Ertapenem Aurovitas 1 g powder for concentrate for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ertapenem Aurovitas 1 g powder for concentrate for solution for infusion EFG

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Ertapenem Aurovitas contains ertapenem, which is an antibiotic belonging to the beta-lactam group. It has the ability to destroy a wide variety of bacteria (microorganisms) that cause infections in different parts of the body.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow your doctor's instructions regarding dosage, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of down the drain or in household waste.

Ertapenem can be administered to individuals aged 3 months and older.

Treatment:

Your doctor has prescribed ertapenem because you or your child has one (or more) of the following types of infection:

• Abdominal infection
• Lung infection (pneumonia)
• Gynecological infections
• Skin infections of the foot in diabetic patients

Prevention:

Prevention of surgical site infections in adults following colon or rectal surgery.

2. What you need to know before using Ertapenem Aurovitas

Do not use Ertapenem Aurovitas

• If you are allergic to the active substance (ertapenem) or to 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 infections).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Ertapenem Aurovitas.

If you experience an allergic reaction during treatment (such as swelling of the face, tongue, or throat, difficulty breathing or swallowing, or skin rash), inform your doctor immediately, as you may require urgent medical treatment.

Although antibiotics, including ertapenem, destroy certain bacteria, other bacteria and fungi may continue to grow excessively. This is known as bacterial overgrowth. Your doctor will monitor for bacterial overgrowth and treat it if necessary.

It is important that you inform your doctor if you develop diarrhea before, during, or after your treatment with ertapenem. This may be due to a condition known as colitis (inflammation of the intestine). Do not take any medication for diarrhea without first consulting your doctor.

Inform your doctor if you are taking medications called valproic acid or sodium valproate (see below Other medicines and Ertapenem Aurovitas).

Inform your doctor of any other medical conditions you currently have or have had, including:

• Kidney disease. It is especially important that your doctor knows if you have kidney disease and if you are receiving dialysis treatment.
• Allergies to any medicines, including antibiotics.
• Disorders of the central nervous system, such as localized tremors or seizures.

Children and adolescents (from 3 months to 17 years of age)

Experience with ertapenem in children under two years of age is limited. For this age group, your doctor will decide whether the potential benefit justifies its use. There is no experience with ertapenem in children under 3 months of age.

Other medicines and Ertapenem Aurovitas

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

Inform your doctor, pharmacist, or nurse if you are taking medications called valproic acid or sodium valproate (used to treat epilepsy, bipolar disorder, migraines, or schizophrenia). This is because ertapenem may affect how other medicines work. Your doctor will decide whether you should use ertapenem in combination with these medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Ertapenem has not been studied in pregnant women. Ertapenem should not be used during pregnancy unless your doctor decides that the potential benefit justifies the potential risk to the fetus.

Women receiving ertapenem should not breastfeed, as it has been detected in breast milk and may therefore affect the breastfed infant.

Driving and using machines

Do not drive or operate any tools or machinery until you know how this medicine affects you.

Certain adverse effects such as dizziness and somnolence have been reported with ertapenem, which may affect patients' ability to drive or use machines.

Ertapenem Aurovitas contains sodium

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

3. How to use Ertapenem Aurovitas

Ertapenem will always be prepared and administered intravenously (into a vein) by a doctor or other healthcare professional.

The recommended dose of ertapenem for adults and adolescents aged 13 years and older is 1 gram (g) given once daily. The recommended dose for children aged 3 months to 12 years is 15 mg/kg, given twice daily (without exceeding 1 g/day). Your doctor will decide how many days of treatment you need.

To prevent surgical site infections following colon or rectal surgery, the recommended dose of ertapenem is 1 g given as a single intravenous dose 1 hour before surgery.

It is very important that you continue receiving ertapenem for the full duration prescribed by your doctor.

