Noradrenaline Altan 0.04 mg/ml solution for infusion

Package leaflet: Information for the user

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, as you may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Noradrenalina 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 requiring an immediate increase in blood pressure to normal levels.

2. What you need to know before using Noradrenalina Altan

Do not use Noradrenalina Altan

• If you are allergic to noradrenaline or to any of the other ingredients of this medicine (listed in section 6).
• If you are going to be administered certain anaesthetic 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 cardiac arrhythmias (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 obstruction in the limbs or abdomen (acute impairment of normal blood circulation).

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

In cases where it is necessary to administer Noradrenalina simultaneously with blood or plasma transfusion, the latter must be administered through a separate drip.

Children and adolescents

This medicine is indicated only for use in adults.

Other medicines and Noradrenalina Altan

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, such as:

• certain anaesthetic gases (halogenated),
• certain antidepressants (imipramine, adrenergic-serotonergic agents such as venlafaxine or duloxetine, monoamine oxidase inhibitors such as moclobemide or phenelzine),
• linezolid (an antibiotic),
• methylene blue (an antidote for methemoglobinemia).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or nurse 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.

There is no available information regarding the use of noradrenaline during breastfeeding.

Noradrenalina Altan contains sodium

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

3. How to use Noradrenalina Altan

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

This medicine will be given by intravenous infusion (into 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 Noradrenalina Altan than you should:

In case of overdose, the following symptoms may occur: cutaneous vasoconstriction (narrowing of blood vessels in the skin), pressure ulcers (skin ulcers), circulatory collapse (circulatory failure), and hypertension (high blood pressure).

If adverse reactions related to an excessive dose occur, contact your doctor immediately. Dose reduction is recommended, 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 about the use of this medicine, ask your doctor or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. The following adverse effects have been reported:

• Anxiety, insomnia,
• Headaches, tremor, confusion,
• Acute glaucoma,
• Tachycardia (fast heart rate), bradycardia (slow heart rate), arrhythmia (irregular heartbeat), palpitations, increased cardiac muscle contractility, acute heart failure (heart failure),
• Hypertension (high blood pressure) and tissue hypoxia (reduced oxygen supply to an organ); coldness and pallor of limbs and face, painful and cold extremities (gangrene),
• Respiratory insufficiency or difficulty, dyspnoea (difficulty breathing),
• Nausea, vomiting,
• Urinary retention,
• Locally, possible irritation and necrosis (cellular injury leading to cell death in 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,
• Reduced urine output,
• 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 visual perception of light), retrosternal pain (chest pain), pharyngeal pain (sore throat), pallor, profuse sweating, and vomiting.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 stated on the bag and carton (after EXP). The expiry date is the last day of the month indicated.

Once opened, the product must be used immediately.

Do not store above 25 °C.

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

Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Noradrenalina 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 components (excipients) are: sodium chloride, disodium edetate, hydrochloric acid (to adjust pH), sodium hydroxide (to adjust pH), and water for injections.

Appearance of the product and contents of the pack

Clear, colourless infusion solution supplied in 100 ml polypropylene bags.

Pack sizes of 1, 10 and 25 bags.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Altan Pharmaceuticals, S.A.

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

Edificio Prisma

28230 Las Rozas, Madrid.

Spain

Manufacturer

Altan Pharmaceuticals S.A.

Polígono Industrial de Bernedo s/n

01118 Bernedo (Álava)

Spain

This medicinal product is authorised in the European Economic Area member states under the following names:

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

Germany: Noradrenalin Altan 0,04 mg/ml Infusionslösung

Date of the most recent review of this leaflet: 08/2023

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

This information is intended for healthcare professionals only:

This is an extract from the Summary of Product Characteristics 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 should be familiar with the full Summary of Product Characteristics.

Therapeutic indications

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

Posology and method of administration

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

Blood pressure must be carefully monitored throughout treatment.

Dosage

Initial dose:

The initial dose of noradrenaline base generally ranges between 0.05–0.15 micrograms/kg/min.

Dose titration:

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

Duration of treatment:

Treatment should be maintained until high-dose vasoactive drug support is no longer required. At that point, the infusion should be gradually tapered and then switched to a lower-concentration infusion. Abrupt discontinuation may result in acute hypotension.

Overdose

Symptoms

In case of overdose, the following may be observed: cutaneous vasoconstriction, pressure ulcers (decubitus), circulatory collapse, and hypertension.

Treatment

If adverse reactions related to excessive dosage occur, dose reduction is recommended, if possible.

Special precautions for disposal and other handling

This medicinal product must not be used if the solution is not colourless or if it contains precipitates.

This medicinal product must not be used if it is not clear and contains particles.

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

For single use only.

This medicinal product is already diluted and ready for use. It must be used without prior dilution. It must be administered using a suitable infusion pump capable of accurately and consistently delivering the specified minimum volume at a strictly controlled infusion rate according to dose adjustment instructions.

Any unused medicinal product and materials that have come into contact with it must be disposed of in accordance with local regulations.