Noradrenaline Aguettant 1 mg/ml concentrate for infusion solution

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Noradrenalina Aguettant 1 mg/ml

concentrate for solution for infusion

norepinephrine

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Noradrenalina Aguettant is and what it is used for
2. What you need to know before being administered Noradrenalina Aguettant
3. How Noradrenalina Aguettant is administered
4. Possible side effects
5. How to store Noradrenalina Aguettant
6. Contents of the pack and other information

1. What Noradrenalina Aguettant Concentrate is and what it is used for

Noradrenalina Aguettant contains the active substance noradrenaline and causes narrowing of the blood vessels (vasoconstriction).

Noradrenaline is indicated in adults for the emergency restoration of blood pressure in cases of acute hypotension (low blood pressure).

2. What you need to know before Noradrenalina Aguettant Concentrate is administered to you

Do not administer Noradrenalina Aguettant

• if you are allergic to noradrenaline or any of the other ingredients of this medicine (listed in section 6);
• if you are hypotensive (have low blood pressure) due to hypovolemia (low blood volume);
• if you are taking certain anesthetics such as halothane or cyclopropane (this may increase the risk of irregular heartbeats).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before Noradrenalina Aguettant is administered to you if:

• you have significant left ventricular dysfunction (heart disease);
• you have coronary (blood clot in a blood vessel of the heart), mesenteric (blood clot in a vein draining blood from the intestine), or peripheral vascular thrombosis (blood clot in a vein of the arm or leg);
• you have hypotension (low blood pressure) following a myocardial infarction (heart attack);
• you have Prinzmetal's variant angina;
• you develop cardiac arrhythmias during treatment – you will require a reduced dose;
• you have hyperthyroidism (thyroid gland disorder);
• you have diabetes mellitus;
• you are elderly.

Additional follow-up tests you may need during treatment:

Your blood pressure and heart rate will be monitored frequently during treatment to prevent hypertension (high blood pressure).

Children and adolescents

The safety and efficacy of noradrenaline in children under 18 years of age have not been established. Therefore, its use is not recommended in children.

Other medicines and Noradrenalina Aguettant

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

The following medicines may affect the action of Noradrenalina Aguettant:

• Halothane, cyclopropane, chloroform, enflurane, or other halogenated anesthetics are contraindicated (see section 2 of this leaflet, subsection “Do not administer Noradrenalina Aguettant”): these medicines are anesthetics that cause insensitivity to pain and are used before certain surgeries. If you are taking these medicines along with noradrenaline, this could increase the risk of irregular heartbeats.
• Amitriptyline, imipramine, trimipramine, moclobemide, iproniazid, phenelzine, fluoxetine, sertraline, desipramine: these medicines are used to treat depression. Taking any of these together with noradrenaline may dangerously increase its blood concentration and thus its vasopressor effect.
• Digitalis glycosides may occasionally cause irregular heartbeats.
• Levodopa may enhance the effects of noradrenaline.
• Antihistamines, as some may block the uptake of catecholamines by peripheral tissues and increase the toxicity of injected noradrenaline.
• Chlorpheniramine hydrochloride, tripelennamine hydrochloride: significantly increase the toxicity of noradrenaline.
• Non-selective MAO inhibitors (or within 14 days after stopping such therapy): increase the pressor effect of sympathomimetics, which is usually moderate. These should be used only under strict medical supervision.
• Selective MAO-A inhibitors: by extrapolation from non-selective MAO inhibitors, there is a risk of increased pressor effect. Should be used only under close medical supervision.
• Linezolid, an antibiotic (a medicine used to treat infections caused by bacteria and other microorganisms), may dangerously increase the blood concentration of noradrenaline and thus its vasopressor effect when taken together.
• Alpha- and beta-blockers: if you are taking these medicines along with noradrenaline, this may increase the risk of severe hypertension (high blood pressure).
• Thyroid hormones, cardiac glycosides (heart), antiarrhythmic agents: if you are taking these medicines along with noradrenaline, this may lead to increased cardiac effects (heart).
• Ergot alkaloids or oxytocin may enhance the vasopressor and vasoconstrictive effects (increased blood pressure).
• Desmopressin or vasopressin: their antidiuretic effect is reduced.
• Lithium: reduces the effect of noradrenaline.
• Guanethidine, guanadrel, reserpine, methyldopa, tricyclic antidepressants, amphetamine, doxapram, mazindol, Rauwolfia alkaloids: may potentiate the effects of noradrenaline.
• Propofol: concomitant administration may cause propofol infusion syndrome (PRIS).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before this medicine is administered to you. Noradrenaline may harm the fetus. Your doctor will decide whether you should be given noradrenaline.

