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

Ephedrine Hydrochloride

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this Package 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 Package Leaflet, Tell the Doctor, Pharmacist, or Nurse. See Section 4.

Package Leaflet Contents

• 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. Package Contents 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 Regional Anesthesia, Both Spinal and Epidural, in Adults and Children (Over 12 Years).
This Medication Should Only be Used by an Anesthesiologist 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 Medication (Listed in Section 6);
• If the Patient is Taking Another Indirect Sympathomimetic Medication, Such as Phenylpropanolamine, Phenylephrine, Pseudoephedrine (Medications Used to Treat Nasal Congestion) or Methylphenidate (Medication Used to Treat Attention Deficit Hyperactivity Disorder (ADHD));
• If the Patient is Taking an Alpha-Sympathomimetic Medication (Medications Used to Treat Low Blood Pressure);
• If the Patient is Taking or Has Taken Non-Selective Monoamine Oxidase Inhibitors (Medications Used to Treat Depression) Within the Last 14 Days.

Warnings and Precautions

Before Starting Ephedrine Kabi, Discuss the Following 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 a Weakness in the Wall of a Blood Vessel Leading to a Balloon-Like Bulge (Aneurysm);
• If the Patient Has High Blood Pressure;
• If the Patient Has Narrowing and/or Blockage of Blood Vessels (Atherosclerosis);
• If the Patient Has an Overactive Thyroid Gland (Hyperthyroidism);
• If the Patient Has or is Suspected to Have Glaucoma (Increased Eye Pressure) or an Enlarged Prostate;
• If the Patient is Scheduled for Surgery Requiring Anesthesia;
• If the Patient is Currently Taking or Has Taken Monoamine Oxidase Inhibitors for Depression Within the Last 14 Days.

Ephedrine Kabi and Other Medications

Tell Your Doctor About All Medications the Patient is Currently Taking or Plans to Take, Including:

• Methylphenidate, Used to Treat Attention Deficit Hyperactivity Disorder (ADHD);
• Other Vasoconstrictor Medications, Such as Phenylpropanolamine or Pseudoephedrine (Used to Treat Nasal Congestion) and Phenylephrine (Used to Treat Low Blood Pressure);
• Alpha- and Beta-Adrenergic Receptor Inhibitors (Used to Treat Low Blood Pressureand Nasal Congestion);
• Antidepressant Medications;
• Ergot Alkaloids, a Type of Medication Used to Treat Migraines;
• Linezolid, Used to Treat Infections;
• Guanethidine and Related Medications, Used to Treat High Blood Pressure;
• Sibutramine, a Medication Used to Suppress Appetite;
• Inhalational Anesthetics, Such as Halothane;
• Asthma Medications, Such as Theophylline;
• Corticosteroids, a Type of Medication Used to Reduce Swelling;
• Antiepileptic Medications;
• Doxapram, Used to Treat Breathing Disorders;
• Oxytocin, Used During Childbirth;
• Reserpine and Methyldopa and Related Medications, Used to Treat High Blood Pressure.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, Thinks She May be Pregnant or is Planning to Have a Child, She Should Consult a Doctor or Pharmacist Before Using this Medication.
Ephedrine Should be Avoided During Pregnancy or Used with Caution and Only if Necessary.
Depending on the Patient's Condition and the Doctor's Recommendations, Breastfeeding May be Interrupted for a Few Days After Ephedrine Administration.

Ephedrine Kabi, 3 mg/ml, Solution for Injection Contains Sodium

This Medication Contains 3.21 mg of Sodium (a Major Component of Common Salt) per 1 ml of Solution for Injection.
This is Equivalent to 0.16% of the Maximum Recommended Daily Sodium Intake for Adults.
This Medication Contains 32.1 mg of Sodium (a Major Component of Common Salt) per 10 ml Ampoule.
This is Equivalent to 1.6% of the Maximum Recommended Daily Sodium Intake for Adults.

