Norepinephrine Sopharma

Leaflet attached to the packaging: Patient information

Norepinephrine Sopharma, 1 mg/ml, concentrate for solution for infusion

Norepinephrinum (Noradrenalinum)

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.
• If you have any further questions, ask your doctor or nurse.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Norepinephrine Sopharma and what is it used for

Norepinephrine Sopharma is indicated for use in adults in emergency situations to increase blood pressure to normal values.

2. Important information before using Norepinephrine Sopharma

When not to use Norepinephrine Sopharma:

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

Warnings and precautions

Before starting treatment with Norepinephrine Sopharma, the patient should discuss it with their doctor or nurse if they:

• have diabetes;
• have high blood pressure;
• have hyperthyroidism;
• have low oxygen levels in the blood;
• have high carbon dioxide levels in the blood;
• have blood clots or obstruction of blood vessels supplying the heart, intestines, or other parts of the body;
• have low blood pressure due to a heart attack;
• have angina pectoris (chest pain), especially Prinzmetal's angina;
• are elderly;
• have liver or kidney dysfunction;
• are at risk of extravasation (risk of blood or lymph leaking from a vessel into surrounding tissues).

Children and adolescents

The safety and efficacy of norepinephrine (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.

Norepinephrine Sopharma and other medicines

The patient should tell their doctor or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• Many medicines increase the toxic effects of norepinephrine (noradrenaline), such as:
• antidepressants, including monoamine oxidase inhibitors, which are taken currently or have been taken in the preceding 14 days, as well as tricyclic antidepressants;
• anesthetics (especially anesthetic gases, such as cyclopropane, halothane, chloroform, enflurane);
• medicines used to treat high blood pressure (e.g., guanethidine, reserpine, methyldopa, beta-adrenolytics);
• linezolid (an antibiotic);
• medicines with adrenergic and serotonergic effects (used, for example, to treat asthma and heart disorders);
• thyroid hormones;
• medicines used to treat heart diseases (cardiac glycosides, antiarrhythmic drugs);
• ergot alkaloids or oxytocin.

Using norepinephrine (noradrenaline) with propofol (an anesthetic) may lead to the development of a propofol syndrome, a severe disorder that occurs in patients anesthetized with propofol in intensive care units. Based on blood tests, the doctor will detect metabolic disorders that can lead to kidney, heart, and respiratory failure, and even death.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Norepinephrine (noradrenaline) may harm the unborn child. The doctor will decide whether to administer Norepinephrine Sopharma.

Before using any medicine, the patient should consult their doctor or nurse.

Driving and using machines

The condition for which Norepinephrine Sopharma is used excludes the possibility of driving vehicles and operating machines.

Norepinephrine Sopharma contains sodium

One 1 ml ampoule contains 0.147 mmol (3.39 mg) of sodium.

One 4 ml ampoule contains 0.588 mmol (13.56 mg) of sodium.

This medicine contains less than 1 mmol of sodium (23 mg) per 1 ml, which means it is essentially sodium-free.

3. How to use Norepinephrine Sopharma

Norepinephrine Sopharma will be administered in a hospital by a doctor or nurse. Fluids to supplement blood volume will also be administered, both before and during the administration of norepinephrine (noradrenaline). Initially, the medicine is diluted and then administered as an intravenous infusion.

The initial dose of Norepinephrine Sopharma will depend on the patient's condition. The usual dose is between 0.4 and 0.8 mg (norepinephrine) per hour. The doctor will determine the appropriate dose for the patient. After the initial dose, the doctor will assess the response to treatment and adjust the dose accordingly.

The doctor will frequently check the vein into which Norepinephrine Sopharma is being administered to ensure that the medicine is not leaking into the surrounding tissues, which could cause a severe skin reaction, especially when administered into a vein in the leg. Sometimes, the medicine may cause the vein to appear whiter than usual, which may be due to leakage of norepinephrine (noradrenaline) into the tissues; in such cases, the doctor may decide to change the infusion site. If leakage into the tissues occurs, the doctor will administer an injection into the affected area as soon as possible.

Using a higher dose of Norepinephrine Sopharma than recommended

Overdose of this medicine is unlikely, as it is administered in a hospital. However, if there are any doubts, the patient should consult their doctor or nurse.

Symptoms of overdose include: severe high blood pressure, bleeding into the brain, slow heart rate, very severe headache, hypersensitivity to light, chest pain, paleness, high fever, excessive sweating, vomiting, and fluid in the lungs causing shortness of breath.

If there are any further doubts about the use of this medicine, the patient should consult their doctor or nurse.

4. Possible side effects

Like all medicines, Norepinephrine Sopharma can cause side effects, although not everybody gets them.

The patient should immediately inform their doctor if they experience:

• itching rash with sudden onset (urticaria), 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.

