Norepinephrine sopharma

Package leaflet: Information for the patient

Norepinephrine Sopharma, 1 mg/ml, concentrate for solution for infusion
Norepinephrinum (Noradrenalinum)
Please read all of this leaflet carefully before the medicine is administered, as it contains
important information for the patient

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

Contents of the leaflet

1. What Norepinephrine Sopharma is and what it is 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 pack and other information

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

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

2. Important information before using Norepinephrine Sopharma

When not to use Norepinephrine Sopharma:

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

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

• has diabetes;
• has high blood pressure;
• has hyperthyroidism;
• has low oxygen levels in the blood;
• has high carbon dioxide levels in the blood;
• has blood clots or blocked blood vessels supplying the heart, intestines, or other parts of the body;
• has low blood pressure due to myocardial infarction (heart attack);
• has angina pectoris (chest pain), particularly Prinzmetal's angina;
• is elderly;
• has impaired liver or kidney function;
• is at risk of extravasation (risk that blood or lymph may leak out of the 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
Tell the doctor or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Many medicines increase the toxic effects of norepinephrine (noradrenaline), for example:

• antidepressants, including monoamine oxidase inhibitors taken currently or within the preceding 14 days, and tricyclic antidepressants;
• anaesthetic medicines (particularly anaesthetic gases such as cyclopropane, halothane, chloroform, enflurane);
• medicines used for high blood pressure (e.g. guanethidine, reserpine, methyldopa, beta-blockers);
• linezolid (an antibiotic);
• medicines with adrenergic and serotonergic activity (used, for example, in the treatment of asthma and heart disorders);
• thyroid hormones;
• medicines used in heart disease (cardiac glycosides, antiarrhythmics);
• ergot alkaloids or oxytocin.

The use of norepinephrine (noradrenaline) together with propofol (an anaesthetic medicine) may lead to propofol infusion syndrome, a serious condition occurring in patients anaesthetized with propofol in intensive care units. Based on blood tests, the doctor may detect metabolic disturbances that may lead to kidney and heart failure and death.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Norepinephrine (noradrenaline) may harm the unborn child. The doctor will decide whether Norepinephrine Sopharma should be administered.
Before using any medicine, consult a doctor or nurse.
Driving and operating machinery
The condition for which Norepinephrine Sopharma is used precludes the ability to drive or operate machinery.
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.
One 10 ml ampoule contains 1.478 mmol (33.98 mg) of sodium.
This medicine contains less than 1 mmol of sodium (23 mg) per 1 ml, meaning it is essentially sodium-free.

3. How to use Norepinephrine Sopharma

Norepinephrine Sopharma will be administered in a hospital by a doctor or nurse. Blood volume-replacing fluids will also be given, both before and during the administration of norepinephrine (noradrenaline). This medicine is first diluted and then administered as an intravenous infusion.

The initial dose of Norepinephrine Sopharma will depend on the patient's condition. The usual dose ranges from 0.4 to 0.8 mg (of norepinephrine) per hour. The doctor will determine the appropriate dose for the patient. After the initial dose is given, 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 infused to ensure that the medicine is not leaking into the surrounding tissues, as this could cause severe skin reactions, especially when the medicine is administered into a vein in the leg. Sometimes, this medicine may cause the vein to appear paler than usual, which may indicate leakage of norepinephrine (noradrenaline) into the tissues; in such a case, the doctor may decide to change the infusion site. If leakage into tissues occurs, the doctor will administer an injection at the leakage site as quickly as possible.

Overdose of Norepinephrine Sopharma

Overdose of this medicine is unlikely because it is administered in a hospital setting. However, you should contact the doctor or nurse if you have any concerns.

Symptoms of overdose include: severe arterial hypertension, cerebral hemorrhage, slow heart rate, severe headache, photophobia, chest pain, pallor, high fever, intense sweating, vomiting, and pulmonary edema causing shortness of breath.

If you have any further questions about the use of this medicine, consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must inform the doctor immediately if the patient develops:

• sudden onset of itchy rash (urticaria), swelling of the 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.

Other possible adverse reactions include:

• lactic acidosis (leads to a significant decrease in blood pH – this is a serious, sometimes life-threatening condition caused by very high levels of lactic acid);
• hyperglycemia (high blood glucose concentration);
• anxiety;
• insomnia;
• high blood pressure;
• slow heart rate;
• fast heart rate;
• heart rhythm disorders;
• abnormal ECG findings;
• breathing difficulties;
• headache;
• confusion;
• weakness;
• tremor;
• dizziness;
• restlessness;
• acute glaucoma;
• poor blood flow to hands and feet;
• a potentially life-threatening type of circulatory failure, so-called cardiogenic shock;
• tissue necrosis;
• nausea, vomiting;
• development of tolerance to treatment, resulting in reduced effectiveness;
• decreased 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 adverse reactions worsen or if any adverse reactions not listed in this leaflet occur,
inform the doctor or nurse.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform the doctor. 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, e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables better assessment of the benefit-risk balance of the medicine.

5. How to store Norepinephrine Sopharma

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Keep the ampoules in the outer packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging following the term "EXP".
The expiry date refers to the last day of the stated month.
From a microbiological point of view, the product should be used immediately after dilution.
Medicines must not be disposed of via the sewage system. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Norepinephrine Sopharma contains

• The active substance is norepinephrine (noradrenaline) in the form of norepinephrine bitartrate (noradrenaline bitartrate). Each millilitre (ml) of concentrate for solution for infusion contains 1 mg of norepinephrine (noradrenaline), equivalent to 2 milligrams (mg) of norepinephrine bitartrate (noradrenaline bitartrate). One 1 ml ampoule contains 1 mg of norepinephrine (noradrenaline), equivalent to 2 mg of norepinephrine bitartrate (noradrenaline bitartrate). One 4 ml ampoule contains 4 mg of norepinephrine (noradrenaline), equivalent to 8 mg of norepinephrine bitartrate (noradrenaline bitartrate). One 10 ml ampoule contains 10 mg of norepinephrine (noradrenaline), equivalent to 20 mg of norepinephrine bitartrate (noradrenaline bitartrate). After appropriate dilution, each ml contains 40 micrograms of norepinephrine (noradrenaline), equivalent to 80 micrograms of norepinephrine bitartrate (noradrenaline bitartrate).
• 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 pack
This medicinal product is available as a concentrate for solution for infusion (sterile concentrate). It is a clear, colourless to slightly yellow solution, practically free from visible particles.
The product is supplied in ampoules made of colourless glass with a marked break point (coloured dot), containing 1 ml, 4 ml, or 10 ml of concentrate for solution for infusion. Packs contain 5 or 10 ampoules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sopharma Warszawa Sp. z o.o.
Al. Jerozolimskie 136, 02-305 Warsaw
Poland

Manufacturer
SOPHARMA AD
16, Iliensko Shosse Str.
1220 Sofia
Bulgaria

This medicinal product is authorised in the member countries 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

Information intended exclusively for medical professionals:

Intravenous administration.
Route and method of infusion administration
Administer as a diluted solution through a central line.
The infusion should be administered at a controlled rate using a syringe pump, infusion pump, or drip counter.
Pharmaceutical incompatibilities
Pharmaceutical incompatibilities have been reported between infusion solutions containing norepinephrine bitartrate and 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. Any unused portion of the vial should be discarded.
Before administration, dilute with sodium chloride 9 mg/ml (0.9%) with glucose 5% solution: sodium chloride 9 mg/ml (0.9%) with glucose 5% infusion solution or sodium chloride 9 mg/ml (0.9%) with 5% glucose solution (1:1). Either add 2 ml of concentrate to 48 ml of diluent for administration via syringe pump, or add 20 ml of concentrate to 480 ml of diluent for administration via drip counter. In both cases, the final concentration of the infusion solution will be 40 mg/L norepinephrine (equivalent to 80 mg/L norepinephrine bitartrate). Other dilutions of norepinephrine different from 40 mg/L may also be used (see section 4.2). If other dilutions of norepinephrine are used instead of 40 mg/L, the infusion rate must be accurately recalculated before starting treatment. Compatibility has been demonstrated with polyethylene bottles containing the above-described solutions.
The infusion solution should be used immediately after dilution.
Any unused product or waste material should be disposed of in accordance with local regulations.