Cefepime Sandoz Powder for injection
Cefepime Sandoz Powder for injection is a brand of medicine containing the active ingredient cefepime.
Find out more about active ingredients.
Consumer medicine information (CMI) leaflet
Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.
Cefepime hydrochloride powder for injection
Consumer Medicine Information
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Cefepime Sandoz.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you.
Keep this leaflet. You may need to read it again.
WHAT CEFEPIME SANDOZ IS USED FOR
Cefepime Sandoz contains the active ingredient cefepime.
Cefepime belongs to a group of antibiotics called cephalosporins. It works by killing the bacteria that are causing the infection.
This medicine is an injectable antibiotic used to treat serious infections in adults caused by bacteria in the:
- lung (pneumonia and bronchitis)
- kidney and bladder (urinary tract infections)
- abdomen (peritonitis and biliary tract infections)
- womb or vagina
- blood (septicaemia).
It may also be given before surgery or if you have a lack of white blood cells with fever.
Cefepime Sandoz is also used for serious infections in children over 2 months of age caused by bacteria in the:
- lung (pneumonia)
- kidney and bladder (urinary tract infections)
- blood (septicaemia).
It may also be given if the child has a lack of white blood cells with fever.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.
This medicine is not addictive.
This medicine is available only with a doctor’s prescription.
BEFORE YOU ARE GIVEN CEFEPIME SANDOZ
When you must not be given it
Do not receive this medicine if you have an allergy to:
- Cefepime, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description
- beta-lactam or penicillin antibiotics
- any other similar medicines such as cephalosporin antibiotics and penicillin.
Some of the symptoms of an allergic reaction may include:
- shortness of breath
- wheezing or difficulty breathing
- swelling of the face, lips, tongue or other parts of the body
- rash, itching or hives on the skin
Do not receive this medicine after the expiry date printed on the vial or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, it may not work as well.
If you are not sure whether you should start receiving this medicine, talk to your doctor.
Before you are given it
Tell your doctor if you have had any type of allergic reaction to penicillin medicines.
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
- kidney disease
- severe bowel conditions or bowel disease
- frequent infections such as fever, severe chills, sore throat or mouth ulcers or lack of white blood cells (neutropenia).
- a recent bone marrow transplant
- cancer of the blood
- low blood pressure
- if you have ever suffered diarrhoea as a result of taking medicine.
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding. Your doctor can discuss with you the risks and benefits involved.
If you have not told your doctor about any of the above, tell him/her before you are given Cefepime Sandoz.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Cefepime Sandoz may interfere with each other. These include:
- any other antibiotic
- fluid tablets (diuretics) such as Lasix, Midamor or Moduretic.
These medicines may be affected by Cefepime Sandoz or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while receiving and after receiving this medicine.
HOW CEFEPIME SANDOZ IS GIVEN
How much is given
Your doctor will decide what dose you will receive.
The usual dose for an adult is 1 gram given by injection every 12 hours (2 each day) for 7 to 10 days.
The dose for a child aged between 2 months and 12 years will depend on this child’s weight, severity of the infection and medical condition of the child.
How it is given
Cefepime Sandoz is given as a slow injection (or drip) into a vein or as a deep injection into a large muscle.
The injection will be given to you by a nurse or doctor, you will not be giving the injection to yourself.
If you are given too much (overdose)
As Cefepime Sandoz is given to you under the supervision of your doctor, it is very unlikely that you will receive too much. However, if you experience any unexpected or worrying side effects after being given Cefepime Sandoz, telephone your doctor or the Poisons Information Centre (telephone Australia 13 11 26 or New Zealand 0800 POISON or 0800 764766) for advice, or go to Accident and Emergency at the nearest hospital.
You may need urgent medical attention.
WHILE YOU ARE BEING GIVEN CEFEPIME SANDOZ
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are being given Cefepime Sandoz.
If you become pregnant while you are being given this medicine, tell your doctor immediately.
If you are about to have any urine tests for sugar while being given Cefepime Sandoz, make sure your doctor knows which test is used. It may interfere with the results of some tests.
Tell any other doctors, dentists, and pharmacists who treat you that you have been given this medicine.
Tell your doctor, nurse or pharmacist if the following occurs:
- If the symptoms of your infection do not improve within a few days, or if they become worse.
