Ertapenem Aptapharma

Package Leaflet: Information for the User

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

Ertapenem

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package 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 symptoms 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 Package Leaflet

• 1. What Ertapenem AptaPharma is and what it is used for
• 2. Important information before using Ertapenem AptaPharma
• 3. How to use Ertapenem AptaPharma
• 4. Possible side effects
• 5. How to store Ertapenem AptaPharma
• 6. Contents of the pack and other information

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

Ertapenem AptaPharma contains ertapenem, which is an antibiotic belonging to the beta-lactam group. It is a bactericidal drug that acts on many types of bacteria (microorganisms) that cause infections in different parts of the body.
Ertapenem AptaPharma can be administered to patients aged 3 months and older.
Treatment:
Your doctor has prescribed Ertapenem AptaPharma because he has diagnosed at least one of the following infections in you or your child:

• intra-abdominal infection;
• infection of the lungs (pneumonia);
• gynecological infection;
• skin and skin structure infections in patients with diabetes.

Prevention:

• of surgical site infections in adult patients undergoing surgery of the colon or rectum.

2. Important information before using Ertapenem AptaPharma

When not to use Ertapenem AptaPharma

• if you are allergic to the active substance (ertapenem) or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to antibiotics such as penicillins, cephalosporins, or carbapenems (used to treat various types of infections).

Warnings and precautions

Before starting treatment with Ertapenem AptaPharma, 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 medical attention immediately, as immediate medical attention may be required.
Although antibiotics like Ertapenem AptaPharma kill some types of bacteria, other bacteria and fungi may continue to overgrow. This phenomenon is called superinfection. Your doctor will monitor you and treat if necessary.
If diarrhea occurs before, during, or after treatment with Ertapenem AptaPharma, be sure to inform your doctor, as this may indicate the presence of a condition called colitis (inflammation of the large intestine). Before consulting your doctor, do not take any anti-diarrheal medications.
Tell your doctor if you are taking medications containing valproic acid or sodium valproate (see below: Ertapenem AptaPharma and other medicines).
Tell your doctor about any previous illnesses and current complaints, including:

• kidney disease. It is especially important to inform your doctor about existing kidney disease or dialysis therapy;
• allergies to any medications, including antibiotics;
• central nervous system disorders, such as partial seizures or convulsions.

Children and adolescents (from 3 months to 17 years)

Experience with the use of Ertapenem AptaPharma in children under 2 years of age is limited. The doctor, considering the expected benefits, will decide whether to use the medicine in this age group. There is no experience with the use of the medicine in children under 3 months of age.

Ertapenem AptaPharma and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Tell your doctor, nurse, or pharmacist if you are taking medications containing valproic acid or sodium valproate (used to treat epilepsy, bipolar affective disorder, migraine, or schizophrenia), as Ertapenem AptaPharma may affect the way some other medicines work. Your doctor will decide whether to use Ertapenem AptaPharma with these medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using Ertapenem AptaPharma.
No studies have been conducted on the use of Ertapenem AptaPharma in pregnant women. Ertapenem AptaPharma should not be used in pregnant women unless the doctor considers that the expected benefits outweigh the potential risk to the fetus.
It is important that you inform your doctor before starting treatment with Ertapenem AptaPharma if you are breastfeeding or plan to breastfeed.
Women taking Ertapenem AptaPharma should not breastfeed, as the medicine passes into breast milk and may have an adverse effect on the baby.

Driving and using machines

Do not drive or operate machinery until you know how Ertapenem AptaPharma affects you.
During treatment with Ertapenem AptaPharma, dizziness and drowsiness have been reported. They may affect your ability to drive or operate machinery.

