2 g/0.5 g powder for concentrate for infusion solution,
ceftazidime/avibactam solution
What Zavicefta is and what it is used for
What Zavicefta is
Zavicefta is an antibiotic medicine that contains the two active substances ceftazidime and avibactam.
- Ceftazidime belongs to a group of antibiotics called “cephalosporins”. It can kill many types of bacteria.
- Avibactam is a “beta-lactamase inhibitor” that helps ceftazidime kill some bacteria that it cannot kill on its own.
What Zavicefta is used for
Zavicefta is used in adult and pediatric patients from 3 months of age to treat:
- infection in your stomach and intestines (abdomen)
- infection in the bladder and kidneys, “urinary tract infections”
- infection in the lung, “pneumonia”
- infection caused by bacteria that other antibiotics may not be able to kill
Zavicefta is used in adults to treat infection in the blood linked to infection in the abdomen, urinary tract, or pneumonia .
How Zavicefta works
Zavicefta works by killing certain types of bacteria that can cause serious infections.
What you need to know before you use Zavicefta
Do not use Zavicefta
Do not use Zavicefta:
- if you are allergic to ceftazidime, avibactam, or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to any other cephalosporin – antibiotics
- if you have ever had a severe allergic reaction to other antibiotics belonging to the penicillin or carbapenem groups.
Do not use Zavicefta if any of the above apply to you. If you are not sure, talk to your doctor or nurse before using Zavicefta.
Warnings and precautions
Talk to a doctor or nurse before using Zavicefta:
- if you have ever had an allergic reaction (even if it was just a rash) to other antibiotics belonging to the penicillin or carbapenem groups.
- If you have kidney problems – your doctor may give you a lower dose to make sure you don’t get too much medicine. This can cause symptoms such as convulsions (see section If you use too much Zavicefta).
If any of the above apply to you (or if you are not sure), talk to your doctor or nurse before using Zavicefta.
Talk to your doctor or nurse if you suffer from diarrhea during your treatment.
Other infection er
There is a small risk that you will get another infection caused by another bacteria during or after treatment with Zavicefta. These include thrush (fungal infection of the mouth or genital area).
Lab samples
Tell your doctor that you are taking Zavicefta if you are going to have tests. This is because you may get an abnormal result on a test called “DAT” or “Coombs”. That test looks for antibodies that attack your red blood cells.
Zavicefta can also affect some tests for sugar in the urine. Tell the person taking the test that you have received Zavicefta.
Pediatric patients
Zavicefta should not be used in pediatric patients younger than 3 months. This is because it is not known whether the drug is safe to use in this age group.
Other medicines and Zavicefta
Tell the doctor or nurse if you are using, have recently used, or might be using other medicines.
Tell your doctor if you are taking any of the following medicines before using Zavicefta:
- an antibiotic called Chloramphenicol
- a type of antibiotic called an aminoglycoside, such as gentamicin, tobramycin
- a diuretic tablet called Furosemide
- medicine for gout called Probenecid
Before using Zavicefta, tell your doctor if any of the above applies to you.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
Driving ability and use of machinery
Zavicefta can cause dizziness. This may affect your ability to drive and use tools and machines.
Zavicefta contains sodium
This medicine contains approximately 146 mg of sodium (the main ingredient in common/table salt) per vial. This corresponds to 7.3% of the maximum recommended daily intake of sodium for adults.
Talk to your doctor or pharmacist if you need 3 or more vials every day for a longer period, especially if you have been recommended a low salt (low sodium) diet.
How to use Zavicefta
You will be given Zavicefta by a doctor or nurse.
How much to use
The recommended dose for adults is one vial (2 g ceftazidime and 0.5 g avibactam) every 8 hours. Dose one for pediatric patients from 3 months of age is calculated by the doctor based on the child’s weight and age.
It is given as a drip into a vein, which normally takes about 2 hours.
Treatment usually lasts from 5 up to 14 days depending on the type of infection you have and how you respond to treatment.
