Noradrenaline swiss2care

Package leaflet: Information for the patient

Noradrenaline Swiss2Care
1 mg/ml, concentrate for solution for infusion
Noradrenalinum
Please read carefully the entire leaflet before use, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Noradrenaline Swiss2Care is and what it is used for
2. Important information before using Noradrenaline Swiss2Care
3. How to use Noradrenaline Swiss2Care
4. Possible side effects
5. How to store Noradrenaline Swiss2Care
6. Contents of the package and other information

1. What Noradrenaline Swiss2Care is and what it is used for

Noradrenaline Swiss2Care contains noradrenaline and acts as a vasoconstrictor (causes narrowing of blood vessels).
Noradrenaline Swiss2Care is indicated for use in adults during emergency situations to increase arterial blood pressure to normal levels.

2. Important information before using Noradrenaline Swiss2Care

When not to use Noradrenaline Swiss2Care

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

Warnings and precautions
Before starting treatment with Noradrenaline Swiss2Care, discuss with the doctor or
nurse if the patient:

• has diabetes
• has liver failure
• has severe kidney function impairment
• has high blood pressure
• has hyperthyroidism
• has low blood oxygen levels
• has high blood carbon dioxide levels
• has increased intracranial pressure (intracranial pressure)
• has blood clots or blocked blood vessels supplying blood to the heart, intestines, or other parts of the body
• has low blood pressure due to heart attack
• has a type of chest pain (angina) called Prinzmetal's angina
• has severe left ventricular dysfunction (heart disease)
• has recently suffered a myocardial infarction
• has heart rhythm disorders (too fast, too slow, or irregular heartbeat), dose reduction may be necessary
• is an elderly person.

Children and adolescents
The safety and efficacy of noradrenaline in children under 18 years of age have not been established. Therefore, use of this medicine is not recommended in this age group.
Noradrenaline Swiss2Care and other medicines
Tell the doctor or nurse about all medicines the patient is currently taking or has taken recently, as well as any medicines the patient plans to use. This is particularly 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 have been taken within the last 14 days
• medicines used to treat depression called "tricyclic antidepressants",
• such as imipramine or desipramine
• medicines affecting adrenergic and serotonergic receptors, for example used in
• the treatment of asthma and heart diseases
• linezolid (an antibiotic)
• anaesthetics (especially inhalational anaesthetics such as cyclopropane, halothane,
• chloroform, enflurane)
• medicines used to treat high blood pressure (e.g. guanethidine, reserpine,
• methyldopa, alpha- and beta-adrenergic blockers)
• medicines used to treat heart rhythm disorders
• cardiac glycosides (used in the treatment of heart diseases)
• levodopa (used in the treatment of Parkinson's disease)
• thyroid hormones
• oxytocin (used to enhance uterine contractions)
• antihistamines (used to treat allergies)
• amphetamine
• doxapram (used in respiratory disorders)
• mazindol (used in the treatment of obesity)
• medicines used to treat migraine (ergot alkaloids)
• lithium (used in the treatment of certain psychiatric disorders)

Concomitant use of noradrenaline with propofol (an anaesthetic medicine) may lead to
the development of propofol infusion syndrome (PRIS) – a serious condition occurring in patients anaesthetized with propofol in intensive care units. In such
cases, the doctor detects metabolic disturbances based on blood tests, which may lead to
kidney failure, heart failure, and death.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have
a child, she should consult her doctor before using this medicine. Noradrenaline may have harmful effects on the unborn child. The doctor will decide whether noradrenaline should be administered. It is not known whether this medicine passes into human milk. Since many medicines pass into human
milk, caution should be exercised when administering noradrenaline to breastfeeding women.
Driving and operating machinery
There is no available information; therefore, driving vehicles or operating machinery is not recommended.
Noradrenaline Swiss2Care contains sodium
Ampoules containing 4 ml of concentrate for solution for infusion contain less than
1 mmol (23 mg) of sodium per ampoule, meaning the medicine is considered "sodium-free".
Each ampoule containing 8 ml of concentrate for solution for infusion contains 26.4 mg
of sodium (main component of table salt). This corresponds to 1.32% of the maximum recommended daily dietary sodium intake for adults.
3. How to use Noradrenaline Swiss2Care
Noradrenaline is administered in a hospital setting by a doctor or nurse. The medicine is first
diluted and then given as an intravenous infusion.
The initial dose of noradrenaline will depend on the patient's condition. The usual dose
ranges from 0.4 mg to 0.8 mg of noradrenaline per hour. The doctor will determine the appropriate dose for the patient.
After the initial dose is administered, the doctor will assess the patient's response to the medicine and adjust the dose accordingly.
The doctor will monitor the patient's blood pressure and blood volume.
Use of more than the recommended dose of Noradrenaline Swiss2Care
Use of more than the recommended dose is unlikely, as this medicine is administered
in a hospital.
However, consult a doctor or nurse in case of any doubts.
Symptoms that may occur if the patient receives too high a dose of noradrenaline include: very
high blood pressure, slow heartbeat, severe headache, light sensitivity, chest pain, brain hemorrhage, pallor, fever, profuse sweating, vomiting, and fluid in the
lungs causing shortness of breath.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Immediately inform a doctor or nurse if the patient experiences:

• sudden onset of itchy rash (urticaria), swelling of hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), feeling faint

• pain and (or) swelling at the injection site.