Ertapenem AptaPharma contains sodium

The medicine contains approximately 137 mg of sodium (the main component of common salt) per 1 g dose.
This corresponds to 7% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Ertapenem AptaPharma

Ertapenem AptaPharma should always be prepared and administered intravenously by a doctor or other qualified medical personnel.
The recommended dose of Ertapenem AptaPharma for adults and adolescents aged 13 years and older is 1 g once daily. The recommended dose for children aged 3 months to 12 years is 15 mg/kg body weight, administered twice daily (do not exceed 1 g per day). Your doctor will decide how many days you should use the medicine.
To prevent surgical site infections after surgery of the colon or rectum, the recommended dose of Ertapenem AptaPharma is 1 g, administered as a single intravenous dose 1 hour before surgery.
It is very important that you receive Ertapenem AptaPharma for as long as your doctor has prescribed.

Using more than the recommended dose of Ertapenem AptaPharma

If you think you have used more than the recommended dose of Ertapenem AptaPharma, tell your doctor or other qualified medical personnel immediately.

Missing a dose of Ertapenem AptaPharma

If you think you have missed a dose of Ertapenem AptaPharma, tell your doctor or other qualified medical personnel immediately.

4. Possible side effects

Like all medicines, Ertapenem AptaPharma can cause side effects, although not everybody gets them.
Adults aged 18 years and older:
Since the marketing authorization of the medicine, 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. If you experience such symptoms, seek medical attention immediately, as immediate medical attention may be required.
Common (may affect up to 1 in 10 people):

• headache;
• diarrhea, nausea, vomiting;
• rash, itching;
• complications at the injection site (including inflammation, lump formation, swelling at the injection site, or fluid leakage into tissues and skin around the injection site);
• increased platelet count;
• changes in liver function test results.

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

• dizziness, drowsiness, insomnia, confusion, seizures;
• low blood pressure, slow heart rate;
• shortness of breath, throat pain;
• constipation, oral thrush, antibiotic-associated diarrhea, acid reflux, dry mouth, nausea, loss of appetite;
• skin redness;
• vaginal discharge and irritation;
• abdominal pain, fatigue, fungal infection, fever, swelling and/or edema, chest pain, taste disturbances;
• changes in some blood and urine test results.

Rare (may affect up to 1 in 1000 people):

• decreased white blood cell count, decreased platelet count;
• low blood glucose;
• agitation, anxiety, depression, tremors;
• heart rhythm disorders, high blood pressure, bleeding, rapid heart rate;
• nasal congestion, cough, nosebleeds, pneumonia, abnormal breathing sounds, wheezing;
• gallbladder inflammation, difficulty swallowing, fecal incontinence, jaundice, liver function disorders;
• skin inflammation, skin fungal infections, skin peeling, surgical wound infections;
• muscle cramps, shoulder pain;
• urinary tract infections, kidney function disorders;
• miscarriage, genital bleeding;
• allergy, general malaise, pelvic inflammatory disease, changes in the white part of the eye, fainting;
• the skin at the injection site may become hard;
• blood vessel swelling in the skin.

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

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

There have also been reports of changes in some blood test results.
If you experience a rash or blisters with fluid on the skin over a large area, seek medical attention immediately.
Children and adolescents (from 3 months to 17 years):
Common (may affect up to 1 in 10 people):

• diarrhea;
• diaper rash;
• pain at the infusion site;
• changes in white blood cell count;
• changes in liver function test results.

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

• headache;
• flushing, high blood pressure, red or purple, flat, small spots on the skin;
• stool color changes, black stools;
• skin redness, skin rash;
• burning, itching, redness, and warmth at the infusion site, redness at the injection site;
• increased platelet count;
• changes in some blood test results.

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 leaflet, tell your 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:
Jerozolimskie Avenue 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 medicine.

5. How to store Ertapenem AptaPharma

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of the month.
Do not store above 25°C.
After reconstitution: The reconstituted solution should be used immediately.
After dilution: The chemical and physical stability of ertapenem solutions after dilution (approximately 20 mg/mL) has been demonstrated for 6 hours at 25°C or for 24 hours at 2-8°C (in the refrigerator). After removal from the refrigerator, the solution should be used within 4 hours. Ertapenem AptaPharma solutions should not be frozen.
From a microbiological point of view, the medicine should be used immediately, unless the reconstitution and dilution method precludes the risk of microbial contamination. If the medicine is not used immediately, the user is responsible for the storage conditions prior to administration.
Do not use this medicine if the reconstituted solutions contain particles or discoloration.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Ertapenem AptaPharma contains

The active substance of Ertapenem AptaPharma is 1g ertapenem.
The other ingredients are: sodium bicarbonate, sodium hydroxide.

