Ertapenem Aurobindo

Package leaflet: Information for the user

Ertapenem Aurobindo 1 g powder for concentrate for solution for infusion

Equivalent medicinal product
Please read this leaflet carefully before taking 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.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Ertapenem Aurobindo contains ertapenem, which is an antibiotic belonging to the beta-lactam class.
It is effective against a broad spectrum of bacteria (microorganisms) that cause infections in various parts of the body.
Ertapenem Aurobindo can be administered to patients from the age of 3 months.

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

• Abdominal infections.
• Lung infection (pneumonia).
• Gynecological infections.
• Skin and soft tissue infections of the foot in diabetic patients.

Prophylaxis:
Prevention of surgical site infection in adults following surgery of the colon or rectum.

2. What you need to know before taking Ertapenem Aurobindo

Do not use Ertapenem Aurobindo

• 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 Aurobindo.
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 Aurobindo, are effective against certain bacteria, other bacteria and fungi may grow more than usual. This phenomenon is known as overgrowth. Your doctor will monitor you for such overgrowth and treat you if necessary.
It is important that you inform your doctor if you develop diarrhoea before, during, or after treatment with Ertapenem Aurobindo. This is because you may have a condition known as 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 containing valproic acid or sodium valproate (see "Other medicines and Ertapenem Aurobindo").
Inform your doctor about 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 or are undergoing dialysis treatment.
• Allergies to any medicines, including antibiotics.
• Disorders of the central nervous system, such as localized tremors or seizures.

Children and adolescents (aged between 3 months and 17 years)
Experience with ertapenem is limited in children under two years of age. In this age group, the doctor will decide whether the potential benefit of using the medicine outweighs the risks. There is no experience with use in children under 3 months of age.

Other medicines and Ertapenem Aurobindo
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
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 Aurobindo may affect the way some other medicines work. Your doctor will decide whether Ertapenem Aurobindo should be used in combination with these other medicines.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Ertapenem has not been studied in pregnant women. Ertapenem Aurobindo should not be used during pregnancy unless your doctor decides that the potential benefits justify the possible risks to the fetus.
Women receiving treatment with Ertapenem Aurobindo must not breastfeed, as the medicine has been detected 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.
When using Ertapenem Aurobindo, certain side effects such as dizziness and somnolence have been reported, which may affect the ability to drive or use machinery in some patients.

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

3. How to use Ertapenem Aurobindo

Ertapenem Aurobindo must always be prepared and administered intravenously (into a vein) by a doctor or other healthcare professional.
The recommended dose of Ertapenem Aurobindo for adults and adolescents aged 13 years and older 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 exceeding 1 g per day). Your doctor will decide the number of days needed for treatment.
The recommended dose of Ertapenem Aurobindo for the prevention of surgical site infections following colorectal surgery is 1 g given as a single intravenous dose 1 hour before surgery.
It is very important to continue taking Ertapenem Aurobindo for the entire duration prescribed by your doctor.
If you take more Ertapenem Aurobindo than you should
If you think you have taken too much Ertapenem Aurobindo, contact your doctor or another healthcare professional immediately.
If you forget to take Ertapenem Aurobindo
If you think you have missed a dose, contact 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 aged 18 years and older:
Since the medicine has been marketed, serious allergic reactions (anaphylaxis) and hypersensitivity syndromes (including 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 urgent medical treatment may be required.

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

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

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

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

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

• Decrease in white blood cells in the blood, decrease in platelets in the blood.

• 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, inability to control bowel movements, jaundice, liver disorders.

• Skin inflammation, fungal skin infection, skin peeling, infection of surgical wounds.

• Muscle cramps, shoulder pain.

• Urinary tract infections, kidney dysfunction.

• Abortion, genital bleeding.

• Allergic reaction, feeling unwell, pelvic peritonitis, changes in the white part of the eye, fainting.

• The skin may become hard at the injection site.

• Swelling of blood vessels in 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 certain blood tests have also been reported.
Inform your doctor or nurse immediately if you develop raised or fluid-filled skin lesions over a large area of the body.

