Ertapenem Hikma

Package leaflet: Information for the user

Ertapenem Hikma 1 g powder for concentrate for solution for

infusion
Ertapenem
Generic medicine
Please read this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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 side 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 is effective against a broad spectrum of bacteria (microorganisms) that cause infections in various parts of the body. Ertapenem Hikma can be administered to individuals from the age of 3 months.

Treatment:
Your doctor has prescribed Ertapenem Hikma for you or for the child to treat one (or more) of the following types of infection:

• Abdominal infections
• Lung infection (pneumonia)
• Gynecological infections
• Foot skin infections in diabetic patients

Prevention:

• Prevention of surgical site infection in adults following surgery on the colon or rectum.

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 medicine (listed in section 6)
• if you are allergic to antibiotics such as penicillins, cephalosporins or carbapenems (which are used to treat various types of infections).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Ertapenem Hikma.
During treatment, if you experience an allergic reaction (such as swelling of the face, tongue or throat,
difficulty breathing or swallowing, rash), inform your doctor immediately as you may require urgent
medical treatment.
While antibiotics, including Ertapenem Hikma, are effective against certain bacteria, other bacteria and
fungi may overgrow more than usual. This is known as overgrowth. Your doctor will monitor you for any
overgrowth and treat you if necessary.
It is important that you inform your doctor if you have diarrhoea before, during or after treatment with
Ertapenem Hikma. This is because you may have a condition known as colitis (an inflammation of the
intestine). Do not take any medicine for diarrhoea without first consulting your doctor.
Inform your doctor if you are taking medicines containing valproic acid or sodium valproate (see below
Other medicines and Ertapenem Hikma).
Inform your doctor of any medical conditions you currently have or have had in the past, including:

• Kidney disease. It is very important that your doctor knows if you have kidney disease and if you are undergoing dialysis
• 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 Hikma is limited in children under two years of age. In this age group, the doctor must evaluate the potential benefit of using the medicine. There is no experience with children under 3 months of age.
Other medicines and Ertapenem Hikma
Inform your doctor if you are taking or might take any other medicines, including those obtained without a prescription.
Inform your doctor, nurse or pharmacist if you are taking medicines containing valproic acid or sodium valproate (used to treat epilepsy, bipolar disorder, migraine or schizophrenia). This is because Ertapenem Hikma may affect the way some other medicines work. Your doctor will decide whether you should use Ertapenem Hikma together with these other medicines.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, if you suspect you may be pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.
Ertapenem Hikma has not been studied in pregnant women. Ertapenem Hikma should not be used during pregnancy unless your doctor decides that the potential benefits outweigh the possible risks to the fetus.
Women receiving treatment with Ertapenem Hikma must not breast-feed, as the medicine has been found in breast milk and the infant may therefore be affected.
Driving and using machines
Do not drive or operate machinery until you know how this medicine affects you.
Dizziness and somnolence have been reported with the use of Ertapenem Hikma; in some patients these effects may impair the ability to drive or use machinery.
Ertapenem Hikma contains sodium
This medicine contains approximately 137 mg of sodium (a main component of cooking salt) per 1.0 g dose. This corresponds to 6.85% of the maximum recommended daily dietary intake of sodium for an adult.

3. How to use Ertapenem Hikma

Ertapenem Hikma must always be prepared and administered intravenously (into a vein) by a
doctor or other healthcare professional.
The recommended dose of Ertapenem Hikma for adults and adolescents from the age of 13 is 1
gram (g) once daily. The recommended dose for children from 3 months to 12 years of age is 15
mg/kg administered twice daily (not to exceed 1 g per day). Your doctor will decide how long
treatment should last.
The recommended dose of Ertapenem Hikma for prevention of surgical site infections after
surgery on the colon or rectum is 1 g administered as a single intravenous dose 1 hour
before surgical incision.
It is very important to continue taking Ertapenem Hikma for the entire duration prescribed by your doctor.
If you use more Ertapenem Hikma than you should
If you think you have received too much Ertapenem Hikma, contact your doctor or a healthcare
professional immediately.
If you forget to take Ertapenem Hikma
If you think you have missed a dose, contact your doctor or a healthcare professional immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Adults aged 18 years and older:
Since the medicine was placed on the market, severe allergic reactions (anaphylaxis) and hypersensitivity syndromes (including 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 occur, inform your doctor immediately, as urgent medical treatment may be required.

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

• Headache
• Diarrhoea, nausea, vomiting
• Skin rash, itching
• Problems at the vein where the medicine was injected (including inflammation, swelling, injection site swelling, fluid leakage into the surrounding tissues and skin)
• Increased platelet count
• Changes in liver function tests

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

• Dizziness, drowsiness, insomnia, confusion, seizures
• Low blood pressure, slowed heart rate
• Shortness of breath, sore throat
• Constipation, fungal infection of the mouth, antibiotic-associated diarrhoea, acid regurgitation, dry mouth
• Digestive difficulties, loss of appetite
• Skin redness
• Vaginal discharge and irritation
• Abdominal pain, fatigue, fungal infection, fever, oedema/swelling, chest pain
• Taste disturbances
• Changes in certain laboratory blood and urine tests

