Patient Medication Information: uses, side effects, how to take - Merrem (Pfizer Canada, PM 00045774)
ABOUT THIS MEDICATION
What the medication is used for:
MERREM is used to treat bacterial infections which may occur in the lungs, bladder and kidneys, abdomen, skin, brain (meningitis), female reproductive organs (including infections which may occur after child birth) and infections of the blood which may include the whole body.
Antibacterial drugs like MERREM treat only bacterial infections. They do not treat viral infections. Although you may feel better early in treatment, MERREM should be used exactly as directed. Misuse or overuse of MERREM could lead to the growth of bacteria that will not be killed by MERREM (resistance). This means that MERREM may not work for you in the future.
What it does:
MERREM prevents the formation of the bacterial cell wall, leading to bacterial death and a reduction in the infection.
When it should not be used:
If you are allergic to Meropenem or any of the other ingredients of MERREM.
What the medicinal ingredient is:
Meropenem (as meropenem trihydrate)
What the important nonmedicinal ingredients are:
Sodium carbonate
What dosage forms it comes in:
MERREM is available as an injection for intravenous use (into a large vein) containing either 500 mg or 1 g of meropenem.
MERREM comes in clear, glass vial containers.
WARNINGS AND PRECAUTIONS
BEFORE you use MERREM, talk to your doctor or pharmacist if you:
- have ever had an allergic reaction to any other antibiotic including penecillins, carbapenems or other cephalosporins;
- are taking carbapenems or valproic acid;
have any health problems in particular if you
- have any problems with your kidneys;
have suffered diarrhoea as a result of taking
other antibiotics;
are pregnant or trying to become pregnant;
- are breast-feeding or planning to breastfeed.
While being treated with MERREM:
- tell your doctor immediately if you develop a severe skin rash or blisters.
- Your injection must not be mixed with or added to solutions containing other drugs.
MERREM is not recommended for children under 3 months of age.
- MERREM injections should only be given to the patients for whom it has been prescribed.
- You should only stop receiving MERREM when your doctor tells you.
Driving and using machines
MERREM has been associated with adverse effects such as headache and involuntary muscle movements, shaking or convulsions that could result in loss of consciousness. Do not drive or operate machinery if you have these symptoms.
INTERACTIONS WITH THIS MEDICATION
Tell your doctor or pharmacist about any other medicines you are taking including probenecid (for gout) or sodium valproate (antiepileptic).
PROPER USE OF THIS MEDICATION
Usual dose:
MERREM will be given to you by your doctor or a nurse.
Intravenous injection: this will be dissolved in the liquid specified by your doctor and will be given to you intravenously (in the vein) by the healthcare professional.
The exact dose you are given will be decided by your doctor. It will vary depending on the type of infection that you have, where the infection is in the body and the severity of the infection.
Adults
The dose for adults is usually 500 mg to 1 g given every 8 hours. For meningitis (infection of the brain), the dose is 2 grams given every 8 hours.
The dose for children over 3 months old and up to 12 years of age is decided using the weight of the child. The usual dose range is 10 to 40 mg of MERREM for each kilogram of body weight given every 8 hours.
The dose of MERREM may need to be reduced if your kidneys are not working properly.
Your injections should normally be given at the same times each day.
Overdose:
If you are accidentally given more than the prescribed dose you should talk to a doctor or pharmacist immediately.
| In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
Missed Dose
If you feel an injection was missed during treatment, talk to your (attending) healthcare professional.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, MERREM can have side effects.
Common side effects include: inflammation at site of injection, nausea, vomiting, diarrhoea, skin rash, itchiness, headache, and tingling
Other side effects include: sore veins where MERREM is injected, fungal infections of the mouth or the vagina, rare allergic reactions and very rarely damage to red blood cells. Signs of this include unexpected breathlessness and/or red/brown urine, and should be reported to your doctor immediately.
Occasionally MERREM may be associated with changes in your blood which may require your doctor to do certain blood tests.
Convulsions have been reported very occasionally.
Do not be alarmed by this list of possible events. You may not have any of them.
If you notice any side effects whilst using MERREM please inform your doctor or pharmacist.
If you experience symptoms such as severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness, you may have Clostridium difficile colitis (bowel inflammation). If this occurs, stop taking MERREM and contact your healthcare professional immediately.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
|---|---|---|---|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharma-cist* | ||
| Only if severe | In all cases | |||
| Common | n/a | |||
| Uncommon | Serious hypersensitivity and allergic reactions, occasionally fatal, with symptoms such as severe rash with or without high fever, with itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing | √ | ||
| Seizures | √ | |||
| Inflammation of the colon caused by a bacteria, Clostridium (Pseudomembranous colitis ) | √ | |||
| Severe skin reactions like erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Sudden onset of a severe rash or blistering or peeling skin. This may be associated with a high fever) | √ | |||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM |
|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharma-cist* |
|---|
| Only if severe | In all cases |
|---|---|
| Not Known | |
Serious hypersensitivity reactions involving fever, skin rash, enlarged lymph nodes, and changes in blood tests (increased liver enzymes and white blood cells)†. These may be signs of a multi-organ sensitivity disorder known as DRESS or of a skin reaction known as AGEP. | |
| √ | |
*If you think you have these side effects, it is important that you seek medical advice from your doctor immediately.
†These would only be seen if a blood test was done.
This is not a complete list of side effects. For any unexpected effects while taking MERREM, contact your doctor or pharmacist.
HOW TO STORE IT
The healthcare professional will store, prepare, dispense, administer and dispose of the medication. Before vials are prepared, the medication should be stored at 15°C - 30°C and not frozen.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect. NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice. |
MORE INFORMATION
NOTE: This INFORMATION FOR THE CONSUMER leaflet provides you with the most current information at the time of printing.
For the most current information, the Consumer Information Leaflet plus the full Product Monograph, prepared for health professionals can be found at:
http://www.pfizer.ca
or by contacting the sponsor, Pfizer Canada Inc., at:
1-800-463-6001
Pfizer Canada Inc. Kirkland, Québec H9J 2M5
® Pfizer Ireland Pharmaceuticals
Pfizer Canada Inc., Licensee
© Pfizer Canada Inc. 2018