Labrycor 0.2 mg/ml concentrate for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Labrycor 0.2 mg/ml concentrate for solution for infusion EFG

isoprenaline hydrochloride

Read the entire 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, ask your doctor or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or nurse, even if these are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Labrycor is and what it is used for

Labrycor contains the active substance isoprenaline, which has a stimulating effect on part of the nervous system (sympathomimetic). Among other effects, isoprenaline increases heart rate, enhances cardiac contractility, and dilates blood vessels, thereby reducing blood pressure.

Labrycor is used for the treatment of:

• slow heart rate in patients awaiting pacemaker implantation or when pacemaker implantation is contraindicated.
• sudden fainting with loss of consciousness caused by a decrease in heart rate (known as Stokes-Adams syndrome).

2. What you need to know before using Labrycor

Do not use Labrycor

• if you are allergic to isoprenaline hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• if you are also receiving adrenaline, a medicine used in intensive care to treat cardiac arrest.
• if you have a faster than normal heart rate.
• if your heart is under stress (atrial or ventricular hyperexcitability).
• if you have received an excessive amount of a type of medicine called cardiac glycoside, such as digoxin (digitalis), a medicine used to treat cardiac arrhythmia and heart failure.
• if you are suffering a heart attack (myocardial infarction).
• if you have chest pain (angina pectoris).
• if you have irregular heartbeat (ventricular arrhythmia) requiring treatment.

Warnings and precautions

Talk to your doctor or nurse before using Labrycor

• if you have heart problems.
• if you have diabetes.
• if you are taking digoxin (digitalis) (another medicine that affects the heart).
• if you have hyperthyroidism. This medicine should be avoided in cases of uncontrolled hyperthyroidism.
• if you have seizure disorders.
• if you have ever had a reaction to a medicine affecting the heart and circulation (belonging to the group of sympathomimetic amines).
• during treatment with this medicine, you will be monitored by ECG and your dose may be adjusted.
• if you are being treated for reduced blood volume in the body (shock), Labrycor can only be used once blood volume has been restored.
• extreme caution must be exercised when doses are high enough to achieve a heart rate exceeding 130 beats/minute.

Other medicines and Labrycor

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.

This is especially important if you are taking any of the following medicines:

• other cardiac or central nervous system stimulants.
• adrenaline (a medicine used in intensive care to treat cardiac arrest).
• digitalis glycosides (another medicine that affects the heart).
• monoamine oxidase inhibitors (MAOIs), a class of medicine used to treat depression.
• antidepressants (such as imipramine).
• sulfates, such as salicylamide (analgesic).
• entacapone (a medicine used in the treatment of Parkinson's disease).
• doxapram (a medicine used in intensive care to increase respiratory rate).
• ergotamine (a medicine used to treat acute migraine attacks).
• sympathomimetic vasoconstrictors (such as oxytocin).

Labrycor must not be administered under the effects of anaesthesia with chloroform, cyclopropane, halothane, or any other halogenated anaesthetic.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

It is preferable to avoid the use of isoprenaline during pregnancy. The clinical benefits should be weighed against the potential risks to the mother and baby.

A decision must be made whether to discontinue breastfeeding or to discontinue therapy, taking into consideration the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Labrycor contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per ml; therefore, it is essentially “sodium-free”.

Driving and use of machines

Since this medicine will be administered to you by a healthcare professional as an emergency treatment, this section is not relevant to you.

3. How to use Labrycor

This medicine will be administered to you by intravenous infusion by a specialist doctor.

Your doctor will decide the most appropriate dose for you. The medicine will be diluted in physiological saline solution or isotonic glucose solution.

Your doctor will carefully increase the dose of Labrycor while closely monitoring your heart rate.

Isoprenaline is not intended for routine use.

If you use more Labrycor than you should

Symptoms of overdose include nausea, headache, extra heartbeats, and increased heart rate.

If you use more Labrycor than you should, contact your doctor or nurse immediately.

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

If necessary, you may be given a plasma or blood transfusion.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Frequency not known (may affect an unknown number of people):

• increased heart rate
• heart rhythm disorders
• chest pain
• low blood pressure
• high blood pressure
• nervousness
• tremors
• dizziness
• headaches
• nausea
• feeling of weakness and sweating

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Labrycor

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

Do not use this medicine after the expiry date stated on the carton and on the label of the vial, after EXP. The expiry date refers to the last day of the month indicated.

