Adrenaline noridem

PACKAGE LEAFLET

Package leaflet: information for the user

Adrenalina Noridem, 1 mg/mL, solution for injection
Adrenalinum
Please read all of this leaflet carefully before receiving this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

1. What Adrenalina Noridem is and what it is used for

Adrenaline belongs to a class of medicinal products known as adrenergic and
dopaminergic agents. Adrenalina Noridem is used in life-threatening situations such as
severe allergic reactions or cardiac arrest.

2. Important information before receiving Adrenalina Noridem

When not to use Adrenalina Noridem:

• if the patient is allergic to adrenaline or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before receiving Adrenalina Noridem, discuss with your doctor,
pharmacist, or nurse if any of the following apply:

• elderly patients;
• presence of any heart-related problems, especially those affecting heart rate or causing chest pain;
• presence of brain-related conditions (such as stroke, brain injury, or vascular disease);
• hyperthyroidism, diabetes, or glaucoma (increased intraocular pressure);
• pheochromocytoma (a tumor of the adrenal gland);
• low blood potassium levels or high blood calcium levels;
• benign prostatic hyperplasia or kidney disease;
• shock or significant blood loss;
• planned general anesthesia;
• hypertension;
• atherosclerosis, i.e. narrowing and hardening of blood vessels in the body (further information available from your doctor).

If any of the above conditions apply to the patient, please consult a
doctor before receiving this medicine.

Adrenalina Noridem and other medicines
Inform your doctor or pharmacist about all other medicines the patient is currently taking or may take in the future.
A large number of medicinal products may interact with Adrenalina Noridem, potentially altering their effects significantly. These include:

• monoamine oxidase inhibitors (MAO inhibitors), such as moclobemide, or tricyclic antidepressants such as imipramine, amitriptyline (both used in the treatment of depression);
• cardiac glycosides, such as digoxin, used in heart failure;
• guanethidine, used for rapid control of blood pressure;
• diuretics (so-called water pills), such as hydrochlorothiazide, furosemide;
• inhaled anesthetics, such as halothane;
• drugs affecting blood pressure, including beta-blockers, e.g. propranolol, atenolol, bisoprolol, or phentolamine;
• antidiabetic agents, such as insulin or oral hypoglycemics (e.g. glipizide);
• aminophylline and theophylline (used in asthma treatment);
• corticosteroids (used to treat inflammatory conditions such as asthma or arthritis);
• antihistamines (e.g. diphenhydramine) used in allergy treatment;
• medications used in psychiatric disorders, such as chlorpromazine, periciazine, or fluphenazine;
• medications used in thyroid hormone replacement therapy;
• oxytocin (used to induce labor after term and to control postpartum bleeding);
• all cough suppressants or cold remedies (sympathomimetics).

If the patient is taking any of the listed medicines, inform the doctor before
receiving Adrenalina Noridem.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Adrenalina Noridem should not be used during pregnancy or labor.
Adrenaline passes into human milk. If breastfeeding, consult a doctor
before using Adrenalina Noridem.
Adrenaline should be used during pregnancy and breastfeeding only if the doctor considers it essential.

Driving and operating machinery
It is highly unlikely that this section would be relevant to the patient due to the critical condition requiring adrenaline treatment, which typically excludes the ability to drive or operate machinery.
Before attempting such activities, consult your doctor.

Adrenalina Noridem contains sodium metabisulfite and sodium chloride
Sodium metabisulfite (a preservative) may rarely cause severe allergic (hypersensitivity) reactions and bronchospasm (wheezing).
This medicinal product contains less than 1 mmol of sodium (23 mg) per dose (i.e. the product is considered "sodium-free").
Adrenalina Noridem may be diluted with 0.9% sodium chloride solution. This should be taken into account in patients on a sodium-restricted diet.

