Noradrenaline Kalceks 1 mg/ml concentrate for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Noradrenalina Kalceks 1mg/ml concentrate for solution for infusion EFG

Norepinephrine

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not adverse effects listed in this leaflet. See section 4.

Leaflet contents

1. What Noradrenalina Kalceks is and what it is used for
2. What you need to know before using Noradrenalina Kalceks
3. How to use Noradrenalina Kalceks
4. Possible adverse effects
5. How to store Noradrenalina Kalceks
6. Contents of the pack and other information

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

Noradrenalina Kalceks contains the active substance norepinephrine (hereinafter referred to as noradrenaline) and acts as a vasoconstrictor (causes narrowing of the blood vessels).

Noradrenalina Kalceks is used in adults in emergency situations to increase blood pressure to normal levels.

2. What you need to know before using Noradrenalina Kalceks

Do not administer Noradrenalina Kalceks

• if you are allergic to noradrenaline or to any of the other components of this medicine (listed in section 6)
• if you have low blood pressure due to reduced blood volume
• if you are to be given certain anaesthetics such as halothane or cyclopropane (as these may increase the risk of irregular heartbeats).

Warnings and precautions

Before receiving noradrenaline, consult your doctor or nurse if:

• you have diabetes
• you have hepatic insufficiency
• you have severe renal disorders
• you have high blood pressure
• you have excessive production of thyroid hormones
• you have low levels of oxygen in your blood
• you have high levels of carbon dioxide in your blood
• you have increased pressure within the skull (intracranial pressure)
• you have blood clots or blockages in 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 severe left ventricular failure (a heart condition)
• you have recently had a myocardial infarction
• you have cardiac arrhythmias (your heart beats too fast, too slow, or irregularly); you will require a reduced dose
• you are elderly.

Children and adolescents

The safety and efficacy of noradrenaline in children or adolescents under 18 years of age have not been established. Therefore, its use is not recommended in this age group.

Other medicines and Noradrenalina Kalceks

Inform your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines. This is particularly important if you are taking or have recently taken any of the following medicines:

• antidepressant medicines known as 'monoamine oxidase inhibitors' that you are currently taking or have taken within the last 14 days
• antidepressant medicines known as 'tricyclic antidepressants', e.g., imipramine or desipramine
• adrenergic-serotonergic medicines, e.g., those used in the treatment of asthma and heart diseases
• linezolid (an antibiotic)
• anaesthetics (particularly anaesthetic gases such as cyclopropane, halothane, chloroform, enflurane)
• medicines for treating high blood pressure (e.g., guanethidine, reserpine, methyldopa, alpha and beta blockers)
• medicines for treating cardiac arrhythmias
• cardiac glycosides (for treating heart conditions)
• levodopa (a medicine for treating Parkinson's disease)
• thyroid hormones
• oxytocin (used to increase uterine contractions)
• antihistamines (medicines for treating allergy)
• amphetamines
• doxapram (a medicine for respiratory disorders)
• mazindol (a medicine for treating obesity)
• medicines for treating migraine (ergot alkaloids)
• lithium (a medicine for treating certain mental illnesses)

Using noradrenaline with propofol (an anaesthetic) may lead to propofol infusion syndrome (PRIS), a serious condition affecting patients receiving propofol sedation in intensive care units. Your doctor would detect, through blood tests, metabolic disturbances in your body that could lead to renal failure, cardiac failure, and death.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before receiving this medicine. Noradrenaline may harm the fetus. Your doctor will decide whether you should be given noradrenaline.

It is unknown whether this medicine is excreted in breast milk. Since many medicines are excreted in breast milk, caution is recommended when administering noradrenaline to breastfeeding women.

Driving and using machines

No data are available. Therefore, driving or operating machinery is not recommended.

Noradrenalina Kalceks contains sodium

Vials containing 1 ml, 2 ml, 4 ml, or 5 ml of concentrate for solution for infusion contain less than 1 mmol of sodium (23 mg) per vial, i.e., essentially "sodium-free".

Each vial containing 8 ml of concentrate for solution for infusion contains 26.4 mg of sodium (the main component of table/cooking salt). This corresponds to 1.32% of the maximum recommended daily dietary intake of sodium for an adult.

Each vial containing 10 ml of concentrate for solution for infusion contains 33 mg of sodium (the main component of table/cooking salt). This corresponds to 1.65% of the maximum recommended daily dietary intake of sodium for an adult.

3. How to use Noradrenaline Kalceks

Noradrenaline will be administered to you by a doctor or nurse in the hospital. It is first diluted and then infused into a vein.

The initial dose of noradrenaline will depend on your condition. The usual dose is between 0.4 mg and 0.8 mg of noradrenaline per hour. Your doctor will determine the correct dose for you. After the initial dose, your doctor will assess your response and adjust the dose as necessary.

Your doctor will monitor your blood pressure and blood volume.

If you receive more Noradrenaline Kalceks than you should

It is unlikely that you will receive too much, as this medicine will be administered to you in a hospital setting. However, if you have any concerns, speak to your doctor or nurse.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number (91) 562 04 20.

Symptoms that may occur if you are given too much noradrenaline include severe high blood pressure, slow heartbeats, severe headache, light sensitivity, chest pain, brain hemorrhage, pallor, fever, intense sweating and vomiting, fluid in the lungs causing breathing difficulty.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Consult your doctor or nurse immediately if you experience:

• sudden rash with itching (urticaria), swelling of 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.

