Norepinephrine Kalceks

Package leaflet: Information for the user

Norepinefrina Kalceks 1 mg/ml concentrate for solution for infusion

norepinephrine
equivalent medicine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

1. What Norepinefrina Kalceks is and what it is used for

Norepinefrina Kalceks contains the active substance norepinephrine and acts as a vasoconstrictor (causes
narrowing of blood vessels).
Norepinefrina Kalceks is used in adults in emergency situations to increase blood pressure and restore it
to normal levels.

2. What you should know before receiving Norepinephrine Kalceks

Do not receive Norepinephrine Kalceks

• if you are allergic to norepinephrine or to any of the other ingredients of this medicine (listed in section 6)
• if you have low blood pressure due to low blood volume
• if you are receiving certain anaesthetics such as halothane or cyclopropane (this may increase the risk of irregular heartbeat).

Warnings and precautions
Talk to your doctor or nurse before receiving norepinephrine if:

• you have diabetes
• you have liver failure
• you have severe kidney disease
• you suffer from high blood pressure
• you have an overactive thyroid
• you have low levels of oxygen in your blood
• you have high levels of carbon dioxide in your blood
• you have increased pressure inside the skull (intracranial pressure)
• you have blood clots or blockages in the blood vessels supplying the heart, intestines, or other parts of the body
• you have low blood pressure following a heart attack
• you have a type of angina (chest pain) called Prinzmetal's angina
• you have significant dysfunction of the left ventricle (a heart condition)
• you have recently had a myocardial infarction
• you have heart rhythm disorders (your heartbeat is too fast, too slow, or irregular); in this case, the dose may need to be reduced
• you are elderly

Children and adolescents
The safety and efficacy of norepinephrine in children under 18 years of age have not yet been established. Therefore, use in children is not recommended.
Other medicines and Norepinephrine Kalceks
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines. It is particularly important if you are using or have recently used any of the following medicines:

• medicines used to treat depression called "monoamine oxidase inhibitors" (MAOIs), taken currently or within the last 14 days
• medicines used to treat depression called "tricyclic antidepressants", e.g. imipramine or desipramine
• adrenergic-serotonergic medicines, used, for example, in the treatment of asthma and heart diseases
• linezolid (an antibiotic)
• anaesthetics (particularly anaesthetic gases such as cyclopropane, halothane, chloroform, enflurane)
• medicines used to treat high blood pressure (e.g. guanethidine, reserpine, methyldopa, alpha-blockers and beta-blockers)
• medicines used to treat heart rhythm disorders
• cardiac glycosides (used to treat heart diseases)
• levodopa (used to treat Parkinson's disease)
• thyroid hormones
• oxytocin (used to enhance uterine contractions)
• antihistamines (used to treat allergies)
• amphetamine
• doxapram (used for respiratory diseases)
• mazindol (used to treat obesity)
• medicines used to treat migraine (ergot alkaloids)
• lithium (used to treat certain mental disorders)

The use of norepinephrine together with propofol (an anaesthetic) may cause propofol infusion syndrome (PRIS), a serious clinical condition affecting patients sedated with propofol in intensive care units. Your doctor may detect metabolic abnormalities from blood tests, which could lead to kidney failure, heart failure, and death.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, please consult your doctor before receiving this medicine. Norepinephrine may cause harm to the unborn child. Your doctor will decide whether you should receive norepinephrine.
It is not known whether this medicine is excreted in human breast milk. Since many medicines are excreted in human breast milk, caution should be exercised when administering norepinephrine to nursing women.
Driving and using machines
No information is available. Therefore, driving vehicles or operating machinery is not recommended.
Norepinephrine Kalceks contains sodium
The 1 ml, 2 ml, 4 ml, and 5 ml vials of concentrate for infusion solution contain less than 1 mmol of sodium (23 mg) per vial, i.e., essentially "sodium-free".
Each 8 ml vial of concentrate for infusion solution contains 26.4 mg of sodium (a main component of table salt). This corresponds to 1.32% of the maximum daily recommended dietary intake for an adult.
Each 10 ml vial of concentrate for infusion solution contains 33 mg of sodium (a main component of table salt). This corresponds to 1.65% of the maximum daily recommended dietary intake for an adult.

