Merozin Solution

MEROZIN contains the active ingredient meropenem. Meropenem belongs to a group of medicines called carbapenem antibiotics. It works by killing bacteria, which can cause serious infections.

MEROZIN is prescribed by doctors for bacterial infections in adults and children.

These infections may occur in the lungs, bladder and kidney, abdomen, skin, brain or female reproductive organs. For certain infections your doctor may also prescribe an aminoglycoside type of antibiotic (for example, gentamycin, tobramycin, streptomycin).

MEROZIN should not be administered to you:

• if you are allergic (hypersensitive) to meropenem or any of the other ingredients of MEROZIN (listed in section 6).
• if you are allergic (hypersensitive) to other antibiotics such as penicillins, cephalosporins, or carbapenems, as you may also be allergic to MEROZIN.
• if you are pregnant or breastfeeding (see Pregnancy, breastfeeding and fertility).

Warnings and precautions

Take special care with MEROZIN:

• if you have ever had an allergic reaction to any other antibiotics;
• if severe diarrhoea develops during treatment, consult your doctor immediately as this may be a symptom of a condition called pseudomembranous colitis that could be life-threatening. Do not take any medication to stop the diarrhoea. (See POSSIBLE SIDE EFFECTS);
• if you have kidney problems or receive dialysis for kidney failure, as your doctor may want to adjust your dose;
• if you have liver problems as your doctor will need to closely monitor your condition;
• if you have epilepsy and are taking valpromide (valproic acid) as MEROZIN should not be administered at the same time (see Other medicines and MEROZIN).

You may develop signs and symptoms of severe skin reactions (see POSSIBLE SIDE EFFECTS). If this happens, talk to your doctor or nurse immediately so that they can treat the symptoms.

You may develop a positive blood test (“Coombs test”) which indicates the presence of antibodies that may destroy red blood cells. Your doctor will discuss this with you.

If you are not sure if any of the above apply to you, talk to your doctor or nurse before MEROZIN is administered to you.

Children and adolescents :

Safety and efficacy have not been established in children less than 3 months old and MEROZIN is not recommended for children younger than 3 months.

You will not be expected to give yourself MEROZIN. It will be given to you by a person who is qualified to do so.

Your doctor will tell you how long your treatment with MEROZIN will last.

Your doctor will determine the dose you require. The dose depends on the type of infection that you have, where the infection is in the body and how serious the infection is. Your doctor will also take into account your kidney function.

MEROZIN will be given to you as an injection or infusion into a large vein.

Your healthcare provider will ensure that the injection is not mixed with, or added to, solutions that contain other medicines.

The injection may take about 5 minutes and the infusion between 15 and 30 minutes. You should normally have your injections at the same times each day.

Safety and efficacy in babies under 3 months have not been established and MEROZIN is therefore not recommended in this age group.

If you are given more MEROZIN than you should

Since a healthcare provider will administer MEROZIN, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you missed a dose of MEROZIN

Since a healthcare provider will administer MEROZIN, it is unlikely that the dose will be missed.

MEROZIN can have side effects.

Not all side effects reported for MEROZIN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using MEROZIN, please consult your doctor, pharmacist or other healthcare provider for advice.

If any of the following happens, tell your doctor or nurse immediately, as he/she may decide to stop administering MEROZIN:

Severe allergic reactions:

• Swelling of the face, lips, tongue or other parts of the body.
• Shortness of breath, wheezing or trouble breathing.
• Severe rash, itching or hives on the skin.
• Serious allergic skin reactions which include:
• Fever, skin rash, and changes in the blood tests that check how the liver is working (increased levels of liver enzymes) and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes. These may be signs of a multi-organ sensitivity disorder known as “Drug reaction with eosinophilia and systemic symptoms” (DRESS) - syndrome.
• Severe red scaly rash, itching, skin bumps that contain pus, blisters or peeling of the skin (erythema multiforme), sometimes also with fever and joint pains.
• Severe skin rashes that can appear as reddish circular patches (often with central blisters on the trunk), skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome) or a more severe form (toxic epidermal necrolysis).

Damage to red blood cells:

The signs include breathlessness when you do not expect it, red or brown urine, yellowing of skin and eyes, abnormal paleness, fever (haemolytic anaemia).

Apnoea:

Breathing stops and starts while sleeping.

Pseudomembranous colitis:

Watery diarrhoea, bloody stools, and fever. These are all very serious side effects. If you have them, you may have had a serious reaction to MEROZIN. You may need urgent medical attention or further hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects

• Unexplained bruising, bleeding (thrombocythaemia)
• Headache
• Diarrhoea
• Abdominal (stomach) pain
• Feeling sick (nausea)
• Being sick (vomiting)
• Constipation
• Blood tests show that you liver is not functioning well
• Skin rash, itchy skin
• Pain and inflammation

Less frequent side effects

• Infections of the mouth (white lesions on the inside of your mouth) or the vagina (itchiness and a thick white discharge) that are caused by a fungus (thrush)
• Sore throat
• Other changes in your blood. Some signs are frequent infections, high temperature and sore throat (agranulocytosis). Your doctor may do blood tests from time-to-time
• Bruising easily (thrombocytopenia)
• Changes in your blood. These include less blood platelets (this 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
• Low blood sugar
• Acute disorientation and confusion (delirium)
• A tingling feeling (pins and needles)
• Fits (convulsions)
• Nose bleeding
• Inflammation of the bowel with diarrhoea
• Skin rashes or other skin conditions, such as flushing, hives, itching, dry skin
• Blood tests showing that kidneys are not functioning well
• Pain at the injection site.

Frequency unknown:

• Reduced sense of touch and sensation (numbness), cold/blue/aching feet when resting, sore legs or feet (symptoms of a blood circulation disorder).

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 Med Safety APP (Medsafety X SAHPRA) and the eReporting platform (who-umc.org) found on the SAHPRA website. By reporting side effects, you can help provide more information on the safety of MEROZIN.

Storage will be handled by healthcare providers.

Dry powder: Store all medicines out of reach of children. Store at or below 25 °C. Do not freeze. Keep the vial in the outer carton in order to protect from light.

Reconstituted solution: The reconstituted solution should be used immediately. Do not freeze the reconstituted solution. Single use only. Discard any unused portion.

Do not use MEROZIN after the expiry date which is stated on the container. The expiry date refers to the last day of that month.

Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).