Ertapenem eugia

Package leaflet: Information for the user

Ertapenem Eugia, 1 g, powder for solution for infusion
Ertapenemum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, nurse, or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, nurse, or pharmacist. See section 4.

Leaflet contents:

1. What Ertapenem Eugia is and what it is used for
2. Important information before using Ertapenem Eugia
3. How to use 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, an antibiotic belonging to the beta-lactam group. It is a medicine
that kills a wide range of bacteria (microorganisms) causing infections in various parts of the body.
Ertapenem Eugia can be administered to individuals aged 3 months and older.

Treatment:
Your doctor has prescribed Ertapenem Eugia because they have diagnosed you or your child with at least one of the following infections:

• Intra-abdominal infection,
• Lung infection (pneumonia),
• Gynecological infection,
• Diabetic foot infections.

Prophylaxis:
Prevention of surgical site infection in adults following surgery of the colon or rectum.

2. Important information before using Ertapenem Eugia

When not to use Ertapenem Eugia:
if the patient is allergic to the active substance (ertapenem) or to any of the other
components of this medicine (listed in section 6);
if the patient is allergic to antibiotics such as penicillins, cephalosporins or carbapenems
(used to treat various types of infections).

Warnings and precautions
Before starting treatment with Ertapenem Eugia, discuss it 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 immediate medical advice,
as immediate medical intervention may be necessary.
Although antibiotics such as Ertapenem Eugia kill certain types of bacteria, other bacteria and
fungi may overgrow. This phenomenon is known as overgrowth. Your doctor will monitor you and, if necessary, initiate appropriate treatment.
If diarrhoea develops during or after treatment with Ertapenem Eugia, inform your doctor immediately, as this may indicate a condition called colitis (inflammation of the large intestine).
Do not take any anti-diarrhoeal medicines before consulting your doctor.
Inform your doctor if you are taking valproic acid or sodium valproate (see below: Ertapenem Eugia and other medicines).
Inform your doctor about any past or current medical conditions, including:

• kidney problems. It is especially important to inform your doctor about existing kidney disease or if you are undergoing dialysis;
• allergies to any medicines, including antibiotics;
• disorders of the central nervous system, such as myoclonus or seizures.

Children and adolescents (aged 3 months to 17 years)
Experience with the use of Ertapenem Eugia in children under two years of age is
limited. The doctor will decide whether to use the medicine in this age group, weighing the expected benefits. There is no experience with the use of Ertapenem Eugia in children under 3 months of age.

Ertapenem Eugia and other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as
well as any medicines you plan to take.
Inform your doctor, nurse, or pharmacist if you are taking valproic acid or sodium valproate (used to treat epilepsy, bipolar disorder, migraine, or schizophrenia), because Ertapenem Eugia may affect the way some other medicines work. Your doctor will decide whether Ertapenem Eugia should be used together with these medicines.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should inform her doctor before using Ertapenem Eugia.
Studies on the use of Ertapenem Eugia in pregnant women have not been conducted. Ertapenem Eugia should not be used during pregnancy unless the physician considers that the expected benefit justifies the potential risk to the fetus.
Women receiving Ertapenem Eugia should not breastfeed, as the medicine passes into human milk and may have adverse effects on the breastfed infant.

Driving and operating machinery
Do not drive or operate machinery until you know how this medicine affects you.
Dizziness and somnolence have been reported during treatment with Ertapenem Eugia. These may affect the ability to drive and operate machinery.

Ertapenem Eugia contains sodium
This medicine contains approximately 137 mg of sodium (the main component of table salt) per vial.
This corresponds to 6.85% of the recommended maximum daily sodium intake for an adult.

