Ceftazidime Astro-Pharma
Italy
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE USER
CEFTAZIDIME Astro-Pharma 1 g Powder for solution for injection/infusion, 2 g Powder for solution for infusion
Ceftazidime
Generic medicine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or nurse.
- If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of this leaflet:
- What CEFTAZIDIME Astro-Pharma is and what it is used for
- What you need to know before you are given CEFTAZIDIME Astro-Pharma
- How to use CEFTAZIDIME Astro-Pharma
- Possible side effects
- How to store CEFTAZIDIME Astro-Pharma
- Contents of the pack and other information
1. WHAT CEFTAZIDIME Astro-Pharma IS AND WHAT IT IS USED FOR
CEFTAZIDIME Astro-Pharma 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 Astro-Pharma is used to treat serious bacterial infections of:
- 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 Astro-Pharma may also be used:
- to prevent infections during surgical procedures on the prostate gland in men
- to treat patients with low white blood cell counts (neutropenia) who have fever due to a bacterial infection.
2. What you should know before being given CEFTAZIDIMA Astro-Pharma
Do not be given CEFTAZIDIMA Astro-Pharma if:
- you are allergic to ceftazidime or to any of the other ingredients of this medicine ( listed in section 6 ).
- you have previously had a severe allergic reaction to any other antibiotic (penicillins, monobactams, or carbapenems), as you may also be allergic to CEFTAZIDIMA Astro-Pharma.
➔ Inform your doctor before starting treatment with CEFTAZIDIMA Astro-Pharma if you think
this applies to you. CEFTAZIDIMA Astro-Pharma must not be administered to you.
Take special care with CEFTAZIDIMA Astro-Pharma
Be cautious of certain symptoms such as allergic reactions, nervous system disorders, and
gastrointestinal disturbances like diarrhoea while being treated with CEFTAZIDIMA Astro-Pharma. This will reduce the
risk of potential problems. See ( Conditions requiring caution ) in section 4.
If you have had an allergic reaction to other antibiotics, you may also be allergic to
CEFTAZIDIMA Astro-Pharma.
If you need blood or urine tests
CEFTAZIDIMA Astro-Pharma may interfere with test results for sugar 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 CEFTAZIDIMA Astro-
Pharma.
Other medicines and CEFTAZIDIMA Astro-Pharma
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 be given CEFTAZIDIMA Astro-Pharma without first consulting your doctor if you are taking:
- an antibiotic called chloramphenicol
- a type of antibiotics called aminoglycosides, for example gentamicin, tobramycin
- diuretic tablets called furosemide ➔ Inform your doctor if this applies to you.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding,
please consult your doctor before using this medicine.
Driving and using machines
CEFTAZIDIMA Astro-Pharma may cause undesirable effects that could affect your ability to drive, such as dizziness.
Do not drive or operate machinery unless you are certain you will not be affected.
CEFTAZIDIMA Astro-Pharma contains sodium.
You should take into account the following information if you are on a sodium-restricted diet.
| Dosage of CEFTAZIDIMA Astro-Pharma | Amount per vial |
| CEFTAZIDIMA Astro-Pharma 1 g | 52 mg |
| CEFTAZIDIMA Astro-Pharma 2 g | 104 mg |
3. How CEFTAZIDIMA Astro-Pharma is administered
CEFTAZIDIMA Astro-Pharma is generally administered by a doctor or nurse.
It may be given as an intravenous infusion or as an injection directly into a
vein or into a muscle.
CEFTAZIDIMA Astro-Pharma is prepared by the doctor, pharmacist, or nurse using
water for injections or appropriate infusion fluids.
Recommended dose
The correct dose of CEFTAZIDIMA Astro-Pharma will be decided by your doctor and depends on the severity and
type of infection; whether you are being treated with other antibiotics; your body weight and age; and your
kidney function.
Use in children
Newborns (0–2 months) – For each kg of the child's body weight, 25 to 60 mg of CEFTAZIDIMA Astro-Pharma will be administered daily, divided into two doses.
Children (over 2 months of age) and children weighing less than 40 kg – For each kg of body weight of the infant or child, 100 to 150 mg of CEFTAZIDIMA Astro-Pharma will be administered daily, 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 CEFTAZIDIMA Astro-Pharma three times daily. The maximum dose is 9 g per day.
