Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - ertapenem

Document Subject

Generated Narrative: MedicinalProductDefinition mp34b5097700b5b214baa08b9eb1554dbe

identifier: http://ema.europa.eu/identifier/EU/1/22/1656/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Ertapenem SUN 1 g powder for concentrate for solution for infusion

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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part: nan

type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-34b5097700b5b214baa08b9eb1554dbe

identifier: http://ema.europa.eu/identifier/EU/1/22/1656/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - ertapenem

Attesters

What is in this leaflet

1. What Ertapenem SUN is and what it is used for
2. What you need to know before you are given 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

Ertapenem SUN contains ertapenem which is an antibiotic of the beta-lactam group. It has the ability to kill a wide range of bacteria (germs) that cause infections in various parts of the body.

Ertapenem SUN can be given to persons 3 months of age and older.

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

• Infection in the abdomen
• Infection affecting the lungs (pneumonia)
• Gynaecological infections
• Skin infections of the foot in diabetic patients.

Prevention:

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

Do not use Ertapenem SUN

• if you are allergic to the active substance (ertapenem) or 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 infections).

Warnings and precautions Talk to your doctor, nurse or pharmacist before taking Ertapenem SUN.

During treatment, if you experience an allergic reaction (such as swelling of the face, tongue or throat, difficulty in breathing or swallowing, skin rash), tell your doctor straight away as you may need urgent medical treatment.
While antibiotics including Ertapenem SUN kill certain bacteria, other bacteria and fungi may continue to grow more than normal. This is called overgrowth. Your doctor will monitor you for overgrowth and treat you if necessary.

It is important that you tell your doctor if you have diarrhoea before, during or after your treatment with Ertapenem SUN. This is because you may have a condition known as colitis (an inflammation of the bowel). Do not take any medicine to treat diarrhoea without first checking with your doctor.

Tell your doctor if you are taking medicines called valproic acid or sodium valproate (see Other medicines and Ertapenem SUN below).

Tell your doctor about any medical condition you have or have had including:

• Kidney disease. It is particularly important that your doctor knows if you have kidney disease and whether you undergo dialysis treatment.
• Allergies to any medicines, including antibiotics.
• Central nervous system disorders, such as localised tremors, or seizures.

Children and adolescents (3 months to 17 years of age) Experience with Ertapenem SUN is limited in children less than two years of age. In this age group your doctor will decide on the potential benefit of its use. There is no experience in children under 3 months of age.

Other medicines and Ertapenem SUN Tell your doctor if you are taking, have recently taken or might take any other medicines.

Tell your doctor, nurse or pharmacist 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 can affect the way some other medicines work. Your doctor will decide whether you should use Ertapenem SUN in combination with these other medicines.

Pregnancy and breast-feeding If you are pregnant or breast-feeding, 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 the potential benefit justifies the potential risk to the foetus.

Women who are receiving Ertapenem SUN should not breast-feed, because it has been found in human milk and the breast-fed baby may therefore be affected.

Driving and using machines Do not drive or use any tools or machines until you know how you react to the medicine. Certain side effects, such as dizziness and sleepiness, have been reported with Ertapenem SUN, which may affect some patients ability to drive or operate machinery.

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

Ertapenem SUN will always be prepared and given to you intravenously (into a vein) by a doctor or another healthcare professional.

The recommended dose of Ertapenem SUN for adults and adolescents 13 years of age and older is 1 gram (g) given once a day. The recommended dose for children 3 months to 12 years of age is 15 mg/kg given twice daily (not to exceed 1 g/day). Your doctor will decide how many days treatment you need.

For prevention of surgical site infections following surgery of the colon or rectum, 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 as long as your doctor prescribes it.

If you are given more Ertapenem SUN than you should If you are concerned that you may have been given too much Ertapenem SUN, contact your doctor or another healthcare professional immediately.

If you miss a dose of Ertapenem SUN If you are concerned that you may have missed a dose, contact your doctor or another healthcare professional immediately.

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, severe allergic reactions (anaphylaxis), hypersensitivity syndromes (allergic reactions including 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 tell your doctor straight away as you may need urgent medical treatment.

