ERTAPENEM 1 g Powder

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Ertapenem Fresenius Kabi, 1 g, Powder for Concentrate for Solution for Infusion
   1. Read the Package Leaflet Carefully Before Using the Medicinal Product, as it Contains Important Information for the Patient.
   2. Package Leaflet Contents
3. What is Ertapenem Fresenius Kabi and What is it Used For
4. Important Information Before Using Ertapenem Fresenius Kabi
   1. When Not to Use Ertapenem Fresenius Kabi
   2. Warnings and Precautions
   3. Children and Adolescents (Aged 3 Months to 17 Years)
   4. Ertapenem Fresenius Kabi and Other Medicinal Products
   5. Pregnancy and Breastfeeding
   6. Driving and Using Machines
   7. Ertapenem Fresenius Kabi Contains Sodium
5. How to Use Ertapenem Fresenius Kabi
   1. Using More Than the Recommended Dose of Ertapenem Fresenius Kabi
   2. Missing a Dose of Ertapenem Fresenius Kabi
6. Possible Side Effects
   1. Reporting Side Effects
7. How to Store Ertapenem Fresenius Kabi
8. Contents of the Package and Other Information
   1. What Ertapenem Fresenius Kabi Contains
   2. What Ertapenem Fresenius Kabi Looks Like and Contents of the Package
   3. Marketing Authorization Holder
   4. Manufacturer
   5. This Medicinal Product is Authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) Under the Following Names:
   6. Information Intended for Healthcare Professionals Only:
   7. Instructions for Reconstitution and Dilution of Ertapenem Fresenius Kabi:
   8. Adult Patients and Adolescents (Aged 13 to 17 Years)
   9. Children (Aged 3 Months to 12 Years)

Package Leaflet: Information for the User

Ertapenem Fresenius Kabi, 1 g, Powder for Concentrate for Solution for Infusion

Ertapenem

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

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Keep this Package Leaflet, You May Need to Read it Again.
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In Case of Any Doubts, Consult a Doctor, Nurse, or Pharmacist.
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If the Patient Experiences Any Side Effects, Including Those Not Listed in this Package Leaflet, Inform a Doctor, Nurse, or Pharmacist. See Section 4.

Package Leaflet Contents

• 1. What is Ertapenem Fresenius Kabi and What is it Used For
• 2. Important Information Before Using Ertapenem Fresenius Kabi
• 3. How to Use Ertapenem Fresenius Kabi
• 4. Possible Side Effects
• 5. How to Store Ertapenem Fresenius Kabi
• 6. Contents of the Package and Other Information

1. What is Ertapenem Fresenius Kabi and What is it Used For

Ertapenem Fresenius Kabi Contains Ertapenem, Which is a Beta-Lactam Antibiotic. It is a Bactericidal Medicinal Product that Acts on Many Types of Bacteria (Microorganisms) that Cause Infections in Different Parts of the Body.
Ertapenem Fresenius Kabi Can be Administered to Patients Aged 3 Months and Older.
Treatment:
Your Doctor Has Prescribed Ertapenem Fresenius Kabi Because You Have Been Diagnosed with at Least One of the Following Infections:

• Intra-Abdominal Infection;
• Pulmonary Infection (Pneumonia);
• Gynecological Infection;
• Diabetic Foot Infection.

Prevention:

• Surgical Site Infections in Adult Patients Undergoing Colorectal Surgery.

2. Important Information Before Using Ertapenem Fresenius Kabi

When Not to Use Ertapenem Fresenius Kabi

• If the Patient is Allergic to the Active Substance (Ertapenem) or Any of the Other Ingredients of this Medicinal Product (Listed in Section 6);
• If the Patient is Allergic to Antibiotics Such as Penicillins, Cephalosporins, or Carbapenems (Used to Treat Various Infections).

