Ephedrine kabi

Package leaflet: Information for the patient

Ephedrine Kabi, 3 mg/ml, solution for injection
Ephedrine Kabi, 10 mg/ml, solution for injection
Ephedrine Kabi, 30 mg/ml, solution for injection
Ephedrini hydrochloridum
Please read all of this leaflet carefully before use, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

1. What Ephedrine Kabi is and what it is 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 pack and other information

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

The active substance in Ephedrine Kabi is ephedrine hydrochloride.
Ephedrine belongs to a group of medicines called sympathomimetics. Sympathomimetic drugs
affect the part of the nervous system that functions automatically.
Ephedrine Kabi is an injection solution in an ampoule, used in the treatment of low blood pressure
occurring during general and regional anaesthesia, including both spinal and epidural anaesthesia,
in adults and children (over 12 years of age).
This medicine may be used only by an anaesthesiologist or under their supervision.

2. Important information before using Ephedrine Kabi

When not to use Ephedrine Kabi

• if the patient is allergic to ephedrine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if the patient is taking another sympathomimetic agent, such as phenylpropanolamine, phenylephrine, pseudoephedrine (medicines used in the treatment of nasal congestion) or methylphenidate (a medicine used in the treatment of attention deficit hyperactivity disorder (ADHD));
• if the patient is taking an alpha-sympathomimetic medicine (medicines used in the treatment of low blood pressure);
• if the patient is taking or has taken within the last 14 days non-selective monoamine oxidase inhibitors (medicines used in the treatment of depression).

Warnings and precautions
Before starting treatment with Ephedrine Kabi, discuss with your doctor:

• if the patient has diabetes;
• if the patient has heart disease or any other heart condition, including angina pectoris;
• if the patient has weakened blood vessel walls leading to an aneurysm;
• if the patient has high blood pressure;
• if the patient has narrowing and/or blockage of blood vessels (peripheral vascular disease);
• if the patient has overactivity of the thyroid gland (hyperthyroidism);
• if the patient has or is suspected of having glaucoma (increased pressure in the eye) or benign prostatic hyperplasia (enlarged prostate);
• if the patient is due to undergo surgery requiring anaesthetic agents;
• if the patient is currently taking or has taken within the last 14 days any monoamine oxidase inhibitors used to treat depression.

Ephedrine Kabi and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken,
as well as any medicines the patient plans to take.
This is particularly important for the following medicines:

• methylphenidate, used in the treatment of attention deficit hyperactivity disorder (ADHD);
• other vasoconstrictors such as phenylpropanolamine or pseudoephedrine (medicines used for nasal congestion) and phenylephrine (a medicine used in the treatment of low blood pressure);
• alpha- and beta-adrenergic receptor blockers (administered orally and/or intranasally), used among others in the treatment of low blood pressure and nasal congestion;
• medicines used to treat depression;
• ergot alkaloids, a group of medicines used to treat migraine;
• linezolid, used to treat infections;
• guanethidine and related medicines, used to treat high blood pressure;
• sibutramine, a medicine used to suppress appetite;
• inhaled anaesthetics, such as halothane;
• medicines used to treat asthma, such as theophylline;
• corticosteroids, a group of medicines used to reduce swelling caused by various conditions;
• antiepileptic medicines;
• doxapram, a medicine used to treat breathing disorders;
• oxytocin, a medicine used during childbirth;
• reserpine, methyldopa and related medicines, used to treat high blood pressure.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become
pregnant, she should consult her 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 as advised by the doctor, breastfeeding may need to be
interrupted for several 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 table salt) in 1 ml of solution for injection.
This corresponds to 0.16% of the maximum recommended daily dietary intake of sodium for adults.
This medicine contains 32.1 mg of sodium (the main component of table salt) in each 10 ml ampoule.
This corresponds to 1.6% of the maximum recommended daily dietary intake of sodium for adults.