Other possible side effects include:

• lactic acidosis (leading to a significant decrease in blood pH - a serious, potentially life-threatening condition caused by very high levels of lactic acid);
• hyperglycemia (high blood sugar levels);
• anxiety;
• insomnia;
• high blood pressure;
• slow heart rate;
• fast heart rate;
• heart rhythm disturbances;
• abnormal ECG;
• breathing difficulties;
• headache;
• confusion;
• weakness;
• tremors;
• dizziness;
• anxiety;
• acute glaucoma;
• poor blood flow to hands and feet;
• a potentially life-threatening type of circulatory failure, known as cardiogenic shock;
• gangrene;
• nausea, vomiting;
• development of tolerance to treatment, resulting in decreased effectiveness;
• decrease in blood plasma volume;
• urinary retention;
• pain, swelling, irritation, or ulceration at the injection site.

The doctor will monitor blood pressure and blood volume.

If any of the side effects worsen or if the patient experiences any side effects not listed in the leaflet, they should inform their doctor or nurse.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor.

Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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, e-mail: ndl@urpl.gov.pl

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Norepinephrine Sopharma

Keep the medicine out of the sight and reach of children.

Store in a temperature below 25°C.

Store the ampoules in the outer packaging to protect from light.

Do not use this medicine after the expiry date stated on the packaging after the abbreviation "EXP".

The expiry date refers to the last day of the month stated.

From a microbiological point of view, the product should be used immediately after dilution.

Medicines should not be disposed of via wastewater. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Norepinephrine Sopharma contains

• The active substance is norepinephrine (noradrenaline) in the form of norepinephrine hydrochloride (noradrenaline hydrochloride). Each milliliter (ml) of concentrate for solution for infusion contains 1 mg of norepinephrine (noradrenaline), equivalent to 2 milligrams (mg) of norepinephrine hydrochloride (noradrenaline hydrochloride). One 1 ml ampoule contains 1 mg of norepinephrine (noradrenaline), equivalent to 2 mg of norepinephrine hydrochloride (noradrenaline hydrochloride). One 4 ml ampoule contains 4 mg of norepinephrine (noradrenaline), equivalent to 8 mg of norepinephrine hydrochloride (noradrenaline hydrochloride). After appropriate dilution, each ml contains 40 micrograms of norepinephrine (noradrenaline), equivalent to 80 micrograms of norepinephrine hydrochloride (noradrenaline hydrochloride).
• The other ingredients are: sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), water for injections.

What Norepinephrine Sopharma looks like and contents of the packaging

This medicinal product is a concentrate for solution for infusion (sterile concentrate). It is a clear, colorless to yellowish solution, practically free from particulate matter.

The product is available in ampoules made of colorless glass with a marked break point (colored dot), containing 1 ml or 4 ml of concentrate for solution for infusion.

The packaging contains 5 or 10 ampoules.

Not all pack sizes may be marketed.

Marketing authorization holder

Sopharma Warszawa Sp. z o.o.

Al. Jerozolimskie 136, 02-305 Warsaw

Manufacturer

SOPHARMA AD

16, Iliensko Shosse Str.

1220 Sofia

Bulgaria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Bulgaria: Норепинефрин Софарма 1 mg/ml концентрат за инфузионен разтвор

Estonia: Norepinephrine Sopharma

Latvia: Norepinephrine Sopharma 1 mg/ml koncentrāts infūziju šķīduma pagatavošanai

Lithuania: Norepinephrine Sopharma 1 mg/ml koncentratas infuziniam tirpalui

Poland: Norepinephrine Sopharma

Date of last revision of the leaflet:

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Information intended for healthcare professionals only:

Intravenous administration.

Route and method of administration of the infusion

Administer as a diluted solution through a central venous catheter.

The infusion should be administered at a controlled rate, using a syringe pump, infusion pump, or drop counter.

Incompatibilities

There have been reports of incompatibilities of norepinephrine hydrochloride solutions with the following substances: iron salts, alkalizing and oxidizing agents, barbiturates, chlorpheniramine, chlorothiazide, nitrofurantoin, novobiocin, phenytoin, sodium bicarbonate, sodium iodide, streptomycin, sulfadiazine, sulfafurazole.

Administration and preparation Dilution instructions:

For single use only. Discard any unused contents of the ampoule.

Before administration, dilute with sodium chloride 9 mg/ml (0.9%) solution or glucose 5% solution.

Add 2 ml of concentrate to 48 ml of diluent solution for administration via a syringe pump, or add 20 ml of concentrate to 480 ml of diluent solution for administration via a drop counter.

In both cases, the final concentration of the solution for infusion is 40 micrograms of norepinephrine (noradrenaline) per ml, equivalent to 80 micrograms of norepinephrine hydrochloride (noradrenaline hydrochloride) per ml.

Other dilutions of norepinephrine than 40 micrograms/ml may also be used (see section 4.2).

If other dilutions of norepinephrine are used, the infusion rate should be carefully recalculated before starting treatment.

Compatibility of polyethylene bottles with the above-mentioned solutions has been demonstrated.

The solution for infusion should be used immediately after dilution.

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