Noradrenaline Zentiva

Package Leaflet: Information for the Patient

Noradrenaline Zentiva, 1 mg/mL, Concentrate for Solution for Infusion

Noradrenaline (Norepinephrine)

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or nurse.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of Contents of the Leaflet

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

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

Noradrenaline Zentiva contains the active substance noradrenaline (norepinephrine) (as noradrenaline bitartrate). It is indicated for use in adult patients in emergency situations to increase blood pressure to normal values.

2. Important information before using Noradrenaline Zentiva

When not to use Noradrenaline Zentiva

Warnings and precautions

Before starting treatment with Noradrenaline Zentiva, the patient should discuss it with their doctor or nurse if they:

• have diabetes
• have high blood pressure
• have hyperthyroidism (when the thyroid gland produces too many thyroid hormones)
• have low oxygen levels in the blood
• have high carbon dioxide levels in the blood
• have increased intracranial pressure (intracranial pressure)
• have blood clots or obstruction of blood vessels supplying the heart, intestines, or other parts of the body
• have low blood pressure due to heart attack
• have angina pectoris (chest pain), especially Prinzmetal's angina
• have severe left ventricular dysfunction
• have recently had a heart attack
• have heart rhythm disturbances (too fast, too slow, or irregular heartbeat), which may require a dose reduction
• are elderly
• have liver or kidney dysfunction

Children and adolescents

The safety and efficacy of Noradrenaline Zentiva in children and adolescents under 18 years of age have not been established. Therefore, the use of this medicine is not recommended in this age group.

Noradrenaline Zentiva and other medicines

The patient should tell their doctor or nurse about all medicines they are taking or have recently taken, as well as any medicines they plan to take. This is especially important if the patient is taking or has recently taken any of the following medicines:

• medicines used to treat depression called "monoamine oxidase inhibitors", which are currently being taken or were taken in the last 14 days
• medicines used to treat depression called "tricyclic antidepressants", such as imipramine or desipramine
• medicines that affect adrenergic and serotonergic receptors, such as those used to treat asthma and heart disease
• linezolid (an antibiotic)
• anesthetics (especially inhaled anesthetics, such as cyclopropane, halothane, chloroform, enflurane)
• medicines used to treat high blood pressure (such as guanethidine, reserpine, methyldopa, alpha- and beta-adrenergic blockers)
• medicines used to treat heart rhythm disturbances
• cardiac glycosides (used to treat heart disease)
• levodopa (used to treat Parkinson's disease)
• thyroid hormones
• oxytocin (used to stimulate uterine contractions)
• antihistamines (used to treat allergies)
• amphetamines
• doxapram (used to treat breathing disorders)
• mazindol (used to treat obesity)
• medicines used to treat migraines (ergot alkaloids)
• lithium (used to treat certain mental disorders)

Propofol Infusion Syndrome (PRIS)
Concomitant administration of noradrenaline and propofol (an anesthetic) may lead to the development of propofol infusion syndrome, a severe disorder that occurs in patients anesthetized with propofol in intensive care units. Based on blood tests, the doctor will diagnose metabolic disorders that can lead to kidney, heart, and respiratory failure.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine. Noradrenaline may harm the unborn child. The doctor will decide whether to administer Noradrenaline Zentiva. It is not known whether this medicine passes into human milk. Caution should be exercised when administering noradrenaline to a breastfeeding woman, as many medicines pass into breast milk.

Driving and using machines

The patient should not drive or operate machinery while taking Noradrenaline Zentiva.

Noradrenaline Zentiva contains sodium

Noradrenaline Zentiva contains 13.3 mg of sodium (the main component of common salt) per 4 mL ampoule and 33.3 mg of sodium per 10 mL ampoule. This corresponds to 0.7% and 1.7% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Noradrenaline Zentiva

Noradrenaline Zentiva will be administered in a hospital by a doctor or nurse. Fluids to replenish blood volume will also be administered, both before and during administration of Noradrenaline Zentiva. Initially, the medicine is diluted and then administered as an intravenous infusion.

