Consumer medicine information

1. Why am I being treated with Zavicefta?

Zavicefta contains the active ingredients, ceftazidime and avibactam. It is used to treat serious infections of the tissues and organs within the stomach, urinary tract or kidney or certain serious lung infections.
For more information, see Section 1. Why am I being treated with Zavicefta? in the full CMI.

2. What should I know before treatment with Zavicefta?

Do not start treatment if you/your child have ever had an allergic reaction to Zavicefta/ceftazidime/avibactam, other antibiotics that are the same type, or any of the ingredients listed at the end of the CMI including sodium carbonate.
Tell the doctor if you/your child have had any allergic reaction to any antibiotic, have other medical conditions, are on a controlled sodium diet, take any other medicines or if you are pregnant, plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before treatment with Zavicefta? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Zavicefta and affect how it works.
More instructions can be found in in Section 3. What if I am taking other medicines? in the full CMI.

4. How is Zavicefta given?

The doctor will decide how much Zavicefta is needed. It will depend on the type of infection, age and bodyweight (for children) and if you/your child have kidney problems.
More instructions can be found in Section 4. How is Zavicefta given? in the full CMI.

5. What should I know during treatment with Zavicefta?

6. Are there any side effects?

Side effects may include swelling of the face, lips, mouth or throat, difficulty swallowing or breathing; shortness of breath or breathing difficulties; nausea or vomiting; changes in taste or a metallic taste; stomach or abdominal pain; severe diarrhoea or stools that contains blood or mucus; severe skin rash; weight gain; increased urine volume; night urination; numbness or a tingling sensation; redness, pain or swelling at the injection site or vein; headaches; dizziness; fever; itchy skin; hives/skin rash; white, furry layer on the tongue; unusual vaginal discharge; yellowing of skin and eyes (jaundice),.problems with your liver or kidneys, certain blood cells or the way your blood clots.
For more information, including what Zavicefta to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Ceftazidime (as pentahydrate)/avibactam (as sodium).

2 Qualitative and Quantitative Composition

Each vial contains ceftazidime (as pentahydrate) equivalent to 2000 mg ceftazidime and avibactam (as sodium) equivalent to 500 mg avibactam.
After reconstitution, 1 mL of solution contains 167.3 mg of ceftazidime (CAZ) and 41.8 mg of avibactam (AVI).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder for Injection.
Zavicefta is white to light yellow powder.
The reconstituted solution is a clear and colourless to yellow solution free from visible particulate matter.

4 Clinical Particulars

4.9 Overdose

Overdose with ceftazidime/avibactam can lead to neurological sequelae including encephalopathy, convulsions and coma, due to the ceftazidime component.
Serum levels of ceftazidime can be reduced by haemodialysis or peritoneal dialysis. During a 4-hour haemodialysis period, 55% of the avibactam dose was removed.
For advice on the management of overdose please contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. For ceftazidime, a mouse micronucleus test and an Ames test were both negative for mutagenic effects. In genotoxicity assays with avibactam, there was no induction of gene mutation in the in vitro bacterial reverse mutation tests, nor were there any indications of genotoxicity in an in vitro micronucleus test in mouse lymphoma cells. In cultured human lymphocytes, statistically significant increases in chromosomal aberrations were observed under a single treatment condition (44 h harvest time, -S9). As these findings were not replicated in an independent study, the results are considered to be of limited biological relevance. When administered up to the limit dose of 2 g/kg IV, avibactam was negative in a rat in vivo micronucleus assay. No genetic toxicology studies have been conducted on ceftazidime-avibactam.
Carcinogenicity. Carcinogenicity studies have not been conducted with ceftazidime-avibactam.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Ceftazidime (as pentahydrate).
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSCEFPEN.gif CAS number. 78439-06-2.
Ceftazidime (as pentahydrate) is a white to almost white crystalline powder. It is soluble in acid, alkali and dimethyl sulphoxide and slightly soluble in water, methanol and dimethylformamide.
Chemical structure. Avibactam (as sodium).
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSAVIBNA.gif CAS number. 1192491-61-4.
Avibactam (as sodium) is a crystalline powder. It is freely soluble in water, relatively soluble in methanol and insoluble in ethanol.

7 Medicine Schedule (Poisons Standard)

S4, Prescription Only Medicine.

Summary Table of Changes

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