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Ceftriaxone Sandoz

ceftriaxone sodium powder for injection
Consumer Medicine Information

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Ceftriaxone Sandoz. It does not contain all the information that is known about Ceftriaxone Sandoz. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What Ceftriaxone Sandoz is used for

The name of your medicine is Ceftriaxone Sandoz. It contains the active ingredient ceftriaxone sodium.
Ceftriaxone Sandoz is an antibiotic used to treat infections in different parts of the body caused by bacteria.
Ceftriaxone Sandoz is also used to prevent infections before, during and after surgery.
Ceftriaxone Sandoz belongs to a group of antibiotics called cephalosporins. These antibiotics work by killing the bacteria that are causing your infection.
Your doctor may have prescribed Ceftriaxone Sandoz for another reason. Ask your doctor if you have any questions about why Ceftriaxone Sandoz has been prescribed for you.
This medicine is available only with a doctor's prescription.
Ceftriaxone Sandoz is not addictive.

Before you are given Ceftriaxone Sandoz

When you must not be given it

Do not use Ceftriaxone Sandoz if:

1. you have an allergy to ceftriaxone, or any other cephalosporins

Some of the symptoms of an allergic reaction may include asthma, wheezing, shortness of breath, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, skin rash, itching or hives.

2. you have had a serious allergic reaction to any penicillins.

You may be more likely to have an allergic reaction to Ceftriaxone Sandoz if you are allergic to penicillin medicines.

3. You have an allergy to medicines used to treat infections (antibiotics).

Ceftriaxone Sandoz must not be given to newborns with the following conditions:
yellowing of the skin and/or eyes, a condition called jaundice
a decrease in albumin in the blood, causing water retention
too much acid in the blood which may cause an increased rate of breathing
hyperbilirubinaemia.
Ceftriaxone Sandoz must not be given to newborns if they require intravenous calcium containing solutions or to premature newborns up to 41 weeks of age.
Do not use Ceftriaxone Sandoz if the packaging is torn or shows signs of tampering.
Do not use Ceftriaxone Sandoz after the expiry date on the pack has passed.
If you are not sure whether you should be given Ceftriaxone Sandoz, talk to your doctor, nurse or pharmacist.

Before you are given it

Tell your doctor if:

1. you have had any type of allergic reaction to any cephalosporin or penicillin medicines

You may have an increased chance of being allergic to Ceftriaxone Sandoz if you are allergic to any cephalosporins or penicillins.

2. you are allergic to lignocaine or other local anaesthetics

Lignocaine can be mixed with Ceftriaxone Sandoz prior to injection.

3. you have allergies to:

any other medicines
any other substances, such as foods, preservatives or dyes.

4. you are pregnant, or intend to become pregnant

Ceftriaxone Sandoz may affect your developing baby if you use it during pregnancy. Your doctor will discuss the risks and benefits of using Ceftriaxone Sandoz during pregnancy.

5. you are breast feeding or intend to breast feed

Ceftriaxone Sandoz passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of using it when breast feeding.

6. if you have or have had any medical conditions, including:

kidney disease
stomach or bowel problems
liver disease.
If you have not told your doctor about any of the above, tell them before you are given Ceftriaxone Sandoz.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interfere with Ceftriaxone Sandoz. These include:
chloramphenicol.
This medicine may be affected by Ceftriaxone Sandoz, or may affect how well it works. You may need to use different amounts of your medicine, or you may need to use different medicines. Your doctor will advise you.
Talk to your doctor about the need for an additional method of contraception while using Ceftriaxone Sandoz.
Some antibiotics may decrease the effectiveness of some birth control pills.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while using Ceftriaxone Sandoz.

How Ceftriaxone Sandoz is given

Ceftriaxone Sandoz must only be given by a doctor or nurse.
Ceftriaxone Sandoz can be given in two ways:
as a slow injection into a vein
as a deep injection into a large muscle.
Ceftriaxone Sandoz must not be mixed or administered with calcium-containing solutions, even via different infusion lines.
Your doctor will decide what dose and how long you will receive Ceftriaxone Sandoz. This depends on your condition and whether you are taking any other medicines. For most infections, Ceftriaxone Sandoz is usually given once or twice a day.
The length of treatment is usually between 4 days and 2 weeks.
Sometimes only a single dose of Ceftriaxone Sandoz is required for the treatment and prevention of certain infections.

If you are given too much (overdose)

If you are given too much Ceftriaxone Sandoz, you may experience symptoms such as skin reactions, chills, fever, stomach upsets, diarrhoea, headache or dizziness.

