Ephedrine Kabi

Leaflet attached to the packaging: patient information

Ephedrine Kabi, 3 mg/ml, solution for injection

Ephedrine Kabi, 10 mg/ml, solution for injection

Ephedrine Kabi, 30 mg/ml, solution for injection

Ephedrine hydrochloride

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist or nurse.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Ephedrine Kabi and what is it used for
• 2. Important information before using Ephedrine Kabi
• 3. How to use Ephedrine Kabi
• 4. Possible side effects
• 5. How to store Ephedrine Kabi
• 6. Contents of the packaging and other information

1. What is Ephedrine Kabi and what is it used for

The active substance of Ephedrine Kabi is ephedrine hydrochloride.
Ephedrine belongs to a group of medicines called sympathomimetics. Sympathomimetic medicines
affect the part of the nervous system that works automatically.
Ephedrine Kabi is a solution for injection in an ampoule, used to treat low blood pressure during general and local anesthesia, both spinal and epidural, in adults and children (over 12 years).
This medicine can only be used by an anesthesiologist or under their supervision.

2. Important information before using Ephedrine Kabi

When not to use Ephedrine Kabi

treatment of rhinitis) or methylphenidate (a medicine used in treatment of so-called "attention deficit hyperactivity disorder (ADHD)");treatment of low blood pressure);treatment of depression).

Warnings and precautions

Before starting treatment with Ephedrine Kabi, the patient should discuss it with their doctor:

Ephedrine Kabi and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
This is especially important in the case of the following medicines:

• methylphenidate, used in the treatment of so-called "attention deficit hyperactivity disorder (ADHD)";
• other vasoconstrictor medicines, such as phenylpropanolamine or pseudoephedrine (medicines used in rhinitis) and phenylephrine (a medicine used in treatment of low blood pressure);
• alpha- and beta-adrenergic receptor inhibitors (administered orally and/or intranasally), used, among others, in treatment of low blood pressureand rhinitis;
• medicines used in treatment of depression;
• ergot alkaloids, a type of medicine used in treatment of migraine;
• linezolid, used in treatment of infections;
• guanethidine and related medicines, used in treatment of high blood pressure;
• sibutramine, a medicine used to suppress appetite;
• inhalation anesthetics, such as halothane;
• medicines used in treatment of asthma, such as theophylline;
• corticosteroids, a type of medicine used to relieve swelling caused by various conditions;
• medicines used in treatment of epilepsy;
• doxapram, a medicine used in treatment of respiratory disorders;
• oxytocin, a medicine used during childbirth;
• reserpine and methyldopa and related medicines, used in treatment of high blood pressure.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Ephedrine should be avoided during pregnancy or used with caution and only when necessary.
Depending on the patient's condition and according to the doctor's recommendations, breastfeeding may be discontinued for a few days after administration of ephedrine.

Ephedrine Kabi, 3 mg/ml, solution for injection contains sodium

This medicine contains 3.21 mg of sodium (the main component of common salt) in 1 ml of solution for injection.
This corresponds to 0.16% of the maximum recommended daily intake of sodium in the diet for adults.
This medicine contains 32.1 mg of sodium (the main component of common salt) in each 10 ml ampoule.
This corresponds to 1.6% of the maximum recommended daily intake of sodium in the diet for adults.

Ephedrine Kabi, 10 mg/ml, solution for injection contains sodium

This medicine contains 2.36 mg of sodium (the main component of common salt) in 1 ml of solution for injection.
This corresponds to 0.12% of the maximum recommended daily intake of sodium in the diet for adults.
This medicine contains 11.8 mg of sodium (the main component of common salt) in each 5 ml ampoule.
This corresponds to 0.59% of the maximum recommended daily intake of sodium in the diet for adults.

Ephedrine Kabi, 30 mg/ml, solution for injection

This medicine contains less than 1 mmol of sodium (23 mg) in 1 ml of solution, i.e. the medicine is considered "sodium-free".

3. How to use Ephedrine Kabi

The doctor or nurse will administer Ephedrine Kabi to the patient's vein (intravenously). The doctor will determine the appropriate dose for the patient and the time and method of injection.

Recommended doses are:

Adults and elderly patients, 3 mg/ml solution for injection

The patient will receive a slow injection of a dose of 3 to 6 mg (maximum 9 mg) into a vein, repeated if necessary every 3-4 minutes up to a maximum dose of 30 mg.
The total dose must be less than 150 mg/24 hours.

Adults and elderly patients, 10 mg/ml solution for injection

The patient will receive a slow injection of a dose of 5 mg (maximum 10 mg) into a vein, repeated if necessary every 3-4 minutes up to a maximum dose of 30 mg.
The total dose must be less than 150 mg/24 hours.

Adults and elderly patients, 30 mg/ml solution for injection

The patient will receive a slow injection of a dose of 3 to 6 mg (maximum 9 mg) into a vein, repeated if necessary every 3-4 minutes up to a maximum dose of 30 mg.
The total dose must be less than 150 mg/24 hours.
Ephedrine Kabi at a concentration of 10 mg/ml and 30 mg/ml should be diluted before use.

