ERTAPENEM QILU 1 g POWDER FOR CONCENTRATE FOR INFUSION SOLUTION

2. What you need to know before you use Ertapenem Qilu

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 normal. This is called 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 suffer from a disease 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 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 convulsions (seizures).

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

Experience with Ertapenem Qilu in children under two years of age 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 Qilu

Inform your doctor if you are taking, have recently taken, 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, think you may be pregnant, or plan to become 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 who are receiving Ertapenem Qilu should not breastfeed because it has been found in breast milk and may affect the infant.

Driving and using machines

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

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

Ertapenem Qilu contains sodium

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

3. How to use Ertapenem Qilu

This medication will always be prepared and administered intravenously (in a vein) by a doctor or other healthcare professional.

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 from 3 months to 12 years of age is 15 mg/kg, administered twice a day (not exceeding 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 intravenous dose 1 hour before surgery.

If you are given too much Ertapenem Qilu

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

If you miss a dose of Ertapenem Qilu

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

If you stop using Ertapenem Qilu

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Adults 18 years of age and older:

Since this medication has been marketed, serious 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.

Common side effects(may affect up to 1 in 10 people) are:

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

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

• Dizziness, somnolence, insomnia, confusion, convulsions
• Low blood pressure, slow heart rate
• Difficulty breathing, throat pain
• 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.
• Changes in some urine and blood tests

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

• Decrease in white blood cells, decrease in platelet count in the blood
• Low blood sugar
• Irritability, anxiety, depression, tremor
• Irregular heartbeat, increased blood pressure, bleeding, rapid heartbeat
• Nasal congestion, cough, nosebleed, pneumonia, unusual breathing sounds and wheezing
• Gallbladder inflammation, 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
• Allergy, discomfort, pelvic peritonitis, changes in the white part of the eye, fainting.
• The skin may become hardened at the injection site
• Swelling of the blood vessels in the skin

Side effects 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 state)
• Abnormal movements
• Muscle weakness
• Unstable gait
• Discolored teeth

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

If you develop fluid-filled or elevated skin patches over a large area of your body, inform your doctor or nurse immediately.

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

Common 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

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

• Headache
• Flushing, high blood pressure, small, smooth, red or purple spots under the skin
• Discolored stools, black tarry stools
• Redness of the skin, skin rash
• Itching, burning, redness, and warmth at the infusion site, redness at the injection site
• Increased platelet count
• Changes in some blood tests

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

• Hallucinations
• Altered mental state (including aggression)

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ertapenem Qilu

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the label of the package and vial after EXP. The expiration date is the last day of the month indicated.

Do not store above 25°C.

After reconstitution:

Reconstituted solutions should be used immediately.

After dilution:

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

From a microbiological point of view, unless the method of reconstitution and dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user.

6. Container contents and additional information

Composition of Ertapenem Qilu

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

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

Appearance of the product and container contents

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

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

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

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

QILU PHARMA SPAIN S.L.

Paseo de la Castellana 40,

floor 8, Madrid - 28046

Spain

Manufacturer

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

Phone: +34 93 342 7890

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

Date of last revision of this leaflet:February 2024

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

-

------------------------------------------------------------------------------------------------------------------------

This information is intended for healthcare professionals only:

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 of age)

Reconstitution:

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

Dilution

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

For a 50 ml vial of diluent: For a dose of 1 g, remove 10 ml from a 50 ml vial of 9 mg/ml (0.9%) sodium chloride injection solution and discard. Transfer the contents of the reconstituted 1 g vial of Ertapenem Qilu to the 50 ml vial of 9 mg/ml (0.9%) sodium chloride injection 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 vial of Ertapenem Qilu with 10 ml of water for injections or 9 mg/ml (0.9%) sodium chloride injection solution to obtain a reconstituted solution of approximately 100 mg/ml. Shake well to dissolve.

Dilution

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

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

Infusion

Infuse over a period of 30 minutes.

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

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