Ephedrine Kabi, 10 mg/ml, Solution for Injection Contains Sodium

This Medication Contains 2.36 mg of Sodium (a Major Component of Common Salt) per 1 ml of Solution for Injection.
This is Equivalent to 0.12% of the Maximum Recommended Daily Sodium Intake for Adults.
This Medication Contains 11.8 mg of Sodium (a Major Component of Common Salt) per 5 ml Ampoule.
This is Equivalent to 0.59% of the Maximum Recommended Daily Sodium Intake for Adults.

Ephedrine Kabi, 30 mg/ml, Solution for Injection

This Medication Contains Less than 1 mmol of Sodium (23 mg) per 1 ml of Solution, Which Means it is Considered Sodium-Free.

3. How to Use Ephedrine Kabi

The Doctor or Nurse Will Administer Ephedrine Kabi into the Patient's Vein (Intravenously). The Doctor Will Determine the Appropriate Dose for the Patient and the Time and Method of Administration.

Recommended Doses are:

Adults and Elderly Patients, 3 mg/ml Solution for Injection

The Patient Will Receive a Slow Intravenous Injection of 3 to 6 mg (Maximum 9 mg), Repeated as Needed 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 Intravenous Injection of 5 mg (Maximum 10 mg), Repeated as Needed 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 Intravenous Injection of 3 to 6 mg (Maximum 9 mg), Repeated as Needed 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 10 mg/ml and 30 mg/ml Must be Diluted Before Use.

Use in Children and Adolescents

• Children Under 12 Years: Ephedrine Kabi is Not Recommended for Children Under 12 Years Due to Lack of Sufficient Data on Efficacy, Safety, and Dosage Recommendations.
• Children Over 12 Years: Dosage and Administration are the Same as for Adult Patients.

Patients with Renal or Hepatic Impairment

No Dose Adjustment is Necessary for Patients with Renal or Hepatic Impairment.
In Case of Further Doubts, Consult a Doctor, Pharmacist, or Nurse.

4. Possible Side Effects

Like All Medications, Ephedrine Kabi Can Cause Side Effects, Although Not Everybody Gets Them.
The Most Serious Side Effects that Require Immediate Medical Attention Are:

• Abnormal Heart Rhythm;
• Pounding Heart (Feeling of Heartbeats), High Blood Pressure, Rapid Heart Rate;
• Chest Pain, Slow Heart Rate, Low Blood Pressure;
• Heart Failure (Cardiac Arrest);
• Brain Hemorrhage;
• Fluid Accumulation in the Lungs (Pulmonary Edema);
• Increased Eye Pressure (Glaucoma);
• Difficulty Urinating.

Other Side Effects that May Occur While Taking this Medication Include:

• 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 Determined from Available Data):

• Blood Coagulation Disorders;
• Allergic Reactions;
• Changes in Personality or Mood, 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 Package Leaflet, Tell the 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
Phone: +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.

5. How to Store Ephedrine Kabi

Store the Medication Out of Sight and Reach of Children.
Do Not Use this Medication After the Expiration Date Stated on the Label After: "EXP".
The Expiration Date Refers to the Last Day of the Specified Month.
No Special Storage Instructions for the Medication.
Use the Medication 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 Medication is Stable for 72 Hours at 25°C and for 72 Hours at a Temperature of 2 to 8°C.
Do Not Use this Medication if Particles are Visible in the Solution.
Medications Should Not be Disposed of in Sewers or Household Waste. Ask a Pharmacist How to Dispose of Medications that are No Longer Needed. This Will Help Protect the Environment.