Warnings and Precautions

Before Starting Treatment with Ertapenem Fresenius Kabi, Discuss this with Your Doctor, Nurse, or Pharmacist.
If Allergic Reactions Occur During Treatment (Such as Swelling of the Face, Tongue, or Throat, Difficulty Breathing or Swallowing, Skin Rash), Seek Medical Attention Immediately, as Immediate Medical Attention May be Required.
Although Antibiotics Like Ertapenem Fresenius Kabi Kill Some Types of Bacteria, Other Bacteria and Fungi May Continue to Overgrow. Your Doctor Will Closely Monitor Your Condition and Modify Treatment if Necessary.
If Diarrhea Occurs Before, During, or After Treatment with Ertapenem Fresenius Kabi, Inform Your Doctor, as this May be a Sign of Colitis (Inflammation of the Colon). Do Not Take Any Anti-Diarrheal Medicines Before Consulting Your Doctor.
Inform Your Doctor About the Use of Medicines Containing Valproic Acid or Sodium Valproate (Used to Treat Epilepsy, Bipolar Disorder, Migraine, or Schizophrenia), as Ertapenem Fresenius Kabi May Affect the Action of Some Medicines. Your Doctor Will Decide Whether to Use Ertapenem Fresenius Kabi with These Medicines.

Children and Adolescents (Aged 3 Months to 17 Years)

Experience with the Use of Ertapenem Fresenius Kabi in Children Under 2 Years of Age is Limited. Your Doctor Will Decide Whether to Use the Medicinal Product in this Age Group, Taking into Account the Expected Benefits. There is No Experience with the Use of Ertapenem Fresenius Kabi in Children Under 3 Months of Age.

Ertapenem Fresenius Kabi and Other Medicinal Products

Inform Your Doctor About All Medicines You are Currently Taking and Those You Plan to Take, Including Those Available Without a Prescription.
Inform Your Doctor, Nurse, or Pharmacist About the Use of Medicines Containing Valproic Acid or Sodium Valproate (Used to Treat Epilepsy, Bipolar Disorder, Migraine, or Schizophrenia), as Ertapenem Fresenius Kabi May Affect the Action of Some Medicines. Your Doctor Will Decide Whether to Use Ertapenem Fresenius Kabi with These Medicines.

Pregnancy and Breastfeeding

If You are Pregnant, Think You May be Pregnant, or Plan to Become Pregnant, Consult Your Doctor Before Using Ertapenem Fresenius Kabi.
No Studies Have Been Conducted on the Use of Ertapenem Fresenius Kabi in Pregnant Women. Ertapenem Fresenius Kabi Should Not be Used in Pregnant Women Unless the Doctor Considers the Expected Benefit to the Mother to be Greater than the Potential Risk to the Fetus.
It is Important for the Patient to Inform the Doctor if She is Breastfeeding or Plans to Breastfeed Before Starting Treatment with Ertapenem Fresenius Kabi.
Women Using Ertapenem Fresenius Kabi Should Not Breastfeed, as the Medicinal Product Passes into Breast Milk and May Have an Unfavorable Effect on the Baby.

Driving and Using Machines

Do Not Drive or Operate Machines Until You Know How Ertapenem Fresenius Kabi Affects You. During Treatment with Ertapenem Fresenius Kabi, Dizziness and Drowsiness Have Been Reported. These May Affect the Ability to Drive or Operate Machines.

Ertapenem Fresenius Kabi Contains Sodium

The Medicinal Product Contains 137 mg of Sodium (Main Component of Common Salt) per Vial, Which is 6.9% of the Maximum Recommended Daily Intake of Sodium in the Diet for Adults.

3. How to Use Ertapenem Fresenius Kabi

Ertapenem Fresenius Kabi is Always Prepared and Administered Intravenously by a Doctor or Other Qualified Medical Personnel.
The Recommended Dose of Ertapenem Fresenius Kabi for Adults and Adolescents Aged 13 Years and Older is 1 g Once a Day. The Recommended Dose for Children Aged 3 Months to 12 Years is 15 mg/kg Body Weight Twice a Day (Not Exceeding 1 g per Day). The Doctor Will Decide How Many Days to Use the Medicinal Product.
To Prevent Surgical Site Infections After Colorectal Surgery, the Recommended Dose of Ertapenem Fresenius Kabi is 1 g, Administered as a Single Intravenous Dose 1 Hour Before Surgery.
It is Very Important for the Patient to Receive Ertapenem Fresenius Kabi for as Long as the Doctor Prescribes.

