NOREPINEPHRINE B. BRAUN 0.5 mg/mL CONCENTRATE FOR INFUSION SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Noradrenaline B. Braun 0.5mg/ml concentrate for solution for infusion

L-Norepinephrine

Contents of the pack:

1. What is Noradrenaline B. Braun and what is it used for
2. What you need to know before you use Noradrenaline B. Braun
3. How to use Noradrenaline B. Braun
4. Possible side effects
5. Storage of Noradrenaline B. Braun
6. Contents of the pack and further information

1. What is Noradrenaline B. Braun and what is it used for

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

Noradrenaline B. Braunis used for the treatment of acute hypotension (low blood pressure).

2. What you need to know before you use Noradrenaline B. Braun

Do not use Noradrenaline B. Braun:

• If you are allergic to noradrenaline bitartrate or to any of the other ingredients of this medicine (listed in section 6).
• As the only therapy if you have low blood pressure (hypotension) due to a decrease in blood volume (hypovolemia).
• In the lower limbs of elderly patients with occlusive diseases, due to a possible decrease in the diameter of blood vessels (vasoconstriction).
• If you are going to be administered other medicines during anesthesia, such as halothane or cyclopropane.
• If you have stomach or intestinal ulcers or bleeding.

In patients who do not tolerate sulfites

Warnings and precautions:

Talk to your doctor before you start using Noradrenaline B. Braun.

Inform your doctor of any allergy or medical problem you have or have had, especially if:

• You are diabetic.
• You have an overproduction of thyroid hormones (hyperthyroidism).
• You lack oxygen.
• You have any occlusive disease, such as hardening of the arteries (arteriosclerosis) or inflammation of a vein with thrombus formation (Buerger's disease).
• You have had a blood clot in a blood vessel (thrombosis).
• If you have high carbon dioxide levels in your blood
• If you have low oxygen levels in your blood.

Using Noradrenaline with other medicines:

Tell your doctor or pharmacist if you are using, or have recently used, other medicines, including those obtained without a prescription.

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

It is important that you inform your doctor if you are using or have recently used any of the following medicines:

• Organic anesthetics (in particular cyclopropane and halothane)
• Antidepressant medicines: tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs) or maprotiline
• Digitalis glycosides
• Ergoloid mesylates or ergotamine
• Levodopa
• Cocaine
• Chlorpheniramine hydrochloride, tripelennamine hydrochloride, and desipramine
• Medicines for the treatment of allergies: antihistamines
• Amphetamines
• Doxapram
• Mazindol
• Mecamylamine or methyldopa
• Methylphenidate
• Rauwolfia alkaloids
• Other sympathomimetics
• Thyroid hormones
• Dihydroergotamine, ergometrine, methylergometrine, or methysergide
• Medicines for blood pressure (such as guanadrel and guanethidine) or for increasing urine elimination (diuretics)
• Desmopressin, lysine vasopressin, or vasopressin
• Beta-blockers
• Lithium

Pregnancy and breastfeeding

Pregnancy:

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

Breastfeeding:

Consult your doctor or pharmacist before using any medicine. It is not known if it is excreted in breast milk, so your doctor will assess the need for its administration.

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

Ampoules 10 ml:

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

Vial 50 ml:

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

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

3. How to use Noradrenaline B. Braun

Noradrenaline B. Braun is administered intravenously.

This medicine will always be administered by healthcare personnel.

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

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

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

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

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

A severe increase in blood pressure with intense headache, rejection of light, acute pain behind the sternum (in the chest), pain in the pharynx, paleness, and intense sweating and vomiting.

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

• adequate fluid and salt replacement therapy
• a medicine by intravenous route that decreases blood pressure (antihypertensive), if necessary, for the effects of the increase in blood pressure.

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

4. Possible side effects

Like all medicines, Noradrenaline B. Braun can cause side effects, although not everybody gets them.

The leakage of fluid from the vein to the outside can destroy the surrounding tissue.

A reduction in heart rate may occur.

Prolonged use can decrease cardiac output.

Prolonged administration of noradrenaline may cause loss of blood volume, which, if not corrected, may cause a relapse in low blood pressure when treatment is stopped.

A severe narrowing of the veins may occur. This would decrease blood flow and tissue perfusion, with a consequent lack of oxygen in these tissues, increased blood acidity, and damage due to lack of blood flow.

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

Rare (affect 1 to 10 in every 10,000 patients):

Disorders of the skin and subcutaneous tissue:

Pallor of the skin along the injection vein, scar formation (cutaneous scarification), bluish discoloration, flushing or redness of the skin, rash, urticaria, or itching (pruritus).

Cardiac disorders:

Irregular heartbeats, decreased heart rate.

Respiratory disorders:

Wheezing or difficulty breathing.

General disorders and administration site conditions:

Severe dizziness or feeling of fainting.

Very rare (affect less than 1 in every 10,000 patients):

Disorders of the skin and subcutaneous tissue:

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, such as those with nervous system disorders or hyperthyroidism, it produces:

Nervous system, thoracic, and mediastinal disorders:

Fear, anxiety, pulsating headache, and difficulty breathing.

Cardiac disorders:

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

If you think any of the side effects you are experiencing are serious, or if you notice any side effects not mentioned in this leaflet, inform your doctor or nurse.

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Noradrenaline B. Braun

Keep out of the sight and reach of children.

No special storage conditions are required.

Store in the original packaging to protect from light.

Do not use this medicine after the expiry date which is stated on the packaging (after EXP:). The expiry date is the last day of the month shown.

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

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 further information

Composition of Noradrenaline B. Braun

The active substance is L-noradrenaline.

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

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

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

The other ingredients (excipients) are: sodium chloride, sodium metabisulfite (E-223), and hydrochloric acid (for pH adjustment) and water for injectable preparations in sufficient quantity.

Appearance of the product and packaging

Noradrenaline B. Braun is an injectable solution presented in 10 ml ampoules and 50 ml vials of colorless glass. It is presented in packaging containing 10 ampoules of 10 ml and 1 vial of 50 ml.

Marketing authorization holder

• BRAUN MEDICAL, S.A.

Ctra. de Terrassa, 121

Rubí (Barcelona) - 08191 - Spain

Manufacturer

• 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

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

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This information is intended only for healthcare professionals:

Noradrenaline B. Braun should be administered intravenously: the initial dose is administered at a rate of 8 to 12 micrograms (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 to 2 to 4 micrograms (0.002 to 0.004 mg) (base) per minute, titrating the dosage according to the patient's response.

In case of septic shock, doses should be adjusted to 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 infusion solution 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 taken into account that 1 mg of L-noradrenaline bitartrate is equivalent to 0.5 mg of L-noradrenaline base.

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

Duration of treatment

Infusion should be continued until adequate blood pressure and tissue perfusion are maintained without treatment. The infusion of noradrenaline should be gradually reduced, 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, gradually adjusting the administration rate 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).