Ertapenem Aspen 1 g Infusion

ERTAPENEM ASPEN contains the active substance ertapenem. ERTAPENEM ASPEN belongs to a group of medicines called antibiotics 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 ASPEN can be given to persons 3 months of age and older.

ERTAPENEM ASPEN should not be administered to you :

• if you are hypersensitive (allergic) to ertapenem or any of the other ingredients of ERTAPENEM ASPEN (listed in section 6).
• if you are hypersensitive (allergic) to any other medicine used to treat bacterial infections (antibiotics such as penicillins, cephalosporins or carbapenems). See Other medicines and ERTAPENEM ASPEN.
• if you have an infection in your brain or spinal cord (bacterial meningitis).
• if you have an abnormal heart beat (heart block) or a severe condition wherein the blood flow to your body is affected (severe shock) e.g. after trauma, severe burns, blood loss.
• if you are hypersensitive (allergic) to medicines that block the sensation of pain (anaesthetics). See Other medicines and ERTAPENEM ASPEN.

ERTAPENEM ASPEN is not recommended in infants under the age of 3 months of age (see section Children and adolescents).

Warnings and precautions

Special care should be taken with ERTAPENEM ASPEN :

• if you are allergic to other antibiotics, such as penicillins, cephalosporins or carbapenems, as you could experience a serious allergic reaction to ERTAPENEM ASPEN. 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.
• if you have a history of fits (seizures) or any abnormal brain tissue.
• if you have kidney problems. It is particularly important that your doctor knows if you have kidney disease and whether you undergo dialysis treatment.
• it is important to tell your doctor if you experience any loose stools or pain in your stomach before, during or after your treatment with ERTAPENEM ASPEN, as these may be signs of an inflammation of the intestines (colitis). Do not take any medicine to treat diarrhoea without first checking with your doctor.
• tell your doctor if you notice a different infection that happens during or immediately after the first infection (superinfection). While antibiotics including ERTAPENEM ASPEN 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.
• if you also take medicine to treat fits (seizures) such as valproic acid or sodium valproate. ERTAPENEM ASPEN may lower the valproic acid levels in your body and put you at risk for fits (seizures). See section Other medicines and ERTAPENEM ASPEN.
• If you have any severe infection, tell your doctor.

Children and adolescents

ERTAPENEM ASPEN is suitable for use in children and adolescents aged 3 months to 17 years. Experience with ERTAPENEM ASPEN 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.

Do not share medicines prescribed for you with any other person. You will not be expected to give yourself ERTAPENEM ASPEN. It will be given to you by a person who is qualified to do so. The usual dose of ERTAPENEM ASPEN in patients aged 13 years and older is 1 gram given once a day.

The usual dose of ERTAPENEM ASPEN in patients aged 3 months to 12 years is 15 mg/kg twice daily (not to exceed 1g/day). Your doctor will decide how many days treatment you need. ERTAPENEM ASPEN may be administered into your vein (intravenous infusion) or into your muscle (intramuscular injection). When administered intravenously, ERTAPENEM ASPEN should be infused over a period of 30 minutes. Your doctor will tell you how long your treatment with ERTAPENEM ASPEN will last. If you have the impression that the effect of ERTAPENEM ASPEN is too strong or too weak, tell your doctor or pharmacist.

If you receive more ERTAPENEM ASPEN than you should In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Since a healthcare provider will administer ERTAPENEM ASPEN, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to use ERTAPENEM ASPEN Since a healthcare provider will administer ERTAPENEM ASPEN, it is unlikely that the dose will be missed.

ERTAPENEM ASPEN can have side effects. Not all side effects reported for ERTAPENEM ASPEN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving ERTAPENEM ASPEN, please consult your healthcare provider for advice. If any of the following happens, stop using ERTAPENEM ASPEN and tell your doctor immediately:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting,
• an allergic reaction to certain medicines, which shows signs of skin rash, fever, swollen lymph nodes, blood abnormalities and inflammation of your organs (Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome or Acute Generalised Exanthematous Pustulosis (AGEP)). These are all very serious side effects. If you have them, you may have had a serious reaction to ERTAPENEM ASPEN. You may need urgent hospitalisation.

