EFEDRINA FRESENIUS KABI 10 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the Patient

Efedrina Fresenius Kabi 10 mg/ml Solution for Injection

efedrine hydrochloride

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 further questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

Efedrina Fresenius Kabi contains the active substance efedrine hydrochloride.

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

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

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

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

Your doctor will not give you Efedrina Fresenius Kabi if:

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

Warnings and precautions

Talk to your doctor before you start using this medicine if:

• You are diabetic.
• You have any heart disease or any other cardiac condition, including angina pectoris.
• You have weakness in the wall of the blood vessels that causes a bulge (aneurysm).
• You have arterial hypertension.
• You have narrowing and/or blockage of the blood vessels (occlusive vascular diseases).
• You have an overactive thyroid gland (hyperthyroidism).
• You know or suspect that you may have glaucoma (increased eye pressure) or prostate enlargement (prostate hypertrophy).
• You are about to undergo an operation that requires anesthesia.
• You are currently taking or have taken in the last 14 days any monoamine oxidase inhibitor to treat depression.

This medicine contains an active substance that may induce a positive response in doping control.

Other medicines and Efedrina Fresenius Kabi

Tell your doctor, nurse, or pharmacist if you are taking, have recently taken, or might 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 (medicine used to treat hypotension).
• alpha and beta-adrenergic blockers (oral and/or nasal use) used to treat hypotension 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 other related medicines, used to treat arterial hypertension.
• sibutramine, a medicine used as an appetite suppressant.
• inhalation anesthetics, such as halothane.
• medicines used to treat asthma, such as theophylline.
• corticosteroids, a type of medicine used to relieve inflammation in a wide range 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 arterial hypertension.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before using this medicine.

During pregnancy, the use of efedrine should be avoided or used with caution, and only when necessary.

Depending on your disease, and following the doctor's recommendations, breastfeeding may be suspended for several days after the administration of efedrine.

Efedrina Fresenius Kabi contains sodium

This medicine contains 2.36 mg of sodium (main component of table/cooking salt) per ml. This is equivalent to 0.12% of the maximum daily intake of sodium recommended for an adult.

This medicine contains 11.8 mg of sodium (main component of cooking/table salt) in each 5 ml ampoule. This is equivalent to 0.59% of the maximum daily intake of sodium recommended for an adult.

3. How to use Efedrina Fresenius Kabi

Your doctor or nurse will give you this medicine by a vein (intravenously). Your doctor will determine the correct dose for you and when and how the injection should be given.

The recommended dose is:

Adults and elderly for 10 mg/ml

You will be given a slow injection of 5 mg (maximum 10 mg) in a vein, repeated if necessary, every 3-4 minutes up to a maximum of 30 mg.

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

The 10 mg/ml dose should 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 dosage recommendations.

• Children over 12 years

The posology 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 other questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most serious side effects that require immediate medical attention are:

• abnormal heart rhythm;
• palpitations (feeling the heartbeat), arterial hypertension, rapid heartbeat;
• heart pain, slow heartbeat, arterial hypotension;
• heart failure (cardiac arrest);
• brain hemorrhage;
• fluid accumulation between the lungs (pulmonary edema);
• increased eye pressure (glaucoma);
• difficulty urinating.

The following are other side effects that you might experience.

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

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

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

• affects blood coagulation;
• allergy;
• changes in personality or the way you feel or think, fear;
• tremor, excessive saliva production;
• decreased appetite;
• reduction of potassium levels in the blood, change in blood glucose levels.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Efedrina Fresenius Kabi

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

Do not use this medicine after the expiry date which is stated on the label after “EXP”. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

After opening the ampoule, the product should be used immediately; however, the undiluted solution can be stored in a syringe for 72 hours at 25 °C and for 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Efedrina Fresenius Kabi

The active substance is efedrine hydrochloride.

Each ml of injectable solution contains 10 mg of efedrine hydrochloride.

Each 5 ml glass ampoule contains 50 mg of efedrine hydrochloride.

• The other ingredients (excipients) are sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), and water for injectable preparations.

Appearance of the product and pack contents

Efedrina Fresenius Kabi is a clear, colorless to pale yellow injectable solution.

Efedrina Fresenius Kabi 10 mg/ml solution for injection is available in 5 ml glass ampoules. In pack sizes of 5 and 10 ampoules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of this leaflet: March 2024

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

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This information is intended only for healthcare professionals:

Therapeutic indication

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

Posology and method of administration

Posology 10 mg/ml

Adults

Slow intravenous injection of 5 mg (maximum 10 mg), repeated as necessary every 3-4 minutes up to a maximum of 30 mg. Lack of efficacy after 30 mg should lead to reconsideration of the choice of therapeutic agent. The total dose administered during 24 hours should not exceed 150 mg.

Pediatric population

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

• Children under 12 years

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

• Children over 12 years

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

Patients with renal or hepatic insufficiency

No dose adjustment is recommended for patients with renal or hepatic insufficiency.

Elderly patients

Same as adults.

Method of administration

Efedrine should only be used by or under the supervision of an anesthesiologist 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, convulsions, and coma are observed.

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

Treatment

Treatment of efedrine 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 for the treatment of supraventricular tachycardia. Marked hypokalemia (<2.8 mmol/l) due to potassium compartment shift predisposes to cardiac arrhythmias and may be corrected by potassium chloride infusion in addition to propranolol and correcting respiratory alkalosis, when present.

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

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

Preparation

For single use.

Instructions for dilution of 10 mg/ml:

Dilute the injectable solution to a final concentration of 5 mg/ml as appropriate, as described in Posology and method of administration.

Efedrina Fresenius Kabi is compatible with:

• sodium chloride 9 mg/ml (0.9% w/v)
• glucose 50 mg/ml (5% w/v) infusion
• Ringer's lactate infusion

Shelf life

Unopened: 30 months

Shelf life after opening the ampoule:

The product should be used immediately.

Shelf life of the undiluted solution when stored in a syringe:

Chemical and physical stability has been demonstrated for 72 hours at 25 °C and for 72 hours at 2 to 8 °C.

Shelf life after dilution:

Chemical and physical stability has been demonstrated for 72 hours at 25 °C and for 72 hours at 2 to 8 °C.

From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and normally should not exceed 24 hours at 2 to 8 °C, unless the dilution has been carried out under controlled and validated aseptic conditions.