Package leaflet: Information for the user

Ceftazidime Almus

1 g/3 ml powder and solvent for injectable solution for intramuscular use
Equivalent medicine
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Ceftazidime Almus is and what it is used for
What you need to know before using Ceftazidime Almus
How Ceftazidime Almus is administered
Possible side effects
How to store Ceftazidime Almus
Contents of the pack and other information

1. What Ceftazidime Almus is and what it is used for

Ceftazidime Almus is an antibiotic used in adults and children (including newborns). It
works by killing the bacteria that cause infections and belongs to a group of medicines called
cephalosporins.
Ceftazidime Almus is used to treat serious infections of the:

lungs or chest
lungs and bronchi in patients with cystic fibrosis
brain (meningitis)
ear
urinary tract
skin and soft tissues
abdomen and abdominal wall (peritonitis)
bones and joints

Ceftazidime Almus may also be used:

to prevent infections during prostate surgery in men;
to treat patients with a low number of white blood cells (neutropenia) who have fever due to a bacterial infection

2. What you need to know before using Ceftazidime Almus

Do not use Ceftazidime Almus:

if you are allergic to ceftazidime, to other medicines similar to Ceftazidime Almus (cephalosporins), or to any of the other ingredients of this medicine (listed in section 6);
if you have previously experienced a severe allergic reaction to any other antibiotic (penicillins, monobactams, or carbapenems), as you may also be allergic to Ceftazidime Almus.

Warnings and precautions
Take special care with Ceftazidime Almus
Be alert for certain symptoms such as allergic reactions, nervous system disorders, and gastrointestinal disturbances such as diarrhoea while being treated with Ceftazidime Almus. This will reduce the risk of potential problems. See (Conditions requiring caution) in section 4.
If you have previously had an allergic reaction to other antibiotics, you may also be allergic to Ceftazidime Almus.
Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported during treatment with ceftazidime. Contact your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.
If you require blood or urine tests
Ceftazidime Almus may interfere with test results for glucose in urine and with the blood test known as the Coombs test. If you are undergoing these tests:
Inform the person collecting the sample that you are being treated with Ceftazidime Almus.

Other medicines and Ceftazidime Almus
Inform your doctor if you are taking, have recently taken, or might take any other medicines. This includes medicines you can obtain without a prescription.
Do not use Ceftazidime Almus without first consulting your doctor if you are taking:

an antibiotic called chloramphenicol
medicines that are toxic to the kidneys
a medicine used to stimulate the excretion of water and electrolytes from the kidneys (a diuretic called furosemide)
a medicine used to reduce uric acid levels in the blood (probenecid). Inform your doctor if this applies to you

Pregnancy, breastfeeding and fertility
Consult your doctor before receiving Ceftazidime Almus:

if you are pregnant, suspect you may be pregnant, or are planning a pregnancy
if you are breastfeeding

Your doctor will assess the benefit of treatment with Ceftazidime Almus against the potential risk to the baby.
Driving and using machines
Ceftazidime Almus may cause side effects that affect your ability to drive, such as dizziness. Do not drive or operate machinery unless you are certain you are not affected.
Ceftazidime Almus contains sodium
This medicine contains 25.25 mg of sodium (the main component of table salt) per vial. This corresponds to 1.26% of the maximum recommended daily dietary intake of sodium for an adult. This should be taken into consideration in patients with impaired renal function or those on a low-sodium diet.

