Label: information for the user

Ertapenem SUN 1 g powder for concentrate for solution for infusion

ertapenem

Read this label carefully before starting to use this medication, as it contains important information for you.

- Keep this label, as you may need to refer to it again.

-If you have any questions, consult your doctor, pharmacist, or nurse.

-This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.

- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

Ertapenem SUN 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 SUN can be administered to individuals aged 3 months and above.

Treatment:

Your doctor has prescribed Ertapenem SUN because you or your child suffer from one (or more) of the following types of infection:

•Abdominal infection

•Pulmonary infection (pneumonia)

•Gynecological infections

•Foot skin infections in diabetic patients

Prevention:

•Prevention of surgical wound infections in adults after colon or rectal surgery.

No use Ertapenem SUN

-if you are allergic to the active ingredient (ertapenem) or any of the other components of this medication (listed in section 6).

-if you are allergic to antibiotics such as penicillins, cephalosporins, or carbapenems (used to treat various infections).

Warnings and Precautions

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

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 SUN, destroy certain bacteria, other bacteria and fungi may continue to grow more than usual. This is known as bacterial overgrowth. Your doctor will monitor bacterial overgrowth and treat you if necessary.

It is essential to inform your doctor if you have diarrhea before, during, or after your treatment with Ertapenem SUN. This is because you may develop a condition 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 belowUse of Ertapenem SUN with other medications).

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

−kidney disease. It is especially important for your doctor to know 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 seizures.

Children and Adolescents (3 months to 17 years of age)

The experience with Ertapenem SUN in children under two years 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 Medications and Ertapenem SUN

Inform your doctor if you are taking, have taken recently, or may need to take any other medication.

Inform your doctor, pharmacist, or nurse if you are taking medications called valproic acid or sodium valproate (used to treat epilepsy, bipolar disorder, migraines, or schizophrenia). This is because Ertapenem SUN may affect how other medications work. Your doctor will decide if Ertapenem SUN should be used in combination with these medications.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

Ertapenem SUN has not been studied in pregnant women. Ertapenem SUN should not be used during pregnancy unless your doctor decides that the potential benefit justifies the potential risk to the fetus.

Women receiving Ertapenem SUN should not breastfeed because it has been found in breast milk and may affect the infant.

Driving and Operating Machines

Do not drive or use any tools or machines until you know how you react to the medication.

Certain adverse effects, such as dizziness and somnolence, associated with Ertapenem SUN may affect patients' ability to drive or operate machines.

Ertapenem SUN contains sodium

This medication contains approximately 158 mg of sodium (main component of table salt/for cooking) in each 1 g dose. This is equivalent to 7.9% of the recommended daily maximum sodium intake for an adult.

Ertapenem SUN will always be prepared and administered by a doctor or other healthcare professional through intravenous (into a vein) injection.

The recommended dose of Ertapenem SUN for adults and adolescents 13 years of age and older is 1 gram administered once a day. The recommended dose for children 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 SUN is 1 g administered as a single intravenous dose 1 hour before surgery.

It is very important that you continue receiving Ertapenem SUN for the entire time your doctor has told you.

If you are given more Ertapenem SUN than you should

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

If you forget a dose of Ertapenem SUN

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Adults 18 years of age and older:

Since the medicine was marketed, severe 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.

Side effectsfrequent(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 leakage of liquid into the surrounding tissue and skin)

•Increased platelet count

•Changes in liver function tests

Side effectsinfrequent(may affect up to 1 in 100 people) are:

•Dizziness, somnolence, insomnia, confusion, convulsions

•Low blood pressure, slow heart rate

•Difficulty breathing, sore throat

•Constipation, oral thrush, antibiotic-associated diarrhea, acid reflux, dry mouth, indigestion, loss of appetite

•Facial flushing

•Vaginal discharge and irritation

•Abdominal pain, fatigue, fungal infections, fever, edema/swelling, chest pain, altered taste.

•Alterations in some urine and blood tests

Side effectsrare(may affect up to 1 in 1,000 people) are:

•Decreased white blood cell count, decreased platelet count in the blood

•Low blood sugar

•Irritability, anxiety, depression, tremor

•Irregular heart rate, increased blood pressure, bleeding, rapid heart rate

•Congestion, cough, nasal bleeding, pneumonia, unusual breathing sounds and pings

•Bile duct inflammation, difficulty swallowing, fecal incontinence, yellow skin discoloration (jaundice), liver disorder

•Skin inflammation, fungal skin infections, skin peeling, post-surgical wound infections

•Muscle cramps, shoulder pain

•Urinary tract infections, kidney insufficiency

•Abortion, genital bleeding

•Allergy, discomfort, 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

Side effectsfrequency not known(cannot be estimated from available data) are:

•Hallucinations

•Decreased level of consciousness

•Altered mental state (including aggression, delirium, disorientation, changes in mental state)

•Abnormal movements

•Muscle weakness

•Unstable gait

•Stained teeth

Also, changes in some blood parameters have been reported.

