Ephedrine Fresenius Kabi 30 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ephedrine Fresenius Kabi 30 mg/ml solution for injection

ephedrine 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, pharmacist or nurse.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Efedrina Fresenius Kabi is and what it is used for

Efedrina Fresenius Kabi contains the active substance ephedrine hydrochloride.

Ephedrine belongs to a group of medicines called sympathomimetics. Sympathomimetic medicines affect the part of the nervous system that functions automatically.

This medicine is an injectable solution in an ampoule used for the treatment of arterial hypotension during general and local/regional anaesthesia, either spinal or epidural, in adults and children (over 12 years of age).

This product should only be used by, or under the supervision of, an anaesthetist.

2. What you need to know before using Efedrina Fresenius Kabi

Your doctor will not administer Efedrina Fresenius Kabi if:

• You are allergic to ephedrine or to any of the other components of this medicine (listed in section 6).
• You are taking other indirect sympathomimetic agents such as phenylpropanolamine, phenylephrine, pseudoephedrine (medicines used to relieve nasal congestion) or methylphenidate (a medicine used to treat “attention deficit hyperactivity disorder (ADHD)”).
• You are taking an alpha-sympathomimetic agent (a medicine used to treat low blood pressure).
• You are taking or have taken a non-selective monoamine oxidase inhibitor (MAOI) within the last 14 days (a medicine used to treat depression).

Warnings and precautions

Talk to your doctor before using this medicine if:

• You have diabetes.
• You have heart disease or any other cardiac condition, including angina pectoris.
• You have a weakness in the blood vessel wall causing a bulge (aneurysm).
• You have high blood pressure.
• You have stenosis and/or occlusion of blood vessels (occlusive vascular diseases).
• You have an overactive thyroid gland (hyperthyroidism).
• You know or suspect you may have glaucoma (increased eye pressure) or prostate enlargement (prostatic hypertrophy).
• You are about to undergo surgery requiring anesthesia.
• You are currently taking or have taken any monoamine oxidase inhibitor (MAOI) within the last 14 days for the treatment of depression.

This medicine contains an active substance that may cause a positive doping test.

Other medicines and Efedrina Fresenius Kabi

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

This information is especially important with the following medicines:

• Methylphenidate, used to treat “attention deficit hyperactivity disorder (ADHD)”.
• Other vasoconstrictors such as phenylpropanolamine or pseudoephedrine (medicines used as nasal decongestants), phenylephrine (a medicine used to treat low blood pressure).
• Alpha- and beta-adrenergic blockers (oral and/or nasal) used to treat low blood pressure or nasal congestion, among others.
• Medicines used to treat depression.
• Ergot alkaloids, a type of medicine used to treat migraine.
• Linezolid, used to treat infections.
• Guanethidine and related medicines, used to treat high blood pressure.
• Sibutramine, a medicine used as an appetite suppressant.
• Inhaled anesthetics, such as halothane.
• Medicines used to treat asthma, such as theophylline.
• Corticosteroids, a type of medicine used to reduce inflammation in a wide variety of different diseases.
• Medicines for epilepsy.
• Doxapram, a medicine used to treat respiratory problems.
• Oxytocin, a medicine used during childbirth.
• Reserpine, methyldopa, and related medicines, used to treat high blood pressure.

Pregnancy and breastfeeding

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

During pregnancy, ephedrine should be avoided or used with caution and only when necessary.

Depending on your condition and following your doctor’s recommendations, breastfeeding may need to be interrupted for several days after administration of ephedrine.

Efedrina Fresenius Kabi contains sodium

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

3. How to use Ephedrine Fresenius Kabi

Your doctor or nurse will administer this medicine to you into a vein (intravenous route). Your doctor will determine the correct dose for you and when and how the injection should be given.

Recommended dose:

Adults and elderly patients for 30 mg/ml

You will be given a slow intravenous injection of 3 to 6 mg (maximum 9 mg), repeated if necessary every 3–4 minutes up to a maximum of 30 mg.

The total dose must not exceed 150 mg/24 hours.

The 30 mg/ml dose must be diluted before use.

Use in children and adolescents

• Children under 12 years

This medicine is not recommended for use in children under 12 years of age due to insufficient data on efficacy, safety, and dosing recommendations.

• Children over 12 years

The dosage and method of administration are the same as in adults.

Patients with kidney or liver disease

No dose adjustment is recommended for patients with kidney or liver disease.

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

4. Possible adverse effects

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

The most serious adverse effects requiring immediate medical attention are:

• abnormal heart rhythm;
• palpitations (feeling your heartbeat), high blood pressure, rapid heartbeat;
• chest pain, slow heartbeat, low blood pressure;
• heart failure (cardiac arrest);
• brain hemorrhage;
• fluid accumulation in the lungs (pulmonary edema);
• increased eye pressure (glaucoma);
• difficulty urinating.

Listed below are other possible adverse effects that may occur.