Inform a doctor or nurse as soon as possible if any of the following occur:

• anxiety, insomnia, confusion, weakness, psychotic state
• headache, tremor
• slow or rapid heartbeat
• heart rhythm disorders
• abnormal ECG findings
• potentially life-threatening type of circulatory failure, so-called "cardiogenic shock"
• weakening of the heart muscle due to severe physical or emotional stress, palpitations, increased myocardial contractility
• high blood pressure, reduced oxygen supply to certain organs (hypoxia)
• reduced blood flow to hands and feet (cold extremities, pallor and (or) limb pain)
• tissue death (necrosis)
• reduced blood plasma volume
• breathing difficulties
• pallor, skin scarring, bluish skin discoloration, hot flushes
• skin redness, skin rash, urticaria or itching
• nausea, vomiting
• urine retention
• irritation or ulceration at the injection site

In cases of hypersensitivity or overdose, the following adverse reactions may occur more frequently: very high blood pressure, unusual light sensitivity or photophobia, chest pain, sore throat, pallor, excessive sweating and vomiting.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring of 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 responsible entity or parallel importer. Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store Noradrenaline Swiss2Care

Keep this medicine out of sight and reach of children.
Do not store above 25°C. Store in the original 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 product has been shown to be chemically and physically stable for 48 hours at 25°C after dilution to 4 mg/litre noradrenaline in sodium chloride solution 9 mg/ml (0.9%), or in glucose solution 50 mg/ml (5%), or in glucose solution 50 mg/ml (5%) with sodium chloride solution 9 mg/ml (0.9%). Protection from light is not required.

From a microbiological standpoint, the diluted solution should be used immediately. If not used immediately, the user is responsible for the storage conditions and duration prior to use, which should generally not exceed 12 hours at 25°C in a plastic syringe for an electric syringe pump.

Do not use this medicine after the expiry date stated on the carton and on the ampoule. The expiry date refers to the last day of the stated month.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Noradrenaline Swiss2Care contains

• The active substance is noradrenaline. Each 1 ml of concentrate for solution for infusion contains norepinephrine bitartrate equivalent to 1 mg of noradrenaline. Each ampoule containing 4 ml of concentrate for solution for infusion contains norepinephrine bitartrate equivalent to 4 mg of noradrenaline. Each ampoule containing 8 ml of concentrate for solution for infusion contains norepinephrine bitartrate equivalent to 8 mg of noradrenaline.
• Other components of the medicine are: sodium chloride, hydrochloric acid or sodium hydroxide (for pH adjustment), water for injections.

What Noradrenaline Swiss2Care looks like and contents of the pack
A clear, colourless or slightly yellow solution, practically free from visible solid particles.
4 ml or 8 ml of solution in ampoules made of colourless glass, packed in a cardboard box.
Pack size: 10 ampoules

Marketing Authorisation Holder in France, country of export, and manufacturer:
LABORATOIRE AGUETTANT
1, Rue Alexander Fleming
69007 Lyon
France
Manufacturers:
DELPHARM TOURS
Rue Paul Langevin
37170 Chanbray-lès-Tours
France
HAUPT PHARMA LIVRON
Rue Comte de Sinard
26250 Livron-sur-Drôme
France

Parallel importer:
Swiss2Care Sp. z o.o. Sp. k.
ul. Mostowa 38/1
87-100 Toruń
Poland

Repackaged in:
CEFEA Sp. z o.o. Sp. k.
ul. Działkowa 56
02-234 Warsaw
Poland

Marketing Authorisation numbers in France, country of export: 34009 560 935 5 7
34009 564 612 6 4
Parallel import licence number: 217/23

Information intended exclusively for medical professionals:

Method of administration
Intravenous administration after dilution.
Administer as a diluted solution through a central line. The infusion rate must be controlled using a syringe pump, infusion pump, or drip counter. Undiluted medication must not be used.

Pharmaceutical incompatibilities
Solutions for infusion containing tartaric acid noradrenaline have been found incompatible with the following substances: iron salts, alkalizing and oxidizing compounds, barbiturates, chlorpheniramine, chlorothiazide, nitrofurantoin, novobiocin, phenytoin, sodium bicarbonate, sodium iodide, streptomycin, sulfadiazine, sulfafurazole.
This medicinal product must not be mixed with other medicinal products except those listed below.

Dilution instructions
For single use only. Any unused contents of the ampoule must be discarded.
Inspect the solution before use. Do not use the solution if visible particles or solids are present. Do not use the infusion solution if it is brown in color.

Dilute before use with:

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

Add 2 ml of concentrate to 48 ml of glucose solution 50 mg/ml (5%) (or any of the diluents listed above) for administration via syringe pump,
or add 20 ml of concentrate to 480 ml of glucose solution 50 mg/ml (5%) (or any of the diluents listed above) for administration via drip counter.
In both cases, the final concentration of the infusion solution is 40 mg/liter noradrenaline (equivalent to 80 mg/liter noradrenaline tartrate).
Other dilutions of noradrenaline different from 40 mg/liter may also be used. When using dilutions other than 40 mg/liter of noradrenaline, the infusion rate must be accurately calculated 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 dot facing upwards. If solution is present 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; hold the lower part of the ampoule in one hand and, with the other hand, snap off the top part of the ampoule away from the colored dot (see images below).

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