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

• Decrease in white blood cells, decrease in platelets
• Low blood sugar levels
• Agitation, anxiety, depression, tremor
• Irregular heartbeat, increased blood pressure, bleeding, rapid heartbeat
• Nasal congestion, cough, nosebleeds, pneumonia, abnormal breathing sounds, wheezing
• Inflammation of the gallbladder, difficulty swallowing, faecal incontinence, jaundice, liver disorders
• Skin inflammation, fungal skin infection, skin peeling, wound infection after surgery
• Muscle cramps, shoulder pain
• Urinary tract infections, kidney abnormalities
• Spontaneous abortion, genital bleeding
• Allergic reactions, malaise, pelvic peritonitis, changes in the white part of the eye, fainting
• The skin may become hardened at the injection site
• Swelling of blood vessels under the skin

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

• Hallucinations
• Reduced consciousness
• Altered mental state (including aggression, delirium, disorientation, changes in mental status)
• Abnormal movements
• Muscle weakness
• Unsteady gait
• Discoloration of teeth

Changes in blood test results have also been reported.
If you develop raised or fluid-filled skin lesions 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 (which may affect up to 1 in 10 patients) are:

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

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

• Headache
• Hot flushes, high blood pressure, flat red or purple pinpoint spots under the skin
• Change in stool colour, black tarry stools
• Skin redness, skin rash
• Burning, itching, redness and warmth at the infusion site, redness at the injection site
• Increased platelet count in blood tests
• Changes in certain laboratory blood tests

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

• Hallucinations
• Altered mental state (including aggression)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, nurse, or pharmacist. You can also report side effects directly via the national reporting system: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 and the carton, following
Exp. The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep in the original packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. These measures will help protect the environment.

6. Package contents and other information

What Ertapenem Hikma contains
The active substance in Ertapenem Hikma is ertapenem.
Each vial contains 1 g of ertapenem.
The other components are:
Sodium hydrogen carbonate
and Sodium hydroxide.

Description of the appearance of Ertapenem Hikma and contents of the pack
Ertapenem Hikma is a lyophilized powder, white to slightly yellow, for concentrate for infusion solution.
Solutions of Ertapenem Hikma range from colourless to pale yellow. Variations in colour within this range do not affect the potency of the medicinal product.
Ertapenem Hikma is supplied in packs of 1 vial or 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder Manufacturer
Hikma Farmacêutica (Portugal), S.A. ACS Dobfar S.p.A.
Estrada do Rio da Mó 8, 8A and 8B Nucleo Industriale S.Atto
2705-906 Terrugem SNT, Portugal S. Nicolò a Tordino
Tel.: +351 219608410 64100- Teramo Italy

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
France: Ertapenem Hikma 1 g, powder for solution for dilution 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
United Kingdom: Ertapenem 1 g Powder for concentrate for solution for infusion

This Patient Information Leaflet was last updated on: 09/2023

The following information is intended exclusively for physicians and healthcare professionals:
Instructions for reconstitution and dilution of Ertapenem Hikma:
For single use only.

Preparation for intravenous administration:
Ertapenem Hikma must be reconstituted and subsequently diluted prior to administration.

Adults and adolescents (13 to 17 years of age)
Reconstitution
Reconstitute the contents of one 1 g Ertapenem vial with 10 mL of water for injections or with sodium chloride 9 mg/mL (0.9%) 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 contents of the reconstituted vial into a 50 mL bag of sodium chloride 9 mg/mL (0.9%) solution; or
For a 50 mL diluent vial: For a 1 g dose, withdraw 10 mL from a 50 mL vial of sodium chloride 9 mg/mL (0.9%) solution and discard. Transfer the contents of the reconstituted 1 g Ertapenem Hikma vial into the 50 mL vial of sodium chloride 9 mg/mL (0.9%) solution.

Infusion
Administer the infusion over 30 minutes.

Children (from 3 months to 12 years of age)
Reconstitution
Reconstitute the contents of one 1 g Ertapenem Hikma vial with 10 mL of water for injections or with sodium chloride 9 mg/mL (0.9%) solution to obtain a reconstituted solution of approximately 100 mg/mL. Shake well to dissolve.

Dilution
For a diluent bag: Transfer a volume corresponding to 15 mg/kg body weight (not exceeding 1 g/day) into a bag containing sodium chloride 9 mg/mL (0.9%) solution to achieve a final concentration of 20 mg/mL or less; or
For a diluent vial: Transfer a volume corresponding to 15 mg/kg body weight (not exceeding 1 g/day) into a vial containing sodium chloride 9 mg/mL (0.9%) solution to achieve a final concentration of 20 mg/mL or less.

Infusion
Infuse over 30 minutes.

The reconstituted solution must be diluted immediately after preparation in sodium chloride 9 mg/mL (0.9%) solution. Diluted solutions must be used immediately. Chemical and physical in-use stability of diluted solutions has been demonstrated for 6 hours at room temperature (25°C) or for 24 hours at 2–8°C (refrigerated). From a microbiological standpoint, the product should be used immediately. If not used immediately, storage conditions and duration prior to use are the responsibility of the user and should normally not exceed 24 hours at 2–8°C, unless reconstitution has been carried out under validated aseptic and controlled conditions.

Diluted solutions must be used within 4 hours after removal from refrigeration.
Do not freeze reconstituted Ertapenem Hikma solutions.

Reconstituted solutions should be inspected visually for particulate matter and discoloration whenever solution and container permit. Ertapenem Hikma solutions range from colourless to pale yellow. Colour variations within this range do not affect the potency of the medicinal product.

Any unused medicinal product and waste material derived from this medicinal product must be disposed of in accordance with local regulations.