Ertapenem Hikma 1 g powder for concentrate for infusion solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ertapenem Hikma 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, consult your doctor, pharmacist or nurse.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they

are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

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

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

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 dose, 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 via wastewater or household waste.

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 Hikma

Do not use Ertapenem Hikma:

• if you are allergic to the active substance (ertapenem) or to any of the other ingredients of this

medicinal product (listed in section 6).

• if you are allergic to antibiotics such as penicillins, cephalosporins, or carbapenems (which are used

to treat various infections).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting treatment with ertapenem.

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. 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 have diarrhoea before, during, or after your treatment with ertapenem. This may be due to a condition called colitis (inflammation of the intestine). Do not take any medicine for diarrhoea without first consulting your doctor.

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

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 whether the potential benefit justifies treatment. There is no experience with ertapenem in children under 3 months of age.

Other medicines and Ertapenem Hikma

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

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 you should use ertapenem in combination with these medicines.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist 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 breast-feed, as it has been detected in breast milk and may therefore affect the infant.

Driving and using machines

Do not drive or operate 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 a patient's ability to drive or use machines.

Ertapenem Hikma contains sodium

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

3. How to take Ertapenem Hikma

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, administered 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 entire duration prescribed by your doctor.

If you have been given more Ertapenem Hikma than you should

If you are concerned that you may have received 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 number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to receive Ertapenem Hikma

If you are concerned that a dose has been missed, consult your doctor or another 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 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 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, yeast infection of the mouth, 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 disturbances
• 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 platelet count in the blood
• 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, wound infection after surgery
• 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 the available data) are:

• Hallucinations
• Decreased level of consciousness
• Altered mental state (including aggression, delirium, disorientation, changes in mental state)
• 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 spots on your skin over a large 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
• Stinging, 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 the available data) are:

• Hallucinations
• Altered mental state (including aggression)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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, website: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ertapenem Hikma

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

Do not use this medicine after the expiry date stated on the container.

The expiry date refers to the last day of the month indicated.

Do not store above 25 °C. Store in the original container.

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. Contents of the pack and other information

Composition of Ertapenem Hikma

The active substance in Ertapenem Hikma is ertapenem.

• Each vial contains 1 g of ertapenem (as ertapenem sodium).
• The other components are: sodium hydrogen carbonate and sodium hydroxide.

Appearance of the product and contents of the pack

Ertapenem Hikma is a lyophilized powder for concentrate for solution for infusion, white to yellowish in colour.

Solutions of Ertapenem Hikma range from colourless to pale yellow. Colour variations within this range do not affect efficacy.

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

Only certain pack sizes may be marketed.

You can request further information about this medicinal product by contacting the local representative of the marketing authorization holder:

Hikma España, S.L.U.
Calle Anabel Segura nº11, Edificio A, planta 1ª, oficina 2
28108 - Alcobendas, Madrid
Spain

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

France: Ertapenem Hikma 1 g, poudre pour solution à diluer pour perfusion
Italy: Ertapenem Hikma 1 g Polvere per concentrato per soluzione per infusione
Portugal: Ertapenem Hikma 1 g
Spain: Ertapenem Hikma 1 g Polvo para concentrado para solución para perfusión EFG
United Kingdom: Ertapenem 1 g Powder for concentrate for solution for infusion

Date of the most recent review of this leaflet: February 2023

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

This information is intended for healthcare professionals only:

Instructions for reconstituting and diluting Ertapenem Hikma:

For single use only.

Preparation for intravenous administration:

Ertapenem Hikma must be reconstituted and then diluted prior to administration.

Adults and adolescents (13 to 17 years of age)

Reconstitution:
Reconstitute the contents of the 1 g vial of Ertapenem Hikma 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.

Dilution:
For a 50 ml infusion bag: For a 1 g dose, immediately transfer the contents of the reconstituted vial into a 50 ml bag of 9 mg/ml (0.9%) sodium chloride solution.
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 vial of Ertapenem Hikma 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 vial of Ertapenem Hikma 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 an infusion bag: transfer a volume equivalent to 15 mg/kg body weight (not exceeding 1 g/day) into 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) 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 diluted in 9 mg/ml (0.9%) sodium chloride solution immediately after preparation. The solutions are physically and chemically stable for 6 hours at room temperature (25°C) or for 24 hours between 2 and 8°C (refrigerated). From a microbiological standpoint, diluted solutions should be used immediately. If not used immediately, storage times and conditions are the responsibility of the user and normally should not exceed 24 hours between 2 and 8°C, unless reconstitution has been carried out under controlled and validated aseptic conditions.

Once removed from the refrigerator, 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. Ertapenem Hikma solutions range from colorless to pale yellow. Variation in color within this range does not affect efficacy.

Any unused medicinal product and materials that have come into contact with it must be disposed of in accordance with local regulations.