Dosage

The initial dose of Noradrenaline Zentiva will depend on the patient's condition. The usual dose is between 0.4 mg and 0.8 mg of noradrenaline per hour. The doctor will determine the dose suitable for the patient. After the initial dose, the doctor will assess the patient's response to the medicine and adjust the dose accordingly.

Administration

The doctor will frequently check the vein into which Noradrenaline Zentiva is being administered to ensure that the medicine is not leaking into the surrounding tissues, as this could cause a severe skin reaction, especially if the medicine is administered into a vein in the leg. Sometimes, the medicine may cause the vein to appear whiter than usual, which may be due to leakage of Noradrenaline Zentiva into the tissues; in such cases, the doctor may decide to change the infusion site. If leakage into the tissues occurs, the doctor will administer an injection into the affected area as soon as possible.
The doctor will monitor the patient's blood pressure and blood volume.

Using a higher dose of Noradrenaline Zentiva than recommended

Using a higher dose than recommended is unlikely, as the medicine is administered in a hospital.
However, the patient should consult their doctor or nurse if they have any doubts.
Symptoms of overdose are: very high blood pressure, bleeding into the brain, slow heartbeat, severe headache, sensitivity to light, chest pain, paleness, fever, excessive sweating, vomiting, and fluid in the lungs causing shortness of breath.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or nurse.

4. Possible side effects

Like all medicines, Noradrenaline Zentiva can cause side effects, although not everybody gets them.

The patient should immediately inform their doctor if they experience:

• itching rash with sudden onset (hives), swelling of hands, feet, ankles, face, lips, mouth, or throat (which may cause difficulty swallowing or breathing), feeling of fainting.
• pain and/or swelling at the injection site.

Other possible side effects include:

• anxiety, insomnia, confusion, weakness, psychotic state
• headaches, tremors
• decreased or accelerated heart rate
• heart rhythm disturbances
• abnormal ECG recording
• a potentially life-threatening type of circulatory failure, known as "cardiogenic shock"
• weakening of the heart muscle due to severe physical or emotional stress, palpitations, increased heart contractility
• high blood pressure, decreased oxygen supply to certain organs (hypoxia)
• decreased blood flow to hands and feet (cold extremities, paleness, and/or pain in the extremities)
• gangrene (tissue death due to lack of blood flow or severe bacterial infection)
• decreased blood volume
• breathing difficulties
• paleness, skin scarring, bluish discoloration of the skin, hot flashes, or redness of the skin, skin rash, hives, or itching;
• nausea, vomiting
• urinary retention
• irritation or ulceration at the injection site

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Noradrenaline Zentiva

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or ampoule after: EXP. The expiry date refers to the last day of the month.
Store in a temperature below 25°C. Store the ampoules in the outer packaging to protect from light.
Chemical and physical stability has been demonstrated for 48 hours at a temperature of 22°C ± 2°C with exposure to daylight and at 30°C for the concentrate diluted in 5% glucose solution (w/v), 0.9% sodium chloride solution (w/v), and 0.45% sodium chloride solution (w/v) with 5% glucose solution (w/v).
From a microbiological point of view, the product should be used immediately. If not used immediately, the responsibility for storage conditions and storage time rests with the user and should not exceed 24 hours at a temperature of 2°C to 8°C, provided that the dilution has taken place in controlled and validated aseptic conditions.

6. Contents of the pack and other information

What Noradrenaline Zentiva contains

• The active substance is noradrenaline (norepinephrine). Each mL of concentrate for solution for infusion contains noradrenaline bitartrate, equivalent to 1 mg of noradrenaline (norepinephrine). One ampoule containing 1 mL of concentrate for solution for infusion contains noradrenaline bitartrate equivalent to 1.0 mg of noradrenaline. One ampoule containing 4 mL of concentrate for solution for infusion contains noradrenaline bitartrate equivalent to 4.0 mg of noradrenaline.

