Meropenem 500 mg/1000 mg Solution

MEROPENEM SHANUR contains meropenem trihydrate. MEROPENEM SHANUR belongs to a group of medicines called carbapenem antibiotics. It works by killing bacteria, which can cause serious infections.

You should not be administered MEROPENEM SHANUR • if you are hypersensitive (allergic) to meropenem or any of the ingredients of MEROPENEM SHANUR (listed in section 6). • if you are allergic to penicillins or any other antibiotics known as beta-lactams.

Warnings and precautions

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

• if your child is under 3 months of age, as the safety and efficacy of MEROPENEM SHANUR in children under 3 years have not been established.
• if you have had allergic reactions to penicillins or any other antibiotics known as beta-lactams.
• if you have health problems, such as liver or kidney problems.

Tell your doctor immediately • if you develop seizures during treatment with MEROPENEM SHANUR. • if you develop severe diarrhoea, do not treat with antidiarrhoeal medicines. You may develop a positive antiglobulin test which indicates the presence of antibodies in your blood that may destroy red blood cells. Your doctor will monitor you and will discuss this with you. If you are not sure if any of the above applies to you, talk to your doctor or nurse before being given MEROPENEM SHANUR.

Using other medicines with MEROPENEM SHANUR

Always tell your health care provider if you are taking any other medicine. (This includes complementary or traditional medicines).

In particular, tell your doctor, pharmacist or nurse if you are taking any of the following medicines:

• Probenecid (used to treat gout), as it may lessen the effects of MEROPENEM SHANUR
• Valproic acid/sodium valproate/valpromide (used to treat epilepsy). MEROPENEM SHANUR should not be used because it may decrease the effect of sodium valproate.
• Oral anti-coagulant medicines (used to treat or prevent blood clots).

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding your baby, please consult your health care provider for advice before MEROPENEM SHANUR is administered to you. It is preferable to avoid the use of MEROPENEM SHANUR during pregnancy. Your doctor will decide whether you should use MEROPENEM SHANUR. It is important that you tell your doctor if you are breastfeeding or if you intend to breastfeed before receiving MEROPENEM SHANUR. MEROPENEM SHANUR may pass into the breast milk and it may affect the baby. Therefore, your doctor will decide whether you should use MEROPENEM SHANUR while breastfeeding.

Driving and using machines

No studies on the effect on the ability to drive and use machines have been performed. However, Meropenem has been associated with headache; tingling or pricking skin (paraesthesia); and involuntary muscle movements, leading the person’s body to shake rapidly and uncontrollably (convulsions) that are usually accompanied with a loss of consciousness, and any of these could affect your ability to drive or operate machines.

MEROPENEM SHANUR contains sodium. MEROPENEM SHANUR contains sodium. This should be taken into consideration by patients on a controlled sodium diet.

Do not share medicines prescribed for you with any other person. Carefully follow all instructions given to you by your doctor, nurse or pharmacist. MEROPENEM SHANUR will be given to you as an injection or infusion into a large vein. You will not be expected to give yourself MEROPENEM SHANUR. It will be given to you by a person who is qualified to do so. The usual dose is by intravenous administration every 8 hours depending 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.

Adults

The dose for adults is usually between 500 mg (milligrams) and 2 g (gram). You will usually receive a dose 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 MEROPENEM SHANUR 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. The injection may take about 5 minutes or between 15 and 30 minutes. If you have the impression that MEROPENEM SHANUR is too strong or too weak, tell your doctor or pharmacist.

If you are given more MEROPENEM SHANUR than you should

Since a healthcare professional will administer MEROPENEM SHANUR, he/she will control the dosage, and it is unlikely that you will be given too much. However, in the event of over-dosage, your doctor will manage the over-dosage.

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

If any of the following happens, while or after receiving MEROPENEM SHANUR, tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing and breathing,
• severe rash, itching or hives on the skin,
• fainting.

These are very serious side effects. If you have them, you may have had a serious allergic reaction to MEROPENEM SHANUR. 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:

Less frequent side effects:

• severe diarrhoea containing blood and/or mucus,
• fits (convulsions),
• feeling tired all the time, pale skin, fever, breathlessness, confusion. These may be signs of a decrease in red blood cells (haemolytic anaemia).
• fever (high temperature) and sore throat with a rash, that develops quickly, with itching and peeling or flaking of your skin and possibly blistering of the mouth and the genital and anal regions. Your eyes may also be affected and may be red and swollen. These may be signs of a potentially life-threatening rash called Stevens Johnson Syndrome.

Other serious skin reactions:

• blistering of the skin, severe skin reaction (toxic epidermal necrolysis),
• skin rash accompanied by other symptoms such as fever, swollen glands and an increase of eosinophils (a type of white blood cell). The rash appears as small, itchy red bumps (drug reaction with eosinophilia and systemic symptoms (DRESS)).

These are serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• abdominal (stomach) pain, feeling sick (nausea), being sick (vomiting), diarrhoea,
• headache,
• skin rash, itchy skin,
• pain and inflammation,
• increased numbers of platelets in your blood (shown in a blood test),
• changes in blood tests, including tests that show how well your liver is working.

Less frequent side effects:

• hives,
• pain at the injection site, inflammation of a clot in a vein,
• changes in your blood. These include reduced numbers of platelets (which may make you bruise more easily), increased numbers of some white blood cells, decreased numbers of other white cells and increased amounts of a substance called ‘bilirubin’. Your doctor may do blood tests from time to time,
• changes in blood tests, including tests that show how well your kidneys are working,
• a tingling feeling (pins and needles),
• infections of the mouth or the vagina that are caused by a fungus (thrush).

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

Store all medicines out of reach of children. Store at or below 30 °C. Your doctor, pharmacist or healthcare professional knows how to store MEROPENEM SHANUR. The healthcare professional who is administering MEROPENEM SHANUR to you will make sure that the medicine is not used after the expiry date printed on the vial. They will also reconstitute MEROPENEM SHANUR and visually inspect the solution before giving it to you. Only clear solution without particles will be used.