3. How Ceftazidime Almus is administered

Use this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Ceftazidime Almus is usually administered by a doctor or nurse. It may be
given as an injection directly into the muscle.
Ceftazidime Almus is prepared by the doctor or nurse using water for injectable preparations.
Recommended dose
Your doctor will determine the appropriate dose of Ceftazidime Almus based on the type and severity
of the infection, whether you are receiving treatment with other antibiotics, your body weight and age, and your kidney function.
Newborns (0–2 months)
For each kg of the child's body weight, 25 to 60 mg of Ceftazidime Almus per day will be administered, divided into two doses.
Children (over 2 months) and children weighing less than 40 kg
For each kg of body weight, 100 to 150 mg per day will be administered, divided into three doses. The maximum dose is 6 g per day.
Adults and adolescents weighing 40 kg or more
1 to 2 g of Ceftazidime Almus three times daily. The maximum dose is 9 g per day.
Patients over 65 years of age
The daily dose generally should not exceed 3 g per day, especially if over 80 years of age.
Patients with kidney problems
You may be given a different dose than usual. The doctor or nurse will decide how much Ceftazidime Almus you need based on the severity of your kidney disease. Your doctor will monitor you closely and may perform kidney function tests at more regular intervals.
If you are given more Ceftazidime Almus than you should
If you accidentally use more than the prescribed dose, contact your doctor or the nearest hospital immediately.
If you forget to use Ceftazidime Almus
If you miss an injection, you should take it as soon as possible. Do not take a double dose (two injections at the same time) to make up for a missed dose.
If you stop treatment with Ceftazidime Almus
Do not stop treatment with this medicine unless your doctor tells you to. If you have any further questions about using this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

Conditions requiring immediate attention
The following serious side effects have occurred in a small number of people, but their exact frequency is unknown.
Contact your doctor immediately if you experience any of the following symptoms:

Severe allergic reaction. Signs include raised, itchy rash, swelling, sometimes of the face or mouth, causing breathing difficulties and low blood pressure.
Nervous system disorders: tremors, seizures and, in some cases, coma. These have occurred in people who were given too high a dose, especially in those with kidney disease.
Reddish spots on the trunk; the spots are target-like or circular macules, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
Generalized, red, scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized acute exanthematous pustulosis).

Common side effects (may affect up to 1 in 10 people)

Diarrhoea
Swelling and redness along the vein
Raised, red, possibly itchy rash
Pain, burning, swelling or inflammation at the injection site. Inform your doctor if any of these conditions concern you. Common side effects that may be detected by blood tests include:
- Increase in a type of white blood cells (eosinophilia)
- Increase in platelet count (cells that help blood clotting)
- Increase in liver enzymes.

Uncommon side effects (may affect up to 1 in 100 people)

Inflammation of the intestine, which may cause pain or diarrhoea that may contain blood
Candidiasis – fungal infections of the mouth or vagina
Headache
Dizziness
Stomach pain
Nausea or vomiting
Fever and chills
Itching. Inform your doctor if you experience any of these conditions. Uncommon side effects that may be detected by blood tests include:
- Decrease in white blood cell count
- Decrease in platelet count (cells that help blood clotting)
- Increase in blood levels of urea, nitrogen or creatinine.

Very rare side effects (may affect up to 1 in 10,000 people)

Kidney inflammation or kidney failure.

Side effects of unknown frequency (frequency cannot be estimated from available data)

Sensation of pins and needles
Unpleasant taste in the mouth
Yellowing of the whites of the eyes or skin. Other side effects that may be detected by blood tests include:
- Too rapid destruction of red blood cells
- Increase in certain types of white blood cells
- Severe decrease in white blood cell count.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ceftazidime Almus

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Exp.”. The expiry date refers to the last day of that month.
Store the vials protected from light and at a temperature not exceeding 25°C.
After reconstitution of the powder with water for injections, the solution should be used within 6 hours if stored at room temperature; if stored at 4°C, the solution must be used within one day.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Ceftazidima Almus contains
One vial of powder contains:
Active substance: ceftazidime pentahydrate 1.164 g (equivalent to ceftazidime 1 g)
Excipients: anhydrous sodium carbonate
One solvent vial contains:
Excipients: water for injections

Description of the appearance of Ceftazidima Almus and contents of the pack
1 vial of powder + 3 ml solvent vial.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Almus S.r.l. - Via Cesarea, 11/10 - 16121 Genoa
Manufacturer
Laboratorio Farmaceutico C.T. S.r.l. - Via Dante Alighieri 71 - 18038 Sanremo (IM)