Noradrenaline bitartrate equivalent to 10.0 mg of noradrenaline is contained in one ampoule with 10 mL of concentrate for solution for infusion.
The other ingredients are: sodium chloride, disodium edetate, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), water for injections.

What Noradrenaline Zentiva looks like and contents of the pack

The concentrate for solution for infusion (sterile concentrate) is a clear, colorless to yellowish solution, free from visible particles.
The product is available in ampoules made of colorless glass type I, with a capacity of 1 mL, 4 mL, or 10 mL, with a plastic stopper in a cardboard box.
Pack sizes: 10 ampoules containing 1 mL; 5, 10, or 50 ampoules containing 4 mL; and 10 ampoules containing 10 mL.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Zentiva, k.s.
U Kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer

Zentiva, k.s.
U Kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

For further information about this medicine, please contact the local representative of the marketing authorization holder:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. +48 22 375 92 00

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

Czech Republic: Norepinephrine Zentiva
Denmark, Norway, Sweden: Noradrenalin Zentiva
Poland: Noradrenaline Zentiva
Spain: Noradrenalina Zentiva 1mg/ml concentrado para solución para perfusión EFG
Date of last revision of the leaflet:July 2025
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Noradrenaline Zentiva, 1 mg/mL, concentrate for solution for infusion

Information intended for healthcare professionals only:

Intravenous administration.

Route and method of administration of the infusion

Administer as a diluted solution through a central venous line.
The infusion should be administered at a controlled rate, using a syringe pump, infusion pump, or drop counter.
Incompatibilities:
Incompatibilities have been reported between noradrenaline bitartrate infusion solutions and the following substances: iron salts, alkalizing and oxidizing agents, barbiturates, chlorpheniramine, chlorothiazide, nitrofurantoin, novobiocin, phenytoin, sodium bicarbonate, sodium iodide, streptomycin, sulfadiazine, sulfafurazole.

Use and preparation Dilution instructions

For single use only. Dispose of any unused contents of the ampoule.
Inspect the solution before use. Do not use the medicine if the solution contains visible particles. Do not use the solution if it has a brown color.
Dilute using one of the following solutions (diluents): 5% glucose solution (w/v), 0.9% sodium chloride solution (w/v), or 0.45% sodium chloride solution (w/v) with 5% glucose solution (w/v).
Dilution ratio (e.g.):
Add 1 mL of concentrate to 24 mL of solution (diluent).
Add 2 mL of concentrate to 48 mL of solution (diluent).
Add 4 mL of concentrate to 96 mL of solution (diluent).
Add 10 mL of concentrate to 240 mL of solution (diluent).
Add 20 mL of concentrate to 480 mL of solution (diluent).
In each case, the final concentration of the infusion solution is 40 mg/L of noradrenaline (which corresponds to 80 mg/L of noradrenaline bitartrate). The medicinal product can also be diluted to concentrations other than 40 mg/L of noradrenaline. If diluted to a concentration other than 40 mg/L of noradrenaline, the infusion rate should be carefully recalculated before starting treatment.
After dilution
Chemical and physical stability has been demonstrated for 48 hours at a temperature of 22°C ± 2°C with exposure to daylight and at 30°C for the concentrate diluted in 5% glucose solution (w/v), 0.9% sodium chloride solution (w/v), and 0.45% sodium chloride solution (w/v) with 5% glucose solution (w/v).
Only clear, colorless solutions without visible particles should be used.
From a microbiological point of view, the product should be used immediately. If not used immediately, the responsibility for storage conditions and storage time rests with the user and should not exceed 24 hours at a temperature of 2°C to 8°C, provided that the dilution has taken place in controlled and validated aseptic conditions.
Any unused product or waste material should be disposed of in accordance with local requirements.