Patient Medication Information: uses, side effects, how to take - Zeftera
ABOUT THIS MEDICATION
What the medication is used for:
ZEFTERA is used for the treatment of bacterial infections. Your doctor prescribed ZEFTERA because you have a serious infection on or just under your skin, often referred to as a complicated skin and skin structure infection (cSSSI).
What it does:
ZEFTERA is a beta-lactam antibiotic that is believed to work by binding to the penicillin-binding proteins of certain bacteria, helping to stop their growth and reduce the infection.
When it should not be used:
Do not use ZEFTERA if:
$ you are allergic to ceftobiprole medocaril or any of its
ingredients;
$ you are allergic to other β-lactam antibiotics such as
penicillins, cephalosporins or carbapenems.
What the medicinal ingredient is:
Ceftobiprole medocaril.
What the nonmedicinal ingredients are:
Citric acid monohydrate and sodium hydroxide.
What dosage forms it comes in:
ZEFTERA is a yellowish or slightly brown coloured powder in a glass vial, ceftobiprole 500mg (as ceftobiprole medocaril). The powder is mixed with water for injections or dextrose 50 mg/ml (5%) solution for injection in the vial to make a solution. The solution is then taken from the vial and added to an infusion bag or other suitable infusion container with sodium chloride 9 mg/ml (0.9%) solution for injection, dextrose 50 mg/ml (5%) solution for injection or Lactated Ringer’s injection infusion solution. The medicine is then given intravenously (into a vein).
WARNINGS AND PRECAUTIONS
Serious and occasionally fatal allergic (hypersensitivity) reactions have been reported in patients receiving β-lactam antibiotics (same class as ZEFTERA). Allergic reactions have also been observed with ZEFTERA use. Talk to your doctor if you have had any previous allergic reactions to penicillins, cephalosporins or other allergens.
Before ZEFTERA is administered, it is important that you tell your doctor if you have diarrhea before, during or after your treatment with ZEFTERA. This is because you may have a condition known as colitis (an inflammation of the bowel). Do not take any medicine to treat diarrhoea without first checking with your doctor.
BEFORE ZEFTERA is administered talk to your doctor if:
- You have other infections. While antibiotics including ZEFTERA kill certain bacteria, other bacteria and fungi may continue to grow more than normal. This is called overgrowth. Your doctor will monitor you for overgrowth and treat you if necessary.
- You have kidney disease or if you are having or have had dialysis.
You are pregnant or are planning to become pregnant.
- You are breast-feeding or if you intend to breast-feed.
- You are taking or have recently taken any other medicines, including medicines you get without a prescription.
- You are under 18 years of age. ZEFTERA should not be given to children or adolescents as there is no experience with the use of ZEFTERA in children.
- You have any allergies to any medicines, including antibiotics
- You have any allergies to this drug or its ingredients
- You have a pre-existing central nervous system disorder as you may experience seizures during treatment with ZEFTERA.
INTERACTIONS WITH THIS MEDICATION
No specific drug interactions with ZEFTERA have been identified yet and no specific drug interaction studies have been conducted. However, the potential for drug interaction with ZEFTERA still exists. Always tell your doctor if you are taking or have recently taken any other medicines, including medicines you get without a prescription.
Co-administration of some cephalosporins (same class as ZEFTERA) with aminoglycosides have caused kidney toxicity. Tell your doctor if you are taking aminoglycosides.
PROPER USE OF THIS MEDICATION
Usual adult dose:
ZEFTERA will always be prepared and given to you by a doctor or another healthcare professional.
The usual dose of ZEFTERA is 500 mg given intravenously (into a vein) over a period of two hours every eight hours, or over a period of an hour every 12 hours, for 7 to 14 days, depending on your condition. Your doctor will decide how long you should be treated. It is very important that you continue to receive ZEFTERA for as long as your doctor prescribes it
In some cases ZEFTERA may be prescribed to patients receiving homecare. The visiting healthcare professional will administer ZEFTERA.
Overdose:
If you are concerned that you may have been given too much ZEFTERA, talk to your doctor or healthcare professional immediately, or contact your local poison control centre.
Missed dose:
If you are concerned that you have missed a dose of ZEFTERA, talk to your doctor or healthcare professional immediately.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, ZEFTERA can cause side effects, although not everybody gets them.
A very common side effect reported in more than 10% of patients receiving ZEFTERA is: nausea
Common side effects (1-10%) include: vomiting, diarrhea, indigestion or heartburn, headache, rash, unusual taste, and reactions in and under the skin where the infusion goes into the vein.
Uncommon side effects (≥0.1% - <1%) include: dizziness, itching, low sodium levels in the blood (hyponatremia), fungal infections (these can be in different parts of your body), allergic (hypersensitivity) reactions (including itching and hives), increase in some liver test enzymes.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or healthcare professional.
| 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 | |||||
| Uncommon | $ Inflammation of bowel with diarrhea (Clostridium difficile colitis). Symptoms: Diarrhea (may have blood and mucous mixed in it); may be accompanied by stomach cramps) | 9 | ||||
$ Serious allergic (hypersensitivity) reactions. Symptoms include: difficulty in breathing, swollen mouth, throat and extremities, severe rash or itching. | 9 | |||||
This is not a complete list of side effects. For any unexpected effects while taking ZEFTERA, contact your doctor or pharmacist.
HOW TO STORE IT
For prepared infusion solutions (i.e. reconstituted and diluted):
Once prepared, ZEFTERA infusion solutions may be stored at room temperature (25ºC), or in the refrigerator (2-8ºC). The length of time the solution can be stored depends on the method of preparation, and the dosing regimen you have been prescribed. It is very important that the prepared infusions are stored properly by the health professional.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:
By toll-free telephone: 866-234-2345
By toll-free fax: 866-678-6789
By email: CanadaVigilance@hc-sc.gc.ca
By regular mail:
Canada Vigilance National Office
Marketed Health Products Safety and Effectiveness Information Bureau
Marketed Health Products Directorate
Health Products and Food Branch
Health Canada
Tunney’s Pasture, AL 0701C
Ottawa, ON K1A 0K9
NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document plus the full Product Monograph, prepared for health professionals can be found at:
http://www.janssen-ortho.com
or by contacting the sponsor, Janssen-Ortho Inc., at: 1-800-567-3331
Janssen-Ortho Inc.
Toronto, Ontario M3C 1L9
Last revised: June 2008
*All trademark rights used under license