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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ertapenem Lorien 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 other people, 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 Lorien is and what it is used for

2. What you need to know before using Ertapenem Lorien

3. How to use Ertapenem Lorien

4. Possible side effects

   1. Storage of Ertapenem Lorien

5. Contents of the pack and other information

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

This medicine 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.

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

Treatment:

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

• Abdominal infection
• Infection affecting the lungs (pneumonia)
• Gynecological infections
• Skin infections of the foot in diabetic patients

Prophylaxis:

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

2. What you need to know before using Ertapenem Lorien

Do not use this medicine:

• 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 you start using Ertapenem Lorien.

If you experience an allergic reaction during treatment (such as swelling of the face, tongue, or throat, difficulty breathing or swallowing, 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 overgrow abnormally. This is known as bacterial overgrowth. Your doctor will monitor for bacterial overgrowth and treat you if necessary.

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

Inform your doctor if you are taking medicines called valproic acid or sodium valproate (see below Ertapenem Lorien with other medicines).

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

• Kidney disease. It is especially important that your doctor knows if you have kidney disease or 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 on the potential benefit of its use. There is no experience in children under 3 months of age.

Other medicines and Ertapenem Lorien

Tell 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 medicines 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 ertapenem should be used in combination with these medicines.

Pregnancy and breastfeeding

If you are pregnant, 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 must not breastfeed because it has been found 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.

Ertapenem has been associated with certain adverse effects such as dizziness and somnolence, which may affect a patient's ability to drive or operate machinery.

Ertapenem Lorien contains sodium

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

3. How to use Ertapenem Lorien

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 will need.

To prevent surgical site 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 duration prescribed by your doctor.

If you use more Ertapenem Lorien than you should

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

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

If you forget to use Ertapenem Lorien

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

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

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 drug has been marketed, serious allergic reactions (anaphylaxis) and hypersensitivity syndromes (allergic reactions such as: skin 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
• Skin rash, itching
• Problems with 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 surrounding skin)
• 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 yeast 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, altered taste
• Changes 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 platelet count
• Low blood sugar levels
• Irritability, 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
• Skin may harden at the injection site
• Swelling of blood vessels in the skin

Adverse effects with frequency not known (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 or raised lesions 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
• Pale stools, black tarry stools
• Skin redness, skin 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 with frequency not known (cannot be estimated from available data) are:

• Hallucinations
• Altered mental state (including aggression)

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet.

You may 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 Lorien

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

Do not use this medicine after the expiry date stated on the vial and the carton, after EXP or CAD. The expiry date refers to the last day of that month.

Do not store above 25 °C.

After reconstitution/dilution:

Diluted solutions must be used immediately. If not used immediately, storage times in use are the user's responsibility. Diluted solutions (approximately 20 mg/ml of ertapenem) are physically and chemically stable for 6 hours at room temperature (25 °C) or for 24 hours between 2 and 8 °C (in a refrigerator). Once removed from the refrigerator, the solutions must be used within the following 4 hours. Do not freeze ertapenem solutions.

6. Contents of the pack and other information

Composition of Ertapenem Lorien

• The active substance is ertapenem. Each vial contains 1 g of ertapenem (as ertapenem sodium).
• The other components are: Sodium hydrogen carbonate (E-500) and Sodium hydroxide (E-524) (to adjust pH).

Appearance of the product and contents of the pack

Ertapenem Lorien is a white to pale yellow lyophilized powder or cake. Solutions of Ertapenem Lorien range from colorless to pale yellow. Color variations within this range do not affect efficacy.

Ertapenem Lorien is available in packs containing 1 vial or 10 vials.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Lorien, S.L.
Av. Josep Tarradellas, 8. Ático 1ª
08029 Barcelona
Spain

Manufacturer

Pharma Revolta s.r.o.
Rybné námestie 1
811 02 Bratislava
Slovakia

Date of the most recent revision of this summary: April 2024

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

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This information is intended for healthcare professionals only:

Instructions for reconstituting and diluting Ertapenem Lorien:

For single use only.

Preparation for intravenous administration:

Ertapenem Lorien must be reconstituted and then diluted before administration.

Adults and adolescents (aged 13 to 17 years)

Reconstitution

Reconstitute the contents of the 1 g vial of Ertapenem Lorien 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.

Dilution

For a 50 ml diluent bag: For a 1 g dose, immediately transfer the entire contents of the reconstituted vial into 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 entire contents of the reconstituted 1 g vial of Ertapenem Lorien into the 50 ml vial of 9 mg/ml (0.9%) sodium chloride solution.

Infusion

Infuse over a period of 30 minutes.

Children (aged 3 months to 12 years)

Reconstitution

Reconstitute the contents of the 1 g vial of Ertapenem Lorien 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.

Dilution

For a diluent bag: Transfer a volume equivalent to 15 mg/kg body weight (not exceeding 1 g/day) into a bag of 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) into 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.

The reconstituted solution must be immediately diluted in 9 mg/ml (0.9%) sodium chloride solution after preparation. Diluted solutions must be used immediately. If not used immediately, the in-use storage times are the responsibility of the user. Diluted solutions (approximately 20 mg/ml of ertapenem) are physically and chemically stable for 6 hours at room temperature (25°C) or for 24 hours between 2 and 8°C (refrigerated). After removal from refrigeration, solutions must be used within 4 hours. Do not freeze reconstituted solutions.

Whenever possible, reconstituted solutions should be inspected visually for particulate matter or discoloration prior to administration. Solutions of Ertapenem Lorien range from colorless to pale yellow. Color variations within this range do not affect efficacy.

Disposal of unused medicine and all materials that have come into contact with it must be carried out in accordance with local regulations.

Incompatibilities:

Do not use solvents or infusion solutions containing dextrose for reconstitution or administration of ertapenem.