ERANZA 1000mg Powder for Solution for Injection/Infusion

What is ERANZA 1000mg

Eranza 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.

How to use ERANZA 1000mg

Eranza will always be prepared and given to you intravenously (into a vein) by a doctor or another healthcare professional. The recommended dose of Eranza for adults and adolescents 13 years of age and older is 1000 mg 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 1000 mg/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 Eranza is 1000 mg administered as a single intravenous dose 1 hour before surgery. It is very important that you continue to receive Eranza for as long as your doctor prescribes it. If you are given more Eranza than you should If you are concerned that you may have been given too much Eranza, contact your doctor or another healthcare professional immediately. If you miss a dose of Eranza If you are concerned that you may have missed a dose, contact your doctor or another healthcare professional immediately.

Mode of Action ERANZA 1000mg

Ertapenem inhibits bacterial cell wall synthesis following attachment to penicillin binding proteins (PBPs). In Escherichia coli, affinity is strongest to PBPs 2 and 3.

ERANZA 1000mg Interactions ERANZA 1000mg

Information not available.

Dosage of ERANZA 1000mg

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Possible side effects of ERANZA 1000mg

Like all medicines, this medicine can cause side effects, although not everybody gets them. Adults 18 years of age and older: Since ertapenem 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. The most common (more than 1 in 100 patients and less than 1 in 10 patients) 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 Less common (more than 1 in 1,000 patients and less than 1 in 100 patients) 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 Side effects reported rarely (more than 1 in 10,000 patients and less than 1 in 1,000 patients) 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. Side effects reported (frequency not known) since ertapenem has been marketed 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. Children and adolescents (3 months to 17 years of age): The most common (more than 1 in 100 patients and less than 1 in 10 patients) side effects are: Diarrhoea Diaper rash Pain at the infusion site Changes in white blood cell count Changes in liver function tests Less common (more than 1 in 1,000 patients and less than 1 in 100 patients) 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 (frequency not known) since ertapenem has been marketed are: Hallucinations Altered mental status (including aggression

ERANZA 1000mg Contraindications ERANZA 1000mg

Do not have Eranza 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 Eranza. 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 Eranza 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 Eranza. 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 Eranza 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 localized tremors, or seizures. Children and adolescents (3 months to 17 years of age) Experience with ertapenem 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 Eranza Always tell your doctor about all medicines that you are taking or plan to take, including those obtained without a prescription. 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 Eranza can affect the way some other medicines work. Your doctor will decide whether you should use Eranza in combination with these other medicines. Pregnancy and breast-feeding It is important that you tell your doctor if you are pregnant or are planning to become pregnant before receiving Eranza. Ertapenem has not been studied in pregnant women. Eranza should not be used during pregnancy unless your doctor decides the potential benefit justifies the potential risk to the foetus. It is important that you tell your doctor if you are breast-feeding or if you intend to breast-feed before receiving Eranza. Women who are receiving ertapenem 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, which may affect some patients’ ability to drive or operate machinery. Eranza contains sodium Eranza contains sodium. Eranza contains approximately 6.0 mEq (approximately 137 mg) of sodium per 1000 mg dose which should be taken into consideration by patients on a controlled sodium diet

Storage of ERANZA 1000mg

Keep this medicine out of the sight and reach of children. Do not store above 25°C. Store in the original package. Do not use this medicine after the expiry date which is stated on the package after “EXP”. The expiry date refers to the last day of that month. Do not use this medicine if you notice any visible signs of deterioration. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.