Noradrenaline Sviss2care

Leaflet attached to the packaging: patient information

Noradrenaline Swiss2Care

1 mg/ml, concentrate for solution for infusion

Noradrenaline

Read the leaflet carefully before using the medicine, 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, pharmacist, or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, tell the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Noradrenaline Swiss2Care and what is it 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 packaging and other information

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

Noradrenaline Swiss2Care contains noradrenaline and acts as a vasoconstrictor (causes blood vessels to narrow).
Noradrenaline Swiss2Care is indicated for use in adults in emergency situations, in order to increase blood pressure to normal values.

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 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 Noradrenaline Swiss2Care, discuss it with your doctor or nurse if the patient:

• has diabetes
• has liver failure
• has severe kidney function disorders
• has high blood pressure
• has hyperthyroidism
• has low oxygen levels in the blood
• has high carbon dioxide levels in the blood
• has increased intracranial pressure (intracranial pressure)
• has blood clots or obstruction of 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 angina pectoris (chest pain) called Prinzmetal's angina
• has severe left ventricular heart function disorders (heart disease)
• has recently had a heart attack
• has heart rhythm disturbances (too fast, too slow, or irregular heartbeat), a dose reduction may be necessary
• is 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 medicine is not recommended in this age group.

Noradrenaline Swiss2Care and other medicines

Tell your doctor or nurse about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans 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
• taken currently or were taken in the last 14 days
• medicines used to treat depression called "tricyclic antidepressants",
• for example, imipramine or desipramine
• medicines that affect adrenergic and serotonergic receptors, for example, used in
• treatment of 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-adrenolytics)
• 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 in respiratory disorders)
• mazindol (used to treat obesity)
• medicines used to treat migraines (ergot alkaloids)
• lithium (used to treat certain mental disorders)

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 a case, the doctor, based on blood tests, will diagnose metabolic disorders that may lead to kidney failure, heart failure, and death.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor before using this medicine. Noradrenaline may have a harmful effect on the unborn child. The doctor will decide whether to administer noradrenaline. 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 using machines

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

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, which means the medicine 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.

3. How to use Noradrenaline Swiss2Care

Noradrenaline is administered in a hospital by a doctor or nurse. The medicine 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 medicine and adjust the dose accordingly.
The doctor will monitor the patient's blood pressure and blood volume.

Using a higher dose of Noradrenaline Swiss2Care than recommended

Using a higher dose than recommended is unlikely, as the 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 much noradrenaline are: very high blood pressure, slow heartbeat, very 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 medicines, this medicine can cause side effects, although not everybody gets them.
Inform the doctor or nurse immediatelyif the patient experiences:

• 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 the doctor or nurse as soon as possible if the following occur:

• anxiety, insomnia, confusion, weakness, psychotic state
• headache, tremor
• decreased or accelerated heart rate
• heart rhythm disturbances
• abnormal ECG recording
• a 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 heart muscle contractility
• high blood pressure, decreased oxygen supply to some organs (hypoxia)
• decreased blood flow to hands and feet (cold extremities, paleness, and (or) pain in the extremities)
• gangrene (tissue necrosis)
• decreased blood plasma volume
• breathing difficulties
• paleness, skin scarring, blue 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

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 any side effects occur, including any side effects not listed in this leaflet, tell the doctor, pharmacist, 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, 02-222 Warsaw
Phone: +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 or parallel importer. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Noradrenaline Swiss2Care

Store the 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, prepare the diluted solution immediately.
Shelf-life after dilution
The chemical and physical stability of the product has been demonstrated for 48 hours at 25°C after dilution to 4 mg/liter of noradrenaline in sodium chloride 9 mg/ml (0.9%) solution or glucose 50 mg/ml (5%) solution or glucose 50 mg/ml (5%) solution with sodium chloride 9 mg/ml (0.9%) solution. Protection from light is not necessary.
From a microbiological point of view, the diluted solution should be used immediately, and the storage time and conditions before use are the responsibility of the user and are usually not longer than 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 month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Noradrenaline Swiss2Care contains

• The active substance is noradrenaline. Each 1 ml of concentrate for solution for infusion contains noradrenaline bitartrate equivalent to 1 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 8 ml of concentrate for solution for infusion contains noradrenaline bitartrate equivalent to 8 mg of noradrenaline.
• The other ingredients are: sodium chloride, hydrochloric acid or sodium hydroxide (for pH adjustment), water for injections.

What Noradrenaline Swiss2Care looks like and what the pack contains

A clear, colorless or yellowish solution, practically free from visible particles.
4 ml or 8 ml of solution in colorless glass ampoules in a cardboard box.
Pack size: 10 ampoules

Marketing authorization holder in France, country of export, and manufacturer:

LABORATOIRE AGUETTANT
1, Rue Alexander Fleming
69007 Lyon
France
Manufacturer:
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

Repackaged by:

CEFEA Sp. z o.o. Sp. k.
ul. Działkowa 56
02-234 Warsaw

French marketing authorization number, country of export: 34009 560 935 5 7
34009 564 612 6 4
Parallel import authorization number: 217/23

Date of leaflet approval: 03.10.2023

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Information intended exclusively for healthcare professionals:

Method of administration
Intravenous administration after dilution.
Administer as a diluted solution through a central line. The infusion rate should be controlled using a syringe pump, infusion pump, or drop counter. Do not use undiluted medicine.
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 those mentioned below.
Dilution instructions
For single use only. Discard any unused contents of the ampoule.
Inspect the solution 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 can 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).
Ampoule opening instructions

• 1) Turn the ampoule with the colored dot upwards. If there is a solution in the upper part of the ampoule, gently tap with your finger to transfer 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 away from the colored dot (see pictures below).

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