Consumer medicine information

Ceftazidime Juno 2 g Powder for injection

Ceftazidime

BRAND INFORMATION

Brand name

Ceftazidime Juno

Active ingredient

Ceftazidime

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Ceftazidime Juno 2 g Powder for injection.

What is in this leaflet


This leaflet answers some common questions about Ceftazidime Juno. It does not contain all the available information.
It does not take the place of talking to your doctor and pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you being given Ceftazidime Juno against the benefits this medicine is expected to have for you.
If you have any concerns about being given this medicine, ask your doctor or pharmacist.
Keep this leaflet in a safe place.
You may need to read it again.

What Ceftazidime Juno is used for


Ceftazidime is an antibiotic used to treat infections in different parts of the body caused by bacteria.
Ceftazidime will not work against infections caused by viruses such as colds or the flu.
Ceftazidime belongs to a group of antibiotics called cephalosporins (cef-a-loe-SPOR-ins). These antibiotics work by killing the bacteria that are causing your infection.
Your doctor may have prescribed ceftazidime for another reason
Ask your doctor if you have any questions about why ceftazidime has been prescribed for you.
This medicine is available only with a doctor’s prescription.

Before you are given Ceftazidime Juno

When you must not be given it


Ceftazidime Juno if you have an allergy to:
  • ceftazidime
  • other cephalosporins
  • any of the ingredients listed at the end of this leaflet.
  • lignocaine

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.

You must not be given this medicine if you have had a serious allergic reaction to penicillin antibiotics.
Ceftazidime should not be mixed with lignocaine and given to you if you have had an allergic reaction to lignocaine.
Sometimes Ceftazidime Juno is mixed with lignocaine hydrochloride so that the injection into the muscle is less painful.

Before you are given it


Tell your doctor if you have any types of allergies to penicillin antibiotics.
You may have an increased chance of being allergic to Ceftazidime if you are allergic to penicillins.
Tell your doctor or pharmacist if you have allergies to:
  • any other medicines
  • any other substances, such as foods, preservatives or dyes.

Tell your doctor if you have or have ever had any other health problems or medical conditions, including:
  • kidney disease
  • liver disease.
  • stomach or bowel illness (eg colitis)
  • blood clotting disorder
  • prolonged antibiotic use.
  • central nervous system disorders

Tell your doctor or pharmacist if you are pregnant or intend to become pregnant.
Like most cephalosporin medicines, ceftazidime is not recommended for use during pregnancy. If there is a need to consider ceftazidime during your pregnancy, your doctor or pharmacist will discuss with you the benefits and risks of using it.
Tell your doctor or pharmacist if you are breast-feeding or plan to breast-feed.
Like most cephalosporin medicines, ceftazidime is not recommended while you are breast-feeding. If there is a need to consider ceftazidime while you are breast feeding, your doctor or pharmacist will discuss the possible risks and benefits of using it.
If you have not told your doctor or pharmacist about any of the above, tell them before you are given ceftazidime.

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 ceftazidime may interfere with each other. These include:
  • chloramphenicol, an antibiotic used to treat bacterial infections
  • diuretics, medicines which help to reduce the amount of excess fluid in the body by increasing the amount of urine produced
  • aminoglycosides, antibiotics used to treat serious bacterial infections.

These medicines may be affected by Ceftazidime or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Talk to your doctor about the need for an additional method of contraception while being given ceftazidime.
Some antibiotics may decrease the effectiveness of some birth control pills, although this has not been shown with ceftazidime.
Your doctor or pharmacist may have more information on medicines to be careful with or avoid while being given ceftazidime

How Ceftazidime Juno is given

How much is given


Ceftazidime Juno is given as a slow injection or infusion (intravenous drip) into a vein. Alternatively, it can be given as a deep injection into a large muscle.
Ceftazidime Juno should only be given by a doctor or nurse.
Your doctor will decide what dose you will receive and how long you will receive Ceftazidime Juno for. This depends on your infection and other factors, such as your weight. For most infections, Ceftazidime Juno is usually given in divided doses throughout the day.
Sometimes only a single dose of Ceftazidime Juno is required for the treatment of certain infections.

If you take too much (overdose)


As ceftazidime is given under medical supervision, it is very unlikely that you will receive too much.
However, if you experience severe side effects after being given ceftazidime, tell your doctor or nurse immediately or telephone your doctor or the poisons Information Centre (13 11 26) for advice or go to Accident and Emergency at the nearest hospital. Do this even if there are no signs of discomfort or poisoning.
Symptoms of a ceftazidime overdose may include the side effects listed below in the ‘Side Effects’ section, but are usually of a more severe nature.
You may need urgent medical attention.
Ask your doctor if you have any concerns.