It is unknown whether this medicine is excreted in breast milk. Because many medicines are excreted in breast milk, caution should be exercised when administering noradrenaline to a woman who is breastfeeding.

Driving and using machines

As this medicine will be administered in a hospital setting, your doctor will inform you when you may resume driving or operating machinery.

Noradrenalina Aguettant contains sodium

This medicine contains 3.3 mg of sodium (main component of table/cooking salt) per ml. This corresponds to 0.16% of the maximum daily recommended sodium intake for an adult.

3. How to administer Noradrenalina Aguettant Concentrate

A doctor or nurse will administer Noradrenalina Aguettant to you in the hospital.

Dosage

Noradrenalina Aguettant is first diluted and then infused into a vein. It must not be mixed with other medicines. The dose of noradrenaline depends on the patient's condition. Your doctor will determine the most appropriate dose. The initial dose is 0.4 to 0.8 mg per hour of noradrenaline (equivalent to 0.8 to 1.6 mg per hour of noradrenaline tartrate). Subsequently, the dose may be adjusted using an infusion pump according to the treatment response, aiming to achieve a normal blood pressure. Your doctor will monitor your blood pressure and blood volume.

If you are given more noradrenaline than you should

It is unlikely that you will receive an excessive amount, as this medicine is administered in a hospital setting. However, speak to your doctor or nurse if you have any concerns.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone (91) 562 04 20.

Symptoms that may occur if you are given too much noradrenaline include severe high blood pressure, slow heart rate, severe headache, light sensitivity, chest pain, cerebral hemorrhage, pallor, fever, profuse sweating, vomiting, and pulmonary edema causing breathing difficulty.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The frequency of the listed adverse effects is unknown (frequency cannot be estimated from the available data).

Inform your doctor or nurse immediately if you experience:

• difficulty or irregular breathing,
• fast, slow or irregular heartbeat, palpitations,
• chest or throat pain.

Inform your doctor or nurse as soon as possible if you experience:

• anxiety, insomnia, confusion, headache, psychotic state, weakness, tremor, decreased alertness, anorexia, nausea, vomiting,
• high blood pressure,
• pallor (loss of skin color), sweating, light sensitivity, gangrene (painful, cold limbs that may turn purple or very dark/black, with tissue necrosis),
• skin necrosis if the infusion is not administered directly into the vein,
• acute glaucoma (eye problem),
• skin sloughing, bluish discoloration of the skin, hot flushes or skin redness, skin rashes, hives or itching,
• urinary retention.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Noradrenaline Aguettant Concentrate

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and on the label of the ampoule following EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C. Store the ampoule in the outer packaging to protect it from light.

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

6. Contents of the pack and other information

Composition of Noradrenaline Aguettant

The active substance is noradrenaline (norepinephrine).

Each ml of concentrate for solution for infusion contains 2 mg of noradrenaline tartrate (norepinephrine), equivalent to 1 mg of noradrenaline (norepinephrine).

Each 4 ml ampoule contains 8 mg of noradrenaline tartrate (norepinephrine), equivalent to 4 mg of noradrenaline (norepinephrine).