If you use more Ertapenem Aurovitas than you should

If you are concerned that you may have received too much ertapenem, consult your doctor or other healthcare professional immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Ertapenem Aurovitas

If you are concerned that a dose has been missed, consult your doctor or other healthcare professional immediately.

4. Possible adverse effects

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

Adults aged 18 years and older:

Since the medicine has been marketed, serious allergic reactions (anaphylaxis) and hypersensitivity syndromes (allergic reactions including rash, fever, abnormal blood tests) have been reported. Early signs of a serious allergic reaction may include swelling of the face and/or throat. If these symptoms occur, inform your doctor immediately, as you may require urgent medical treatment.

Frequent adverse effects (may affect up to 1 in 10 people) are:

• Headache.
• Diarrhea, nausea, vomiting.
• Rash, itching.
• Problems at the vein where the medicine is administered (including inflammation, formation of a lump, swelling at the injection site, or leakage of fluid into the tissue and skin surrounding the injection site).
• Increased platelet count.
• Changes in liver function tests.

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

• Dizziness, drowsiness, insomnia, confusion, seizures.
• Low blood pressure, slow heart rate.
• Difficulty breathing, sore throat.
• Constipation, oral fungal infection, antibiotic-associated diarrhea, acid reflux, dry mouth, indigestion, loss of appetite.
• Skin redness.
• Vaginal discharge and irritation.
• Abdominal pain, fatigue, fungal infection, fever, edema/swelling, chest pain, taste disturbance.
• Abnormalities in certain urine and blood tests.

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

• Decrease in white blood cells, decrease in the number of platelets in the blood.
• Low blood sugar levels.
• Irritation, anxiety, depression, tremor.
• Irregular heart rate, increased blood pressure, bleeding, rapid heart rate.
• Nasal congestion, cough, nosebleeds, pneumonia, unusual breathing sounds and wheezing.
• Inflammation of the gallbladder, difficulty swallowing, fecal incontinence, yellowing of the skin (jaundice), liver disorder.
• Skin inflammation, fungal skin infection, skin peeling, surgical wound infection.
• Muscle cramps, shoulder pain.
• Urinary tract infection, kidney failure.
• Abortion, genital bleeding.
• Allergic reaction, malaise, pelvic peritonitis, changes in the white part of the eye, fainting.
• The skin may harden at the injection site.
• Swelling of blood vessels in the skin.

Adverse effects reported with unknown frequency (cannot be estimated from available data) are:

• Hallucinations.
• Decreased level of consciousness.
• Altered mental state (including aggression, delirium, disorientation, changes in mental status).
• Abnormal movements.
• Muscle weakness.
• Unsteady gait.
• Stained teeth.

Changes in certain parameters measured in blood tests have also been reported.

If you develop fluid-filled spots or raised areas over a wide area of your body, inform your doctor or nurse immediately.

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

Frequent adverse effects (may affect up to 1 in 10 people) are:

• Diarrhea.
• Diaper dermatitis.
• Pain at the infusion site.
• Changes in white blood cell count.
• Changes in liver function tests.

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

• Headache.
• Hot flushes, high blood pressure, small smooth red or purple spots under the skin.
• Discolored stools, black tarry stools.
• Skin redness, rash.
• Burning, itching, redness, and warmth at the infusion site, redness at the injection site.
• Increased platelet count.
• Changes in certain blood tests.

Adverse effects reported with unknown frequency (cannot be estimated from available data) are:

• Hallucinations.
• Altered mental state (including aggression).

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ertapenem Aurovitas

Keep this 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 month indicated.

Do not store above 30°C.

After reconstitution: reconstituted solutions should be used immediately.

After dilution:

Chemical and physical in-use stability of diluted solutions has been demonstrated for 6 hours at 15–25°C and for 24 hours at 2–8°C (in refrigerator). The solutions should be used within 4 hours after removal from the refrigerator. Do not freeze ertapenem solutions.

From a microbiological standpoint, the medicine should be used immediately unless the method of opening prevents the risk of microbiological contamination. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user.