While you are using Ceftriaxone Sandoz

Things you must do

If the symptoms of your infection do not improve within a few days, or if they become worse, tell your doctor.
If you get severe diarrhoea tell your doctor, pharmacist or nurse immediately. Do this even if it occurs several weeks after Ceftriaxone Sandoz has been stopped.
Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care. Do not take any diarrhoea medicine without first checking with your doctor.
If you get a sore white mouth or tongue while using or soon after stopping Ceftriaxone Sandoz, tell your doctor. Also tell your doctor if you get vaginal itching or discharge.
This may mean you have a fungal infection called thrush. Sometimes the use of Ceftriaxone Sandoz allows fungi to grow and the above symptoms to occur. Ceftriaxone Sandoz does not work against fungi.
If you become pregnant while you are using Ceftriaxone Sandoz, tell your doctor immediately.
If you are about to start taking any new medicine, tell your doctor and pharmacist that you are using Ceftriaxone Sandoz.
If you have to test your urine for sugar while you are being given Ceftriaxone Sandoz, make sure your doctor knows which type of test you use.
Ceftriaxone Sandoz may affect the results of some of these tests.
If you have to have any blood tests, tell your doctor you are being given Ceftriaxone Sandoz.
Ceftriaxone Sandoz may affect the results of some blood tests.
Tell all the doctors, dentists and pharmacists who are treating you that you are using Ceftriaxone Sandoz.

Things to be careful of

Be careful driving or operating machinery until you know how Ceftriaxone Sandoz affects you.
Ceftriaxone Sandoz may cause dizziness in some people. Make sure you know how you react to Ceftriaxone Sandoz before you drive a car, operate machinery or do anything else that may be dangerous if you are affected.

Side effects

Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well while you are being given Ceftriaxone Sandoz.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.

While using Ceftriaxone Sandoz

Tell your doctor or nurse if you notice any of the following and they worry you:
oral thrush - white, furry, sore tongue and mouth
vaginal thrush - sore and itchy vagina sometimes with a white discharge
pain or swelling at the injection site
diarrhoea
nausea (feeling sick) or vomiting
headache or dizziness
taste disturbances
fever.
These side effects are usually mild.
Tell your doctor or nurse immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:
severe abdominal cramps or stomach cramps
watery and severe diarrhoea, which may also be bloody
severe skin rash, itching or hives
peeling or flaking of the skin
swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
wheezing or shortness of breath
swelling of the hands, feet or ankles
bleeding or bruising more easily than normal
signs of frequent infections such as fever, severe chills, sore throat or mouth ulcers
signs of anaemia such as, tiredness, being short of breath when exercising, looking pale
yellowing of the skin or eyes
fast or irregular heart beat
passing less urine than is normal
pain when passing urine.
These are serious side effects. You may need urgent medical attention. Serious side effects are rare.

After finishing Ceftriaxone Sandoz

Tell your doctor immediately if you notice any of the following side effects, even if they occur several weeks after stopping treatment with Ceftriaxone Sandoz:
severe abdominal cramps or stomach cramps
watery and severe diarrhoea, which may also be bloody
fever, in combination with one or both of the above.
These are rare but serious side effects. You may have a serious condition affecting your bowel. You may need urgent medical attention. However, these side effects are rare.
Do not take any diarrhoea medicine without first checking with your doctor.
Other side effects not listed above may also occur in some patients.
Tell your doctor if you notice anything else that is making you feel unwell.
Do not be alarmed by this list of possible side effects. You may not experience any of them.

Storage

Ceftriaxone Sandoz will be stored in the pharmacy or on the ward.
The powder for injection is kept in a cool, dry place protected from light and moisture, where the temperature stays below 25°C.
The reconstituted solution can be kept in a refrigerator between 2°C and 8°C for not more than 24 hours after mixing. Do not freeze.

Product description

What it looks like

Ceftriaxone Sandoz is a white to yellowish powder. It is reconstituted before being injected.
Ceftriaxone Sandoz is available in packs containing 1 vial.

Ingredients

Each vial contains 1000mg or 2000mg of ceftriaxone, as the sodium salt.
Ceftriaxone Sandoz does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

Sponsor

Ceftriaxone Sandoz is supplied in Australia by:
Sandoz Pty Ltd
ABN 60 075 449 553
19 Harris Street
Pyrmont NSW 2009
Australia
Tel: 1800 634 500

Australian Registration Number

1g vial AUST R 75959
2g vial AUST R 75960
This leaflet was revised in December 2011.