Prospecto: information for the user

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

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any questions, consult your doctor, pharmacist, or nurse.

-This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to use Ertapenem Aurovitas

3.How to use Ertapenem Aurovitas

4.Adverse effects

5.Storage of Ertapenem Aurovitas

6.Contents of the package and additional information

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.

Ertapenemcan be administered to individuals aged 3 months and above.

Treatment:

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

•Abdominal infection

•Pulmonary infection (pneumonia)

•Gynecological infections

•Skin infections of the foot in diabetic patients

Prevention:

Prevention of surgical wound infections in adults after colon or rectal surgery.

No use Ertapenem Aurovitas

•If you are allergic to the active ingredient (ertapenem) or to any of the other components of this medication (listed in section 6).

•If you are allergic to antibiotics such as penicillins, cephalosporins, or carbapenems (used to treat various infections).

Warnings and Precautions

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

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

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

It is essential to inform your doctor if you have diarrhea before, during, or after your treatment with ertapenem. This is because you may suffer from a condition known as colitis (inflammation of the intestine). Do not take any medication to treat diarrhea without consulting your doctor first.

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

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

-Kidney disease. It is especially important for your doctor to know if you have kidney disease and if you are receiving dialysis treatment.

-Allergies to any medication, including antibiotics.

-Central nervous system disorders, such as localized tremors or seizures.

Children and Adolescents (3 months to 17 years of age)

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

Other Medications and Ertapenem Aurovitas

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

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

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

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 because it has been found in breast milk and may affect the infant.

Driving and Operating Machines

Do not drive or use any tools or machines until you know how you react to the medication.

Certain adverse effects with ertapenem, such as dizziness and somnolence, may affect patients' ability to drive or operate machines.

Ertapenem Aurovitas contains sodium

This medication contains 137 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 6.85% of the maximum daily sodium intake recommended for an adult.

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

The recommended dose of ertapenem for adults and adolescents 13 years of age and older is 1 gram (g) administered once a day. The recommended dose for children 3 months to 12 years of age is 15 mg/kg, administered twice a day (not exceeding 1 g/day). Your doctor will decide how many days of treatment you need.

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

It is very important that you continue receiving ertapenem for the entire time your doctor has prescribed.

If you use more Ertapenem Aurovitas than you should

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

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

If you forgot to use Ertapenem Aurovitas

If you are concerned that you may have forgotten a dose, consult your doctor or other healthcare professional immediately.

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

Adults 18 years of age and older:

Since the medicine was marketed, severe allergic reactions (anaphylaxis) and hypersensitivity syndromes (allergic reactions including skin rash, fever, abnormal blood tests) have been reported. The first signs of a severe allergic reaction may include swelling of the face and/or throat. If these symptoms appear, inform your doctor immediately as you may need urgent medical treatment.

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

•Headache.

•Diarrhea, nausea, vomiting.

•Skin rash, itching.

•Problems in the vein where the medicine is administered (including inflammation, lump formation, swelling at the injection site or leakage of liquid into the surrounding tissue and skin).

•Increased platelet count.

•Changes in liver function tests.

Poorly frequent (may affect up to 1 in 100 people):

•Dizziness, somnolence, insomnia, confusion, convulsions.

•Low blood pressure, slow heart rate.

•Difficulty breathing, sore throat.

•Constipation, oral thrush infection, antibiotic-associated diarrhea, acid reflux, dry mouth, indigestion, loss of appetite.

•Facial flushing.

•Vaginal discharge and irritation.

•Abdominal pain, fatigue, fungal infection, fever, edema/swelling, chest pain, altered taste.

•Alterations in some urine and blood tests.

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

•Decreased white blood cell count, decreased platelet count in the blood.

•Low blood sugar.

•Irritation, anxiety, depression, tremor.

•Irregular heart rate, increased blood pressure, bleeding, rapid heart rate.

•Congestion, cough, nasal bleeding, pneumonia, unusual breathing sounds and beeps.