3. How to use Ertapenem Eugia

Ertapenem Eugia must always be prepared and administered intravenously by a physician or
another qualified healthcare professional.
The recommended dose of Ertapenem Eugia in adults and adolescents aged 13 years and older is 1 gram
(g) once daily. The recommended dose in children aged 3 months to 12 years is 15 mg/kg body weight, given twice
daily (do not exceed 1 g per day). The duration of treatment will be determined by the physician.
To prevent surgical site infections following colorectal or rectal surgery, the recommended dose of Ertapenem Eugia is 1 g, administered as a single intravenous dose 1 hour before surgery.
It is very important that the patient receives Ertapenem Eugia for as long as the physician has prescribed.
Administration of a higher than recommended dose of Ertapenem Eugia
If there is concern that a higher than recommended dose of Ertapenem Eugia has been administered, immediately inform the physician or another qualified healthcare professional.
Missed administration of Ertapenem Eugia
If there is concern that a dose has been missed, immediately inform the physician or another qualified healthcare professional.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Adults aged 18 years and older:
Since the medicine was introduced to the market, severe allergic reactions (anaphylactic reactions) and hypersensitivity syndromes (allergic reactions presenting with rash, fever, and abnormal blood test results) have been reported. Initial symptoms of a severe allergic reaction may include swelling of the face and (or) throat. If such symptoms occur, seek medical advice immediately, as immediate medical intervention may be required.

The following adverse reactions are common (may occur in up to 1 in 10 people):

• Headache
• Diarrhoea, nausea, vomiting
• Rash, itching
• Complications at the vein where the medicine was administered (including inflammation, nodule formation, swelling at the injection site, or leakage of fluid into surrounding tissues and skin around the injection site)
• Increased platelet count
• Changes in liver function test results.

The following adverse reactions are uncommon (may occur in up to 1 in 100 people):

• Dizziness, drowsiness, insomnia, confusion, seizure
• Low blood pressure, slowed heart rate
• Shortness of breath, sore throat
• Constipation, oral fungal infections, antibiotic-associated diarrhoea, gastroesophageal reflux, dry mouth, indigestion, loss of appetite
• Skin redness
• Vaginal discharge and irritation
• Abdominal pain, fatigue, fungal infection, fever, swelling/edema, chest pain, taste disturbances
• Changes in certain blood and urine laboratory test results.

The following adverse reactions are rare (may occur in up to 1 in 1,000 people):

• Decreased white blood cell count, decreased platelet count
• Low blood glucose levels
• Restlessness, anxiety, depression, tremor
• Heart rhythm disorders, elevated arterial blood pressure, bleeding, increased heart rate
• Nasal mucosal congestion, cough, nosebleeds, pneumonia, abnormal breath sounds, wheezing
• Gallbladder inflammation, difficulty swallowing, faecal incontinence, jaundice, liver function disorders
• Skin inflammation, fungal skin infections, skin peeling, postoperative wound infections
• Muscle spasms, shoulder pain
• Urinary tract infections, kidney function disorders
• Miscarriage, genital bleeding
• Hypersensitivity, general malaise, pelvic peritonitis, changes in the sclera of the eye, fainting
• Skin at the injection site may become hardened
• Skin blood vessel swelling.

The following adverse reactions have been reported with unknown frequency (cannot be estimated from available data):

• Hallucinations
• Disorders of consciousness
• Mental status changes (including aggressive behaviour, delirium, disorientation, other mental changes)
• Abnormal movements
• Muscle weakness
• Unsteady gait
• Tooth discoloration.

Cases of changes in certain blood laboratory test results have also been reported.

If raised or fluid-filled spots appear over a large area of the body, inform your doctor or nurse immediately.

Children and adolescents (aged 3 months to 17 years):
The following adverse reactions are common (may occur in up to 1 in 10 people):

• Diarrhoea
• Diaper dermatitis
• Pain at the infusion site
• Changes in white blood cell count
• Changes in liver function test results.

The following adverse reactions are uncommon (may occur in up to 1 in 100 people):

• Headache
• Flushing, high blood pressure; red or purple flat, tiny subcutaneous spots
• Altered stool colour, tarry stools
• Skin redness, skin rash
• Burning, itching, redness, and warmth at the infusion site, redness at the injection site
• Increased platelet count
• Changes in certain blood laboratory test results.

The following adverse reactions have been reported with unknown frequency (cannot be estimated from available data):

• Hallucinations
• Mental status changes (including aggressive behaviour).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, nurse, or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, telephone: +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's representative.

Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Ertapenem Eugia

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after EXP.
The expiry date refers to the last day of the stated month.
Do not store above 30°C.
After reconstitution:
Chemical and physical stability of reconstituted solutions has been demonstrated for 6 hours at
15–25°C or for 24 hours at 2–8°C (in a refrigerator). Solutions should be used within 4 hours after
removal from the refrigerator. Do not freeze Ertapenem Eugia solutions.
From a microbiological point of view, unless the method of opening excludes the risk of microbiological
contamination, the product should be used immediately. If the product is not used immediately, the
user is responsible for the storage duration and conditions.
Do not use this medicine if the patient observes any solid particles or discoloration (other than
colorless or pale yellow) before administration.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. Such measures will help protect the environment.

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.
Other components of the medicine are: sodium hydrogen carbonate, sodium hydroxide used to adjust pH to 7.6, and sodium hydroxide used as a buffering agent.

What Ertapenem Eugia looks like and contents of the pack
Ertapenem Eugia is a white or almost white powder for solution concentrate for infusion.
The solution of ertapenem ranges in colour from colourless to pale yellow. Variations in colour within this range do not affect the efficacy of the medicine.
The vial is made of colourless glass (type I), with a bromobutyl rubber stopper, aluminium seal and polypropylene cap, packed 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 Authorisation 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 medicinal product is authorised in 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

The following information is intended solely for medical or healthcare personnel:

Instructions for reconstitution and dilution of Ertapenem Eugia:
For single use only.
Preparation for intravenous administration:
Ertapenem must be dissolved and then diluted prior to administration.
Needle insertion into the rubber stopper:
To avoid coring of the stopper, when inserting the needle into the rubber stopper for dissolving the product, it is recommended to use a needle with a diameter of 21 gauge or smaller.
The needle should be inserted only into the center of the rubber stopper, vertically.

Adults and adolescents (aged 13 to 17 years)
Dissolution
The contents of a vial containing 1 g of Ertapenem Eugia should be dissolved in 10 ml of Water for Injections or 9 mg/ml (0.9%) sodium chloride solution to obtain a concentrate of approximately 100 mg/ml. Shake well to ensure complete dissolution of the powder (see section 6.4).

Dilution
Bags containing 50 ml of diluent: To obtain a 1 g dose, immediately transfer the dissolved contents of the vial into a bag containing 50 ml of 9 mg/ml (0.9%) sodium chloride solution; or
Vials containing 50 ml of diluent: To obtain a 1 g dose, remove 10 ml from a 50 ml vial containing 9 mg/ml (0.9%) sodium chloride solution. Transfer the dissolved contents of the vial containing 1 g of Ertapenem Eugia into the 50 ml vial containing 9 mg/ml (0.9%) sodium chloride solution.

Infusion
Administer by 30-minute infusion.

Children (aged 3 months to 12 years)
Dissolution
The contents of a vial containing 1 g of Ertapenem Eugia should be dissolved in 10 ml of Water for Injections or 9 mg/ml (0.9%) sodium chloride solution to obtain a concentrate of approximately 100 mg/ml. Shake well to ensure complete dissolution.

Dilution
Diluent bag: To achieve a final concentration of 20 mg/ml or less, transfer a volume equivalent to 15 mg/kg body weight (not exceeding 1 g per day) into a bag containing 9 mg/ml (0.9%) sodium chloride solution; or
Diluent vial: To achieve a final concentration of 20 mg/ml or less, transfer a volume equivalent to 15 mg/kg body weight (not exceeding 1 g per day) into a vial containing 9 mg/ml (0.9%) sodium chloride solution.

Infusion
Administer by 30-minute infusion.

After reconstitution:
Reconstituted solutions should be used immediately.

After dilution:
Chemical and physical stability of diluted solutions has been demonstrated for 6 hours at controlled room temperature of 15–25°C or for 24 hours at 2–8°C (refrigerated). Diluted solutions should be used within 4 hours after removal from the refrigerator. Do not freeze reconstituted solutions.

From a microbiological standpoint, unless the method of opening excludes the risk of microbiological contamination, the product should be used immediately. If the product is not used immediately, the responsibility for storage conditions and duration lies with the user.

Reconstituted solutions should be inspected visually for particulate matter and discoloration, as far as the container allows. Ertapenem solutions may range in color from colorless to pale yellow. Color variations within this range do not affect the potency of the drug.

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