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

• Headache
• Diarrhoea, nausea, vomiting
• Rash, itching
• Problems with the vein into which the medicine is given (including inflammation, formation of a lump, swelling at the injection site, or leaking of fluid into the tissue and skin around the injection site)
• Increase in platelet count
• Changes in liver function tests

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

• Dizziness, sleepiness, sleeplessness, confusion, seizure
• Low blood pressure, slow heart rate
• Shortness of breath, sore throat
• Constipation, yeast infection of 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, abnormal taste
• Changes in some laboratory blood and urine tests

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

• Decrease in white blood cells, decrease in blood platelet count
• Low blood sugar
• Agitation, anxiety, depression, tremor
• Irregular heart rate, increased blood pressure, bleeding, fast heart rate
• Nasal congestion, cough, bleeding from the nose, pneumonia, abnormal breathing sounds, wheezing
• Inflammation of the gall bladder, difficulty in swallowing, faecal incontinence, jaundice, liver disorder
• Inflammation of the skin, fungal infection of the skin, skin peeling, infection of the wound after an operation
• Muscle cramp, shoulder pain
• Urinary tract infection, kidney impairment
• Miscarriage, genital bleeding
• Allergy, feeling unwell, pelvic peritonitis, changes to the white part of the eye, fainting
• The skin may become hard at the site of injection
• Swelling of the skin blood vessels

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

• hallucinations
• decreased consciousness
• altered mental status (including aggression, delirium, disorientation, mental status changes)
• abnormal movements
• muscle weakness
• unsteady walking
• teeth staining

There have also been reports of changes in some laboratory blood tests.

If you experience raised or fluid-filled skin spots over a large area of your body, tell your doctor or nurse straight away.

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

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

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

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

• Headache
• Hot flush, high blood pressure, red or purple, flat, pinhead spots under the skin
• Discoloured faeces, black tar-like faeces
• Skin redness, skin rash
• Burning, itching, redness and warmth at infusion site, redness at injection site
• Increase in platelet count
• Changes in some laboratory blood tests

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

• Hallucinations
• Altered mental status (including aggression)

Reporting of side effects If you get any side effects, talk to your doctor, nurse or pharmacist. 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.

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 label after EXP. The expiry date refers to the last day of that month.

Do not store above 25 C.

What Ertapenem SUN contains 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 .

What Ertapenem SUN looks like and contents of the pack Ertapenem SUN is a off-white to pale yellow powder for concentrate for solution for infusion. Solutions of Ertapenem SUN range from colourless to yellow coloured solutions. Variations of colour within this range do not affect potency.

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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien/ / esk republika/ Danmark/Eesti/ /Hrvatska/Ireland/ sland/ /Latvija/Lietuva/Luxembourg/Luxemburg/Magyarorsz g/ Malta/Nederland/Norge/ sterreich/Portugal/ Slovenija/Slovensk republika/Suomi/Finland/Sverige Sun Pharmaceutical Industries Europe B.V. Polarisavenue 2132 JH Hoofddorp Nederland/Pays-Bas/Niederlande/ /Nizozemsko/ Nederlandene/Holland/ /Nizozemska/The Netherlands/Holland/ /N derlande/Nyderlandai/Pays-Bas/Niederlande/Hollandia/ L-Olanda/Nederland/Nederland/Niederlande/Pa ses Baixos/ Nizozemska/Holandsko/Alankomaat/Nederl nderna/Nederl nderna Tel./ ./tlf./ ./S mi/ ./Tlf./Puh./ +31 (0)23 568 5Deutschland Sun Pharmaceuticals Germany GmbH Hemmelrather Weg 51377 Leverkusen Deutschland Tel. +49 (0) 214 40399 0

Espa a Sun Pharma Laboratorios, S.L.
Rambla de Catalunya 53-08007 Barcelona Espa a tel. +34 93 342 78 France Sun Pharma France 11-15, Quai de Dion Bouton 92800 Puteaux France Tel. +33 1 41 44 44 Italia Sun Pharma Italia Srl Viale Giulio Richard, 3 20143 Milano Italia tel. +39 02 33 49 07 Polska Ranbaxy (Poland) Sp. Z o. o. ul. Kubickiego 02-954 Warszawa
Polska Tel. +48 22 642 07 Rom nia Terapia S.A. Str. Fabricii nr Cluj-Napoca, Jude ul Cluj Rom nia Tel. +40 (264) 501 This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: