NORADRENALINE 1 mg /Ml Concentrate

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Noradrenaline Kabi, 1 mg/ml, Concentrate for Solution for Infusion
   1. Read the Package Leaflet Carefully Before Using the Medicinal Product, as it Contains Important Information for the Patient.
   2. Table of Contents of the Package Leaflet
3. What is Noradrenaline Kabi and What is it Used For
4. Important Information Before Using Noradrenaline Kabi
   1. When Not to Use Noradrenaline Kabi
   2. Warnings and Precautions
   3. Children and Adolescents
   4. Noradrenaline Kabi and Other Medicinal Products
   5. Pregnancy and Breastfeeding
   6. Driving and Using Machines
   7. Noradrenaline Kabi Contains Sodium
5. How to Use Noradrenaline Kabi
   1. Using More Than the Recommended Dose of Noradrenaline Kabi
6. Possible Side Effects
   1. Inform Your Doctor Immediately if You Experience:
   2. Inform Your Doctor as Soon as Possible if You Experience:
   3. Reporting Side Effects
7. How to Store Noradrenaline Kabi
8. Contents of the Package and Other Information
   1. What Noradrenaline Kabi Contains
   2. What Noradrenaline Kabi Looks Like and Contents of the Package
   3. Marketing Authorization Holder and Manufacturer
   4. Marketing Authorization Holder
   5. Manufacturer
   6. This Medicinal Product is Authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) Under the Following Names:
   7. Date of Last Revision of the Package Leaflet: --------------------------------------------------------------------------------------------------------------------
   8. Information Intended for Healthcare Professionals Only:

Package Leaflet: Information for the User

Noradrenaline Kabi, 1 mg/ml, Concentrate for Solution for Infusion

Noradrenaline (Norepinephrine)

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicinal product has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Noradrenaline Kabi and What is it Used For
• 2. Important Information Before Using Noradrenaline Kabi
• 3. How to Use Noradrenaline Kabi
• 4. Possible Side Effects
• 5. How to Store Noradrenaline Kabi
• 6. Contents of the Package and Other Information

1. What is Noradrenaline Kabi and What is it Used For

Noradrenaline Kabi contains noradrenaline (norepinephrine) and acts as a vasoconstrictor (causing blood vessels to narrow).
Noradrenaline Kabi is indicated for use in adult patients in emergency situations to increase blood pressure to normal values.

2. Important Information Before Using Noradrenaline Kabi

When Not to Use Noradrenaline Kabi

• if you are allergic to noradrenaline or any of the other ingredients of this medicinal product (listed in section 6);
• if you have low blood pressure due to reduced blood volume;
• if you are receiving certain inhalational anesthetics, such as halothane or cyclopropane (which may increase the risk of heart rhythm disturbances).

Warnings and Precautions

Before starting treatment with Noradrenaline Kabi, discuss with your doctor or pharmacist if you have:

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

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

Children and Adolescents

The safety and efficacy of noradrenaline in children under 18 years of age have not been established.
Therefore, the use of this medicinal product is not recommended in this age group.

Noradrenaline Kabi and Other Medicinal Products

Inform your doctor about all medicinal products you are currently taking or have recently taken, as well as any medicinal products you plan to take.
This is especially important if you are taking or have recently taken any of the following medicinal products:

• medicinal products used to treat depression, known as "monoamine oxidase inhibitors", which are currently being used or have been used in the last 14 days;
• medicinal products used to treat depression, known as "tricyclic antidepressants" (e.g., imipramine or desipramine);
• linezolid (an antibiotic);
• anesthetics (especially inhalational anesthetics, such as cyclopropane, halothane, chloroform, enflurane);
• medicinal products that affect adrenergic and serotonergic receptors, e.g., used to treat asthma and heart diseases;
• medicinal products used to treat high blood pressure (e.g., guanethidine, reserpine, methyldopa, alpha- and beta-adrenergic blockers);
• Rauvolfia alkaloids;
• medicinal products used to treat heart rhythm disorders;
• cardiac glycosides (used to treat heart diseases);
• levodopa (used to treat Parkinson's disease);
• thyroid hormones;
• oxytocin (used to stimulate uterine contractions);
• antihistamines (used to treat allergies, e.g., chlorpheniramine hydrochloride, tripelennamine hydrochloride);
• amphetamines;
• doxapram (used to treat respiratory disorders);
• mazindol (used to treat obesity);
• medicinal products used to treat migraines (ergot alkaloids);
• lithium (used to treat certain mental disorders);
• vasopressin, desmopressin (antidiuretics, reducing urine production).