3. How is Adrenalina Noridem administered

This medicine may be injected into the muscle (intramuscular administration) or into the bone (intraosseous administration).
Before intravenous injection, it must be diluted. Adrenaline injections should not be administered into areas such as fingers and toes, ears, nose, or penis, because blood flow to these areas may be insufficient.
This medicine will be administered by a trained healthcare professional. The doctor will determine the most appropriate dose and route of administration in each individual case, depending on the patient's age and physical condition.
If an overdose of Adrenalina Noridem is suspected
This is unlikely, as the injection will be given by a doctor or nurse.
Possible symptoms of overdose include: anxiety, disorientation, pallor, abnormally high resting heart rate (tachycardia), slowed heart rate (bradycardia), heart rhythm disturbances (arrhythmias), and cardiac arrest.
If any adverse effects occur, speak to a doctor so that appropriate treatment can be initiated.
If you have already left the medical facility, contact the nearest hospital, your doctor, or a pharmacist.
If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions have also been reported (frequency unknown):

• Headache, dizziness
• Feelings of anxiety, fear, or restlessness
• Tremor
• Insomnia, confusion, irritability
• Mood or behaviour changes
• Dry mouth or excessive salivation
• Weakness or excessive sweating
• Changes in heart rhythm and rate
• Palpitations (fast or irregular heartbeat), tachycardia (abnormally fast resting heart rate), angina pectoris (chest pain of varying severity)
• High blood pressure
• Feeling of coldness in hands or feet
• Shortness of breath
• Decreased appetite, nausea or vomiting
• Repeated injections may damage tissue at the injection site; damage may also occur in the limbs, kidneys, and liver
• Difficulty in urinating, urinary retention
• Metabolic acidosis may occur (imbalance of certain components in the blood)
• Worsening of tremor and rigidity in patients with Parkinson's disease
• Bleeding within the brain
• Paralysis of one side of the body
• Increased blood glucose levels
• Decreased blood potassium levels
• Pulmonary oedema

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 .
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Adrenalina Noridem

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and the ampoule label after EXP. The expiry date refers to the last day of the specified month.
Store below 25°C. Keep the ampoules in the outer cardboard carton to protect from light.
The product is intended for single use only. If only part of the ampoule content is used, any remaining solution must be discarded.
Do not remove the ampoule from the cardboard carton until ready for use.
After dilution, the ready-to-use solution should be administered as soon as possible and under no circumstances should be stored for longer than 24 hours at 2 to 8°C, 3 hours at 23–27°C when exposed to light, or 6 hours at 23 to 27°C if protected from light.
Only use a clear or slightly yellowish solution free from particles or precipitate.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Adrenalina Noridem contains

• The active substance is adrenaline (epinephrine) in the form of adrenaline tartrate (epinephrine tartrate). Each mL of this injection solution contains 1 mg of adrenaline (epinephrine) as adrenaline tartrate.
• The other components are: sodium metabisulfite (E223), sodium chloride, water for injections, hydrochloric acid and sodium hydroxide.

What Adrenalina Noridem looks like and contents of the pack
Adrenalina Noridem is a clear, colourless or slightly yellowish sterile solution for injection contained in ampoules made of amber type I glass, packed in a cardboard box.
Adrenalina Noridem is available in packages containing 5, 10, 25 and 50 ampoules.

Marketing Authorisation Holder:
Noridem Enterprises Limited
Makariou & Evagorou 1
Mitsi Building 3, Office 115
1065 Nicosia, Cyprus
T: +30 210 8161802, F: +30 2108161587

Manufacturer:
DEMO S.A. PHARMACEUTICAL INDUSTRY
21st Km National Road Athens–Lamia,
14568 Krioneri, Attiki, Greece

This medicinal product is authorised in the European Economic Area under the following names:
France: ADRENALINE BRADEX 1 mg/mL, solution injectable
Luxembourg: ADRENALINE BRADEX 1 mg/mL, solution injectable
Belgium: Adrenaline (tartrate) Bradex 1 mg/mL, solution injectable / oplossing voor injectie / Injektionslösung
Denmark: Adrenalin Bradex
Sweden: Adrenalin Bradex
Czech Republic: Adrenalin Bradex
Slovakia: Adrenalin Bradex 1 mg/mL injekčný roztok
Hungary: Adrenalin BRADEX 1 mg/mL oldatos injekció
Germany: Epinephrin BRADEX 1 mg/mL Injektionslösung
Spain: Adrenalina Bradex 1 mg / mL Solución inyectable
Austria: Adrenalin Noridem 1 mg/mL Injektionslösung
Finland: Adrenalin Noridem 1 mg/mL injektioneste, liuos
Norway: Adrenalin Noridem
Netherlands: Adrenaline Noridem 1 mg/mL oplossing voor injectie
Poland: Adrenalina Noridem
Romania: Adrenalina Noridem 1 mg/mL soluţie injectabilă
Portugal: Adrenalina Noridem

