Details for: MEROPENEM FOR INJECTION
Company: AURO PHARMA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02462893 | MEROPENEM FOR INJECTION | MEROPENEM (MEROPENEM TRIHYDRATE) | 1 G / VIAL | POWDER FOR SOLUTION | INTRAVENOUS |
| 02462885 | 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 500 mg is supplied in 30
mL injection vial.
Meropenem for Injection 1 g is supplied in 40 mL
injection vial.
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.
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, diarrhea, 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 get immediate medical help* |
|---|---|---|---|
| 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) | ✔ | ||
| Rare | |||
| Delirium | ✔ | ||
| 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 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 15° C - 30°C and not frozen.
Reporting 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 three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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
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 (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website www.auropharma.ca, or by calling 1-855-648-6681.
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of Revision: January 08, 2020.