Before opening: Do not refrigerate. Store the vial in the outer packaging to protect it from light.

After opening: The product should be used immediately.

After dilution:

The physical and chemical stability of the solution diluted in 5% glucose or 0.9% sodium chloride has been demonstrated for up to 24 hours at 25°C.

From a microbiological standpoint, unless the method of opening excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the user is responsible for the storage conditions and duration during use.

Do not use this medicine if visible signs of deterioration are observed.

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

6. Contents of the container and other information

Composition of Labrycor

The active substance is isoprenaline hydrochloride. Each ml contains 0.2 mg of isoprenaline hydrochloride.

The other components are:

disodium edetate, sodium citrate dihydrate, citric acid, sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injections.

Appearance of Labrycor and contents of the container

Labrycor 0.2 mg/ml concentrate for solution for infusion is a clear, colourless to pale yellow solution, free from visible particles.

1 ml – Each pack contains 1 or 5 glass vials with 1 ml of concentrate for solution for infusion each.

5 ml – Each pack contains 1 or 5 glass vials with 5 ml of concentrate for solution for infusion each.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Macure Healthcare Limited

62 Arclight Building

Triq L-Gharbiel

Is-Swieqi

Malta

Manufacturer 1

SGS Pharma Magyarorszag Kft.

Derkovits Gyula Utca 53,

Budapest XIX, 1193,

Hungary

Tillomed Malta Limited

Malta Life Sciences Park,

LS2.01.06 Industrial Estate,

San Gwann, SGN 3000,

Malta

Local representative

Laphysan SAU

C/ Anabel Segura 11,

Complejo Empresarial Albatros

Edificio A, Planta 4, Puerta D,

28108 Alcobendas (Madrid)

Spain

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

France ISOPRENALINE CHLORHYDRATE TILLOMED 0.2 mg/mL, concentrate for solution for perfusion

Portugal Isoprenalina Tillomed

Austria Labrycor 0.2 mg/ml Konzentrat zur Herstellung einer Infusionslösung

Belgium Labrycor 0.2 mg/ml Konzentrat zur Herstellung einer Infusionslösung

Cyprus Labrycor 0.2 mg/ml Πυκνό διάλυμα για παρασκευή διαλύματος προς έγχυση

Czech Republic Labrycor

Denmark Xytrina

Greece Labrycor

Spain Labrycor 0.2 mg/ml concentrate for solution for infusion EFG

Finland Xytrina 0.2 mg/ml infuusiokonsentraatti, liuosta varten

Ireland Labrycor 0.2 mg/ml concentrate for solution for infusion

Netherlands Labrycor 0.2 mg/ml Concentraat voor oplossing voor infusie

Norway Xytrina

Sweden Xytrina 0.2 mg/ml koncentrat till infusionsvätska, lösning

1 In the printed leaflet, only the actual location will be indicated.

Date of the most recent review of this summary: July 2024

Detailed information on this medicinal product 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:

Labrycor should only be administered by specialist physicians in anaesthesia, cardiology or intensive care, in an intensive care unit or adequately monitored setting. Circulatory and respiratory functions must be closely monitored.

Isoprenaline must not be used routinely.

Route of administration: intravenous.

Dilute 10 ml of concentrate for solution for infusion (= 2.0 mg) in 500 ml of 9 mg/ml (0.9%) sodium chloride injection solution or 50 mg/ml (5%) glucose injection solution. This results in a concentration of 4 micrograms/ml of isoprenaline solution for infusion. Labrycor must be carefully titrated under close supervision to the lowest dose possible that achieves a heart rate of 50–60 beats per minute.

The recommended initial dose is 0.01 micrograms/kg/minute.

The dose may be increased in increments of 0.01 micrograms/kg/minute up to a maximum dose of 0.15 micrograms/kg/minute.

The infusion rate should be adjusted according to the patient's heart rate.

National and international guidelines and recommendations on the appropriate use of isoprenaline must be followed.

Do not inject Labrycor simultaneously with adrenaline under any circumstances. However, if administration of both medicines is necessary, they may be administered alternately every 4 hours.

After dilution in 9 mg/ml (0.9%) sodium chloride injection solution or 50 mg/ml (5%) glucose injection solution, the product has been shown to be physically and chemically stable for 24 hours at 25°C.

From a microbiological standpoint, diluted solutions should be used immediately. If not used immediately, the duration and conditions of storage prior to use of the diluted solution are the responsibility of the user.