NORADRENALINE ALTAN 0.04 mg/mL SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Noradrenaline Altan 0.04 mg/ml Solution for Infusion

noradrenaline (norepinephrine)

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 get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What Noradrenaline Altan is and what it is used for

This medicine contains the active substance noradrenaline which acts as a vasoconstrictor.

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

2. What you need to know before you use Noradrenaline Altan

Do not useNoradrenaline Altan

• If you are allergic to noradrenaline or any of the other ingredients of this medicine (listed in section 6).
• If you are going to be administered certain 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 Noradrenaline Altan:

• if you have significant left ventricular dysfunction (coronary condition),
• if you have recently had a myocardial infarction (heart attack),
• if you have cardiac rhythm disorders (your heart beats too fast, too slow or irregularly),
• if you have hyperthyroidism (overactive thyroid gland),
• if you have diabetes mellitus,
• if you suffer from hypotension (low blood pressure) caused by hypovolemia (low blood volume),
• if you have angina pectoris or any vascular occlusion in the limbs or abdomen (acute difficulty in normal blood circulation).

During the infusion of noradrenaline, the doctor will continuously monitor your blood pressure, heart rate, and the infusion site.

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

Children and adolescents

This medicine is indicated only in adults.

Other medicinesand Noradrenaline Altan

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, such as:

• certain anesthetic gases (halogen),
• certain antidepressants (imipramine, adrenergic-serotonergic such as venlafaxine or duloxetine, monoamine oxidase inhibitors such as moclobemide or phenelzine),
• linezolid (antibiotic),
• methylene blue (antidote against methemoglobinemia).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before receiving this medicine. If you are pregnant, your doctor will decide whether you should be given this medicine as noradrenaline may harm the fetus.

No information is available on the use of noradrenaline during breastfeeding.

Noradrenaline Altan contains sodium

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

3. How to use Noradrenaline Altan

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

This medicine will be administered by intravenous infusion (in a vein) and only through a central venous catheter.

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

If you use more Noradrenaline Altan than you should:

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

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

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported:

• Anxiety, insomnia,
• Headache, tremor, confusion,
• Acute glaucoma,
• Tachycardia (fast heart rate), bradycardia (slow heart rate), arrhythmia (irregular heartbeats), palpitations, increased contractility of the heart muscle, acute heart failure (heart failure),
• Hypertension (high blood pressure) and tissue hypoxia (decreased oxygen supply to an organ); coldness and pallor of the limbs and face, painful and cold limbs (gangrene),
• Respiratory failure, dyspnea (difficulty breathing),
• Nausea, vomiting,
• Urinary retention,
• Locally, possible irritation and necrosis (cellular damage causing cell death in the tissue) at the injection site.

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 occur more frequently: hypertension (high blood pressure), photophobia (abnormal intolerance to light perception), retrosternal pain (chest pain), pharyngeal pain (throat pain), pallor, excessive sweating, and vomiting.

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 side effects 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 Altan

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 bag and carton (after EXP). The expiry date is the last day of the month stated.

Once opened, the product should be used immediately.

Do not store above 25°C.

Do not use this medicine if the solution is not colorless or if it contains precipitates.

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 other information

What Noradrenaline Altan contains

• The active substance is noradrenaline (norepinephrine).

Each ml 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 ingredients (excipients) are: sodium chloride, disodium edetate, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injections.

Appearance and packaging

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

Packs of 1, 10 and 25 bags.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Altan Pharmaceuticals, S.A.

C/ Cólquide 6, Portal 2, 1ª planta – Oficina F

Edificio Prisma

28230 Las Rozas, Madrid.

Spain

Manufacturer

Altan Pharmaceuticals S.A.

Polígono Industrial de Bernedo s/n

01118 Bernedo (Álava)

Spain

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

Cyprus: Noradrenaline Altan 0.04 mg/ml Solution for Infusion

Germany: Noradrenalin Altan 0,04 mg/ml Infusionslösung

Date of last revision of this leaflet: 08/2023

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 for healthcare professionals only:

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

Therapeutic indications

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

Posology and method of administration

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

Blood pressure should be carefully monitored throughout treatment.

Posology

Initial dose:

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

Dose titration:

Once the noradrenaline infusion is 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 to achieve adequate mean blood pressure (above 65 mm Hg depending on the patient's condition).

Duration of treatment:

Treatment should be maintained until high-dose vasopressor support is no longer necessary, at which point the infusion should be gradually decreased and then switched to a lower concentration infusion. Abrupt interruption may cause acute hypotension.

Overdose

Symptoms

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

Treatment

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

Special precautions for disposal and other handling

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

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

This medicine should not be mixed with other medicines.

For single use only.

This medicine 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 delivering the specified minimum volume accurately and constantly at a strictly controlled infusion rate in accordance with the dose adjustment instructions.

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