6. Package Contents and Other Information

What Ephedrine Kabi Contains

The Active Substance of Ephedrine Kabi is Ephedrine Hydrochloride.
1 ml of Solution for Injection Contains 3 mg of Ephedrine Hydrochloride.
Each 10 ml Glass Ampoule 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 5 ml Glass Ampoule 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 1 ml Glass Ampoule 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 Package Contents

Ephedrine Kabi is a Clear, Colorless to Pale Yellow Solution for Injection.
Ephedrine Kabi, 3 mg/ml, Solution for Injection, is Available in a 10 ml Glass Ampoule.
Package Sizes: 5 or 10 Ampoules
Ephedrine Kabi, 10 mg/ml, Solution for Injection, is Available in a 5 ml Glass Ampoule.
Package Sizes: 5 or 10 Ampoules
Ephedrine Kabi, 30 mg/ml, Solution for Injection, is Available in a 1 ml Glass Ampoule.
Package Sizes: 5, 10, or 50 Ampoules
Not All Package 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
For More Detailed Information, Contact the Marketing Authorization Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Phone: +48 22 345 67 89

This Medication is Authorized for Marketing 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 Injektionssvätska, Lösning
Ephedrine Kabi 10 mg/ml Injektionssvätska, Lösning
Ephedrine Kabi 30 mg/ml Injektionssvätska, 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 Package 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 3 to 6 mg (Maximum 9 mg), Repeated as Needed Every 3-4 Minutes, Up to a Maximum Dose of 30 mg. Lack of Efficacy After a Dose of 30 mg Should Prompt Reconsideration of the Choice of Medication. The Total Dose Administered in 24 Hours Must be Less than 150 mg.
Dosage 10 mg/ml
Adults
Slow Intravenous Injection of 5 mg (Maximum 10 mg), Repeated as Needed Every 3-4 Minutes, Up to a Maximum Dose of 30 mg. Lack of Efficacy After a Dose of 30 mg Should Prompt Reconsideration of the Choice of Medication. The Total Dose Administered in 24 Hours Must be Less than 150 mg.
Dosage 30 mg/ml
Adults
Slow Intravenous Injection of 3 to 6 mg (Maximum 9 mg), Repeated as Needed Every 3-4 Minutes, Up to a Maximum Dose of 30 mg. Lack of Efficacy After a Dose of 30 mg Should Prompt Reconsideration of the Choice of Medication. The Total Dose Administered in 24 Hours Must be Less than 150 mg.
Children and Adolescents
Generally, Ephedrine Kabi is Not Recommended for Children Due to Lack of Sufficient Data on Efficacy, Safety, and Dosage Recommendations.
Children Under 12 Years
Safety and Efficacy of Ephedrine in Children Under 12 Years Have Not Been Established. Data are Not Available.
Children Over 12 Years
Dosage and Administration are the Same as for Adult Patients.
Patients with Renal or Hepatic Impairment
No Dose Adjustment is Necessary for Patients with Renal or Hepatic Impairment.
Patients in Advanced Age
As for Other Adult Patients.
Method of Administration
Ephedrine Should Only be Administered Intravenously by an Anesthesiologist or Under Their Supervision.
The Medication Should be Diluted if Necessary (Applies to 10 mg/ml and 30 mg/ml Concentrations) (See Preparation).

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 Care.
To Treat Supraventricular Tachycardia, Labetalol Can be Administered in a Dose of 50 to 200 mg by 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 Infusing Potassium Chloride with Propranolol and Correcting Respiratory Alkalosis if Present.
To Control Symptoms of Central Nervous System Stimulation, a Benzodiazepine and/or a Neuroleptic Medication May be Necessary.
To Counteract Severe Hypertension, Nitrate, Calcium Channel Blockers, Sodium Nitroprusside, Labetalol, or Phentolamine Can be Administered Parenterally.
The Choice of Antihypertensive Medication 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 Medication 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 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 to 8°C.
From a Microbiological Point of View, the Medication Should be Used Immediately. If Not Used Immediately, the User is Responsible for the Storage Conditions and Duration. The Storage Duration Should Not Exceed 24 Hours at a Temperature of 2 to 8°C, Unless Dilution Took Place in Controlled and Validated Aseptic Conditions.