Patients over 65 years of age
The daily dose should generally 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 the usual one. The doctor or nurse will determine how much CEFTAZIDIMA Astro-Pharma 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 CEFTAZIDIMA Astro-Pharma than you should
If you accidentally use a higher dose than prescribed, contact your doctor or the nearest hospital immediately.
If you forget to use CEFTAZIDIMA Astro-Pharma
If you miss an injection, take it as soon as possible. Do not use a double dose (two injections at the same time) to make up for a missed dose; simply take the next dose at the usual time.
If you stop treatment with CEFTAZIDIMA Astro-Pharma
Do not stop treatment with CEFTAZIDIMA Astro-Pharma unless your doctor tells you to do so. If you have any doubts about using this medicine, consult your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Conditions requiring attention
The following serious side effects have occurred in a small number of people, but their exact frequency is unknown:
- Severe allergic reaction. Signs include raised, itchy rash, swelling, sometimes of the face or mouth, causing difficulty breathing.
- Skin rash with blistering formations resembling small targets (a dark spot in the center surrounded by a pale area with a black ring around the edge).
- Widespread rash with blistering and skin peeling (these may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis).
- 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.
- there have been rare reports of severe hypersensitivity reactions with severe skin rash, which may be accompanied by fever, fatigue, facial swelling or swollen lymph nodes, increased eosinophils (a type of white blood cell), and effects on the liver, kidney, or lungs (a reaction known as DRESS). ➔ Contact your doctor or nurse urgently if you experience any of these symptoms.
Common side effects
These may affect up to 1 in 10 patients:
- Diarrhea
- Swelling and redness along the vein
- Raised red rash which may be itchy
- 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 the number of cells that help blood clotting
- Increase in liver enzymes.
Uncommon side effects
These may affect up to 1 in 100 patients:
- Inflammation of the intestine, which may cause pain or diarrhea that may contain blood
- Candidiasis – fungal infections in the mouth or vagina
- Headache
- Dizziness
- Stomach pain
- Nausea or vomiting
- Fever and chills. ➔ Inform your doctor if you experience any of these conditions.
Uncommon side effects that may be detected by blood tests include:
- Decrease in the number of white blood cells
- Decrease in the number of platelets (cells that help blood clotting)
- Increase in blood levels of urea, blood urea nitrogen, or serum creatinine.
Very rare side effects
These may affect up to 1 in 10,000 patients:
- Kidney inflammation or kidney failure
Other side effects
Other side effects have occurred in a small number of people, but their exact frequency is unknown:
- 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 the number of white blood cells.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the 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 Astro-Pharma
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial after Exp. The expiry date refers to the last day of that month.
Before reconstitution, store the vials protected from light.
The product in solution, after reconstitution with water for injection or with compatible infusion fluids (e.g. glucose saline solution or sodium lactate solution), should normally be used within 6 hours if stored at room temperature and within 1 day if stored at 4°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.
6. PACKAGING CONTENTS AND OTHER INFORMATION
What CEFTAZIDIME Astro-Pharma contains
The active substance is ceftazidime (as ceftazidime pentahydrate).
CEFTAZIDIME Astro-Pharma 1 g Powder for injectable/infusion solution contains 1 g of
ceftazidime.
CEFTAZIDIME Astro-Pharma 2 g Powder for infusion solution contains 2 g of ceftazidime.
The excipients are:
Vials of powder: anhydrous sodium carbonate.
Description of the appearance of CEFTAZIDIME Astro-Pharma and packaging contents
CEFTAZIDIME Astro-Pharma 1 g Powder for injectable/infusion solution:
- 1 vial of powder
- 10 vials of powder
CEFTAZIDIME Astro-Pharma 2 g Powder for infusion solution:
- 1 vial of powder
- 10 vials of powder
Marketing Authorization Holder
Astro-Pharma GmbH, Allerheiligenplatz 4, 1200 Vienna - Austria
Manufacturer
Laboratorio Farmaceutico CT Srl - Via Dante Alighieri, n. 71 – 18038 Sanremo (IM)