Tell your doctor immediately if you notice any of the following:

• cough with phlegm or pus, fever, chills, pain in your chest or difficulty breathing, as these may be signs of an infection in your lungs (pneumonia),
• blood disorders which are usually detected in blood tests, but may be seen as pale skin, tiredness, fever, sore throat and mouth, small red spots on the skin, bruising or prolonged bleeding after injury. Blood disorders (such as leucopenia, thrombocytopenia, neutropenia) may be seen with symptoms of severe chills, mouth ulcers, headache, shortness of breath and dizziness,
• altered mental status including feeling unusually angry which may lead to violent behaviour (aggression), feeling unusually confused and out of touch with your surroundings (delirium), feeling a loss of sense of direction (disorientation),
• depressed level of consciousness,
• inflammation of the outer protective layer of the eye, which can be dangerous if left without treatment (scleral disorders),
• changes in the way your heart beats, for example, if you notice it beating faster.
• abnormal bleeding episode inside or outside of the body (haemorrhage),
• blood clots forming at the site of injection of the medicine into your body, or blood clots in a vein in your body, which shows signs of redness, swelling or pain in the affected area (thrombophlebitis),
• leakage of medicine into the surrounding tissues (extravasation),
• difficulty breathing (dyspnoea),
• abdominal pain or tenderness, bloating or a feeling of fullness (distention) in your abdomen, fever with nausea, vomiting, loss of appetite or diarrhoea. These may be signs of pelvic peritonitis, inflammation of the layer that surrounds your organs in your pelvis.
• changes in liver function tests (elevations in ALT, AST, alkaline phosphatase), which may show signs of stomach pain or swelling, nausea, vomiting, yellow skin or eyes, weakness or dark coloured urine,
• inflammation of the gallbladder which may present with severe pain in the upper-right belly or bloating (cholecystitis),
• yellowing of the skin or whites of the eyes due to liver problems (jaundice),
• kidney failure which may cause you to pass abnormally low amounts of urine, swelling due to fluid collecting in your body, nausea, tiredness or shortness of breath,
• loss of a foetus very early in a pregnancy (abortion),
• abnormal bleeding from the genitals (genital bleeding),
• chest pain. These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• headache,
• diarrhoea, nausea, vomiting,
• inflammation of the vagina which may result in itching or discharge (vaginitis),
• 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).

Less frequent side effects:

• fungal infections, fungal infection of the skin (dermatomycosis), infection of the wound after an operation, urinary tract infection
• inflammation of the colon (pseudo-membranous enterocolitis),
• loss of appetite (anorexia), high or low blood sugar levels (hyperglycaemia, hypoglycaemia),
• confusion, feeling troubled or nervous (agitation), feeling abnormally worried (anxiety), feeling abnormally sad or low (depression),
• dizziness, feeling very sleepy (somnolence), inability to sleep (insomnia), fits (seizures), confusion,
• changes in taste,
• abnormal muscle movement (tremor), fainting (syncope),
• low or high blood pressure (hypotension or hypertension),
• discomfort in the throat (pharyngeal discomfort), stuffy nose (nasal congestion), cough, nose bleeds (epistaxis), abnormal sounds in the lung area when breathing (rales/rhonchi), whistling sound in the lung area when breathing (wheezing),
• fungal infections in the mouth (oral candidiasis),
• difficulty passing stools (constipation), acid reflux, loose stools (diarrhoea), indigestion (dyspepsia), stomach pain, difficulty swallowing (dysphagia), bowel leakage (faecal incontinence),
• skin redness (erythema), itchy skin (pruritis),
• muscle cramps, shoulder pain,
• itching in the vagina (vaginal pruritus),
• abnormal weakness (asthenia), feeling very tired (fatigue), swelling, fever, pain, general feeling of discomfort (malaise),
• 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).

Side effects with an unknown frequency

• seeing or hearing things which are not really there (hallucinations), low level of consciousness, abnormal muscle movements (dyskinesia), quick muscle jerks (myoclonus), changes in the way you walk (gait disturbance),
• teeth stains,
• muscle weakness.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to: SAHPRA: https://www.sahpra.org.za/health-products-vigilance/ Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088 By reporting side effects, you can help provide more information on the safety of ERTAPENEM ASPEN.

Store all medicines out of reach of children.

Storage of unopened vials:

The lyophilised powder in vials should be stored at or below 25 °C.

Storage of reconstituted product:

Single dose preparation: any unused portion should be discarded. Diluted solutions should be used immediately. If not used immediately, in use storage times and conditions are the responsibility of the user. Diluted solutions (approximately 20 mg/ml ertapenem) are physically and chemically stable for 6 hours at room temperature (25 °C) or for 24 hours at 2 °C to 8 °C (in a refrigerator). Solutions should be used within 4 hours of their removal from the refrigerator. Do not freeze solutions of ertapenem.

• Do not store in a bathroom.
• Do not use after the expiry date stated on the label.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).