Do not use this medicine if, in the reconstituted solution, particles are observed, the solution has an unusual colour, or signs of deterioration are present.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Ertapenem Aurovitas

• The active substance is ertapenem. Each vial contains 1.0 g of ertapenem.
• The other components are: sodium hydrogen carbonate, sodium hydroxide to adjust pH to 7.6, and sodium hydroxide used as a buffering agent.

Appearance of the medicinal product and contents of the container

Ertapenem Aurovitas is a white to off-white powder for concentrate for solution for infusion. Ertapenem solutions range from colourless to pale yellow. Variation in colour within this range does not affect efficacy.

20 ml glass type I vial with grey bromobutyl rubber stopper and aluminium cap with a polypropylene disc.

Ertapenem Aurovitas is available in pack sizes of 1 vial, 5 vials, and 10 vials.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

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

Date of the most recent review of this summary: January 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicinal Products and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

This information is intended for healthcare professionals only:

Instructions for reconstituting and diluting ertapenem:

For single use only.

Preparation for intravenous administration:

Ertapenem must be reconstituted and then diluted prior to administration.

Instructions for inserting the needle into the rubber stopper

To prevent the stopper from dislodging when inserting the needle into the rubber stopper, it is recommended to use a needle with a gauge diameter of 21 or smaller for reconstituting the medicine.

The needle must be inserted vertically and only into the center of the rubber stopper.

Adults and adolescents (13 to 17 years of age)

Reconstitution

Reconstitute the contents of the 1 g ertapenem vial with 10 ml of water for injections or 9 mg/ml (0.9%) sodium chloride solution to obtain a reconstituted solution of approximately 100 mg/ml. Shake well to dissolve (see section 6.4).

Dilution

For a 50 ml infusion bag: For a 1 g dose, immediately transfer the contents of the reconstituted vial to a 50 ml bag of 9 mg/ml (0.9%) sodium chloride solution; or

For a 50 ml diluent vial: For a 1 g dose, remove 10 ml from a 50 ml vial of 9 mg/ml (0.9%) sodium chloride solution and discard. Transfer the contents of the reconstituted 1 g ertapenem vial into the 50 ml vial of 9 mg/ml (0.9%) sodium chloride solution.

Infusion

Infuse over a period of 30 minutes.

Children (3 months to 12 years of age)

Reconstitution

Reconstitute the contents of the 1 g ertapenem vial with 10 ml of water for injections or 9 mg/ml (0.9%) sodium chloride solution to obtain a reconstituted solution of approximately 100 mg/ml. Shake well to dissolve (see section 6.4).

Dilution

For an infusion bag: transfer a volume equivalent to 15 mg/kg body weight (not exceeding 1 g/day) to an infusion bag containing 9 mg/ml (0.9%) sodium chloride solution, to achieve a final concentration of 20 mg/ml or less; or

For a diluent vial: transfer a volume equivalent to 15 mg/kg body weight (not exceeding 1 g/day) to a vial of 9 mg/ml (0.9%) sodium chloride solution, to achieve a final concentration of 20 mg/ml or less.

Infusion

Infuse over a period of 30 minutes.

After reconstitution:

Reconstituted solutions must be used immediately.

After dilution:

Chemical and physical in-use stability of diluted solutions has been demonstrated for 6 hours at 15–25°C and 24 hours at 2–8°C (refrigerated). Solutions must be used within 4 hours after removal from the refrigerator. Do not freeze ertapenem solutions.

From a microbiological standpoint, the product should be used immediately unless the method of opening prevents the risk of microbiological contamination. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user.

Whenever possible, reconstituted solutions should be inspected visually for the presence of particles or discoloration prior to administration. Ertapenem solutions range from colorless to pale yellow. Variation in color within this range does not affect efficacy.

Any unused medicine and materials that have come into contact with it should be disposed of in accordance with local regulations.