Concomitant use of noradrenaline with propofol (an anesthetic) may lead to the occurrence of propofol infusion syndrome (PRIS) - a severe disorder occurring in patients anesthetized with propofol in intensive care units. In such cases, the doctor will diagnose metabolic disorders based on blood tests, which can lead to kidney failure, heart failure, and death.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicinal product.
Noradrenaline Kabi may have harmful effects on the unborn child. It is not known whether this medicinal product passes into breast milk. Your doctor will decide whether to administer Noradrenaline Kabi.

Driving and Using Machines

Do not drive or operate machines while under the influence of Noradrenaline Kabi.

Noradrenaline Kabi Contains Sodium

This medicinal product contains 3.4 mg of sodium (the main component of common salt) per ml of concentrate. This corresponds to 0.17% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to Use Noradrenaline Kabi

Noradrenaline Kabi is administered in a hospital by a doctor or nurse. The medicinal product is first diluted and then administered by intravenous infusion.
The recommended dose of noradrenaline will depend on the patient's condition. The usual dose is between 0.4 mg and 0.8 mg of noradrenaline per hour. Your doctor will determine the dose suitable for you. After the initial dose, your doctor will assess your response to the medicinal product and adjust the dose accordingly.

Using More Than the Recommended Dose of Noradrenaline Kabi

Using more than the recommended dose is unlikely, as this medicinal product is administered in a hospital. However, if you have any doubts, consult your doctor or nurse.
Symptoms that may occur if you receive too much noradrenaline include: very high blood pressure, slow heartbeat, severe headache, bleeding into the brain, sensitivity to light, chest pain, paleness, high fever, excessive sweating, vomiting, and fluid in the lungs causing shortness of breath.
If you have any further doubts about using this medicinal product, consult your doctor or nurse.

4. Possible Side Effects

Like all medicinal products, Noradrenaline Kabi can cause side effects, although not everybody gets them.
The frequency of the following side effects is unknown (the frequency cannot be estimated from the available data).

Inform Your Doctor Immediately if You Experience:

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

Inform Your Doctor as Soon as Possible if You Experience:

• anxiety, insomnia, confusion, weakness, psychotic state;
• headache, tremor;
• increased eye pressure (acute glaucoma);
• decreased or accelerated heart rate;
• heart rhythm disorders;
• abnormal ECG recording;
• a potentially life-threatening type of circulatory failure, known as "cardiogenic shock";
• weakened heart muscle due to severe physical or emotional stress, palpitations, increased heart muscle contractility, acute heart failure;
• high blood pressure, reduced oxygen supply to certain organs (hypoxia);
• reduced blood flow to hands and feet (cold limbs, paleness, and (or) limb pain);
• gangrene (tissue death);
• reduced blood volume;
• breathing difficulties;
• nausea, vomiting;
• paleness, skin scarring, blue discoloration of the skin, hot flashes, or skin redness, skin rash, hives, or itching;
• urinary retention;
• irritation or ulceration (cell damage, leading to cell death in tissue) at the injection site.

Your doctor will monitor your blood pressure and blood volume.

