base (equivalent to 50 mg of L-norepinephrine bitartrate).

The other components (excipients) are: sodium chloride, sodium metabisulphite (E-223) and hydrochloric acid (for pH adjustment) and water for injection in sufficient quantity.

Appearance of the product and contents of the package

Noradrenalina B. Braun is an injectable solution that is presented in 10 ml ampoules and 50 ml vials of colourless glass. It is presented in packages containing 10 ampoules of 10 ml and 1 vial of 50 ml.

Holder of the marketing authorization

B. BRAUN MEDICAL, S.A.

Ctra. de Terrassa, 121

Rubí (Barcelona) - 08191 - Spain

Responsible for manufacturing:

B. BRAUN MEDICAL, S.A.

Ronda de los Olivares, Parcela 11

Polígono Industrial Los Olivares

23009-Jaén (Jaén) - Spain

This leaflet was approved in June 2021

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices(AEMPS)http://www.aemps.es/”.

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This information is intended solely for doctors or healthcare professionals:

Noradrenalina B. Braun should be administered by intravenous route: the initial dose is administered at a rate of 8 to 12 micrograms (of 0.008 to 0.012 mg) (base) per minute, adjusting the administration rate to establish and maintain the desired blood pressure.

For maintenance, the rate is adjusted from 2 to 4 micrograms (of 0.002 to 0.004 mg) (base) per minute, titrating the dosage according to the patient's response.

In case of septic shock, the doses should be adjusted around 0.5 μg/kg/min (up to a maximum of 1.0 μg/kg/min) to achieve the desired mean blood pressure. It is recommended to administer it together with doses of 2 – 2.5 μg/kg/min of dopamine, which counteract vasoconstriction, ensuring good renal and splenic circulation.

To prepare the solution for intravenous infusion of noradrenaline, add 4 mg of noradrenaline (base) to 1 liter of 5% glucose solution. The resulting solution will contain 4 micrograms (0.004 mg) of noradrenaline (base) per ml. It should be noted that 1 mg of L-norepinephrine bitartrate is equivalent to 0.5 mg of L-norepinephrine base.

Noradrenalina B. Braun can be used as an emergency measure to maintain perfusion until blood volume replacement therapy is completed.

Duration of treatment

The infusion should be continued until the desired blood pressure and tissue perfusion are maintained without treatment. The noradrenaline infusion should be reduced gradually, avoiding abrupt interruption. In some cases described of vascular collapse due to acute myocardial infarction, treatment was required for up to six days.

Usual pediatric dose

Intravenous infusion, 0.1 microgram (base) per kg per minute, adjusting the administration rate gradually to achieve the desired blood pressure, up to 1 microgram (base) per kg per minute.

When added to local anesthetics, these solutions contain a concentration of noradrenaline around 1: 200,000 (5 μg/ml).