Ephedrine Kabi, 10 mg/ml, solution for injection contains sodium
This medicine contains 2.36 mg of sodium (the main component of table salt) in 1 ml of solution for injection.
This corresponds to 0.12% of the maximum recommended daily dietary intake of sodium for adults.
This medicine contains 11.8 mg of sodium (the main component of table salt) in each 5 ml ampoule.
This corresponds to 0.59% of the maximum recommended daily dietary intake of sodium for adults.

Ephedrine Kabi, 30 mg/ml, solution for injection
This medicine contains less than 1 mmol of sodium (23 mg) per 1 ml of solution; therefore, this medicine is considered "sodium-free".

3. How to use Ephedrine Kabi

Your doctor or nurse will administer Ephedrine Kabi into the patient's vein (intravenously). The doctor will determine the appropriate dose for the patient, as well as the timing and method of injection.

Recommended doses:

Adults and elderly patients, 3 mg/ml injection solution
The patient will receive a slow intravenous injection of 3 to 6 mg (up to a maximum of 9 mg), repeated as necessary every 3–4 minutes, up to a maximum total dose of 30 mg.
The total dose must be less than 150 mg/24 hours.

Adults and elderly patients, 10 mg/ml injection solution
The patient will receive a slow intravenous injection of 5 mg (up to a maximum of 10 mg), repeated as necessary every 3–4 minutes, up to a maximum total dose of 30 mg.
The total dose must be less than 150 mg/24 hours.

Adults and elderly patients, 30 mg/ml injection solution
The patient will receive a slow intravenous injection of 3 to 6 mg (up to a maximum of 9 mg), repeated as necessary every 3–4 minutes, up to a maximum total dose of 30 mg.
The total dose must be less than 150 mg/24 hours.

The 10 mg/ml and 30 mg/ml strengths of Ephedrine Kabi must be diluted before use.

Use in children and adolescents

• Children under 12 years of age: Use of Ephedrine Kabi is not recommended in children under 12 years of age due to insufficient data on efficacy, safety, and dosing recommendations.
• Children over 12 years of age: The dosing and route of administration are the same as in adult patients.

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

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The most serious adverse reactions requiring immediate medical attention are:

• irregular heartbeat;
• palpitations (awareness of heart beating), high blood pressure, rapid heart rate;
• chest pain, slow heartbeat, low blood pressure;
• heart failure (cessation of heart activity);
• intracerebral hemorrhage;
• fluid accumulation in the lungs (pulmonary edema);
• increased eye pressure (glaucoma);
• difficulty passing urine.

Other adverse reactions that may occur during treatment with this medicine are listed below.
Common (may affect up to 1 in 10 patients):

• confusion, feeling anxious, depression;
• nervousness, irritability, restlessness, fatigue, sleep problems, headache, sweating;
• shortness of breath;
• nausea, vomiting.

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl/
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ephedrine Kabi

Keep this medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the label after: "EXP".
The expiry date refers to the last day of the stated month.
There are no special storage requirements for this medicinal product.
Use the medicinal product immediately after opening the ampoule; the undiluted solution may be stored
in a syringe for 72 hours at 25°C and for 72 hours at temperatures from 2 to 8°C.
The diluted medicinal product is stable for 72 hours at 25°C and for 72 hours
at temperatures from 2 to 8°C.
Do not use this medicinal product if solid particles are observed in the solution.
Medicinal products should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicinal products no longer in use. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Ephedrine Kabi contains
The active substance is ephedrine hydrochloride.
1 ml of injection solution contains 3 mg of ephedrine hydrochloride.
Each 10 ml glass ampoule contains 30 mg of ephedrine hydrochloride.