Using More Than the Recommended Dose of Ertapenem Fresenius Kabi

If There is a Concern that a Higher Dose of Ertapenem Fresenius Kabi Than Recommended Has Been Used, Inform a Doctor or Other Qualified Medical Personnel Immediately.

Missing a Dose of Ertapenem Fresenius Kabi

If There is a Concern that a Dose of the Medicinal Product Has Been Missed, Inform a Doctor or Other Qualified Medical Personnel Immediately.

4. Possible Side Effects

Like All Medicinal Products, Ertapenem Fresenius Kabi Can Cause Side Effects, Although Not Everybody Gets Them.
Adult Patients Aged 18 Years and Older:
Since the Marketing Authorization of the Medicinal Product, Severe Allergic Reactions (Anaphylactic Reactions) and Hypersensitivity Syndromes (Allergic Reactions with Rash, Fever, Abnormal Blood Test Results) Have Been Reported. The First Symptoms of a Severe Allergic Reaction May Include Swelling of the Face and (or) Throat. In Case of Such Symptoms, Seek Medical Attention Immediately, as Immediate Medical Attention May be Required.
Common Side Effects (May Affect Up to 1 in 10 Patients):

• Headache;
• Diarrhea, Nausea, Vomiting;
• Rash, Itching;
• Vascular Disorders at the Injection Site (Including Phlebitis, Thrombophlebitis, Swelling at the Injection Site, or Exudation into the Tissues and Skin Around the Injection Site);
• Increased Platelet Count;
• Changes in Liver Function Test Results.

Uncommon Side Effects (May Affect Up to 1 in 100 Patients):

• Dizziness, Drowsiness, Insomnia, Confusion, Seizures;
• Low Blood Pressure, Slow Heart Rate;
• Shortness of Breath, Sore Throat;
• Constipation, Oral Candidiasis, Antibiotic-Associated Diarrhea, Gastroesophageal Reflux, Dry Mouth, Nausea;
• Redness of the Skin;
• Vaginal Discharge and Irritation;
• Abdominal Pain, Fatigue, Fungal Infection, Fever, Swelling and (or) Edema, Chest Pain, Taste Disorders;
• Changes in the Results of Some Blood and Urine Laboratory Tests.

Rare Side Effects (May Affect Up to 1 in 1000 Patients):

• Decreased White Blood Cell Count, Decreased Platelet Count;
• Low Blood Sugar;
• Agitation, Anxiety, Depression, Tremor;
• Heart Rhythm Disorders, High Blood Pressure, Bleeding, Rapid Heart Rate;
• Nasal Congestion, Cough, Nosebleeds, Pneumonia, Abnormal Breathing Sounds, Wheezing;
• Cholecystitis, Difficulty Swallowing, Incontinence, Jaundice, Liver Function Disorders;
• Skin Rash, Fungal Skin Infections, Skin Exfoliation, Surgical Wound Infections;
• Muscle Spasm, Shoulder Pain;
• Urinary Tract Infections, Kidney Function Disorders;
• Miscarriage, Genital Bleeding;
• Allergy, General Malaise, Pelvic Peritonitis, Changes in the Cornea, Fainting;
• The Skin at the Injection Site May Become Hard;
• Vasculitis.

Frequency Not Known (Frequency Cannot be Estimated from the Available Data):

• Hallucinations;
• Changes in Mental Status (Including Aggressive Behavior, Delirium, Disorientation, Other Mental Changes);
• Abnormal Movements;
• Muscle Weakness;
• Unstable Gait;
• Tooth Discoloration.

There Have Also Been Reports of Changes in the Results of Some Blood Laboratory Tests.
In Case of Bulging or Fluid-Filled Spots on a Large Area of the Body, Inform a Doctor or Nurse Immediately.
Children and Adolescents (Aged 3 Months to 17 Years):
Common Side Effects (May Affect Up to 1 in 10 Patients):

• Diarrhea;
• Diaper Rash;
• Pain at the Infusion Site;
• Changes in White Blood Cell Count;
• Changes in Liver Function Test Results.

Uncommon Side Effects (May Affect Up to 1 in 100 Patients):

• Headache;
• Flushing, High Blood Pressure, Red or Purple, Flat, Tiny Spots on the Skin;
• Stools of Changed Color, Tarry Stools;
• Redness of the Skin, Skin Rash;
• Burning, Itching, Redness, and Heat at the Infusion Site, Redness at the Injection Site;
• Increased Platelet Count;
• Changes in the Results of Some Blood Laboratory Tests.