- If you get severe diarrhea, even if it occurs several weeks after Cefepime Sandoz has been stopped. Diarrhoea may mean you have a serious condition affecting your bowel. You may need urgent medical care. Do not take diarrhea medicine without checking with your doctor first.
- If you get a sore white mouth or tongue, or vaginal itching or discharge while receiving or soon after receiving Cefepime Sandoz. This may mean that you have a fungal infection called thrush.
Things to be careful of
Be careful driving or operating machinery until you know how Cefepime Sandoz affects you. This medicine generally does not cause any problems with your ability to drive a car or operate machinery. However, as with other medicines, Cefepime Sandoz may cause dizziness, tiredness, or drowsiness, in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.
Tell your doctor, nurse or pharmacist as soon as possible if you experience any problems while being given Cefepime Sandoz. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor, nurse or pharmacist to answer any questions you may have.
Tell your doctor, nurse or pharmacist as soon as possible if you notice any of the following:
- white, furry, sore tongue and mouth (oral thrush)
- sore and itchy vagina and/or discharge (vaginal thrush)
- itching or burning while passing urine
- cough, sore throat, mouth ulcers
- swelling, pain and inflammation at the site of injection
- any change to your bowel habits - diarrhoea or constipation
- pain in the gut, indigestion or upset stomach
- skin rash or itchiness, skin redness
- sweating feeling unwell, fluid retention, headache, weakness, numbness
- insomnia, anxiety, nervousness, confusion.
The above list includes serious side effects that may require medical attention.
If any of the following happen, tell your doctor or nurse immediately:
- chest pain, increased heartbeat, feeling faint, breathing difficulty, chills, dizziness, asthma.
- Feel confused, suffer hallucinations, twitching muscles or experience a seizure.
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.
Tell your doctor, nurse or pharmacist if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some people.
After treatment with Cefepime Sandoz is finished
Tell your doctor, nurse or pharmacist immediately if you notice any of the following side effects, particularly if they occur several weeks after the treatment with Cefepime Sandoz has finished:
- severe abdominal cramps or stomach cramps
- watery and severe diarrhoea, which may also be bloody
- fever with one or both of the above symptoms.
The above list includes very serious side effects. You may have a serious condition affecting your bowel. You may need urgent medical attention or hospitalisation. These side effects are very rare. Although this side effect is rare, do not take diarrhoea medicine without first checking with your doctor.
AFTER BEING GIVEN CEFEPIME SANDOZ
If you have any queries about any aspect of your medicine, or any questions regarding the information in this leaflet, discuss them with your doctor, nurse or pharmacist.
Cefepime Sandoz will be stored in the pharmacy or on the ward. The powder for injection is kept in a cool dry place, where the temperature stays below 25°C.
The hospital staff will dispose of any unused Cefepime Sandoz.
What it looks like
Cefepime Sandoz comes in 2 types of vials:
- Cefepime Sandoz 1g - 20mL clear glass vial with rubber stopper (latex free) and flip-off aluminium crimp and a white plastic cap, containing a white to pale yellow sterile powder. Available in packs of 1 or 10 vials.
- Cefepime Sandoz 2g - 50mL clear glass bottle with rubber stopper (latex free) and flip-off aluminium crimp and a white plastic cap, containing a white to pale yellow sterile powder. Available in packs of 1 or 10 vials.
Cefepime Sandoz powder for injection is mixed with solution before being given as a injection or being transferred into an infusion bag/glass bottle ready for your infusion in the ward.
- Cefepime Sandoz 1g - 1g cefepime (as hydrochloride)
- Cefepime Sandoz 2g - 2g cefepime (as hydrochloride)
This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.
Your doctor, nurse or pharmacist can inform you what other ingredients are in your injection, infusion bag or glass bottle.
Sandoz Pty Ltd
ABN 60 075 449 553
19 Harris St
Pyrmont NSW 2009
Tel: 1800 634 500
Novartis New Zealand Ltd
Private Bag 65904 Mairangi Bay
Tel: 0800 354 335
This leaflet was prepared in October 2011.
Australian Register Number(s)
Cefepime Sandoz 1g powder for injection: AUST R 171736
Cefepime Sandoz 2g powder for injection: AUST R 171734
CMI provided by MIMS Australia, September 2014