ERTAPENEM SUN

Package leaflet: Information for the user

Ertapenem SUN 1 g powder for concentrate for solution for infusion

ertapenem
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 pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

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

Ertapenem SUN contains ertapenem, 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 SUN can be administered to individuals aged 3 months and older.

Treatment:
Your doctor has prescribed Ertapenem SUN 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

Prophylaxis:

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

2. What you need to know before using 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 (which are used to treat various types of infections).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Ertapenem SUN.
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 SUN, are effective against certain bacteria, other bacteria and
fungi may continue to grow more than usual. This phenomenon is known as overgrowth. Your doctor
will monitor you for such overgrowth and treat it if necessary.
It is important that you inform your doctor if you develop diarrhoea before, during, or after treatment
with Ertapenem SUN. This is because you may have a condition known as colitis (inflammation of the
intestine). Do not use any medicine to treat 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 SUN).
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 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 (aged between 3 months and 17 years)
Experience with Ertapenem SUN is limited in children under two years of age. In this age group, the doctor must decide whether the potential benefit of using the medicine outweighs the risks. There is no experience with 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, nurse, or pharmacist if you are taking medicines containing valproic acid or sodium valproate (used to treat epilepsy, bipolar disorders, migraine, or schizophrenia). This is because Ertapenem SUN may affect the way some other medicines work. Your doctor will decide whether Ertapenem SUN 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 SUN has not been studied in pregnant women. Ertapenem SUN 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 SUN must not breastfeed, 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 drowsiness have been reported with the use of Ertapenem SUN; in some patients, these effects may impair the ability to drive or use machinery.

Ertapenem SUN contains sodium
This medicine contains approximately 158 mg of sodium (the main component of table salt) per 1 g dose. This corresponds to 7.9% of the maximum daily dietary intake recommended for an adult.

3. How to use Ertapenem SUN

Ertapenem SUN must 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 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). The physician will determine the necessary
duration of treatment.
The recommended dose of Ertapenem SUN for the prevention of surgical site infections following
surgery on the colon or rectum is 1 g given as a single intravenous dose 1 hour before surgical incision.
It is very important to continue using Ertapenem SUN for the entire duration prescribed by the doctor.
If you use more Ertapenem SUN than you should
If you think you have used too much Ertapenem SUN, contact your doctor or a healthcare professional immediately.
If you forget to use Ertapenem SUN
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 gets them.
Adults aged 18 years and older:
Since the medicine was placed on the market, severe allergic reactions (anaphylaxis) and hypersensitivity syndromes (allergic reactions including skin rash, fever, abnormal blood tests) have been reported. Early signs of a severe allergic reaction may include swelling of the face and/or throat. If these symptoms occur, inform your doctor immediately, as you may require urgent medical treatment.

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 was injected (including inflammation, swelling, injection site swelling or leakage of fluid into the surrounding tissues and skin)
• 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 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, 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, 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, yellowing of the skin and mucous membranes, 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 reactions, malaise, 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):

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

Changes in 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 white blood cell count
• 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 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):

• Hallucinations
• Altered mental state (including aggression)

Reporting of side effects
If you get any side effects, 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 referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ertapenem SUN

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 label of the
vial after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.

6. Package contents and other information

What Ertapenem SUN contains
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".
Description of the appearance of Ertapenem SUN and contents of the pack
Ertapenem SUN is a white to pale yellow lyophilized powder for concentrate for solution for infusion.
Solutions of Ertapenem SUN range from colourless to yellow. Colour variations within this range do not affect the potency of the drug.
Ertapenem SUN is supplied in packs of 1 vial or 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87, 2132JH Hoofddorp,
The Netherlands
Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87, 2132JH Hoofddorp,
The Netherlands
Terapia S.A.
Str. Fabricii nr. 124, Cluj-Napoca, 400632,
Romania
For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien/България/Česká republika/
Danmark/Eesti/Ελλάδα/Hrvatska/Ireland/Ísland/
Κύπρος/Latvija/Lietuva/Luxembourg/Luxemburg/Magyarország/
Malta/Nederland/Norge/Österreich/Portugal/
Slovenija/Slovenská republika/Suomi/Finland/Sverige
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/
Nederlandene/Holland/Ολλανδία/Nizozemska/The Netherlands/Holland/
Ολλανδία/Nīderlande/Nyderlandai/Pays-Bas/Niederlande/Hollandia/
L-Olanda/Nederland/Nederland/Niederlande/Países Baixos/
Nizozemska/Holandsko/Alankomaat/Nederländerna/Nederländerna
Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./
+31 (0)23 568 5501
Deutschland
Sun Pharmaceuticals Germany GmbH
Hemmelrather Weg 201
51377 Leverkusen
Germany
Tel. +49 (0) 214 40399 0
España
Sun Pharma Laboratorios, S.L.
Rambla de Catalunya 53-55
08007 Barcelona
Spain
tel. +34 93 342 78 90
France
Sun Pharma France
11-15, Quai de Dion Bouton
92800 Puteaux
France
Tel. +33 1 41 44 44 50
Italia
Sun Pharma Italia Srl
Viale Giulio Richard, 3
20143 Milano
Italy
tel. +39 02 33 49 07 93
Polska
Ranbaxy (Poland) Sp. Z o. o.
ul. Kubickiego 11
02-954 Warszawa
Poland
Tel. +48 22 642 07 75
România
Terapia S.A.
Str. Fabricii nr 124
Cluj-Napoca, Judeţul Cluj
Romania
Tel. +40 (264) 501 500
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu .

The following information is intended exclusively for physicians and healthcare professionals:
Instructions for reconstitution and dilution of Ertapenem SUN:
For single use only.
Preparation for intravenous administration:
Ertapenem SUN 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 vial of Ertapenem SUN with 10 mL of water for injections or with 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 diluent 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 injection 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 injection solution and discard. Transfer the contents of the reconstituted 1 g Ertapenem SUN vial into the 50 mL vial of 9 mg/mL (0.9%) sodium chloride injection solution.
Infusion
Administer by infusion over 30 minutes.
Children (3 months to 12 years of age)
Reconstitution
Reconstitute the contents of one 1 g vial of Ertapenem SUN with 10 mL of water for injections or with 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 diluent bag: Transfer a volume equivalent to 15 mg/kg body weight (not exceeding 1 g/day) into a bag containing 9 mg/mL (0.9%) sodium chloride injection 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/day) into a vial containing 9 mg/mL (0.9%) sodium chloride injection 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 9 mg/mL (0.9%) sodium chloride injection solution. Diluted solutions must be used immediately. If not used immediately, storage times during use are the responsibility of the user. Diluted solutions (approximately 20 mg ertapenem/mL) are physically and chemically stable for 6 hours at room temperature (25°C) or for 24 hours between 2°C and 8°C (refrigerated). Solutions must be used within 4 hours after removal from refrigeration. Do not freeze reconstituted solutions.
The reconstituted solution should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. Solutions of Ertapenem SUN range from colourless to yellow. Colour variations within this range do not affect the potency.
Any unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.