Vipranop 5 micrograms/ml solution for injection and infusion

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Vipranop 5 micrograms/ml solution for injection and infusion

noradrenaline (norepinephrine)

Read the entire leaflet carefully before you are administered 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, consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Vipranop is and what it is used for

This medicine contains the active substance noradrenaline (in the form of noradrenaline tartrate), which acts as a vasoconstrictor (narrowing of blood vessels).

This medicine is only indicated in adults.

This medicine is used during surgery to restore and maintain blood pressure following an anaesthesia-induced decrease.

2. What you need to know before Vipranop is administered to you

Vipranop will not be administered to you:

• if you are allergic to noradrenaline or to any of the other components of this medicine (listed in section 6).
• during anaesthesia with cyclopropane or halothane.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before Vipranop is administered to you:

• if you have ischaemic heart disease (a condition caused by narrowing or blockage of the blood vessels supplying the heart muscle),
• if you have angina (chest pain),
• if you have recently had a myocardial infarction (heart attack),
• if you have blood clots or obstructions in the blood vessels supplying the heart, intestine, or other parts of the body (vascular condition),
• if you have hypertension (high blood pressure),
• if you have hypotension (low blood pressure) due to hypovolemia (low blood volume),
• if you have hyperthyroidism (overactive thyroid),
• if you have intracranial hypertension (high pressure in the brain),
• if you are diabetic (a disease characterized by high blood sugar levels over prolonged periods),
• if you are elderly,
• if you have liver problems or severe kidney problems.

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

If noradrenaline must be administered at the same time as a blood or plasma transfusion, the transfusion must be given through a separate infusion system.

Children and adolescents

Vipranop is indicated only for use in adults. This medicine is not recommended for children and adolescents under 18 years of age.

Other medicines and Vipranop

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Vipranop may affect, or be affected by, other medicines.

A number of medicines are known to increase the toxic effects of noradrenaline:

• Certain anaesthetics such as halothane, cyclopropane (anaesthetic gases), and propofol (an injectable anaesthetic).
  • Antidepressants known as serotonergic-adrenergic antidepressants (such as fluoxetine, sertraline), or selective monoamine oxidase inhibitors (MAO) (such as moclobemide), or imipramine-based antidepressants (such as imipramine, trimipramine), or non-selective MAO inhibitors (such as amitriptyline, iproniazid, phenelzine).
• The antibiotic linezolid (a medicine used to treat infections caused by bacteria and other microorganisms).
• Methylene blue (an antidote).
• Medicines that reduce blood pressure (such as guanethidine, reserpine, beta-blockers (e.g., propranolol)).
• Thyroid hormones, digitalis glycosides (a class of medicines that increase cardiac output and heart rate), and antiarrhythmic agents such as digoxin (medicines used to suppress abnormal heart rhythms).
• Ergot alkaloids (such as bromocriptine).
• Medicines that induce contractions (such as oxytocin).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor, pharmacist, or nurse before this medicine is administered to you.

Pregnancy

There is limited data on the use of noradrenaline in pregnant women. Noradrenaline may cross the placenta, cause strong uterine contractions, and reduce placental blood flow, resulting in reduced oxygen supply to the fetus. For this reason, noradrenaline is not recommended during pregnancy unless the benefits to the mother outweigh the potential risks to the fetus. If you are pregnant, your doctor will decide whether noradrenaline should be administered, as it may harm the fetus.

Breastfeeding

It is unknown whether noradrenaline passes into breast milk. This medicine may be used with caution during breastfeeding, as noradrenaline is not absorbed orally.

Vipranop contains sodium

This medicine contains 71 mg of sodium (main component of table/cooking salt) in each 20 ml vial. This corresponds to 3.6% of the maximum daily recommended sodium intake for an adult.

This medicine contains 177 mg of sodium (main component of table/cooking salt) in each 50 ml vial. This corresponds to 8.9% of the maximum daily recommended sodium intake for an adult.

3. How Vipranop is administered

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

This medicine will be given by intravenous infusion (into a vein). An initial bolus of the medicine may be injected into the vein before starting the infusion.

During your treatment, your blood pressure will be monitored, the infusion rate will be continuously supervised, and you will be constantly monitored.

The recommended dose of Vipranop will depend on your medical condition. Your doctor will determine the correct dose for you.

If you are given more Vipranop than you should

It is unlikely that you will receive more medicine than you should, as this medicine will be administered during surgery by a trained healthcare professional. However, if you think you have received too much medicine, contact your doctor or nurse immediately.

The following symptoms may occur in case of overdose: headache, hypertension (severe high blood pressure), slow heartbeats, cutaneous vasoconstriction (narrowing of blood vessels), circulatory collapse (circulatory failure), cerebral haemorrhage (bleeding in the brain), photophobia (sensitivity to light), chest pain, pallor, fever, profuse sweating, pulmonary oedema (excess fluid in the lungs), and vomiting.

If you have any 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 (lack of sleep).
• Headache.
• Tremor (involuntary muscle contraction).
• Dizziness.
• Acute glaucoma (a condition caused by a rapid and sudden increase in the internal pressure of the eye).
• Tachycardia (fast heart rate), bradycardia (slow heart rate), arrhythmia (irregular heartbeat), changes in electrocardiogram (a test of heart activity), cardiogenic shock (drastic drop in blood pressure in the heart area), stress cardiomyopathy (damage to the heart muscle).
• Hypertension (high blood pressure) and tissue hypoxia (reduced oxygen supply to certain organs), coldness and pallor of the face and limbs, painful and cold extremities (gangrene), decreased plasma volume (reduction in the amount of plasma (the liquid part of blood) in the body).
• Dyspnea (difficulty breathing).
• Nausea and vomiting.
• Urinary retention.
• Locally: possibility of irritation and necrosis (cellular damage leading to cell death in tissue) at the injection site.

