NORADRENALIN 1 mg /Ml Concentrate

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Noradrenalin Kalceks, 1 mg/ml, Concentrate for Solution for Infusion
   1. Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Package Leaflet
3. What is Noradrenalin Kalceks and What is it Used For
4. Important Information Before Using Noradrenalin Kalceks
   1. When Not to Use Noradrenalin Kalceks
   2. Warnings and Precautions
   3. Children and Adolescents
   4. Noradrenalin Kalceks and Other Medications
   5. Pregnancy and Breastfeeding
   6. Driving and Operating Machines
   7. Noradrenalin Kalceks Contains Sodium
5. How to Use Noradrenalin Kalceks
   1. Using a Higher Dose of Noradrenalin Kalceks Than Recommended
6. Possible Side Effects
   1. Reporting Side Effects
7. How to Store Noradrenalin Kalceks
8. Contents of the Package and Other Information
   1. What Noradrenalin Kalceks Contains
   2. What Noradrenalin Kalceks Looks Like and Contents of the Package
   3. Marketing Authorization Holder and Manufacturer
   4. This Medication is Authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) Under the Following Names:
   5. Date of Last Revision of the Package Leaflet: April 2022

Package Leaflet: Information for the User

Noradrenalin Kalceks, 1 mg/ml, Concentrate for Solution for Infusion

Noradrenaline

Read the Package Leaflet Carefully Before Using the Medication, 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.
• If you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Noradrenalin Kalceks and What is it Used For

Noradrenalin Kalceks contains noradrenaline and acts as a vasoconstrictor (causes blood vessels to narrow). Noradrenalin Kalceks is indicated for use in adults in emergency situations to increase blood pressure to normal values.

2. Important Information Before Using Noradrenalin Kalceks

When Not to Use Noradrenalin Kalceks

• if the patient is allergic to noradrenaline or any of the other ingredients of this medication (listed in section 6)
• if the patient has low blood pressure due to reduced blood volume
• if the patient is receiving certain anesthetics, such as halothane or cyclopropane (which may increase the risk of heart rhythm disturbances).

Warnings and Precautions

Before starting treatment with Noradrenalin Kalceks, the patient should discuss it with their doctor or pharmacist if they have:

• diabetes
• liver failure
• severe kidney dysfunction
• 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
• a type of angina pectoris (chest pain) called Prinzmetal's angina
• severe left ventricular dysfunction (heart disease)
• recent myocardial infarction
• heart rhythm disturbances (too fast, too slow, or irregular heartbeat), which may require a dose reduction
• are elderly

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 medication is not recommended in this age group.

Noradrenalin Kalceks and Other Medications

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

• medications used to treat depression called "monoamine oxidase inhibitors" which are currently being taken or have been taken in the last 14 days
• medications used to treat depression called "tricyclic antidepressants", such as imipramine or desipramine
• medications 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)
• medications used to treat high blood pressure (such as guanethidine, reserpine, methyldopa, alpha- and beta-adrenergic blockers)
• medications 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 respiratory disorders)
• mazindol (used to treat obesity)
• medications used to treat migraines (ergot alkaloids)
• lithium (used to treat certain psychiatric disorders)

Concomitant use of noradrenaline with propofol (an anesthetic) may lead to the development of propofol infusion syndrome (PRIS) - a serious condition that occurs 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 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 medication. Noradrenaline may have harmful effects on the unborn child. The doctor will decide whether to administer noradrenaline. It is not known whether this medication passes into breast milk. Since many medications pass into breast milk, caution should be exercised when administering noradrenaline to breastfeeding women.

Driving and Operating Machines

There is no available information, therefore, it is not recommended to drive or operate machines.

Noradrenalin Kalceks Contains Sodium

Ampoules containing 1 ml, 2 ml, 4 ml, or 5 ml of concentrate for solution for infusion contain less than 1 mmol (23 mg) of sodium per ampoule, i.e., the medication is considered "sodium-free". Each ampoule containing 8 ml of concentrate for solution for infusion contains 26.4 mg of sodium (the main component of common salt). This corresponds to 1.32% of the maximum recommended daily intake of sodium in the diet for adults. Each ampoule containing 10 ml of concentrate for solution for infusion contains 33 mg of sodium (the main component of common salt). This corresponds to 1.65% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to Use Noradrenalin Kalceks

Noradrenaline is administered in a hospital by a doctor or nurse. The medication is first diluted and then administered by intravenous infusion. The initial 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. The doctor will determine the dose suitable for the patient. After administering the initial dose, the doctor will assess the patient's response to the medication and adjust the dose accordingly. The doctor will monitor the patient's blood pressure and blood volume.