People with kidney problems
If you have problems with your kidneys, your doctor may give you a lower dose, as Zavicefta is excreted via the kidneys.
If you have used too much Zavicefta
You will be given Zavicefta by a doctor or nurse, so it is unlikely that you will receive the wrong dose. If you experience side effects or think you have received too much Zavicefta, you must tell the doctor or nurse immediately. If you get too much Zavicefta, it can affect the brain and cause seizures or coma.
If you forget to use Zavicefta
If you think you have missed a dose, tell your doctor or nurse immediately.
If you have any further questions about this medicine, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects can occur with this medicine:
Serious side effects are
Tell your doctor immediately if you notice any of the following serious side effects, you may need immediate medical treatment:
- severe allergic reaction – signs include swelling of the lips, face, throat, or tongue, a severe rash or other severe skin reaction, and difficulty swallowing or breathing. These reactions can be life-threatening.
- diarrhea that gets worse or doesn’t go away, blood or mucus in the stool – this can happen during or after treatment with Zavicefta. If this happens, you must not take medicines that stop or slow down bowel movements.
Tell the doctor immediately if you notice any of the serious side effects above.
Other side effects are
Tell the doctor or nurse if you notice any of the following side effects:
Very common: (may affect more than 1 in 10 users)
- abnormal results on a test called “DAT” or “Coombs”. That test looks for antibodies that attack your red blood cells. It is possible that this can cause anemia (which can make you feel tired) and jaundice (yellowing of the skin and eyes).
Common: (may affect up to 1 in 10 users)
- fungal infections, including in the mouth and abdomen
- a change in the number of blood cells (called ‘eosinophils’ and ‘thrombocytes’), which show up in blood tests
- headache
- dizziness
- nausea, vomiting
- stomach pains
- diarrhea
- an increase in the number of certain enzymes produced by the liver, which shows up in blood tests
- raised itchy rash (“hives”)
- itching
- redness, pain, or swelling at the site where Zavicefta was given into a vein
- fever
Uncommon: (may affect up to 1 in 100 users)
- an increase in the number of blood cells (called “lymphocytes”), which can be seen in blood tests
- a decrease in the number of blood cells (called “leukocytes”), which can be seen in blood tests
- tingling or numbness
- bad taste in the mouth
- an increase in the levels of certain types of substances in the blood (called “creatinine” and “urea”). These show how well your kidneys are working.
Very rare: (may affect up to 1 in 10,000 users)
- swelling of part of the kidney that causes it to function worse than normal
Frequency not known : (frequency cannot be estimated from the available data)
- a significant decrease in white blood cells that fight infection er – shown through blood tests
- a decrease in the number of red blood cells (hemolytic anemia) – shown by blood tests
- severe allergic reaction (see Serious side effects above )
- the whites of the eyes or the skin turn yellow
- sudden onset of severe rash, blistering or peeling skin, possibly accompanied by high fever or joint pain (these may be signs of more serious conditions such as toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme or a condition known as DRESS, drug reaction with eosinophilia and systemic symptoms )
- swelling under the skin, especially the lips and around the eyes
Tell the doctor or nurse if you notice any of the side effects described above.
How to store Zavicefta
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the container. The expiration date is the last day of the specified month.
Store in the original packaging. Light sensitive.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substances are ceftazidime and avibactam. Each vial contains ceftazidime pentahydrate corresponding to 2 g of ceftazidime and avibactam sodium corresponding to 0.5 g of avibactam.
- The other ingredient is sodium carbonate (anhydrous) (see section 2 “Zavicefta contains sodium”).
Appearance and package sizes of the medicine
Zavicefta is a white to yellow powder to concentrate for infusion, or solution, in a vial. It is available in packs of 10 vials.
Pfizer Ireland Pharmaceuticals
Operations Support Group
Ringaskiddy, County Cork
Ireland
Manufacturer
ACS Dobfar SpA
Via Alessandro Fleming 2
Verona 37135
Italy
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