What Ertapenem AptaPharma looks like and contents of the pack

Ertapenem AptaPharma is a white to yellowish, lyophilized powder for concentrate for solution for infusion.
The solution of Ertapenem AptaPharma is colorless to light yellow. The change in color within the specified range does not affect the efficacy of the medicine.
Ertapenem AptaPharma is available in packs containing 10 vials.

Marketing authorization holder

Apta Medica Internacional d.o.o.
Likozarjeva Ulica 6
1000 Ljubljana
Slovenia
Phone: 00386 51 615 015
e-mail: [email protected]

Manufacturer

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

• S. Nicolò a Tordino 64100 Teramo Italy

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

Date of last revision of the package leaflet: 11/2024

Information intended for healthcare professionals only:

Instructions for reconstitution and dilution of Ertapenem AptaPharma: For single use only.
Preparation of solution for intravenous administration

Before administering Ertapenem AptaPharma, it must be reconstituted and then diluted.

Adults and adolescents (from 13 to 17 years)
Reconstitution
The contents of the vial containing 1 g of Ertapenem AptaPharma should be reconstituted with 10 mL of water for injection or sodium chloride solution 9 mg/mL (0.9%) to obtain a concentrate with a concentration of approximately 100 mg/mL. Shake well to ensure 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 sodium chloride solution 9 mg/mL (0.9%); or
Vials containing 50 mL of diluent: To obtain a dose of 1 g, remove 10 mL from the 50 mL vial containing sodium chloride solution 9 mg/mL (0.9%). Transfer the contents of the vial containing 1 g of Ertapenem AptaPharma after reconstitution to the 50 mL vial containing sodium chloride solution 9 mg/mL (0.9%).
Infusion
Administer over 30 minutes.
Children (from 3 months to 12 years)
Reconstitution
The contents of the vial containing 1 g of Ertapenem AptaPharma should be reconstituted with 10 mL of water for injection or sodium chloride solution 9 mg/mL (0.9%) to obtain a concentrate with a concentration of approximately 100 mg/mL. Shake well to ensure complete dissolution of the powder.
Dilution
Bag 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 sodium chloride solution 9 mg/mL (0.9%); or
Vial 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 sodium chloride solution 9 mg/mL (0.9%).
Infusion
Administer over 30 minutes.
The reconstituted solution should be diluted with sodium chloride solution 9 mg/mL (0.9%) immediately after preparation. The resulting solution should be administered immediately after preparation.
If the solution is not administered immediately after preparation, the user is responsible for the storage conditions prior to administration. The infusion solution (approximately 20 mg/mL of ertapenem) remains physically and chemically stable for 6 hours at room temperature (25°C) or for 24 hours at 2-8°C (in the refrigerator). After removal from the refrigerator, the solution should be used within 4 hours. The reconstituted solution of Ertapenem AptaPharma should not be frozen.
Solutions after reconstitution, if the packaging allows, should be inspected for particles or discoloration before administration. The solution of Ertapenem AptaPharma should be colorless or light yellow. The change in color within the specified range does not affect the efficacy of the medicine.
Any unused medicine or waste material should be disposed of in accordance with local regulations.
Shelf life after reconstitution: The reconstituted solution should be used immediately.
Shelf life after dilution: The chemical and physical stability of ertapenem solutions after dilution (approximately 20 mg/mL) has been demonstrated for 6 hours at 25°C or for 24 hours at 2-8°C (in the refrigerator). After removal from the refrigerator, the solution should be used within 4 hours. Ertapenem AptaPharma solutions should not be frozen.
From a microbiological point of view, the medicine should be used immediately, unless the reconstitution and dilution method precludes the risk of microbial contamination. If the medicine is not used immediately, the user is responsible for the storage conditions prior to administration.