Abexem ® 1 g Solution

ABEXEM contains ertapenem, which is an antibiotic of the beta-lactam group. Ertapenem can kill a wide range of bacteria (germs) that cause infections in various parts of the body. ABEXEM may be given to persons 3 months of age and older.

Your doctor may have prescribed ABEXEM to you or your child if you have one (or more) of the following types of infection:

• Infection in the abdomen
• Skin infections, including diabetic foot infections
• Infection in the lungs (pneumonia)
• Certain urinary infections
• Acute pelvic infections

ABEXEM should not be administered to you:

• if you are hypersensitive (allergic) to the active substance (ertapenem) or any of the other ingredients of ABEXEM (listed in section 6);
• if you are allergic to other beta-lactam antibiotics such as penicillins, cephalosporins (used to treat various infections);
• if you have bacterial meningitis (infection and inflammation of the membranes and fluid around the brain and spinal cord);
• if you are allergic to lidocaine (lignocaine) hydrochloride (a local anaesthetic). If ABEXEM is injected into the muscle, it is dissolved in lidocaine (lignocaine) injection.

Warnings and precautions

Tell your doctor or healthcare provider before ABEXEM injection is given to you, if you:

• have allergies to other medicines or other substances;
• get an allergic reaction (such as swelling of the face, tongue or throat, trouble breathing or swallowing, skin rash) during treatment (tell your doctor straight away as you may need urgent medical treatment). Serious, sometimes fatal allergic reactions have been reported with ertapenem (contained in ABEXEM). See section 4 ;
• have central nervous system disorders, such as localised tremors (shaking), or seizures (“fits”);
• are taking medicines called valproic acid or divalproex sodium (see “Other medicines and ABEXEM” below);
• have advanced kidney disease and if you get dialysis treatment;
• are going to have an operation that may take longer than 4 hours.

It is important that you tell your doctor if you have diarrhoea before, during or after your treatment with ABEXEM. 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.

ABEXEM kills certain bacteria, but other bacteria and fungi may continue to grow more than normal and cause thrush or diarrhoea. This is called overgrowth. Your doctor will monitor you for overgrowth and treat you if necessary. See section 4 “ Possible side effects ”.

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

There is no experience in children under 3 months of age. Experience with ABEXEM is limited in children less than two years of age.

Other medicines and ABEXEM

Always tell your healthcare provider if you are taking any other medicine. This includes all complementary or traditional medicines.

Tell your doctor if you take:

• valproic acid or divalproex sodium (medicines used to treat epilepsy, bipolar disorder, migraines, or schizophrenia);
• probenecid (a medicine for gout).

This is because ABEXEM can affect the way some other medicines work. Your doctor will decide whether you should use ABEXEM in combination with other medicines.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before receiving ABEXEM. Safety in pregnancy has not been established. ABEXEM is passed into in human breastmilk. Safety in nursing mothers has not been established. If you receive ABEXEM you should not breastfeed your baby as the baby may be affected. There is no information on the effect of ABEXEM on fertility in men and women.

Driving and using machines

Dizziness and sleepiness may be side effects of ABEXEM. If you have these side effects, you should not drive or handle tools or machinery.

ABEXEM contains sodium

ABEXEM contains approximately 6,0 millimoles (approximately 137 mg) of sodium per 1,0 g dose. Tell your doctor if you are on a salt restricted diet.

Do not share medicine prescribed for you with any other person. You will not be expected to give yourself ABEXEM. It will be given to you by a person who is qualified to do so.

Your healthcare provider will prepare ABEXEM and give it to you intravenously (into a vein) or intramuscularly (into a muscle). The recommended dose of ABEXEM 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 however prescribe a dose just suitable for you, or your child. The dose will depend on the type of infection you have and the condition of your kidneys. Your doctor will decide for how long to treat you, or your child. The duration will depend on the type of infection and your response on the treatment. It is very important that you continue to receive ABEXEM for as long as your doctor prescribes it.

If you are given more ABEXEM than you should Since a healthcare provider will administer ABEXEM, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage. If you are concerned that you may have been given too much ABEXEM, contact your doctor or another healthcare provider immediately.

If you miss a dose of ABEXEM Since a healthcare provider will administer ABEXEM, it is unlikely that the dose will be missed. If you are concerned that you may have missed a dose, contact your doctor or another healthcare provider immediately.

ABEXEM can have side effects. Not all side effects reported for ABEXEM are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving ABEXEM, please consult your healthcare provider for advice.