Use in children and adolescents

• Children under 12 years of age: Ephedrine Kabi is not recommended for use in children under 12 years of age due to the lack of sufficient data on efficacy, safety, and dosage recommendations.
• Children over 12 years of age: The dosage and method of administration are the same as for adult patients.

Patients with renal or hepatic impairment

No dose adjustment is necessary in patients with renal or hepatic impairment.
In case of any further doubts regarding the use of this medicine, consult a 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 will require immediate medical attention are:

• abnormal heart rhythm;
• palpitations (feeling of heartbeat), high blood pressure, rapid heart rate;
• chest pain, slow heartbeat, low blood pressure;
• heart failure (cardiac arrest);
• intracranial hemorrhage;
• fluid accumulation in the lungs (pulmonary edema);
• increased eye pressure (glaucoma);
• urination difficulties.

Other side effects that may occur when taking this medicine are listed below.
Frequent(may affect up to 1 in 10 patients):

• confusion, feeling of anxiety, depression;
• nervousness, irritability, anxiety, weakness, sleep problems, headache, sweating;
• shortness of breath;
• nausea, vomiting.

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

• blood coagulation disorders;
• allergy;
• changes in personality or way of feeling or thinking, anxiety;
• tremors, excessive salivation;
• decreased appetite;
• low potassium levels in the blood, changes in blood glucose levels.

Reporting side effects

If any side effects occur, including those not listed in the leaflet, the patient should inform their doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl/
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Ephedrine Kabi

The medicine should be stored out of 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 stated.
There are no special precautions for storage.
The medicine should be used immediately after opening the ampoule, undiluted solution can be stored in a syringe for 72 hours at 25°C and for 72 hours at a temperature of 2 to 8°C.
Diluted medicine is stable for 72 hours at 25°C and for 72 hours at a temperature of 2 to 8°C.
Do not use this medicine if solid particles are visible in the solution.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ephedrine Kabi contains

The active substance of the medicine is ephedrine hydrochloride.
1 ml of solution for injection contains 3 mg of ephedrine hydrochloride.
Each glass ampoule with a capacity of 10 ml contains 30 mg of ephedrine hydrochloride.

• Other ingredients are: sodium chloride, sodium citrate dihydrate, citric acid monohydrate, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) and water for injections.

1 ml of solution for injection contains 10 mg of ephedrine hydrochloride.
Each glass ampoule with a capacity of 5 ml contains 50 mg of ephedrine hydrochloride.

• Other ingredients are: sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) and water for injections.

1 ml of solution for injection contains 30 mg of ephedrine hydrochloride.
Each glass ampoule with a capacity of 1 ml contains 30 mg of ephedrine hydrochloride.

• Other ingredients are: sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) and water for injections.

What Ephedrine Kabi looks like and contents of the packaging

Ephedrine Kabi is a clear, colorless to pale yellow solution for injection.
Ephedrine Kabi, 3 mg/ml, solution for injection, is available in a glass ampoule with a capacity of 10 ml
Pack sizes: 5 or 10 ampoules
Ephedrine Kabi, 10 mg/ml, solution for injection, is available in a glass ampoule with a capacity of 5 ml
Pack sizes: 5 or 10 ampoules
Ephedrine Kabi, 30 mg/ml, solution for injection, is available in a glass ampoule with a capacity of 1 ml
Pack sizes: 5, 10 or 50 ampoules
Not all pack sizes may be marketed.

Marketing authorization holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer

Labesfal – Laboratórios Almiro, S.A.
Zona Industrial do Lagedo
3465-157 Santiago de Besteiros
Portugal
To obtain more detailed information, please contact the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89

This medicine is authorized for use in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland)

under the following names:

Austria
Ephedrin Kabi 3 mg/ml Injektionslösung
Ephedrin Kabi 10 mg/ml Injektionslösung
Ephedrin Kabi 30 mg/ml Injektionslösung
Bulgaria
Ephedrine Kabi 10 mg/ml solution for injection
Ефедрин Каби 10 mg/ml инжекционен разтвор
Czech Republic
Ephedrine Kabi
Greece
Ephedrine/Kabi 3 mg/ml ενέσιμο διάλυμα
Ephedrine/Kabi 10 mg/ml ενέσιμο διάλυμα
Ephedrine/Kabi 30 mg/ml ενέσιμο διάλυμα
Spain
Efedrina Fresenius Kabi 3 mg/ml solución inyectable
Efedrina Fresenius Kabi 10 mg/ml solución inyectable
Efedrina Fresenius Kabi 30 mg/ml solución inyectable
Ireland
Ephedrine hydrochloride 3 mg/ml Solution for injection
Ephedrine hydrochloride 10 mg/ml Solution for injection
Ephedrine hydrochloride 30 mg/ml Solution for injection
Germany
Ephedrin Kabi 3 mg/ml Injektionslösung
Ephedrin Kabi 10 mg/ml Injektionslösung
Ephedrin Kabi 30 mg/ml Injektionslösung
Norway
Ephedrine Kabi
Poland
Ephedrine Kabi
Portugal
Efedrina Kabi
Slovakia
Ephedrine Kabi 10 mg/ml
Sweden
Ephedrine Kabi 3 mg/ml injektionsvätska, lösning
Ephedrine Kabi 10 mg/ml injektionsvätska, lösning
Ephedrine Kabi 30 mg/ml injektionsvätska, lösning
Hungary
Ephedrine Kabi 3 mg/ml oldatos injekció
Ephedrine Kabi 10 mg/ml oldatos injekció
Ephedrine Kabi 30 mg/ml oldatos injekció
United Kingdom
(Northern Ireland)
Ephedrine hydrochloride 3 mg/ml Solution for injection
Ephedrine hydrochloride 10 mg/ml Solution for injection
Ephedrine hydrochloride 30 mg/ml Solution for injection

