Ertapenem Eugia

Package Leaflet: Information for the User

Ertapenem Eugia, 1 g, Powder for Concentrate for Solution for Infusion

Ertapenem

Read all of this leaflet carefully before taking 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.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• 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 Pack:

• 1. What Ertapenem Eugia is and what it is used for
• 2. Before you take Ertapenem Eugia
• 3. How to take Ertapenem Eugia
• 4. Possible side effects
• 5. How to store Ertapenem Eugia
• 6. Contents of the pack and other information

1. What Ertapenem Eugia is and what it is used for

Ertapenem Eugia contains ertapenem, which is an antibiotic belonging to the beta-lactam group. It works by killing bacteria that cause infections in different parts of the body.

Ertapenem Eugia can be given to adults and children from 3 months of age.

Treatment:

Your doctor has prescribed Ertapenem Eugia because you or your child have one or more of the following infections:

• intra-abdominal infection
• infection of the lungs (pneumonia)
• gynecological infection
• diabetic foot infection

Prevention:

Prevention of surgical site infection in adults following colorectal surgery.

2. Before you take Ertapenem Eugia

When not to use Ertapenem Eugia:

if you are allergic to the active substance (ertapenem) or any of the other ingredients of this medicine

if you are allergic to antibiotics such as penicillins, cephalosporins, or carbapenems

Warnings and precautions:

Before taking Ertapenem Eugia, tell your doctor, pharmacist, or nurse if:

you have ever had an allergic reaction to any antibiotic

you have kidney problems

you have a history of seizures

you are taking other medicines, including valproic acid or sodium valproate

Children and adolescents (from 3 months to 17 years):

Experience with Ertapenem Eugia in children under 2 years of age is limited. Your doctor will decide whether to use this medicine in this age group.

Ertapenem Eugia with other medicines:

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding:

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

Driving and using machines:

Ertapenem Eugia may cause dizziness or sleepiness. Do not drive or operate machinery until you know how this medicine affects you.

Ertapenem Eugia contains sodium:

This medicine contains 137 mg of sodium per vial, which is approximately 6.85% of the maximum recommended daily intake of sodium for an adult.

3. How to take Ertapenem Eugia

Ertapenem Eugia should always be prepared and administered by a doctor or other qualified healthcare professional.

The recommended dose of Ertapenem Eugia for adults and adolescents from 13 to 17 years is 1 gram once daily.

• For children from 3 months to 12 years, the recommended dose is 15 mg/kg body weight twice daily (do not exceed 1 gram per day).

It is very important that you receive Ertapenem Eugia for as long as your doctor has prescribed it.

If you take more Ertapenem Eugia than you should:

If you think you have been given too much Ertapenem Eugia, tell your doctor or other qualified healthcare professional immediately.

If you miss a dose of Ertapenem Eugia:

If you think you have missed a dose of Ertapenem Eugia, tell your doctor or other qualified healthcare professional immediately.

4. Possible side effects

Like all medicines, Ertapenem Eugia can cause side effects, although not everybody gets them.

Adults (18 years and older):

Severe allergic reactions (anaphylaxis) and hypersensitivity reactions (allergic reactions with rash, fever, and abnormal blood test results) have been reported.

Common (may affect up to 1 in 10 people):

• headache
• diarrhea, nausea, vomiting
• rash, itching
• injection site reactions (including inflammation, lump, swelling, or leakage of fluid at the injection site)
• increased platelet count
• abnormal liver function test results

Uncommon (may affect up to 1 in 100 people):

• dizziness, sleepiness, insomnia, confusion, seizures
• low blood pressure, slow heart rate
• shortness of breath, sore throat
• constipation, oral thrush, antibiotic-associated diarrhea, acid reflux, dry mouth, indigestion, loss of appetite
• redness of the skin
• vaginal discharge or irritation
• abdominal pain, fatigue, fungal infection, fever, swelling, chest pain, taste disturbances
• abnormal results of some blood and urine tests

Rare (may affect up to 1 in 1,000 people):

• low white blood cell count, low platelet count
• low blood sugar
• agitation, anxiety, depression, tremors
• abnormal heart rhythm, high blood pressure, bleeding, fast heart rate
• nasal congestion, cough, nosebleed, pneumonia, abnormal breathing sounds, wheezing
• gallbladder inflammation, difficulty swallowing, fecal incontinence, jaundice, liver function disturbances
• skin inflammation, skin fungal infections, skin peeling, surgical wound infections
• muscle spasms, shoulder pain
• urinary tract infection, kidney function disturbances
• miscarriage, vaginal bleeding
• allergic reactions, general feeling of being unwell, pelvic inflammatory disease, changes in the white part of the eye, fainting
• hardening of the skin at the injection site
• swelling of blood vessels in the skin

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

• hallucinations
• changes in mental status (including aggressive behavior, hallucinations, disorientation, and other mental changes)
• abnormal movements
• muscle weakness
• unsteady gait
• tooth discoloration

Children and adolescents (from 3 months to 17 years):

Common (may affect up to 1 in 10 people):

• diarrhea
• diaper rash
• injection site pain
• changes in white blood cell count
• abnormal liver function test results

Uncommon (may affect up to 1 in 100 people):

• headache
• flushing, high blood pressure, red or purple flat small spots under the skin
• stool color changes, black stools
• redness of the skin, skin rash
• burning, itching, redness, and warmth at the injection site
• increased platelet count
• abnormal results of some blood tests

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

• hallucinations
• changes in mental status (including aggressive behavior)

Reporting of side effects:

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

5. How to store Ertapenem Eugia

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 carton and vial after EXP.