In case of hypersensitivity (allergy) or overdose, the following effects may occur more frequently with hypertension (high blood pressure): severe headache, photophobia (abnormal intolerance to visual perception of light), retrosternal pain (chest pain), pallor (pale skin), fever, profuse sweating, vomiting, pulmonary edema (difficulty breathing), arrhythmia (irregular heartbeat), or cardiac arrest.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is an adverse effect not listed in this leaflet. You may also report them directly through 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 Vipranop

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

Do not use this medicine after the expiry date stated on the label of the vial after EXP. The expiry date is the last day of the month indicated. Your doctor or nurse will verify this.

Store below 25 °C. Keep the vial in the outer packaging to protect it from light. Do not freeze.

For single use only.

Physical and chemical stability has been demonstrated under its conditions of use for 24 hours at 30 °C in a polypropylene syringe. From a microbiological standpoint, the product should be used immediately. If not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user and generally should not exceed 24 hours between 2 and 8 °C, unless the handling has been carried out under controlled and validated aseptic conditions.

This medicine is a clear, colourless solution, practically free from visible particles. The solution should not be used if it appears slightly yellow, pink, or brown, or if it contains particles or a precipitate.

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

6. Contents of the pack and other information

Composition of Vipranop

• The active substance is noradrenaline (norepinephrine) (as noradrenaline (norepinephrine) tartrate).

Each ml of solution contains 5 micrograms of noradrenaline (norepinephrine), equivalent to 10 micrograms of noradrenaline (norepinephrine) tartrate.

Each 20 ml vial contains 100 micrograms of noradrenaline (norepinephrine), equivalent to 200 micrograms of noradrenaline (norepinephrine) tartrate.

Each 50 ml vial contains 250 micrograms of noradrenaline (norepinephrine), equivalent to 500 micrograms of noradrenaline (norepinephrine) tartrate.

• The other components are: sodium chloride, edetate disodium, hydrochloric acid (for pH adjustment) and water for injections.

Appearance of Vipranop and contents of the pack

This medicine is a clear, colourless solution for injection and intravenous infusion, practically free from visible particles, contained in a 20 ml or 50 ml transparent glass vial closed with a chlorobutyl rubber stopper and an aluminium seal.

Vipranop is available in packs of 1 and 10 vials.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Laboratoire AGUETTANT
1, rue Alexander Fleming
69007 Lyon
France

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Aguettant Ibérica SL
Baldiri Reixac, 4-8, Torre I, 4º
08028 Barcelona
Spain

Date of the most recent revision of this summary: 11/2021

Other sources of information

Detailed information on this medicine 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:

Quantitative and qualitative composition:

Each ml of injectable and infusion solution contains 10 micrograms of noradrenaline (norepinephrine) tartrate monohydrate, equivalent to 5 micrograms of anhydrous noradrenaline (norepinephrine).

Each 20 ml vial contains 200 micrograms of noradrenaline (norepinephrine) tartrate monohydrate, equivalent to 100 micrograms of anhydrous noradrenaline (norepinephrine).

Each 50 ml vial contains 500 micrograms of noradrenaline (norepinephrine) tartrate monohydrate, equivalent to 250 micrograms of anhydrous noradrenaline (norepinephrine).

Therapeutic indications:

Vipranop 5 micrograms/ml solution for injection and infusion is indicated for the restoration and maintenance of blood pressure during the perioperative period following hypotension induced by spinal or general anaesthesia in adults.

Posology:

This formulation is appropriate for use in a perioperative setting; the concentration is not suitable for use in critical care settings.

The infusion may be administered as an intravenous bolus via a peripheral venous line or as a continuous infusion using a syringe pump, infusion pump or intravenous drip chamber.

This medicine must not be diluted before use: it is supplied ready for use and must not be mixed with other medicinal products.

The patient must be carefully monitored and must not be left unattended during administration of noradrenaline.

Care must be taken to avoid extravasation. To prevent detachment and necrosis at sites where extravasation has occurred, the area should be infiltrated as soon as possible with 10 ml to 15 ml of saline solution containing 5 mg to 10 mg of phentolamine. Noradrenaline infusion must be stopped.

Initial rate

The initial infusion dose ranges from 0.02 µg/kg/min to 0.05 µg/kg/min of noradrenaline (equivalent to 0.04 µg/kg/min to 0.1 µg/kg/min of noradrenaline tartrate). An initial loading dose (intravenous bolus) of 5 µg to 10 µg of noradrenaline (10 µg to 20 µg of noradrenaline tartrate) may be administered before starting the infusion, following spinal anaesthesia or induction of general anaesthesia.

Dose adjustment

Once noradrenaline infusion has been initiated, the dose may be increased or decreased to maintain adequate blood pressure during the perioperative period. The dose should be adjusted according to the patient's age, weight and clinical condition.

An intravenous bolus of 5 µg to 10 µg of noradrenaline (10 µg to 20 µg of noradrenaline tartrate) may be administered if a rapid increase in blood pressure is required.

Duration of treatment and monitoring

Noradrenaline should be maintained throughout the perioperative period as long as necessary to ensure adequate blood pressure and tissue perfusion.

Discontinuation of therapy

Infusions should be gradually reduced; abrupt discontinuation should be avoided, as it may result in acute hypotension.

Elderly patients

In general, caution should be exercised when selecting the dose for elderly patients, starting with the lowest dose within the recommended dosing range, reflecting the increased likelihood of decreased hepatic, renal or cardiac function, concomitant diseases, or other medicinal therapies.

Refer to the Summary of Product Characteristics for complete information on indication and use.