Label: information for the user

Noradrenaline Altan 0.04 mg/ml infusion solution

noradrenaline (norepinephrine)

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this label. See section 4.

This medication contains the active ingredient noradrenaline that acts as a vasoconstrictor.

This medication is indicated in adults for the treatment of acute hypotensive emergencies that require an immediate increase in blood pressure to normal levels.

No useNoradrenalina Altan

• If you are allergic to norepinephrine or any of the other components of this medication (listed in section 6).
• If you are to be administered some anesthetic gases such as halothane or cyclopropane, as they may increase the risk of irregular heartbeats.

Warnings and precautions

Consult your doctor or nurse before starting to use Noradrenalina Altan:

• If you have significant left ventricular dysfunction (coronary condition),
• If you have recently had a myocardial infarction (heart attack),
• If you have arrhythmias (your heart beats too quickly, too slowly, or irregularly),
• If you have hyperthyroidism (overactive thyroid gland),
• If you have diabetes mellitus,
• If you have hypotension (low blood pressure) caused by hypovolemia (low blood volume),
• If you have angina pectoris or any vascular blockage in extremities or abdomen (acute difficulty in normal blood circulation).

During norepinephrine perfusion, the doctor will continuously monitor your blood pressure, heart rate, and perfusion site.

In cases where it is necessary to administer Noradrenalina at the same time as a blood or plasma transfusion, the latter should be administered through a separate drip.

Children and adolescents

This medication is only indicated for adults.

Other medications and Noradrenalina Altan

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, such as:

• Some anesthetic gases (halogen),
• Some antidepressants (imipramine, adrenergic-serotoninergic such as venlafaxine or duloxetine, monoamine oxidase inhibitors such as moclobemide or phenelzine),
• Linezolid (antibiotic),
• Methylene blue (antidote for methemoglobinemia).

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or nurse before receiving this medication. If you are pregnant, your doctor will decide whether you should receive this medication as norepinephrine may harm the fetus.

No information is available regarding the use of norepinephrine during lactation.

Noradrenalina Altan contains sodium

This medication contains 354 mg of sodium (main component of table salt/for cooking) per 100 ml bag. This is equivalent to 17.7% of the maximum daily sodium intake recommended for an adult.

This medication will be administered to you in the hospital by a doctor or a nurse.

This medication will be administered through intravenous infusion (into a vein) and only through a central venous catheter.

The dosage of this medication will depend on your condition. Your doctor will determine the optimal dosage to use.

If you use more Noradrenalina Altan than you should:

In case of overdose, the following symptoms may appear: cutaneous vasoconstriction (blood vessels constrict),scars(skin ulcers), circulatory collapse (circulation failure) and hypertension (high blood pressure).

In case of adverse reactions related to excessive dosage, contact your doctor immediately. It is recommended to reduce the dosage if possible.

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

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them. The following adverse effects have been reported:

• Anxiety, insomnia,
• Headaches, tremors, confusion,
• Acute glaucoma,
• Tachycardia (rapid heart rate), bradycardia (slow heart rate), arrhythmia (irregular heartbeats), palpitations, increased cardiac muscle contractility, acute heart failure (heart failure),
• High blood pressure (hypertension) and tissue hypoxia (decreased oxygen supply to an organ); coldness and pallor of the limbs and face, painful and cold extremities (gangrene),
• Respiratory failure or difficulty breathing, dyspnea (difficulty breathing),
• Nausea, vomiting,
• Urinary retention,
• Locally, possible irritation and necrosis (cellular injury leading to cell death in tissue) at the injection site.

The continuous administration of a vasopressor to maintain blood pressure in the absence of blood volume replacement may cause the following symptoms:

• Severe peripheral and visceral vasoconstriction,
• Decreased renal blood flow,
• Decreased urine production,
• Hypoxia,
• Increased serum lactate levels.

In case of hypersensitivity or overdose, the following effects may appear more frequently: high blood pressure (hypertension), photophobia (abnormal intolerance to visual perception of light), retrosternal pain (chest pain), pharyngeal pain (throat pain), pallor, intense sweating, and vomiting.