If you experience blisters filled with fluid or raised on a large area of your body, inform your doctor or nurse immediately.

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

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

•Diarrhea

•Diaper rash

•Pain at the infusion site

•Changes in white blood cell count

•Changes in liver function tests

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

•Headache

•Headaches, high blood pressure, small, smooth, red or purple spots under the skin

•Colored stools, black stools like tar

•Facial flushing, 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 effectsfrequency not known(cannot be estimated from available data) are:

•Hallucinations

•Altered mental state (including aggression)

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and on the vial after CAD.

The expiration date is the last day of the month indicated.

Do not store at a temperature above 25 °C.

Composition of Ertapenem SUN

- The active substance of Ertapenem SUN is ertapenem 1 g.

- The other components are: sodium hydrogen carbonate (E500) and sodium hydroxide (E524). See section 2 “Ertapenem SUN contains sodium”

Appearance of Ertapenem SUN and contents of the container

Ertapenem SUN is a powder for concentrate for solution for infusion, white to pale yellow in color.

The solutions of Ertapenem SUN vary from colorless to yellow. Variations of color within this range do not affect efficacy.

Ertapenem SUN is presented in vials of 1 vial or 10 vials.

Only some sizes of containers may be marketed.

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87, 2132JH Hoofddorp,

Netherlands

Responsible Person

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87, 2132JH Hoofddorp,

Netherlands

Terapia S.A.

Str. Fabricii nr. 124, Cluj-Napoca, 400632,

Romania

Contact the local representative of the Marketing Authorization Holder for further information about this medicinal product:

Netherlands/Holland/Ολλανδ?α/Nizozemska/The Netherlands/Holland/

Ολλανδ?α/Niderlande/Nyderlandai/Pays-Bas/Niederlande/Hollandia/

L-O landa/Nederland/Nederland/Niederlande/Países Baixos/

Nizozemska/Holandsko/Alankomaat/Nederländerna/Nederländerna

Tel./???./tlf./τηλ./Sími/τηλ./Tlf./Puh./

+31 (0)23 568 5501

Germany

Sun Pharmaceuticals Germany GmbH

Hemmelrather Weg 201

51377 Leverkusen

Germany

Tel. +49 (0) 214 40399 0

Spain

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona

Spain

tel. +34 93 342 78 90

France

Sun Pharma France

31 Rue des Poissonniers

92200 Neuilly-Sur-Seine

France

Tel. +33 1 41 44 44 50

Italy

Sun Pharma Italia Srl

Viale Giulio Richard, 3

20143 Milano

Italy

tel. +39 02 33 49 07 93

Poland

Ranbaxy (Poland) Sp. Z o. o.

ul. Kubickiego 11

02-954 Warszawa

Poland

Tel. +48 22 642 07 75

Romania

Terapia S.A.

Str. Fabricii nr 124

Cluj-Napoca, Judetul Cluj

Romania

Tel. +40 (264) 501 500

Last update of the summary of product characteristics:

The detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

This information is intended solely for healthcare professionals:

Instructions for reconstituting and diluting Ertapenem SUN:

For single use.

Preparation for intravenous administration: :

Ertapenem SUN must be reconstituted and then diluted before administration.

Adults and adolescents (13 to 17 years of age)

Reconstitution: :

Reconstitute the contents of the 1 g vial of Ertapenem SUN with 10 ml of injectable water 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 dose of 1 g, transfer the contents of the reconstituted vial immediately to a 50 ml bag of 9 mg/ml (0.9 %) sodium chloride solution;

or

For a 50 ml diluent vial: :

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 SUN reconstituted to 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)

Reconstitute the contents of the 1 g vial of Ertapenem SUN with 10 ml of injectable water 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 of 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 diluent vial: transfer a volume equivalent to 15 mg/kg of 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 diluted solutions must be used immediately. If not used immediately, the storage times in use are the responsibility of the user. The 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 the refrigerator). Once removed from the refrigerator, the solutions must be used within 4 hours. Do not freeze the reconstituted solutions.

Whenever the container permits, the reconstituted solutions must be visually inspected before administration for the presence of particles or discoloration. The solutions of Ertapenem SUN vary from colorless to yellow. A variation of color within this range does not affect efficacy.

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