Consult your doctor or nurse as soon as possible if you experience:

• anxiety, insomnia, confusion, weakness, psychotic state
• headache, tremor
• decreased or increased heart rate
• abnormal heart rhythm
• changes in electrocardiogram
• a potentially life-threatening type of circulatory failure called 'cardiogenic shock'
• heart muscle weakness due to intense physical or emotional stress, palpitations, increased myocardial contractility
• high blood pressure, reduced oxygen supply to an organ (hypoxia)
• poor blood flow to your hands and feet (which may cause coldness, paleness and/or pain in the extremities)
• gangrene (tissue death)
• reduction in blood plasma volume
• difficulty breathing
• pallor, skin sloughing, bluish discoloration of the skin, hot flushes or skin redness, rash, urticaria or pruritus
• nausea, vomiting
• urinary retention
• irritation or ulceration at the injection site

In cases of hypersensitivity or overdose, the following effects may occur more frequently: very high blood pressure, abnormal sensitivity or intolerance to light, pain behind the sternum, throat pain, pallor, profuse sweating and vomiting.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Noradrenaline Kalceks

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

Do not store above 25 °C.

Keep the ampoules in the outer packaging to protect them from light.

Shelf-life after opening the ampoule

After opening, the diluted solution must be prepared immediately.

Shelf-life after dilution

Physicochemical stability in use has been demonstrated for 48 hours at 25 °C and 2–8 °C when diluted to 4 mg/litre and 40 mg/litre of noradrenaline in sodium chloride 9 mg/ml (0.9 %) solution, glucose 50 mg/ml (5 %) solution, or sodium chloride 9 mg/ml (0.9 %) with glucose 50 mg/ml (5 %).

From a microbiological standpoint, the diluted solution should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at a temperature of 2 to 8 °C, unless the 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 ampoule after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Noradrenaline Kalceks

• The active substance is norepinephrine (noradrenaline).

Each ml of concentrate for solution for infusion contains norepinephrine tartrate equivalent to 1 mg of norepinephrine (noradrenaline).

Each 2 ml vial of concentrate for solution for infusion contains norepinephrine tartrate equivalent to 2 mg of norepinephrine (noradrenaline).

Each 4 ml vial of concentrate for solution for infusion contains norepinephrine tartrate equivalent to 4 mg of norepinephrine (noradrenaline).

Each 5 ml vial of concentrate for solution for infusion contains norepinephrine tartrate equivalent to 5 mg of norepinephrine (noradrenaline).

Each 8 ml vial of concentrate for solution for infusion contains norepinephrine tartrate equivalent to 8 mg of norepinephrine (noradrenaline).

Each 10 ml vial of concentrate for solution for infusion contains norepinephrine tartrate equivalent to 10 mg of norepinephrine (noradrenaline).

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

Appearance of the product and contents of the pack

Clear solution, ranging from colourless to slightly yellowish, practically free from visible particles.

1 ml, 2 ml, 4 ml, 5 ml, 8 ml or 10 ml of solution packed in colourless glass vials with a break-off point. The vials are placed on a tray and packed in a cardboard box.

Pack sizes: 5 or 10 vials

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

AS KALCEKS
Krustpils iela 71E, Riga, LV-1057, Latvia
Tel.: +371 67083320
E-mail: [email protected]

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Grindeks Kalceks España, S.L.
c/ José Abascal, 58 2º dcha
28003 Madrid
Spain

This medicine is authorised in the European Economic Area (EEA) Member States and 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 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 Norepinefrina Kalceks
Latvia Norepinephrine Kalceks 1 mg/ml koncentrats infuziju škiduma pagatavošanai
Lithuania Norepinephrine Kalceks 1 mg/ml koncentratas infuziniam tirpalui
Norway Norepinephrine Kalceks
Poland Noradrenalin Kalceks
Portugal Norepinefrina Kalceks
Romania Noradrenalina Kalceks 1 mg/ml concentrat pentru solutie perfuzabila
Slovakia Norepinephrine Kalceks 1 mg/ml infúzny koncentrát
Spain Noradrenalina Kalceks 1 mg/ml concentrado para solución para perfusión EFG
Sweden Noradrenalin Kalceks
The 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

Date of most recent review of this leaflet: April 2020

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

This information is intended for healthcare professionals only:

Method of administration

Intravenous route after dilution.

It must be administered as a diluted solution via a central venous catheter. The infusion rate must be controlled using a syringe pump, infusion pump, or drip set.

Do not use undiluted.

Incompatibilities

Solutions for infusion containing norepinephrine tartrate are incompatible with the following substances: iron salts, alkalis and oxidizing agents, barbiturates, chlorpheniramine, chlorothiazide, nitrofurantoin, novobiocin, phenytoin, sodium bicarbonate, sodium iodide, streptomycin, sulfadiazine, sulfafurazole.

This medicine must not be mixed with other medicinal products except those mentioned below.

Dilution instructions

For single use only. Discard any unused portion.

The solution must be inspected visually before use. Do not use the medicine if the solution contains any visible particles or solids. Do not use the infusion solution if it is brown in colour.

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 other diluents listed above) 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 other diluents listed above) for administration using a drip set. In both cases, the final concentration of the infusion solution is 40 mg/litre of norepinephrine (equivalent to 80 mg/litre of norepinephrine tartrate). Other dilutions different from 40 mg/litre of norepinephrine may also be used. If using dilutions other than 40 mg/litre of norepinephrine, carefully verify the infusion rate calculation before starting treatment.

The product is compatible with polyvinyl chloride (PVC), ethylene vinyl acetate (EVA), or polyethylene (PE) infusion bags.

Instructions for opening the vial:

1. Hold the vial with the coloured dot facing upwards. If any solution remains in the upper part of the vial, gently tap with a finger to allow all the solution to flow down to the bottom.
2. Use both hands to open it: while holding the lower part of the vial with one hand, use the other hand to snap off the top of the vial in the direction opposite to the coloured dot (see images below).

Disposal of unused medicine and of all materials that have been in contact with it must be carried out in accordance with local regulations.