Date of last revision of the leaflet:

Information intended for healthcare professionals only:

Therapeutic indications

Treatment of hypotension during spinal, epidural and general anesthesia.

Dosage and administration

Dosage 3 mg/ml
Adults
Slow intravenous injection of a dose of 3 to 6 mg (maximum 9 mg), repeated if necessary every 3-4 minutes up to a maximum dose of 30 mg. Lack of efficacy after a dose of 30 mg should prompt re-evaluation of the choice of medicine. The total dose administered within 24 hours must be less than 150 mg.
Dosage 10 mg/ml
Adults
Slow intravenous injection of a dose of 5 mg (maximum 10 mg), repeated if necessary every 3-4 minutes up to a maximum dose of 30 mg. Lack of efficacy after a dose of 30 mg should prompt re-evaluation of the choice of medicine. The total dose administered within 24 hours must be less than 150 mg.
Dosage 30 mg/ml
Adults
Slow intravenous injection of a dose of 3 to 6 mg (maximum 9 mg), repeated if necessary every 3-4 minutes up to a maximum dose of 30 mg. Lack of efficacy after a dose of 30 mg should prompt re-evaluation of the choice of medicine. The total dose administered within 24 hours must be less than 150 mg.
Children and adolescents
Generally, it is not recommended to use Ephedrine Kabi in children due to the lack of sufficient data on efficacy, safety, and dosage recommendations.
Children under 12 years of age
The safety and efficacy of ephedrine in children under 12 years of age have not been established. Data are not available.
Children over 12 years of age
The dosage and method of administration are the same as for adult patients.
Patients with renal or hepatic impairment
No dose adjustment is necessary in patients with renal or hepatic impairment.
Patients in advanced age
As for other adult patients.
Method of administration
Ephedrine in intravenous injection can only be administered by an anesthesiologist or under their supervision.
The medicine should be diluted if necessary before use (applies to concentrations of 10 mg/ml and 30 mg/ml) (see Preparation).
Intravenous administration.

Overdose

Overdose may lead to nausea, vomiting, fever, paranoid psychosis, ventricular and supraventricular arrhythmias, hypertension, respiratory depression, seizures, and coma.
The lethal dose for an adult is approximately 2 g, which corresponds to a blood concentration of approximately 3.5 to 20 mg/l.
Treatment
Treatment of ephedrine overdose may require intensive supportive treatment.
To treat supraventricular tachycardia, labetalol can be administered in a dose of 50 to 200 mg in slow intravenous injection, with electrocardiographic monitoring.
Significant hypokalemia (<2.8 mmol/l) due to potassium shift in the body is a factor predisposing to cardiac arrhythmias and can be corrected by infusion of potassium chloride along with propranolol and correction of respiratory alkalosis if present.
To control symptoms of central nervous system stimulation, a benzodiazepine and/or a neuroleptic agent may be necessary.
To counteract severe hypertension, nitrate, calcium channel blockers, sodium nitroprusside, labetalol, or phentolamine can be administered intravenously.
The choice of antihypertensive agent depends on availability, concomitant diseases, and the patient's clinical condition.

Preparation

For single use only.
Instructions for diluting the 10 mg/ml solution:
Dilute the solution for injection to achieve a final concentration of 5 mg/ml as described in the SmPC in section 4.2 Dosage and administration.
Instructions for diluting the 30 mg/ml solution:
Dilute the solution for injection to achieve a final concentration of 3 mg/ml or 5 mg/ml as described in the SmPC in section 4.2 Dosage and administration.
Ephedrine Kabi is compatible with:

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

Shelf life

Unopened ampoule:
30 months
Shelf life after opening the ampoule:
the medicine should be used immediately
Shelf life of the undiluted solution, stored in a syringe:
physico-chemical stability has been demonstrated for 72 hours at 25°C and for 72 hours at a temperature of 2°C to 8°C.
Shelf life after dilution:
physico-chemical stability has been demonstrated for 72 hours at 25°C and for 72 hours at a temperature of 2°C to 8°C.
From a microbiological point of view, the medicine should be used immediately. If not used immediately, the responsibility for the storage time and conditions after preparation lies with the user. The storage time should not exceed 24 hours at a temperature of 2°C to 8°C, unless dilution took place in controlled and validated aseptic conditions.