Reporting Side Effects

If you experience any side effects, including any not listed in this package leaflet, please inform your doctor, pharmacist, or nurse. 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 also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. How to Store Noradrenaline Kabi

Store the medicinal product out of sight and reach of children.
Do not store above 25°C.
Store in the outer packaging to protect from light.
Do not use this medicinal product if it has a brown color or contains visible solid particles.
Do not use this medicinal product after the expiry date stated on the ampoule and carton after: EXP.
The expiry date refers to the last day of the month.
Medicinal products should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Noradrenaline Kabi Contains

• The active substance is noradrenaline (norepinephrine). Each 1 ml of concentrate for solution for infusion contains 1 mg of noradrenaline, corresponding to 2 mg of noradrenaline tartrate. Each ampoule containing 1 ml of concentrate for solution for infusion contains 1 mg of noradrenaline, corresponding to 2 mg of noradrenaline tartrate. Each ampoule containing 4 ml of concentrate for solution for infusion contains 4 mg of noradrenaline, corresponding to 8 mg of noradrenaline tartrate. Each ampoule containing 5 ml of concentrate for solution for infusion contains 5 mg of noradrenaline, corresponding to 10 mg of noradrenaline tartrate. Each ampoule containing 8 ml of concentrate for solution for infusion contains 8 mg of noradrenaline, corresponding to 16 mg of noradrenaline tartrate. Each ampoule containing 10 ml of concentrate for solution for infusion contains 10 mg of noradrenaline, corresponding to 20 mg of noradrenaline tartrate.
• The other ingredients are sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), water for injections.

What Noradrenaline Kabi Looks Like and Contents of the Package

This medicinal product is available as a concentrate for solution for infusion. Clear, colorless to pale yellow solution.
Transparent glass ampoules containing:
1 ml of concentrate (packaged in 5, 10, or 50 pieces);
4 ml, 5 ml, 8 ml, or 10 ml of concentrate (packaged in 5 or 10 pieces).
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer

Labesfal - Laboratórios Almiro, S.A
Zona Industrial do Lagedo
3465-157 Santiago de Besteiros
Portugal

This Medicinal Product is Authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) Under the Following Names:

Date of Last Revision of the Package Leaflet: --------------------------------------------------------------------------------------------------------------------

Information Intended for Healthcare Professionals Only:

For intravenous use only, after dilution.
The infusion rate should be controlled using an infusion pump, syringe pump, or drop counter.
Noradrenaline Kabi is administered as a diluted solution through a central venous catheter.
If a central venous catheter is not used, noradrenaline should always be administered in an infusion into a large vein, preferably into the antecubital vein, to minimize the risk of ischemic necrosis (skin, limb).
If possible, avoid inserting a catheter, as reduced blood flow around the catheter may cause stasis and increase the local concentration of the medicinal product.
Incompatibilities
Incompatibilities have been reported between noradrenaline tartrate infusion solution and the following substances: iron salts, alkalizing and oxidizing agents, barbiturates, chlorpheniramine, chlorothiazide, nitrofurantoin, novobiocin, phenytoin, sodium bicarbonate, sodium iodide, streptomycin, sulfadiazine, sulfafurazole.
Dilution Instructions
When administered using a syringe pump, add 2 ml of concentrate to 48 ml of diluent. When administered using a drop counter, add 20 ml of concentrate to 480 ml of diluent. In both cases, the final concentration of the infusion solution is 40 mg/l of noradrenaline (corresponding to 80 mg/l of noradrenaline tartrate).
The medicinal product can also be diluted to concentrations other than 40 mg/l of noradrenaline (see section 4.2). When diluted to a concentration other than 40 mg/l of noradrenaline, the infusion rate should be carefully recalculated before starting treatment.

• The following diluents can be used:

• sodium chloride 9 mg/ml (0.9% w/v) solution with glucose 50 mg/ml (5% w/v) solution,
• glucose 50 mg/ml (5% w/v) solution,
• sodium chloride 9 mg/ml (0.9% w/v) solution.

Any unused medicinal product or waste materials should be disposed of in accordance with local requirements.
Shelf-Life After Opening the Ampoule:
The medicinal product should be used immediately after opening.
Shelf-Life After Dilution:
Chemical and physical stability has been demonstrated for 24 hours at 25°C.
From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, the responsibility for storage conditions and duration lies with the user and should not exceed 24 hours at 2 to 8°C, provided that the dilution has been made under controlled and validated aseptic conditions.