Ran Meropenem Injection

RAN MEROPENEM contains meropenem. Meropenem belongs to a group of medicines known as carbapenem antibiotics. RAN MEROPENEM is used for treatment of a variety of infections caused by susceptible bacteria. RAN MEROPENEM is used to treat the following in adults and children aged 3 months and older:

• Infection affecting the lungs (pneumonia)
• Complicated urinary tract infections
• Inflammatory infections affecting the pelvic area
• Skin Infections
• Acute bacterial infection of the brain (meningitis)
• A serious bloodstream infection (Septicaemia)
• Infections in the abdomen
• RAN MEROPENEM may be used in the management of neutropenic patients.

RAN MEROPENEM should not be administered to you if:

• if you have ever had an allergic reaction to meropenem or to any of the ingredient in RAN MEROPENEM listed in section 6 of the leaflet (an allergic reaction may include skin rash, itching, swelling of the face, lips, tongue and throat or difficulty breathing). You may also develop allergic reaction to RAN MEROPENEM if you have had in the past, an allergic reaction to other carbapenem antibiotics like imipenem, penicillins or other beta lactam class medicines.
• if you are pregnant, think you might be pregnant or you intend to become pregnant
• if you are currently breast feeding.

Warnings and precautions

Tell your doctor or health care provider before being given the injection:

• if you are suffering from problems with your liver or kidneys.
• if you develop offensive-smelling diarrhoea with fever and abdominal pain during the course of therapy.
• if you suffer from seizures.
• if you have a serious allergic reaction that could lead to heart problems. You may develop a positive test (Coombs test) which indicates the presence of antibodies that may destroy red blood cells. Your doctor will discuss this with you. Please consult doctor, even if these statements were applicable to you at any time in the past.

Children and adolescents

Meropenem should not be administered to infants below 3 months of age.

Other medicines and RAN MEROPENEM

Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines). Take care if you are using any of the following medicines with RAN MEROPENEM:

• Probenecid: You/ your child should not be given RAN MEROPENEM and probenecid (used to treat gout) together. This can increase the levels of meropenem in blood and also prolong it’s duration of action.
• Valproic acid: Meropenem can decrease the blood levels of valproic acid (used for treatment of fits/ convulsions) to less than those required for its beneficial effect.
• RAN MEROPENEM should not be used because it may decrease the effect of sodium valproate.
• Oral anti-coagulant agent (used to treat or prevent blood clots). You should always tell your doctor about other medicines that you are taking with or without prescription. Do not take any medicine, vitamin supplement, or other health preparation without first checking with your doctor.

Pregnancy, breast-feeding 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 being administered with RAN MEROPENEM. You should not be administered RAN MEROPENEM if you are pregnant or you think you might be pregnant. The safe use of RAN MEROPENEM in human pregnancy has not been established. You should not be administered RAN MEROPENEM if you are breast feeding as it is excreted in human breast milk in low concentrations.

Driving and using machines

Some side effects associated with use of RAN MEROPENEM may affect the ability to drive and use machines in some patients. Make sure you know how you react to RAN MEROPENEM before you drive, use machines, or engage in any other activity that could be dangerous if you are not alert.

Do not share medicines prescribed for you with any other person.

Use in adults

The usual dose will depend on the type of infection that you have, where the infection is in the body and how serious the infection is. Your doctor will decide on the dose that you need. The dose for adults is usually between 500 mg to 1 g by intravenous administration every 8 hours. However you may receive a dose less often if your kidneys do not work very well.

Use in children and adolescents

The dose for children over 3 months old and up to 12 years of age is decided using the age and weight of the child. The usual dose is between 10 mg and 40 mg of RAN MEROPENEM for each kilogram (kg) that the child weighs. A dose is usually given every 8 hours. Children who weigh over 50 kg will be given an adult dose. RAN MEROPENEM should not be used in children with kidney problems. You or your child would be given RAN MEROPENEM as an injection into the vein over approximately 5 minutes or by intravenous infusion over a period of 15 to 30 minutes. Your doctor will tell you how long your treatment with RAN MEROPENEM will last. Do not stop treatment early. If you have the impression that the effect of RAN MEROPENEM is too strong or too weak, tell your doctor or pharmacist.

How to use RAN MEROPENEM

• RAN MEROPENEM will be given to you as an injection or infusion into a large vein.
• Your doctor or nurse will normally give RAN MEROPENEM to you.
• Your injection should not be mixed with or added to solutions that contain other medicines. You will not be expected to give yourself RAN MEROPENEM. It will be given to you by a person who is qualified to do so.

If you have been given more RAN MEROPENEM than you should

Since a health care provider will administer RAN MEROPENEM, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you have missed a dose

Since a health care provider will administer RAN MEROPENEM, it is unlikely that the dose will be missed.

If you stop taking RAN MEROPENEM

Since a health care provider will administer RAN MEROPENEM, your doctor will tell you how long your treatment with RAN MEROPENEM will last.

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

If any of the following happen, you should not be given RAN MEROPENEM and you should tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching
• Extremely serious allergic skin reaction (Stevens-Johnson Syndrome)

These are very serious side effects. If you have them you may have had a serious allergic reaction or other type of reaction to RAN MEROPENEM. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Seizure or fits

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:

• Feeling sick (nausea), being sick (vomiting), diarrhoea or constipation and stomach-ache
• Headache
• Tenderness and pain with redness and/or swelling at the site of injection

Less frequent side effects:

• White, cream coloured or yellow spots in the mouth with pain or burning sensation, difficulty in swallowing (caused due to fungal infection of the mouth)
• Itching, burning, and soreness, irritation of the vagina and/or vulva, and a whitish or whitish-gray discharge (fungal infection of the vagina)
• Low numbers of some types of blood cells causing anaemia, increased risk of bleeding or increased risk of infections. Increased numbers of a type of blood cell called an eosinophils.
• Offensive-smelling diarrhoea with fever and abdominal pain
• Abnormal liver function tests
• Abnormal blood counts
• Inflammation of veins with formation of clots
• Numbness, tingling or pins and needles sensation
• Mental confusion

Frequency unknown side effects:

• Increase blood creatinine and urea
• Chest pain in the context of allergic reactions, which may be a symptom of allergy triggered cardiac infarction (Kounis syndrome)

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 or pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of RAN MEROPENEM.

Store all medicines out of reach of children. Before reconstitution dry powder should be stored at below 25 °C. The vial must be stored in the carton until required for use. Freshly prepared solutions of RAN MEROPENEM should be given whenever possible, however, constituted solutions of RAN MEROPENEM, as supplied in injection and infusion vials, maintain satisfactory potency at room temperature (up to 25 °C) or under refrigeration (4 °C) as shown in the table below:

After reconstitution do not freeze. Return any unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).