Using a Higher Dose of Noradrenalin Kalceks Than Recommended

Using a higher dose than recommended is unlikely, as the medication is administered in a hospital. However, if there are any doubts, the patient should consult their doctor or nurse. Symptoms that may occur if the patient receives too much noradrenaline include: very high blood pressure, slow heartbeat, severe headache, sensitivity to light, chest pain, bleeding into the brain, paleness, fever, excessive sweating, and vomiting, fluid in the lungs causing shortness of breath.

4. Possible Side Effects

Like all medications, Noradrenalin Kalceks can cause side effects, although not everybody gets them. The patient should immediatelyinform their doctor or nurse if they experience:

• itching rash (hives) with sudden onset, 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.

The patient should inform their doctor or nurse as soon as possible if they experience:

• anxiety, insomnia, confusion, weakness, psychotic state
• headaches, trembling
• decreased or accelerated heart rate
• heart rhythm disturbances
• abnormal ECG
• a potentially life-threatening type of circulatory failure, called "cardiogenic shock"
• weakening of the heart muscle due to severe physical or emotional stress, palpitations, increased heart muscle 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 extremities)
• gangrene (tissue death)
• decreased blood volume
• breathing difficulties
• paleness, skin scarring, blue discoloration of the skin, hot flashes or skin redness, skin rash, hives, or itching
• nausea, vomiting
• urinary retention
• irritation or ulceration at the injection site

In case of hypersensitivity or overdose, the following side effects may occur more frequently: very high blood pressure, unusual sensitivity to light or light intolerance, chest pain, throat pain, paleness, excessive sweating, and vomiting.

Reporting Side Effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C PL-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, it is possible to gather more information on the safety of the medication.

5. How to Store Noradrenalin Kalceks

The medication should be stored out of sight and reach of children. Do not store above 25°C. Store ampoules in the outer packaging to protect from light. Shelf life after first opening of the ampoule After opening, the diluted solution should be prepared immediately. Shelf life after dilution The chemical and physical stability of the product has been demonstrated for 48 hours at 25°C and from 2 to 8°C, after dilution to 4 mg/liter and 40 mg/liter of noradrenaline in sodium chloride 9 mg/ml (0.9%) solution or glucose 50 mg/ml (5%) solution, or sodium chloride 9 mg/ml (0.9%) solution with glucose 50 mg/ml (5%) solution. From a microbiological point of view, the diluted solution should be used immediately. If the solution is not used immediately, the user is responsible for the storage conditions prior to use, and these should not normally exceed 24 hours at 2-8°C, provided that the dilution has been carried out under controlled and validated aseptic conditions. Do not use this medication after the expiry date stated on the carton and on the ampoule. The expiry date refers to the last day of the month stated. Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Noradrenalin Kalceks Contains

The active substance of the medication is noradrenaline. Each 1 ml of concentrate for solution for infusion contains noradrenaline bitartrate equivalent to 1 mg of noradrenaline. Each ampoule containing 2 ml of concentrate for solution for infusion contains noradrenaline bitartrate equivalent to 2 mg of noradrenaline. Each ampoule containing 4 ml of concentrate for solution for infusion contains noradrenaline bitartrate equivalent to 4 mg of noradrenaline. Each ampoule containing 5 ml of concentrate for solution for infusion contains noradrenaline bitartrate equivalent to 5 mg of noradrenaline. Each ampoule containing 8 ml of concentrate for solution for infusion contains noradrenaline bitartrate equivalent to 8 mg of noradrenaline. Each ampoule containing 10 ml of concentrate for solution for infusion contains noradrenaline bitartrate equivalent to 10 mg of noradrenaline. The other ingredients of the medication are: sodium chloride, hydrochloric acid (for pH adjustment), water for injections.

