ERTAPENEM SUN 1 g POWDER FOR CONCENTRATE FOR INFUSION SOLUTION

2. What you need to know before you use Ertapenem SUN

Do not use Ertapenem SUN

• 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 (used to treat various infections).

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting treatment with 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 normal. This is called bacterial overgrowth. Your doctor will monitor bacterial overgrowth and treat you if necessary.

It is important that you inform your doctor if you have diarrhea before, during or after your treatment with Ertapenem SUN. This is because you may suffer from a disease known as colitis (inflammation of the intestine). Do not take any medicine to treat diarrhea without consulting your doctor first.

Inform your doctor if you are using medicines called valproic acid or sodium valproate (see below Use of Ertapenem SUN with other medicines).

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 medicine, 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 SUN in children under 2 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 SUN

Inform your doctor if you are taking, have recently taken or might take any other medicines.

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 SUN may affect how other medicines work. Your doctor will decide whether to use Ertapenem SUN in combination with these medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

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 who are receiving Ertapenem SUN should not breastfeed because it has been found in breast milk and may affect the baby.

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 SUN, such as dizziness and drowsiness, which may affect the patient's ability to drive or use machines.

Ertapenem SUN contains sodium

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

3. How to use Ertapenem SUN

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

The recommended dose of Ertapenem SUN for adults and adolescents 13 years of age and older is 1 gram (g) 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 to receive 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 miss a dose of Ertapenem SUN

If you are concerned that you may have missed a dose, consult your doctor or other 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 medicine has been 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 serious 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.

The frequentside 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

The uncommonside effects (may affect up to 1 in 100 people) are:

• Dizziness, drowsiness, 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
• Abdominal pain, fatigue, fungal infection, fever, edema/swelling, chest pain, altered taste.
• Changes in some urine and blood tests

The rareside effects (may affect up to 1 in 1,000 people) are:

• Decrease in white blood cells, decrease in platelet count
• Low blood sugar
• Irritation, 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

The side effects with frequency not known(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
• Unstable gait
• Discolored teeth

Changes in some parameters measured in blood tests have also been reported.

If you develop skin patches filled with fluid or elevated over a large area of your body, inform your doctor or nurse immediately.

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

The 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

The uncommonside 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, itching, redness, and feeling of heat at the infusion site, redness at the injection site
• Increased platelet count
• Changes in some blood tests

The side effects with frequency not known(cannot be estimated from the available data) are:

• Hallucinations
• Altered mental state (including aggression)

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ertapenem SUN

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 and vial after EXP.

The expiry date is the last day of the month stated.

Do not store above 25°C.

6. Contents of the pack and other information

Composition of Ertapenem SUN

• The active substance of Ertapenem SUN is ertapenem 1 g.
• The other ingredients are: sodium hydrogen carbonate (E500) and sodium hydroxide (E524). See section 2 "Ertapenem SUN contains sodium"

Appearance of Ertapenem SUN and pack contents

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

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

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

Not all pack sizes may be marketed.

Marketing authorization holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87, 2132JH Hoofddorp,

Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87, 2132JH Hoofddorp,

Netherlands

Terapia S.A.

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

Romania

You can request more information about this medicine from the local representative of the marketing authorization holder:

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

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

L-Olanda/Nederland/Nederland/Niederlande/Países Baixos/

Nizozemska/Holandsko/Alankomaat/Nederländerna/Nederländerna

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

+31 (0)23 568 5501

Deutschland

Sun Pharmaceuticals Germany GmbH

Hemmelrather Weg 201

51377 Leverkusen

Deutschland

Tel. +49 (0) 214 40399 0

España

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona

España

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

Italia

Sun Pharma Italia Srl

Viale Giulio Richard, 3

20143 Milano

Italia

tel. +39 02 33 49 07 93

Polska

Ranbaxy (Poland) Sp. Z o. o.

ul. Kubickiego 11

02-954 Warszawa

Polska

Tel. +48 22 642 07 75

România

Terapia S.A.

Str. Fabricii nr 124

Cluj-Napoca, Judetul Cluj

România

Tel. +40 (264) 501 500

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

This information is intended only for healthcare professionals:

Instructions for reconstitution and dilution of 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 water for injection or 9 mg/ml (0.9%) sodium chloride injection 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 injection solution;

or

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 injection solution and discard. Transfer the contents of the reconstituted 1 g vial of Ertapenem SUN to the 50 ml vial of 9 mg/ml (0.9%) sodium chloride injection 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 SUN with 10 ml of water for injection or 9 mg/ml (0.9%) sodium chloride injection 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 injection 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 injection 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 injection solution immediately after preparation. The diluted solutions should be used immediately. If not used immediately, the in-use storage times 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 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 SUN range from colorless to yellow. A variation in color within this range does not affect efficacy.

Disposal of unused medicine and all materials that have come into contact with it should be done in accordance with local regulations.