If any of the following happens, stop using ABEXEM and tell your doctor immediately:

• Serious allergic reactions: wheezing, difficulty breathing, swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• “DRESS” (drug rash with eosinophilia and systemic symptoms): This is a serious or life-threatening allergic reaction that may affect your skin or other parts of your body, such as your liver or blood cells. You may have fever, tender swollen glands in the neck, armpits and groin and a rash.
• Serious skin disorders, such as blistering or peeling of the skin, Stevens-Johnson syndrome (a complex allergic reaction, with skin and mucous membrane lesions, which may become severe and may be fatal).
• Severely upset stomach (pseudomembranous colitis). You may have inflammation of the bowels, that could be life-threatening. The symptoms may include severe abdominal pain and diarrhoea, or diarrhoea tinged with blood, vomiting and fever. These are all very serious side effects. If you have them, you may have had a serious reaction to ABEXEM. You may need urgent medical attention.

Adults 18 years of age and older:

Frequent side effects:

• Headache
• Problems with the vein into which the medicine is given (including inflammation, formation of a lump, swelling at the injection site)
• Diarrhoea, nausea, vomiting
• Rash, itching
• Increase in various liver enzymes. Some of the signs may be yellowing of the skin, whites of the eyes, pain or swelling in the abdomen, nausea and vomiting, dark urine, pale-coloured stools.
• Increased blood platelet count. Some of the signs may be headache, numbness of hands or feet, weakness, bleeding in mouth or gums, bloody stool, easy bleeding or bruising, nosebleeds.

Less frequent side effects:

• Yellowing of the eyes and skin (jaundice or a liver disorder)
• Infections, such as oral thrush, vaginal thrush, yeast and fungal infections, wound infection after an operation, urinary tract infection
• Laboratory tests may show very low white cell or blood platelet counts (which may lead to more infections or bleeding)
• Anorexia (eating disorder)
• Low blood sugar
• Sleepiness, sleeplessness
• Anxiety
• Depression
• Confusion
• Seizure, tremor
• Altered taste sensation
• Fainting
• Changes to the white part of the eye
• Slow heart rate, irregular heartbeat, quick heartbeat
• Low or high blood pressure
• Bleeding
• Shortness of breath
• Sore throat, nasal congestion
• Cough, abnormal breathing sounds, wheezing
• Nose bleeds
• Constipation
• Abdominal pain, inflammation of the membrane that lines the abdomen in the pelvic area
• Acid regurgitation, indigestion
• Dry mouth
• Difficulty swallowing
• Faecal incontinence
• Inflammation of the liver and/or the gallbladder
• Skin redness, inflammation
• Muscle cramp, shoulder pain
• Kidney function affected. Problems to urinate or to pass adequate urine (acute renal insufficiency)
• Miscarriage
• Genital bleeding
• Fatigue
• Leaking of fluid into the tissue and skin around the injection site
• Fever, feeling unwell
• Swelling
• Chest pain
• Changes in various laboratory blood and urine tests, indicating for example effects on the liver, kidneys, sugar, blood chemistry, cholesterol.

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

Frequent side effects:

• Diarrhoea, vomiting
• Nappy rash, rash
• Pain at the infusion site
• Changes in white blood cell count, changes in liver function tests.

Less frequent side effects:

• Headache
• Hot flush, high blood pressure
• Discoloured faeces, black tar-like faeces
• Skin redness, skin rash, tiny purple, red, or brown spots on the skin
• Burning, itching, redness and warmth at infusion site, redness at injection site
• Increase in platelet count and changes in other blood clotting tests.

Frequency unknown:

• Hallucinations
• Altered mental status (including aggression).

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 via the online service for adverse drug reaction reporting by following the link: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of ABEXEM.

Store all medicines out of the reach of children.

Vial with powder: Store at or below 25 ºC. Do not freeze. Do not use ABEXEM after the expiry date which is stated on the vial and carton. The expiry date refers to the last day of that month.

After reconstitution: For single use only.

After dilution: Chemical and physical in-use stability for diluted solutions has been demonstrated for 6 hours at or below 25 °C and for 24 hours at 2 to 8 °C (in a refrigerator). Solutions should be used within 4 hours of their removal from the refrigerator. Do not freeze solutions of ABEXEM.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless reconstitution/dilution (etc.) has taken place in controlled and validated aseptic conditions.

Do not use ABEXEM if you notice particulate matter and discolouration in the reconstituted solutions. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).