Each 8 ml ampoule contains 16 mg of noradrenaline tartrate (norepinephrine), equivalent to 8 mg of noradrenaline (norepinephrine).

The other components are sodium chloride, sodium hydroxide or hydrochloric acid, and water for injections.

Appearance of the product and contents of the pack

Clear, colourless or slightly yellowish solution with pH 3.0 to 4.0, packed in a 4 ml or 8 ml clear glass ampoule.

Cartons containing 10, 50 or 100 ampoules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Laboratoire Aguettant
1 rue Alexander Fleming
69007 Lyon
France

Manufacturer

Laboratoire Aguettant
1 rue Alexander Fleming
69007 Lyon
France

or

Delpharm Tours
Rue Paul Langevin
37 170 Chambray-Les-Tours
France

or

Haupt Pharma Livron
1 rue Comte de Sinard
26250 Livron Sur Drome
France

Local representative:

Aguettant Ibérica S.L.
Baldiri Reixac, 4-8, Torre I, 4º
08028 Barcelona
Spain

This medicinal product is authorized in the Member States of the European Economic Area (EEA) and in the United Kingdom (Northern Ireland) under the following names:

BE, LU: Noradrenaline (Norepinephrine) Aguettant
NL: Noradrenaline Aguettant
ES: Noradrenalina Aguettant
BG: Noradrenalin Aguettant
DK, FI, IS, NO, SE: Noradrenalin Laboratoire Aguettant
AT, DE: Norepinephrin Aguettant
UK (NI), IE: Noradrenaline (Norepinephrine)
PT: Noradrenalina tartarato Aguettant
IT: Noradrenalina tartrato Laboratoire Aguettant

Date of the most recent review of this leaflet: 02/2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

The following information is intended for healthcare professionals only:

Method of administration

For intravenous use only, after dilution. For single use only.

The infusion must be administered at a controlled rate using a syringe pump, infusion pump, or drip counter.

Instructions for dilution

This product must be inspected visually before administration. Only a clear, colourless or slightly yellowish solution free from particles or precipitates should be used. Do not use ampoules showing a pinkish or darker than pale yellow colouration or containing precipitate.

Add 2 ml of Noradrenaline Aguettant to 48 ml of 5% dextrose (or 9 mg/ml (0.9%) sodium chloride, or isotonic saline with dextrose) for administration via syringe pump.

Or add 20 ml of Noradrenaline Aguettant to 480 ml of 5% dextrose (or 9 mg/ml (0.9%) sodium chloride, or isotonic saline with dextrose) for administration via drip counter.

When diluted, the final concentration of the infusion solution is generally 40 mg/litre of noradrenaline (equivalent to 80 mg/litre of noradrenaline tartrate).

If other dilutions are used, carefully verify the calculation before starting treatment.

In the absence of specific data, this medicinal product must not be mixed with other medicinal products.

After dilution: Chemical and physical stability of the diluted product (in 5% dextrose, 9 mg/ml (0.9%) sodium chloride, or dextrose in isotonic saline) has been demonstrated for 48 hours at 30°C.

However, from a microbiological standpoint, the diluted product should be used immediately. If not used immediately, the duration and conditions of storage are the sole responsibility of the user.

Dosage

Initial infusion rate:

The initial infusion rate should be between 10 ml/hour and 20 ml/hour (0.16 ml/min to 0.33 ml/min). This corresponds to 0.4 mg/hour to 0.8 mg/hour of noradrenaline (equivalent to 0.8 mg/hour to 1.6 mg/hour of noradrenaline tartrate).

Dose adjustment:

Once noradrenaline infusion has been established, the dose should be adjusted according to the observed pressor effect. There is considerable individual variability in the dose required to achieve and maintain normotension. The goal should be to achieve a low-normal systolic blood pressure (100–120 mm Hg) or an adequate mean arterial pressure (greater than 65 to 80 mm Hg, depending on the patient's condition).