•Bile duct inflammation, difficulty swallowing, fecal incontinence, yellow skin discoloration (jaundice), liver disorder.

•Skin inflammation, fungal skin infection, skin peeling, post-surgical wound infection.

•Muscle cramps, shoulder pain.

•Urinary tract infection, kidney insufficiency.

•Abortion, genital bleeding.

•Allergy, discomfort, pelvic peritonitis, changes in the white part of the eye, fainting.

•The skin may harden at the injection site.

•Swelling of the blood vessels in the skin.

Frequency unknown (cannot be estimated from available data):

•Hallucinations.

•Decreased level of consciousness.

•Altered mental state (including aggression, delirium, disorientation, changes in mental state).

•Abnormal movements.

•Muscle weakness.

•Unstable walking.

•Stained teeth.

Also, changes in some blood parameters have been reported.

If you have blisters filled with liquid or raised on a large area of your body, inform your doctor or nurse immediately.

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

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

•Diarrhea.

•Diaper rash.

•Pain at the perfusion site.

•Changes in white blood cell count.

•Changes in liver function tests.

Poorly frequent (may affect up to 1 in 100 people):

•Headache.

•Headaches, high blood pressure, small, smooth, red or purple spots under the skin.

•Colored stools, black stools like tar.

•Facial flushing, skin rash.

•Itching, burning, redness, and warmth at the perfusion site, redness at the injection site.

•Increased platelet count.

•Changes in some blood tests.

Frequency unknown (cannot be estimated from available data):

•Hallucinations.

•Altered mental state (including aggression).

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and vial after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

After reconstitution: the reconstituted solutions must be used immediately.

After dilution:

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

From a microbiological point of view, the medication must be used immediately unless the opening method prevents the risk of microbiological contamination. If not used immediately, storage times and conditions before use are the responsibility of the user.

Do not use this medication if you observe the presence of particles in the reconstituted solution, inadequate coloration, or signs of deterioration.

Medications must not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Ertapenem Aurovitas

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

Appearance of the product and contents of the container

Ertapenem Aurovitas is a powder for concentrate for solution for infusion, white to off-white in color. Ertapenem solutions vary from colorless to pale yellow. A variation of color within this range does not affect efficacy.

Type I glass vial of 20 ml with a grey bromobutyl rubber stopper and an aluminum cap with a polypropylene disc.

Ertapenem Aurovitasis presented in containers of 1 vial, 5 vials and 10 vials.

Only some container sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

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

Last review date of this leaflet:August 2024

For detailed information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

This information is intended solely for healthcare professionals:

Instructions on how to reconstitute and dilute ertapenem:

For single use.

Preparation for intravenous administration:

Ertapenem must be reconstituted and then diluted before administration.

Instructions for inserting the needle into the rubber stopper

To prevent the stopper from coming loose when inserting the needle into the rubber stopper, it is recommended to use a needle with a diameter of caliber 21 or less for reconstituting the medication.

The needle should only be inserted into the center of the rubber stopper, vertically.

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

For a 50 ml diluent vial: For a dose of 1 g, remove 10 ml from a 50 ml vial of 9 mg/ml (0.9%) sodium chloride solution and discard. Transfer the reconstituted 1 g ertapenem vial contents to 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 injection 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 diluent bag: Transfer a volume equivalent to 15 mg/kg body weight (not exceeding 1 g/day) to a bag of 9 mg/ml (0.9%) sodium chloride solution, for 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, for a final concentration of 20 mg/ml or less.

Infusion

Infuse over a period of 30 minutes.

After reconstitution:

The reconstituted solutions should be used immediately.

After dilution:

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

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

Whenever the container permits, the reconstituted solutions should be visually inspected before administration for the presence of particles or discoloration. Ertapenem solutions vary from colorless to pale yellow. A variation of color within this range does not affect efficacy.

The disposal of unused medicinal product and all materials that have been in contact with it, will be carried out in accordance with local regulations.