Children and adolescents (from 3 months to 17 years of age):
Common side effects (may affect up to 1 in 10 people) are:

• Diarrhoea.
• Diaper dermatitis.
• Pain at the infusion site.
• Changes in the number of white blood cells in the blood.
• Changes in liver function tests.

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

• Headache.
• Hot flushes, high blood pressure, small flat red or red-purple spots under the skin.
• Change in stool colour, black 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, pharmacist, or nurse. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ertapenem Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after "EXP". The expiry date refers to the last day of that month.
Do not store above 30°C.
After reconstitution: reconstituted solutions must be used immediately.
After dilution:
Chemical and physical in-use stability has been demonstrated for diluted solutions for 6 hours at 15 to 25°C or for 24 hours at 2 to 8°C (refrigerated). Solutions should be used within 4 hours after removal from the refrigerator. Do not freeze reconstituted solutions of Ertapenem Aurobindo.
From a microbiological standpoint, unless the method of opening excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the duration and conditions of in-use storage are the responsibility of the user.
Do not use this medicine if you notice the presence of particles or changes in solution colour outside the normal range.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Ertapenem Aurobindo contains
The active substance in Ertapenem Aurobindo is ertapenem 1 g.
Each vial contains 1.0 g of ertapenem.
The other components are: sodium bicarbonate, sodium hydroxide for pH adjustment to 7.6, and sodium hydroxide as a buffering agent.

Description of the appearance of Ertapenem Aurobindo and contents of the pack
Ertapenem Aurobindo is a white to off-white powder for concentrate for solution for infusion.
Solutions of ertapenem range from colourless to pale yellow. Variations in colour within this range do not affect the potency of the medicinal product.
20 ml Type I glass vials with grey bromobutyl rubber stoppers and sealed with an aluminium cap with a polypropylene disc.
Ertapenem Aurobindo is available in packs of 1 vial, 5 vials or 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Eugia Pharma (Malta) Limited
Vault 14, Level 2,
Valletta Waterfront,
Floriana FRN 1914, Malta

Manufacturers:
APL Swift Services (Malta) Limited, HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000, Malta
Generis Farmacêutica, S.A., Rua João de Deus, 19, Amadora 2700-487, Portugal

This medicinal product is authorised in the European Economic Area Member States under the following names:
Czech Republic: Ertapenem Aurovitas
Italy: Ertapenem Aurobindo
France: Ertapenem Arrow 1 g, poudre pour solution à diluer pour perfusion
Portugal: Ertapenem Generis
Poland: Ertapenem Eugia
Romania: Ertapenem Aurobindo 1g pulbere pentru concentrate pentru solutie perfuzabila
Spain: Ertapenem Aurovitas 1 g polvo para concentrado para solución para perfusión
EFG

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

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

Instructions for inserting the needle into the rubber stopper:
To avoid coring of the stopper, when inserting the needle into the rubber stopper, it is recommended to use a needle of gauge 21 or smaller in diameter for reconstitution of the product.
The needle should be inserted only in the centre of the rubber stopper, vertically.

Adults and adolescents (aged 13 to 17 years)
Reconstitution
Reconstitute the contents of one 1 g vial of Ertapenem Aurobindo with 10 ml of water for injections or with 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; or,
For a 50 ml diluent vial: For a 1 g dose, withdraw 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 Aurobindo into 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 one 1 g vial of Ertapenem Aurobindo with 10 ml of water for injections or with 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 per 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 per 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.

After reconstitution:
Reconstituted solutions should be used immediately.

After dilution:
Chemical and physical in-use stability has been demonstrated for 6 hours at controlled room temperature of 15–25°C or for 24 hours at 2–8°C (refrigerated). Solutions should be used within 4 hours after removal from the refrigerator. Do not freeze reconstituted solutions.

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

Reconstituted solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution clarity and container permit.
Solutions of Ertapenem Aurobindo range from colourless to pale yellow. Colour variations within this range do not affect the potency.

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