What Noradrenalin Kalceks Looks Like and Contents of the Package

A clear, colorless or yellowish solution, practically free from visible particles. 1 ml, 2 ml, 4 ml, 5 ml, 8 ml, or 10 ml of solution are in ampoules made of colorless glass type I with one break point. The ampoules are placed in a blister and a cardboard box. Pack sizes: 5 or 10 ampoules. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

AS KALCEKS Krustpils iela 71E LV-1057 Rīga Latvia

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

Denmark Noradrenalin Kalceks Austria Norepinephrin Kalceks 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung Belgium Noradrenaline (Norepinephrine) Kalceks 1 mg/ml concentraat voor oplossing voor infusie / solution à diluer pour perfusion / Konzentrat zur Herstellung einer Infusionslösung Czech Republic Norepinephrine Kalceks Estonia Norepinephrine Kalceks Finland Noradrenalin Kalceks France NORADRENALINE TARTRATE KALCEKS 1 mg/mL, solution à diluer pour perfusion Germany Norepinephrin Kalceks 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung Hungary Norepinephrine Kalceks 1 mg/ml koncentrátum oldatos infúzióhoz Ireland Noradrenaline (Norepinephrine) 1 mg/ml concentrate for solution for infusion Italy Norepinefrina Kalceks Latvia Norepinephrine Kalceks 1 mg/ml koncentrāts infūziju šķīduma pagatavošanai Lithuania Norepinephrine Kalceks 1 mg/ml koncentratas infuziniam tirpalui Norway Noradrenalin Kalceks Poland Noradrenalin Kalceks Portugal Noradrenalina Kalceks Romania Noradrenalină Kalceks 1 mg/ml concentrat pentru soluţie perfuzabilă Slovakia Norepinephrine Kalceks 1 mg/ml infúzny koncentrát Spain Noradrenalina Kalceks 1 mg/ml concentrado para solución para perfusión EFG Sweden Noradrenalin Kalceks Netherlands Noradrenaline Kalceks 1 mg/ml concentraat voor oplossing voor infusie United Kingdom (Northern Ireland) Noradrenaline (Norepinephrine) 1 mg/ml concentrate for solution for infusion

Date of Last Revision of the Package Leaflet: April 2022

Information intended for healthcare professionals only: Administration Method Intravenous administration after dilution. Administer as a diluted solution through a central venous catheter. The infusion rate should be controlled using a syringe pump, infusion pump, or drop counter. Undiluted medication should not be used. Incompatibilities Noradrenaline bitartrate solutions for infusion have been found to be incompatible with the following substances: iron salts, alkalizing and oxidizing agents, barbiturates, chlorpheniramine, chlorothiazide, nitrofurantoin, novobiocin, phenytoin, sodium bicarbonate, sodium iodide, streptomycin, sulfadiazine, sulfafurazol. This medicinal product must not be mixed with other medicinal products except for those mentioned below. Dilution Instructions For single use only. Unused contents of the ampoule should be discarded. The solution should be inspected before use. Do not use the solution if it contains visible particles/solid matter. Do not use the infusion solution if it has a brown color. Dilute before use using:

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

Add 2 ml of concentrate to 48 ml of glucose 50 mg/ml (5%) solution (or any of the above-mentioned diluents) for administration using a syringe pump or add 20 ml of concentrate to 480 ml of glucose 50 mg/ml (5%) solution (or any of the above-mentioned diluents) for administration using a drop counter. In both cases, the final concentration of the infusion solution is 40 mg/liter of noradrenaline (which corresponds to 80 mg/liter of noradrenaline bitartrate). Other dilutions of noradrenaline may also be used. When using dilutions other than 40 mg/liter of noradrenaline, the infusion rate should be carefully recalculated before starting treatment. The product is compatible with infusion bags made of polyvinyl chloride (PVC), ethylene-vinyl acetate (EVA), or polyethylene (PE). Instructions for Opening Ampoules

• 1) Turn the ampoule with the colored break point upwards. If there is a solution in the upper part of the ampoule, gently tap with a finger to move the entire solution to the lower part of the ampoule.
• 2) Use both hands to open the ampoule; holding the lower part of the ampoule in one hand, break the upper part of the ampoule in the direction of the colored break point (see pictures below).

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.