Frequent (may affect up to 1 in 10 people):

• confusion, anxiety, depression;
• nervousness, irritability, restlessness, weakness, insomnia, headache, sweating;
• shortness of breath;
• nausea, vomiting.

Frequency not known (cannot be estimated from available data):

• affects blood coagulation;
• allergic reaction;
• changes in personality or in the way you feel or think, fear;
• tremor, excessive salivation;
• decreased appetite;
• reduction in blood potassium levels, changes in blood glucose levels.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Ephedrine Fresenius Kabi

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

Do not use this medicine after the expiry date stated on the label after “EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

After opening the ampoule, the product should be used immediately; however, the undiluted solution may be stored in a syringe for up to 72 hours at 25 °C and for up to 72 hours at 2 to 8 °C.

The diluted product is stable for 72 hours at 25 °C and for 72 hours at 2 to 8 °C.

Do not use this medicine if you notice particles in the solution.

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

6. Contents of the pack and other information

Composition of Ephedrine Fresenius Kabi

The active substance is ephedrine hydrochloride.

Each ml of injectable solution contains 30 mg of ephedrine hydrochloride.

Each 1 ml glass ampoule contains 30 mg of ephedrine hydrochloride.

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

Appearance of the product and contents of the pack

Ephedrine Fresenius Kabi is a clear, colourless to pale yellow injectable solution.

Ephedrine Fresenius Kabi 30 mg/ml solution for injection is available in 1 ml glass ampoules. Pack sizes of 5, 10 and 50 ampoules are available.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Fresenius Kabi España, S.A.U.

C/Marina 16-18

08005 – Barcelona, Spain

Manufacturer:

Labesfal Laboratorios Almiro S.A.

Zona Industrial Do Lagedo 3465-157 Santiago de Besteiros

Portugal

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

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

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/).

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This information is intended for healthcare professionals only:

Therapeutic indication

Treatment of hypotension due to spinal, epidural, and general anesthesia.

Dosage and administration

Dosage 30 mg/ml

Adults

Slow intravenous injection of 3 to 6 mg (maximum 9 mg), repeated as necessary every 3–4 minutes up to a maximum of 30 mg. Lack of efficacy after 30 mg should prompt reconsideration of the choice of therapeutic agent. The total dose administered over 24 hours must not exceed 150 mg.

Paediatric population

In general, the use of Efedrina Fresenius Kabi in children is not recommended due to insufficient data on efficacy, safety, and dosage recommendations.

• Children under 12 years of age

The safety and efficacy of ephedrine have not been established in paediatric patients under 12 years of age. No data are available.

• Children over 12 years of age

The dosage and method of administration are the same as in adults.

Patients with renal or hepatic impairment

Dose adjustment is not recommended in patients with renal or hepatic impairment.

Elderly patients

Same as in adults.

Method of administration

Ephedrine must be used only by or under the supervision of an anaesthetist as an intravenous injection.

The medicine must be diluted before use as appropriate (see "Preparation").

For intravenous use.

Overdose

In case of overdose, nausea, vomiting, fever, paranoid psychosis, ventricular and supraventricular arrhythmias, hypertension, respiratory depression, seizures, and coma may occur.

The lethal dose in humans is approximately 2 g, corresponding to blood concentrations of approximately 3.5 to 20 mg/l.

Treatment

Management of ephedrine overdose with this product may require intensive supportive treatment. A slow intravenous injection of 50 to 200 mg of labetalol with electrocardiographic monitoring may be administered to treat supraventricular tachycardia. Marked hypokalaemia (<2.8 mmol/l) due to transcellular potassium shift predisposes to cardiac arrhythmias and can be corrected by potassium chloride infusion, in addition to propranolol and correction of respiratory alkalosis, if present.

A benzodiazepine and/or a neuroleptic agent may be required to control central nervous system (CNS) stimulant effects.

For severe hypertension, parenteral antihypertensive options include intravenous nitrates, calcium channel blockers, sodium nitroprusside, labetalol, or phentolamine. The choice of antihypertensive agent depends on availability, concomitant conditions, and the patient's clinical status.

Preparation

For single use only.

Dilution instructions for 30 mg/ml:

Dilute the injectable solution to a final concentration of 3 mg/ml or 5 mg/ml as appropriate, as described in "Dosage and administration".

Efedrina Fresenius Kabi is compatible with:

• Sodium chloride 9 mg/ml (0.9% w/v)
• Glucose infusion 50 mg/ml (5% w/v)
• Ringer Lactate infusion

Shelf life

Unopened: 3 years

Shelf life after ampoule opening:

The product should be used immediately.

Shelf life of undiluted solution when stored in a syringe:

Chemical and physical in-use stability has been demonstrated for 72 hours at 25 °C and for 72 hours between 2 and 8 °C.

Shelf life after dilution:

Chemical and physical in-use stability has been demonstrated for 72 hours at 25 °C and for 72 hours between 2 and 8 °C.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the times and conditions of in-use storage prior to use are the responsibility of the user and normally should not exceed 24 hours between 2 and 8 °C, unless dilution has taken place under controlled and validated aseptic conditions.