The expiry date refers to the last day of that month.

Do not store above 30°C.

After reconstitution:

The reconstituted solution should be used immediately.

After dilution:

Chemical and physical in-use stability has been demonstrated for 6 hours at controlled room temperature (15-25°C) or for 24 hours at refrigerated temperature (2-8°C). The solution should be used within 4 hours after removal from the refrigerator. Do not freeze the reconstituted solution.

From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Do not use this medicine if you notice any particles or discoloration (other than colorless or pale yellow).

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.

6. Contents of the pack and other information

What Ertapenem Eugia contains:

The active substance is ertapenem.

Each vial contains 1.0 g of ertapenem.

The other ingredients are sodium bicarbonate, sodium hydroxide (to adjust pH to 7.6), and sodium hydroxide (as a buffering agent).

What Ertapenem Eugia looks like and contents of the pack:

Ertapenem Eugia is a white or off-white powder for concentrate for solution for infusion.

The solution for infusion has a color ranging from colorless to pale yellow. Variations in color within this range do not affect the potency of the medicine.

Vials are made of colorless glass (type I), with a bromobutyl rubber stopper, an aluminum seal, and a polypropylene cap, in a cardboard box.

Ertapenem Eugia is available in packs containing 1 vial, 5 vials, or 10 vials.

Not all pack sizes may be marketed.

Marketing Authorization Holder:

Eugia Pharma (Malta) Ltd.

Vault 14, level 2

Valletta Waterfront

Floriana, FRN1914

Malta

e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.

HF 26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Generis Farmacêutica, S.A.

Rua João De Deus 19

2700-487 Amadora

Portugal

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic: Ertapenem Aurovitas

Italy: Ertapenem Aurobindo

France: Ertapenem Arrow 1 g, poudre pour solution à diluer pour perfusion

Portugal: Ertapenem Generis

Poland: Ertapenem Eugia

Romania: Ertapenem Aurobindo 1g pulbere pentru concentrate pentru solutie perfuzabila

Spain: Ertapenem Aurovitas 1 g polvo para concentrado para solución para perfusión

EFG

Date of last revision of the leaflet: 08/2024

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The following information is intended for medical or healthcare professionals only:

Instructions for reconstitution and dilution of Ertapenem Eugia:

For single use only.

Preparation for intravenous administration:

Ertapenem should be reconstituted and then diluted before administration.

Instructions for inserting the needle into the rubber stopper:

To avoid the formation of a core, when inserting the needle into the rubber stopper to reconstitute the product, it is recommended to use a needle of 21 gauge or smaller.

Insert the needle only in the center of the rubber stopper, in a perpendicular direction.

Adults and adolescents (13 to 17 years):

Reconstitution:

The contents of the vial containing 1 g of Ertapenem Eugia should be reconstituted with 10 mL of water for injection or 9 mg/mL (0.9%) sodium chloride solution to obtain a concentrate of approximately 100 mg/mL. Shake well to achieve complete dissolution of the powder.

Dilution:

Bags containing 50 mL of diluent: To obtain a dose of 1 g, immediately transfer the contents of the reconstituted vial to a bag containing 50 mL of 9 mg/mL (0.9%) sodium chloride solution; or

Vials containing 50 mL of diluent: To obtain a dose of 1 g, remove 10 mL from the 50 mL vial containing 9 mg/mL (0.9%) sodium chloride solution. Transfer the contents of the reconstituted vial containing 1 g of Ertapenem Eugia to the 50 mL vial containing 9 mg/mL (0.9%) sodium chloride solution.

Infusion:

Administer over 30 minutes.

Children (from 3 months to 12 years):

Reconstitution:

The contents of the vial containing 1 g of Ertapenem Eugia should be reconstituted with 10 mL of water for injection or 9 mg/mL (0.9%) sodium chloride solution to obtain a concentrate of approximately 100 mg/mL. Shake well to achieve 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 (do not exceed 1 g per day) to a bag containing 9 mg/mL (0.9%) sodium chloride 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 (do not exceed 1 g per day) to a vial containing 9 mg/mL (0.9%) sodium chloride solution.

Infusion:

Administer over 30 minutes.

After reconstitution:

The reconstituted solutions should be used immediately.

After dilution:

Chemical and physical in-use stability has been demonstrated for 6 hours at controlled room temperature (15-25°C) or for 24 hours at refrigerated temperature (2-8°C). The solutions should be used within 4 hours after removal from the refrigerator. Do not freeze the reconstituted solutions.

From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Before administration, the reconstituted solutions should be inspected for particles or discoloration (other than colorless or pale yellow), if possible, given the container. Ertapenem solutions may have a color ranging from colorless to pale yellow. Variations in color within this range do not affect the potency of the medicine.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.