3. How Norepinephrine Kalceks is administered

Norepinephrine will be administered to you in hospital by a doctor or nurse. It is first diluted and then infused into a vein.
The initial dose of norepinephrine will depend on your clinical condition. The usual dose ranges between 0.4 mg and 0.8 mg of norepinephrine per hour. Your doctor will determine the correct dose for you. After the initial dose, your doctor will assess your response to treatment and adjust the dose accordingly.
Your doctor will monitor your blood pressure and blood volume.
If you receive more Norepinephrine Kalceks than you should
It is unlikely that you will receive an excessive dose, as this medicine is administered in a hospital setting. However, if you have any concerns, speak to your doctor or nurse.
Symptoms that may occur if too much norepinephrine is administered include very high blood pressure, slow heart rate, severe headache, sensitivity to light, chest pain, bleeding in the brain, pallor, fever, heavy sweating and vomiting, and fluid in the lungs causing shortness of breath.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody experiences them.
Immediately inform your doctor or nurse if the following occur:

• sudden rash with itching (urticaria), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty swallowing or breathing), feeling faint
• pain and/or swelling at the injection site.

Inform your doctor or nurse as soon as possible if the following occur:

• anxiety, insomnia, confusion, weakness, psychotic state
• headache, tremor
• decreased or increased heart rate
• abnormal heart rhythm
• changes in electrocardiogram
• a potentially fatal type of circulatory failure called "cardiogenic shock"
• weakening of the heart muscle due to intense physical or emotional stress, palpitations, increased contractility of the heart muscle
• high blood pressure, reduced oxygen supply to certain organs (hypoxia)
• poor blood flow to the hands and feet (may cause cold sensation, paleness and/or pain in the limbs)
• gangrene (tissue death)
• reduced plasma volume
• breathing difficulties
• pallor, skin sloughing, bluish discoloration of the skin, hot flushes or skin redness, skin rash, urticaria or itching
• nausea, vomiting
• urinary retention
• irritation or ulceration at the injection site

In case of hypersensitivity or overdose, the following effects may occur more frequently:
very high blood pressure, abnormal sensitivity or intolerance to light, retrosternal pain,
sore throat, pallor, profuse sweating and vomiting.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or nurse.
You may also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Norepinephrine Kalceks

Keep this medicine out of the sight and reach of children.
Do not store above 25 °C.
Keep the vials in the outer packaging to protect the medicine from light.

Shelf life after vial opening
Once opened, the diluted solution must be prepared immediately.

Shelf life after dilution
Chemical and physical in-use stability has been demonstrated for 48 hours at a temperature of 25 °C and 2–8 °C
when diluted to 4 mg/litre and 40 mg/litre norepinephrine in sodium chloride 9 mg/ml (0.9%) solution or
glucose 50 mg/ml (5%) solution, or in sodium chloride 9 mg/ml (0.9%) with glucose 50 mg/ml (5%) solution.
From a microbiological point of view, the diluted solution should be used immediately. If not used immediately,
the in-use storage duration and storage conditions prior to use are the responsibility of the user and should
normally not exceed 24 hours at 2–8 °C, unless dilution has been carried out under controlled and validated
aseptic conditions.

Do not use this medicine after the expiry date stated on the carton and on the vial label after “Exp” or “EXP”.
The expiry date refers to the last day of that month.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Norepinephrine Kalceks contains

• The active substance is norepinephrine.

Each 1 ml vial of concentrate for solution for infusion contains norepinephrine tartrate
equivalent to 1 mg of norepinephrine.
Each 2 ml vial of concentrate for solution for infusion contains norepinephrine tartrate
equivalent to 2 mg of norepinephrine.
Each 4 ml vial of concentrate for solution for infusion contains norepinephrine tartrate
equivalent to 4 mg of norepinephrine.
Each 5 ml vial of concentrate for solution for infusion contains norepinephrine tartrate
equivalent to 5 mg of norepinephrine.
Each 8 ml vial of concentrate for solution for infusion contains norepinephrine tartrate
equivalent to 8 mg of norepinephrine.
Each 10 ml vial of concentrate for solution for infusion contains norepinephrine tartrate
equivalent to 10 mg of norepinephrine.

• The other components are sodium chloride, hydrochloric acid (for pH adjustment), water for injections.

