Prospecto: information for the user

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

ertapenem

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to 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 adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.

Ertapenem Qilu 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.

This medication can be administered to individuals aged 3 months and above.

Treatment:

Your doctor has prescribed Ertapenem Qilu 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.

Do not use Ertapenem Qilu

• if you are allergic to ertapenem or 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, nurse, or pharmacist before starting to use Ertapenem Qilu.

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 Qilu, 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 that you inform your doctor if you have diarrhea before, during, or after your treatment with Ertapenem Qilu. This is because you may develop 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 belowOther medications and Ertapenem Qilu).

Inform your doctor of any other medical condition you 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 medication, including antibiotics.
• central nervous system disorders, such as localized tremors or seizures. (attacks)

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

The experience with Ertapenem Qilu 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 3months of age.

Other medications and Ertapenem Qilu

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 taking medications called valproic acid or sodium valproate (used to treat epilepsy, bipolar disorder, migraines, or schizophrenia). This is because Ertapenem Qilu may affect how other medications work. Your doctor will decide if Ertapenem Qilu should be used 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.

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

Women receiving Ertapenem Qilu should not breastfeed because it has been found in breast milk and may affect the infant.

Driving and operating machinery

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

Certain adverse effects, such as dizziness and somnolence, associated with Ertapenem Qilu may affect patients' ability to drive or operate machinery.

Ertapenem Qilu contains sodium

This medication contains approximately 137mg of sodium (main component of table salt/for cooking) in each 1.0g dose. This is equivalent to 6.85% of the recommended daily maximum sodium intake for an adult.

This medication will always be prepared and administered by a doctor or other healthcare professional through an intravenous (IV) route (into a vein).

The recommended dose of Ertapenem Qilu for adults and adolescents 13 years of age and older is 1 gram (g) administered once a day.

Use in children

The recommended dose for children 3 months to 12 years of age is 15 mg/kg, administered twice a day (not to exceed 1 g per 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 this medication is 1 g administered as a single IV dose 1 hour before surgery.

If you are given more Ertapenem Qilu than you should

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

If you forget to use Ertapenem Qilu

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

If you stop using Ertapenem Qilu

It is very important that you continue to receive Ertapenem Qilu for the entire time that your doctor has told you.

If you have any other questions about the use of this medication, consult your doctor, pharmacist, or nurse.

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

Adults 18 years of age and older:

Since this medicine was marketed, severe allergic reactions (anaphylaxis) and hypersensitivity syndromes (allergic reactions such as: 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 side effects(may affect up to 1 in 10 people) are:

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

Less frequent side 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 thrush, antibiotic-associated diarrhea, acid reflux, dry mouth, indigestion, loss of appetite
• Redness of the skin
• Vaginal discharge and irritation
• Abdominal pain, fatigue, fungal infection, fever, edema/swelling, chest pain, altered taste.
• Alterations in some urine and blood tests

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

• 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
• Runny nose, cough, nasal bleeding, pneumonia, unusual breathing sounds and ringing
• Bile duct inflammation, difficulty swallowing, fecal incontinence, yellowing of the skin (jaundice), liver disorder
• Skin inflammation, fungal skin infection, skin peeling, wound infection after surgery
• 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 blood vessels in the skin

Side effects of unknown frequency(cannot be estimated from available data) are:

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

Also, changes in some blood parameters measured in blood tests have been reported.

If you experience 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 side effects(may affect up to 1 in 10 people) are:

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

Less frequent side effects(may affect up to 1 in 100 people) are:

• Headache
• Flushes, high blood pressure, small, smooth, red or purple spots under the skin
• Colored stools, black stools like tar
• Redness of the skin, skin rash
• Itching, prickling, redness, and warmth at the infusion site, redness at the injection site
• Increased platelet count
• Changes in some blood tests

Side effects of unknown frequency(cannot be estimated from available data) are:

• Hallucinations
• Altered mental state (including aggression)

Reporting of side effects

If you experience any type of side effect, consult your doctor,pharmacistor nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side 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 label of the container and vial after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25 °C.

After reconstitution:

The reconstituted solutions must be used immediately.

After dilution:

Chemical and physical stability has been demonstrated in use of the diluted solutions (approximately 1 mg/ml and 20 mg/ml) for 6 hours at 25 °C, or for 24 hours at 2 to 8 °C (in a refrigerator). Solutions must be used within 4 hours after removal from the refrigerator. Do not freeze Ertapenem Qilu solutions.

From a microbiological standpoint, unless the reconstitution and dilution method excludes the risk of microbial contamination, the product must be used immediately. If not used immediately, storage times and conditions in use are the responsibility of the user.

Composition of Ertapenem Qilu

The active ingredient is ertapenem. Ertapenem Qilu 1gpowder for concentrate for solution for infusion EFG contains 1g of ertapenem.

The other components are: sodium hydrogenocarbonate (for pH adjustment) and sodium hydroxide (for pH adjustment).

Appearance of the product and contents of the package

Ertapenem Qilu is a powder for concentrate for solution for infusion, white to off-white in color.

The solutions of Ertapenem Qilu vary from colorless to pale yellow. Variations in color within this range do not affect efficacy.

Ertapenem Qilu is presented in vials of 1 vial or 10 vials.

Only some package sizes may be marketed.

Holder of the marketing authorization and manufacturer responsible

Holder of the marketing authorization

QILU PHARMA SPAIN S.L.

Paseo de la Castellana 40,

8th floor, Madrid - 28046

Spain

Manufacturer responsible

KYMOS, S.L.

Ronda de Can Fatjó,

7B (Parque Tecnológico del Vallès),

Cerdanyola del Vallès, 08290 Barcelona,

Spain

or

Eurofins Analytical Services Hungary Kft

Anonymus u. 6.

Budapest, H-1045

Hungary

Local representative:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007 Barcelona

Spain

Tel.: +34 93 342 7890

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:February 2024

The information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

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This information is intended solely for healthcare professionals:

Instructions for reconstituting and diluting Ertapenem Qilu:

For single use.

Preparation for intravenous administration:

Ertapenem Qilu must be reconstituted and then diluted before administration.

Adults and adolescents (13 to 17 years old)

Reconstitution:

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

Dilution

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

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

Infusion

Infuse over a period of 30 minutes.

Children (3 months to 12 years old)

Reconstitution

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

Dilution

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

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

Infusion

Infuse over a period of 30 minutes.

The reconstituted solution must be diluted in 9mg/ml (0.9%) sodium chloride solution immediately after preparation. For the shelf life after reconstitution and dilution: see section 5.

Whenever the packaging permits, the reconstituted solutions should be visually inspected before administration for the presence of particles or discoloration. The solutions of Ertapenem Qilu vary from colorless to pale yellow. A variation in color within this range does not affect efficacy. The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.