Information intended exclusively for healthcare professionals:

Preparation and administration
Use only a clear or slightly yellowish solution free from solid particles or precipitate.
Repeated local administration may cause necrosis at injection sites.
The best site for intramuscular injection is the anterolateral surface of the middle third of the thigh.
The needle used for injection must be long enough to deliver the adrenaline into the muscle.
Intramuscular injections of Adrenalina Noridem into the buttocks should be avoided due to the risk of tissue necrosis.
Prolonged administration may lead to metabolic acidosis, renal necrosis, and adrenaline resistance (tachyphylaxis).
Adrenaline should be avoided or used with particular caution in patients undergoing anesthesia with halothane or other halogenated anesthetic agents due to the risk of inducing ventricular fibrillation.
Adrenaline should not be used in combination with local anesthetics for peripheral organs, including fingers and earlobes.
Do not mix with other agents unless compatibility is known.
Adrenaline should not be used during the second stage of labor.
Accidental intravascular injection may cause intracerebral hemorrhage due to a sudden increase in blood pressure.
To assess patient response to adrenaline administration, prompt monitoring of the patient's condition (pulse, arterial pressure, ECG, pulse oximetry) is essential.

Pharmaceutical incompatibilities
Dilution
For intravenous administration, the medicinal product Adrenalina Noridem must be diluted to a concentration of 0.1 mg/mL (diluting the ampoule contents 1:10) using 0.9% sodium chloride solution.

Dosage and method of administration
The medicinal product Adrenalina Noridem is intended for intramuscular and intraosseous administration. It may be used for intravenous administration only after dilution.

Acute anaphylaxis
The preferred route of administration for most individuals requiring adrenaline for treatment of acute anaphylaxis is intramuscular (IM), using the doses specified in Table 1.
The usual recommended dose of adrenaline is 0.01 mg per kilogram of body weight (10 micrograms/kg).
In adults, the usual recommended dose of adrenaline is 0.5 mg (500 micrograms).
In children with unknown body weight, the following table may be used to determine the recommended dose based on age:

Table 1. Dose of adrenaline (epinephrine) for intramuscular injection (BP, 1 mg/mL; 1:1000) in cases of severe anaphylactic reaction

In severely ill patients and in cases of real uncertainty regarding the proper functioning of the circulatory system and absorption from the intramuscular injection site, Adrenalina Noridem may be administered by intravenous injection (IV). Adrenaline should be administered intravenously only by individuals experienced in the use and dosing of vasopressor drugs as part of their routine clinical practice (see section 4.4 SmPC). When administering adrenaline intravenously, the dose should be titrated using 50-microgram boluses according to the patient's response. This dose must be administered only using a solution with a concentration of 0.1 mg/mL (i.e., after diluting the ampoule content at a ratio of 1:10 mL). Do not administer undiluted adrenaline solution at a concentration of 1 mg/mL intravenously.

If multiple doses of adrenaline are required, continuous intravenous infusion of adrenaline is recommended, with the infusion rate adjusted according to the patient's response and under continuous hemodynamic monitoring.

Cardiopulmonary resuscitation

Adults
1 mg adrenaline intravenously or intraosseously, repeated every 3–5 minutes until return of spontaneous circulation. When administering via a peripheral line, flush the line with at least 20 mL of fluid after injection and elevate the limb for 10–20 seconds to facilitate drug delivery into the central circulation.

Children and adolescents
The recommended intravenous or intraosseous dose of adrenaline in children is 10 micrograms/kg. Depending on body weight, such doses may require administration using a 0.1 mg/mL solution (i.e., after diluting the ampoule content at a ratio of 1:10 mL). Subsequent doses of adrenaline may be given every 3–5 minutes. The maximum single dose is 1 mg.

Disposal
Any unused portions of the product or waste materials should be disposed of in accordance with local regulations.

Overdose

Symptoms
Overdose of Adrenalina Noridem causes restlessness, confusion, pallor, tachycardia, bradycardia, cardiac arrhythmias, and cardiac arrest.

Treatment
Treatment is primarily symptomatic and supportive. To counteract the pressor and arrhythmogenic effects of adrenaline, rapid administration of a short-acting alpha-adrenergic receptor blocker such as phentolamine has been attempted, followed by a beta-blocker such as propranolol. A rapidly acting vasodilator such as glyceryl trinitrate has also been used.