Frequency Not Known (Frequency Cannot be Estimated from the Available Data):

• Hallucinations;
• Changes in Mental Status (Including Aggressive Behavior).

Reporting Side Effects

If You Experience Any Side Effects, Including Those Not Listed in this Package Leaflet, Inform a Doctor, Pharmacist, or Nurse. Side Effects Can be Reported Directly to the Department of Drug Safety Monitoring 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.
Reporting Side Effects Will Help to Gather More Information on the Safety of the Medicinal Product.

5. How to Store Ertapenem Fresenius Kabi

Keep the Medicinal Product Out of Sight and Reach of Children.
Do Not Use the Medicinal Product After the Expiration Date Stated on the Vial After: EXP. The Expiration Date Refers to the Last Day of the Month Stated.
Do Not Store Above 25°C.
After Reconstitution
The Solution Should be Used Immediately.
After Dilution
Chemical and Physical Stability of the Solutions After Dilution (Approximately 20 mg/ml) Has Been Demonstrated for 6 Hours at 25°C or for 24 Hours at a Temperature of 2 to 8°C (Stored in a Refrigerator). After Removal from the Refrigerator, the Solution Should be Administered No Later than 4 Hours Later. Solutions of Ertapenem Fresenius Kabi Should Not be Frozen.
For Microbiological Reasons, the Medicinal Product Should be Used Immediately. If the Medicinal Product is Not Used Immediately, the User is Responsible for the Storage Conditions Prior to Administration. The Storage Period Should Not Exceed 24 Hours at a Temperature of 2 to 8°C, Unless Reconstitution and Dilution Were Carried Out Under Controlled and Validated Aseptic Conditions.
Do Not Administer the Solution if You Notice Particles or a Change in Color.
Medicines Should Not be Disposed of via Wastewater or Household Waste. Ask a Pharmacist How to Dispose of Medicines That are No Longer Needed. This Will Help Protect the Environment.

6. Contents of the Package and Other Information

What Ertapenem Fresenius Kabi Contains

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The Active Substance of the Medicinal Product is Ertapenem (in the Form of Ertapenem Sodium).
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The Other Ingredients are Sodium Hydrogen Carbonate, Sodium Hydroxide.

What Ertapenem Fresenius Kabi Looks Like and Contents of the Package

Ertapenem Fresenius Kabi is a White to Yellowish, Freeze-Dried Powder for Solution for Infusion.
The Solution of Ertapenem Fresenius Kabi is Colorless to Light Yellow. A Change in Color Within the Specified Range Does Not Affect the Action of the Medicinal Product.
The Package Contains 10 Vials of 1g Each.
Not All Pack Sizes May be Marketed.

Marketing Authorization Holder

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

Manufacturer

ACS Dobfar S.p.A.
Nucleo Industriale S. Atto

• S. Nicolò a Tordino 64100 TERAMO Italy

For More Detailed Information on this Medicinal Product, 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 Medicinal Product is Authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) Under the Following Names:

Austria, Germany
Ertapenem Fresenius Kabi 1 g Powder for Concentrate for Solution for Infusion
Czech Republic
Ertapenem Fresenius Kabi 1g Powder for Concentrate for Solution for Infusion
Croatia, Denmark, Estonia
Finland, Italy,
Norway, Poland,
Portugal, Sweden
Ertapenem Fresenius Kabi
France
Ertapenem Fresenius Kabi 1 g, Powder for Solution to be Diluted for Infusion
Netherlands
Ertapenem Fresenius Kabi 1 g, Powder for Concentrate for Solution for Infusion
Romania
Ertapenem Fresenius Kabi 1 g Powder for Concentrate for Solution for Infusion
Slovenia
Ertapenem Fresenius Kabi 1 g Powder for Concentrate for Solution for Infusion
Slovakia
Ertapenem Fresenius Kabi 1 g
Spain
Ertapenem Fresenius Kabi 1 g Powder for Concentrate for Solution for Infusion EFG
United Kingdom
(Northern Ireland)
Ertapenem 1g Powder for Concentrate for Solution for Infusion
Date of Last Revision of the Package Leaflet:27.07.2022
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Information Intended for Healthcare Professionals Only:

Instructions for Reconstitution and Dilution of Ertapenem Fresenius Kabi:

After Reconstitution
The Solution Should be Used Immediately.
After Dilution
Chemical and Physical Stability of the Solutions After Dilution (Approximately 20 mg/ml) Has Been Demonstrated for 6 Hours at 25°C or for 24 Hours at a Temperature of 2 to 8°C (Stored in a Refrigerator). After Removal from the Refrigerator, the Solution Should be Administered No Later than 4 Hours Later. Solutions of Ertapenem Fresenius Kabi Should Not be Frozen.
For Microbiological Reasons, the Medicinal Product Should be Used Immediately. If the Medicinal Product is Not Used Immediately, the User is Responsible for the Storage Conditions Prior to Administration. The Storage Period Should Not Exceed 24 Hours at a Temperature of 2 to 8°C, Unless Reconstitution and Dilution Were Carried Out Under Controlled and Validated Aseptic Conditions.
For Single Use Only.
The Solution After Reconstitution Should be Diluted with a Solution of Sodium Chloride 9 mg/ml (0.9%) Immediately After Preparation.
Preparation of the Solution for Intravenous Administration:
Before Administering Ertapenem Fresenius Kabi, Reconstitute and Then Dilute.

Adult Patients and Adolescents (Aged 13 to 17 Years)

Reconstitution
The Contents of the Vial Containing 1 g of Ertapenem Fresenius Kabi Should be Reconstituted in 10 ml of Water for Injections or Sodium Chloride 9 mg/ml (0.9%) Solution to Obtain a Concentrate of Approximately 100 mg/ml. Shake Well to Ensure Complete Dissolution of the Powder (See Section 6.4 SmPC).
Dilution
Bags Containing 50 ml of Diluent
To Obtain a Dose of 1 g, Immediately Transfer the Contents of the Vial After Reconstitution to a Bag Containing 50 ml of Sodium Chloride 9 mg/ml (0.9%) Solution
or
Vials Containing 50 ml of Diluent
To Obtain a Dose of 1 g, Remove 10 ml from a 50 ml Vial Containing Sodium Chloride 9 mg/ml (0.9%) Solution. Transfer the Contents of the Vial Containing 1 g of Ertapenem Fresenius Kabi After Reconstitution to a 50 ml Vial Containing Sodium Chloride 9 mg/ml (0.9%) Solution.
Infusion
Administer Over 30 Minutes.

Children (Aged 3 Months to 12 Years)

Reconstitution
The Contents of the Vial Containing 1 g of Ertapenem Fresenius Kabi Should be Reconstituted in 10 ml of Water for Injections or Sodium Chloride 9 mg/ml (0.9%) Solution to Obtain a Concentrate of Approximately 100 mg/ml. Shake Well to Ensure Complete Dissolution of the Powder.
Dilution
Bags Containing Diluent
To Obtain a Final Concentration of 20 mg/ml or Less, Transfer the Volume Equivalent to 15 mg/kg Body Weight (Not Exceeding 1 g per Day) to a Bag Containing Sodium Chloride 9 mg/ml (0.9%) Solution
or
Vials Containing Diluent
To Obtain a Final Concentration of 20 mg/ml or Less, Transfer the Volume Equivalent to 15 mg/kg Body Weight (Not Exceeding 1 g per Day) to a Vial Containing Sodium Chloride 9 mg/ml (0.9%) Solution.
Infusion
Administer Over 30 Minutes.
Ertapenem Fresenius Kabi Has Been Shown to be Compatible with Solutions for Intravenous Infusion Containing Sodium Heparin and Potassium Chloride.
Inspect the Solutions Obtained After Reconstitution, as Far as the Packaging Allows, for Particles or Changes in Color. The Solution of Ertapenem Fresenius Kabi Should be Colorless or Light Yellow. A Change in Color Within the Specified Range Does Not Affect the Action of the Medicinal Product.
Any Unused Residue of the Medicinal Product or Waste Material Should be Disposed of in Accordance with Local Regulations.