Details for: MEROPENEM FOR INJECTION
Company: SANDOZ CANADA INCORPORATED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02378795 | MEROPENEM FOR INJECTION | MEROPENEM (MEROPENEM TRIHYDRATE) | 1 G / VIAL | POWDER FOR SOLUTION | INTRAVENOUS |
| 02378787 | MEROPENEM FOR INJECTION | MEROPENEM (MEROPENEM TRIHYDRATE) | 500 MG / VIAL | POWDER FOR SOLUTION | INTRAVENOUS |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
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 non-medicinal ingredients are
Sodium carbonate
What dosage form 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.
- 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.
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.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| 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, StevensJohnson 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 | |||
| 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. | |||
*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
The healthcare professional will store, prepare, dispense, administer and dispose of the medication. Before vials are prepared, the medication should be stored at 15C - 30°C and not frozen.
Reporting side effects
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/healthcanada/services/drugs-health-products/medeffectcanada/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
110 Rue de Lauzon
Boucherville QC
J4B 1E6
Or by e-mail at:
medinfo@sandoz.com
This leaflet was prepared by Sandoz Canada Inc.
Last revised: June 17, 2019