Reporting Adverse Effects

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

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

Do not use this medication after the expiration date that appears on the bag and box (after CAD). The expiration date is the last day of the month indicated.

Once opened, the product must be used immediately.

Do not store at a temperature above 25 °C.

Do not use this medication if the solution is not colorless or if it presents precipitates.

Medications should not be thrown away through drains. Ask your pharmacist how to dispose of the medications that you no longer need. This will help protect the environment.

What Noradrenalina Altan Contains

• The active ingredient is noradrenaline (norepinephrine).

Each milliliter of solution contains 0.08 mg (80 micrograms) of noradrenaline (norepinephrine) tartrate, equivalent to 0.04 mg (40 micrograms) of noradrenaline (norepinephrine) base. Each 100 ml bag contains 8 mg of noradrenaline (norepinephrine) tartrate, equivalent to 4 mg of noradrenaline (norepinephrine) base.

• The other components (excipients) are: sodium chloride, disodium edetate, hydrochloric acid (to adjust the pH), sodium hydroxide (to adjust the pH), and water for injection preparations.

Appearance of the Product and Contents of the Package

Transparent and colorless infusion solution, supplied in 100 ml polypropylene bags.

Packaged in 1, 10, and 25 bag sizes.

Only some package sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Altan Pharmaceuticals, S.A.

C/ Cólquide 6, Portal 2, 1st floor – Office F

Edificio Prisma

28230 Las Rozas, Madrid.

Spain

Responsible Manufacturer

Altan Pharmaceuticals S.A.

Polígono Industrial de Bernedo s/n

01118 Bernedo (Álava)

Spain

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

Cyprus: Noradrenaline Altan 0.04 mg/ml Δι?λυμα για ?γχυση

Germany: Noradrenalin Altan 0,04 mg/ml Infusionslösung

Last Review Date of this Leaflet: 08/2023

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

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This information is intended solely for healthcare professionals:

This is an extract from the Product Technical File to assist in the administration of Noradrenalina Altan 0.04 mg/ml infusion solution. When determining the suitability of its use in a specific patient, the prescriber must be familiar with the Product Technical File.

Therapeutic Indications

This medicinal product is indicated in adults for the treatment of acute hypotensive emergencies.

Dosage and Administration Method

Noradrenaline should only be administered intravenously via a central venous catheter. It should be infused at a controlled rate using a suitable infusion pump, without dilution: it is supplied ready for use.

Blood pressure should be closely monitored throughout treatment.

Dosage

Initial Dose:

The initial dose of noradrenaline base typically ranges from 0.05-0.15 micrograms/kg/min.

Dose Titration:

Once noradrenaline infusion has been established, the dose should be titrated in stages of 0.05 - 0.1 micrograms/kg/min of noradrenaline base according to the observed pressor effect. The goal should be to establish a normal low systolic blood pressure (100-120 mm Hg) or achieve an adequate mean blood pressure (above 65 mm Hg depending on the patient's condition).

Treatment Duration:

Treatment should be continued until high-dose vasopressor support is no longer required, at which point the infusion should be gradually reduced and then replaced with a lower concentration infusion. Abrupt discontinuation may cause acute hypotension.

Overdose

Symptoms

In case of overdose, the following may be observed: cutaneous vasoconstriction, scarring, circulatory collapse, and hypertension.

Treatment

In case of adverse reactions related to excessive doses, it is recommended to reduce the dose if possible.

Special Precautions for Disposal and Other Handling

This medicinal product should not be used if the solution is not colorless or if it contains precipitates.

This medicinal product should not be used if it is not transparent and contains particles.

This medicinal product should not be mixed with other medicinal products.

For single use only.

This medicinal product is already diluted and ready for use. It should be used without prior dilution. It should be used with a suitable infusion pump capable of administering the specified minimum volume at a strictly controlled infusion rate according to the dosage adjustment instructions.

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