While you are being given Ceftazidime Juno

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 immediately. Do this even if it occurs several weeks after ceftazidime has been stopped. Do not take any diarrhea medicine without first checking with your doctor.
Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care.
If you get a sore, white mouth or tongue while you are being treated with, or soon after stopping treatment with ceftazidime, tell your doctor. Also tell your doctor if you get vaginal itching or discharge.
Sometimes the use of ceftazidime allows fungi to grow and the above symptoms to occur. Ceftazidime does not work against fungi.
If you become pregnant while you are being treated with this medicine, tell your doctor immediately.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are being given ceftazidime.
If you have to test your urine for sugar while you are being treated with ceftazidime, make sure the doctor knows what type of test you use.
Cefoxitin may affect the results of some of these tests.
If you are about to have any blood or urine tests, tell your doctor that you are being treated with this medicine.
It may interfere with the results of some tests.
Tell any other doctors, dentists, and pharmacists who treat you that you are being treated with this medicine.

Side effects


Tell your doctor or nurse as soon as possible if you do not feel well while you are being treated with ceftazidime.
This medicine helps most people with infections, but it may have unwanted side effects in a few people. 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.
Treatment with ceftazidime, particularly in elderly patients with serious kidney or nervous system problems may rarely cause brain or nervous system disorders.
There have been reports of decreased consciousness, abnormal movements, confusion, agitation, and convulsions or seizures.
Ask your doctor or pharmacist to answer any questions you may have.
Do not be alarmed by the following lists of side effects.
You may not experience any of them.

While using it


Tell your doctor, nurse or pharmacist if you notice any of the following and they worry you:
  • nausea or vomiting
  • diarrhoea
  • pain or tenderness near the injection site
  • headache
  • stomach pain
  • dizziness
  • numbness or tingling
  • oral thrush - white, furry, sore tongue and mouth
  • bad taste
  • vaginal thrush - sore and itchy vagina and/or discharge
  • hot flushes

Tell your doctor or nurse immediately if you notice any of the following:
  • severe abdominal cramps or stomach cramps
  • severe persistent diarrhoea (which may develop during treatment or up to several weeks after you stop ceftazidime)
  • signs of an allergic reaction, such as rash, itching or hives on the skin; swelling of the face, lips, tongue or other parts of the body; shortness of breath, wheezing or difficulty breathing
  • tremors, fits or seizures
  • signs of anaemia, such as tiredness, being short of breath when exercising, looking pale, or yellowing of the eyes or skin
  • high temperature (fever)
  • severe diarrhoea
  • light-headedness or dizziness
  • yellowing of the skin and/or eyes
  • signs of frequent infections such as fever, severe chills, sore throat or mouth ulcers
  • decreased consciousness, abnormal movements, confusion, agitation, convulsions or seizures.

These may be serious side effects. You may need urgent medical attention. Serious side effects are rare.

After finishing it


Tell your doctor immediately if you notice any of the following side effects, particularly if they occur several weeks after stopping treatment with ceftazidime:
  • 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 serious side effects. You may have a serious condition affecting your bowel. Therefore 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 people.
Tell your doctor if you notice anything that is making you feel unwell.

After being given Ceftazidime Juno

Storage


Ceftazidime Juno will be stored in the pharmacy or on the ward. The injection is kept in a cool dry place, protected from light and moisture where the temperature stays below 25°C.

Product description

What it looks like


Ceftazidime Juno is a white or cream coloured powder in a glass vial.

Ingredients


Ceftazidime Juno contains ceftazidime (as pentahydrate), equivalent to 1 g or 2 g of Ceftazidime.
It also contains the active ingredient sodium carbonate.
This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Sponsor


Australian Sponsor:
Juno Pharmaceuticals Pty Ltd
15 – 17 Chapel Street,
Cremorne,
VIC 3121
Ceftazidime Juno is available in the following strengths:

This leaflet was prepared in: February 2024.

BRAND INFORMATION

Brand name

Ceftazidime Juno

Active ingredient

Ceftazidime

Schedule

S4

 

1 Name of Medicine

Ceftazidime (as pentahydrate).

2 Qualitative and Quantitative Composition

Ceftazidime Juno powder for injection is a cephalosporin antibiotic for use by injection only. Ceftazidime pentahydrate is slightly soluble in water and in methanol, practically insoluble in acetone and in ethanol. It dissolves in acid and alkali solutions.
Ceftazidime Juno is in vials containing 1 g and 2 g ceftazidime (as pentahydrate). For the full list of excipients, see Section 6.1 List of Excipients.
For laboratory tests associated with ceftazidime administration, ceftazidime pentahydrate should be used.

3 Pharmaceutical Form

Ceftazidime Juno is a powder for injection and is a white or cream coloured powder.
On the addition of water for injections, Ceftazidime Juno powder for injection dissolves with effervescence to produce a clear, colourless solution for injection.

4 Clinical Particulars

4.9 Overdose

Overdosage can lead to neurological sequelae including encephalopathy, convulsions and coma. Ceftazidime can be removed by haemodialysis.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSCEFPEN.gif Chemical name: (6R,7R)-7-[[(2Z)-2-(2-Aminothiazol-4-yl)-2-[(1-carboxy-1 methylethoxy)imino]acetyl]amino]-8-oxo-3-[(pyridin-1-ium-1-yl)methyl]-5-thia-1azabicyclo[4.2.0]oct-2-ene-2-carboxylate pentahydrate.
Molecular formula: C22H22N6O7S2, 5H2O.
Molecular weight: 636.6.
CAS number. 78439-06-2.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/CEFJUNST.gif