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

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

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

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

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

What Ephedrine Kabi looks like and contents of the pack
Ephedrine Kabi is a clear, colourless to pale yellow injection solution.
Ephedrine Kabi 3 mg/ml, solution for injection, available in 10 ml glass ampoules
Pack sizes: 5 or 10 ampoules
Ephedrine Kabi 10 mg/ml, solution for injection, available in 5 ml glass ampoules
Pack sizes: 5 or 10 ampoules
Ephedrine Kabi 30 mg/ml, solution for injection, available in 1 ml glass ampoules
Pack sizes: 5, 10 or 50 ampoules
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Poland

Manufacturer
Labesfal – Laboratórios Almiro, S.A.
Zona Industrial do Lagedo
3465-157 Santiago de Besteiros
Portugal

For further information, please contact the Marketing Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Poland
Tel.: +48 22 345 67 89

This medicinal product is authorised in the European Economic Area and 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 Ephedrine hydrochloride 3 mg/ml Solution for injection
(Northern Ireland) Ephedrine hydrochloride 10 mg/ml Solution for injection
Ephedrine hydrochloride 30 mg/ml Solution for injection

Information intended exclusively for medical professionals:

Therapeutic indications
Treatment of arterial hypotension during spinal, epidural, and general anaesthesia.

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 cumulative dose of 30 mg. Lack of efficacy after a 30 mg dose should prompt reconsideration of the choice of drug. 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 cumulative dose of 30 mg. Lack of efficacy after a 30 mg dose should prompt reconsideration of the choice of drug. 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 cumulative dose of 30 mg. Lack of efficacy after a 30 mg dose should prompt reconsideration of the choice of drug. Total dose administered within 24 hours must be less than 150 mg.

Children and adolescents
The use of Ephedrine Kabi is generally not recommended in children due to insufficient data on efficacy, safety, and dosing recommendations.

Children under 12 years of age
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
Dosage and administration are the same as for adult patients.

Patients with renal or hepatic impairment
No dose adjustment is required in patients with renal or hepatic impairment.

Elderly patients
Same as for other adult patients.

Route of administration
Ephedrine for intravenous injection must be administered only by an anaesthesiologist or under his/her supervision.

The solution may need to be diluted before use (applies to 10 mg/ml and 30 mg/ml strengths) (see Preparation).

Administration by intravenous route.

Overdose
Overdose may lead to nausea, vomiting, fever, paranoid psychosis, ventricular and supraventricular arrhythmias, arterial hypertension, respiratory depression, seizures, and coma.

The lethal dose in an adult human is approximately 2 g, corresponding to a blood concentration of approximately 3.5 to 20 mg/l.

Treatment
Management of ephedrine overdose may require intensive supportive treatment.

For treatment of supraventricular tachycardia, labetalol 50 to 200 mg may be administered by slow intravenous injection, with electrocardiographic monitoring.

Significant hypokalaemia (<2.8 mmol/l) due to intracellular potassium shift predisposes to cardiac arrhythmias and can be corrected by potassium chloride infusion together with propranolol and correction of respiratory alkalosis if present.

Benzodiazepines and/or neuroleptic drugs may be required to control symptoms of central nervous system stimulation.

To counteract severe arterial hypertension, parenteral (intravenous) nitrates, calcium channel blockers, sodium nitroprusside, labetalol, or phentolamine may be administered.

The choice of antihypertensive agent depends on availability, concomitant diseases, and the patient's clinical condition.

Preparation
For single use only.

Instructions for dilution of 10 mg/ml solution:
Dilute the injection solution to achieve a final concentration of 5 mg/ml, as described in section 4.2 Dosage and administration of the SmPC.

Instructions for dilution of 30 mg/ml solution:
Dilute the injection solution to achieve a final concentration of 3 mg/ml or 5 mg/ml, as described in section 4.2 Dosage and administration of the SmPC.

Ephedrine Kabi is compatible with:

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

Shelf life
Unopened ampoule:
3 years

Shelf life after opening ampoule:
The product should be used immediately.

Shelf life of undiluted solution stored in a syringe:
Physico-chemical stability has been demonstrated for 72 hours at 25°C and for 72 hours at 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 2°C to 8°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, the responsibility for storage conditions and duration prior to use lies with the user. The storage period should not exceed 24 hours at 2°C to 8°C, unless dilution was carried out under controlled and validated aseptic conditions.