ERTAPENEM HIKMA 1 g POWDER FOR CONCENTRATE FOR INFUSION SOLUTION

2. What you need to know before you use 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 medicine (listed in section 6).

Warnings and precautions

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

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 normal. This is called bacterial overgrowth. Your doctor will monitor bacterial overgrowth and treat it if necessary.

It is essential that you inform your doctor if you have diarrhea before, during, or after your treatment with ertapenem. 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 medicines and Ertapenem Hikma).

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.

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 possible benefit of its use. There is no experience in children under 3 months of age.

Other medicines and Ertapenem Hikma

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

Tell 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, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 who are receiving ertapenem 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 medicine affects you.

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

Ertapenem Hikma contains sodium

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

3. How to take Ertapenem Hikma

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

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 from 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 to receive ertapenem for the entire time your doctor has indicated.

If you use more Ertapenem Hikma 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, 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 forget to use Ertapenem Hikma

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Adults 18 years of age and older:

Since the drug was 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.

Frequent side 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, 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 heart rate, increased blood pressure, bleeding, rapid heart rate
• 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)

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

Frequent side 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 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 stools like tar
• 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 or pharmacist, 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 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 which is stated on the carton.

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

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ertapenem Hikma

The active substance of Ertapenem Hikma is ertapenem

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

Appearance of the product and pack contents

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

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

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

Not all pack sizes may be marketed.

You can ask for more information about this medicine from 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 medicine is authorized in the Member States of the European Economic Area under the following names:

France: Ertapenem Hikma 1 g, powder for solution for infusion

Italy: Ertapenem Hikma 1 g powder for concentrate for solution for infusion

Portugal: Ertapenem Hikma 1 g

Spain: Ertapenem Hikma 1 g powder for concentrate for solution for infusion EFG

United Kingdom: Ertapenem 1 g powder for concentrate for solution for infusion

Date of last revision of this leaflet: February 2023

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

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This information is intended only for healthcare professionals:

Instructions for reconstituting and diluting Ertapenem Hikma:

For single use.

Preparation for intravenous administration:

Ertapenem Hikmamust be reconstituted and then diluted before administration.

Adults and adolescents (from 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 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 solution;

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 solution and discard. Transfer the contents of the 1 g vial of Ertapenem Hikma reconstituted to the 50 ml vial of 9 mg/ml (0.9%) sodium chloride solution.

Infusion

Infuse over a period of 30 minutes.

Children (from 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 a bag of diluent: 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 vial of diluent: 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.

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 (in the refrigerator). From a microbiological point of view, the diluted solutions should be used immediately. If not used immediately, the in-use storage times are the responsibility of the user and normally should not exceed 24 hours between 2 and 8°C, unless the reconstitution has been carried out under controlled and validated aseptic conditions.

Once removed from the refrigerator, the solutions should be used within 4 hours. Do not freeze the reconstituted solutions.

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

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