Patient Medication Information: uses, side effects, how to take - Meropenem for Injection (Sandoz Canada)
ABOUT THIS MEDICATION
What the medication is used for:
Meropenem for Injection 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 Meropenem for Injection treat only bacterial infections. They do not treat viral infections. Although you may feel better early in treatment, Meropenem for Injection should be used exactly as directed. Misuse or overuse of Meropenem for Injection could lead to the growth of bacteria that will not be killed by Meropenem for Injection (resistance). This means that Meropenem for Injection may not work for you in the future.
What it does:
Meropenem for Injection 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 Meropenem for Injection.
What the medicinal ingredient is:
Meropenem (as meropenem trihydrate)
What the nonmedicinal ingredients are:
Sodium carbonate
What dosage forms it comes in:
Meropenem for Injection is available as an injection for intravenous use (into a large vein) containing either 500 mg or 1 g of meropenem.
Meropenem for Injection is supplied in glass vials.
WARNINGS AND PRECAUTIONS
BEFORE you use Meropenem for Injection, 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 Meropenem for Injection:
- 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.
Meropenem for Injection is not recommended for children under 3 months of age.
- Meropenem for Injection should only be given to the patients for whom it has been prescribed.
- You should only stop receiving Meropenem for Injection when your doctor tells you.
Driving and using machines
Meropenem for Injection 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:
Meropenem for Injection 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 Meropenem for Injection for each kilogram of body weight given every 8 hours.
The dose of Meropenem for Injection 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.
If you think you have taking too much Meropenem for Injection, contact your healthcare professional, 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, Meropenem for Injection can have side effects.
Common side effects include: inflammation at site of injection, nausea, vomiting, diarrhoea, skin rash, headache, and tingling
Other side effects include: itchiness, abdominal pain, sore veins where Meropenem for Injection 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 Meropenem for Injection may be associated with changes in your blood which may require your doctor to do certain blood tests.
Convulsions have been reported 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 Meropenem for Injection 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 Meropenem for Injection 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 pharmacist * | ||
| Only if severe | In all cases | |||
| Common | n/a | |||
| Uncommon | Serious hypersensitivit y 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 (Pseudomemb ranous 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) | ✓ | |||
| Rare | Delirium | ✓ | ||
| 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 pharmacist * | ||
Only if severe | In all cases | |||
| Not Known | Serious hypersensitivit y 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. | ✓ | ||
| 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 pharmacist * | ||
Only if severe | In all cases | |||
Severe Cutaneous Adverse Reactions (SCAR) (severe skin reactions that may also affect other organs):
blistering (with or without pus) which may also affect your eyes, mouth, nose or genitals, itching, severe rash, bumps under the skin, skin pain, skin color changes (redness, yellowing, purplish) -Swelling and redness of eyes or face -Flu-like feeling, fever, chills, body aches, swollen glands, cough -Shortness of breath, chest pain or discomfort | ✓ | |||
*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 Meropenem for Injection, 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 Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
Visiting the Web page on Adverse Reaction
Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
If you want more information about Meropenem for Injection:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this consumer Information by visiting the Health Canada website; the manufacturer’s website www.sandoz.ca, or by calling1-800-361-3062
or by written request at:
110 Rue de Lauzon
Boucherville QC
J4B 1E6
Or by e-mail at:
medinfo@sandoz.com