Description of the appearance of Norepinephrine Kalceks and contents of the pack
Clear, colourless or slightly yellow solution, practically free from visible particles.
1 ml, 2 ml, 4 ml, 5 ml, 8 ml or 10 ml solution in colourless glass vials with OPC snap-off system. The vials are packed in a pouch and placed in a cardboard box.
Pack sizes: 5 or 10 vials
Not all pack sizes may be marketed.

Marketing Authorisation Holder
AS KALCEKS
Krustpils iela 53, Rīga, LV-1057, Latvia
Tel.: +371 67083320
E-mail: [email protected]

Manufacturer
AS KALCEKS
Krustpils iela 71E, Rīga, LV-1057, Latvia

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Denmark Noradrenalin Kalceks
Austria Norepinephrin Kalceks 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Belgium Noradrenaline (Norepinephrine) Kalceks 1 mg/ml concentraat voor oplossing voor
infusie / solution à diluer pour perfusion / Konzentrat zur Herstellung einer
Infusionslösung
Czech Republic Norepinephrine Kalceks
Estonia Norepinephrine Kalceks
Finland Noradrenalin Kalceks
France NORADRENALINE TARTRATE KALCEKS 1 mg/mL, solution à diluer pour
perfusion
Germany Norepinephrin Kalceks 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Hungary Norepinephrine Kalceks 1 mg/ml koncentrátum oldatos infúzióhoz
Ireland Noradrenaline (Norepinephrine) 1 mg/ml concentrate for solution for infusion
Italy Norepinephrine Kalceks
Latvia Norepinephrine Kalceks 1 mg/ml koncentrāts infūziju šķīduma pagatavošanai
Lithuania Norepinephrine Kalceks 1 mg/ml koncentratas infuziniam tirpalui
Norway Noradrenalin Kalceks
Poland Noradrenalin Kalceks
Portugal Noradrenalina Kalceks
Romania Noradrenalină Kalceks 1 mg/ml concentrat pentru soluţie perfuzabilă
Slovakia Norepinephrine Kalceks 1 mg/ml infúzny koncentrát
Spain Noradrenalina Kalceks 1 mg/ml concentrado para solución para perfusión EFG
Sweden Noradrenalin Kalceks
Netherlands Noradrenaline Kalceks 1 mg/ml concentraat voor oplossing voor infusie
United Kingdom (Northern Ireland) Noradrenaline (Norepinephrine) 1 mg/ml concentrate for solution for
infusion

The following information is intended for healthcare professionals only:

Method of administration
Intravenous use after dilution.
Administer as a diluted solution through a central venous catheter. The infusion must be administered at a controlled rate using a syringe pump, an infusion pump, or a drip device.
Do not use without prior dilution.

Incompatibilities
Incompatibility has been reported between infusion solutions containing norepinephrine tartrate and the following substances: iron salts, alkalis and oxidizing agents, 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 specifically mentioned below.

Instructions for dilution
For single use only. Discard any unused portion.
The solution must be inspected visually before use. This medicinal product must not be used if particulate matter or visible solids are present in the solution. Do not use the infusion solution if it is brown in color.

Dilute before use with:

• glucose 50 mg/ml (5%) solution, or
• sodium chloride 9 mg/ml (0.9%) solution, or
• sodium chloride 9 mg/ml (0.9%) 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 diluting solutions listed above) for administration via syringe pump; or
add 20 ml of concentrate to 480 ml of glucose 50 mg/ml (5%) solution (or any of the diluting solutions listed above) for administration via drip device.
In both cases, the final concentration of the infusion solution is 40 mg/liter of norepinephrine (equivalent to 80 mg/liter of norepinephrine tartrate). Other dilutions different from 40 mg/liter of norepinephrine may also be used. If using dilutions other than 40 mg/liter of norepinephrine, carefully verify the infusion rate calculation before starting treatment.
The medicinal product is compatible with infusion bags made of polyvinyl chloride (PVC), ethylene vinyl acetate (EVA), or polyethylene (PE).

Instructions for opening the ampoule

1. Turn the ampoule with the colored tip upwards. If any solution is present in the upper part of the ampoule, gently tap with the finger to allow all solution to flow to the lower part of the ampoule.
2. Use both hands to open: holding the lower part of the ampoule in one hand, use the other hand to snap off the top part of the ampoule in the direction opposite to the colored mark (see figures below).

Any unused medicine and waste material derived from this medicine must be disposed of in accordance with local applicable regulations.