Ceftazidime Mylan Generics

Package leaflet: Information for the user

Ceftazidime Mylan Generics 1 g/3 ml powder and solvent for injectable solution for

intramuscular use
Ceftazidime Mylan Generics 1 g/10 ml powder and solvent for injectable solution for
intravenous use
Ceftazidime Mylan Generics 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.
• This medicine has been prescribed for you only. Do not pass it on 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. See section 4.

Contents of this leaflet:

1. What Ceftazidime Mylan Generics is and what it is used for
2. What you need to know before you are given Ceftazidime Mylan Generics
3. How Ceftazidime Mylan Generics is administered
4. Possible side effects
5. How to store Ceftazidime Mylan Generics
6. Contents of the pack and other information

1. What Ceftazidime Mylan Generics is and what it is used for

Ceftazidime Mylan Generics 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 Mylan Generics 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.

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Ceftazidime Mylan Generics may also be used:

• to prevent infections during surgical operations on the prostate gland 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 you are given Ceftazidime Mylan Generics

Do not receive Ceftazidime Mylan Generics if:

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

→ Inform your doctor before starting treatment with Ceftazidime Mylan Generics if you think this applies to you. Do not receive Ceftazidime Mylan Generics.
Warnings and precautions
Talk to your doctor before using Ceftazidime Mylan Generics.
Severe skin reactions have been reported in association with ceftazidime treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Take special care with Ceftazidime Mylan Generics
Be alert for certain symptoms such as allergic reactions, nervous system disorders, and gastrointestinal disorders such as diarrhoea while being treated with Ceftazidime Mylan Generics. 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 Mylan Generics.
If you need blood or urine tests
Ceftazidime Mylan Generics 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 Mylan Generics.
Other medicines and Ceftazidime Mylan Generics
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 receive Ceftazidime Mylan Generics without first consulting your doctor if you are taking:

• an antibiotic called chloramphenicol
• a type of antibiotics known as aminoglycosides, for example gentamicin, tobramycin 2/7
• diuretic tablets called furosemide. → Inform your doctor if this applies to you.

Pregnancy and breastfeeding
Inform your doctor before you are given Ceftazidime Mylan Generics:

• if you are pregnant, suspect you may be pregnant, or are planning to become pregnant
• if you are breastfeeding.

Your doctor will assess the benefit of treatment with Ceftazidime Mylan Generics against the risk to the baby.
Driving and using machines
Ceftazidime Mylan Generics may cause side effects that affect your ability to drive, such as dizziness (see section 4. “Possible side effects”).
Do not drive or operate machinery unless you are certain you will not be affected.
Ceftazidime Mylan Generics contains sodium
Ceftazidime Mylan Generics 1 g/3 ml powder and solvent for injectable solution for intramuscular use and Ceftazidime Mylan Generics 1 g/10 ml powder and solvent for injectable solution for intravenous use contain 50.5 mg of sodium (the main component of table salt) per vial. This corresponds to 2.5% of the maximum daily dietary intake recommended for an adult.
Ceftazidime Mylan Generics 2 g powder for infusion solution contains 101 mg of sodium (the main component of table salt) per vial. This corresponds to 5.05% of the maximum daily dietary intake recommended for an adult.
You should take the above into account if you are on a sodium-controlled diet.

3. How Ceftazidime Mylan Generics is administered

Ceftazidime Mylan Generics 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 muscle.
Ceftazidime Mylan Generics is prepared by the doctor, pharmacist, or nurse using water for injections or appropriate infusion fluids.
Recommended dose
The appropriate dose of Ceftazidime Mylan Generics 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 the condition of your kidneys.
Newborns (0–2 months)
For each kg of the child's body weight, 25 to 60 mg of Ceftazidime Mylan Generics per day will be administered, divided into two doses.
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Children (over 2 months) and children weighing less than 40 kg
For each kg of body weight of the infant or child, 100 to 150 mg of Ceftazidime Mylan Generics 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 Mylan Generics three times a day. 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 Mylan Generics 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 Mylan Generics than you should have
If you are accidentally given a higher dose than prescribed, contact your doctor or the nearest hospital immediately.
If you forget to use Ceftazidime Mylan Generics
If you miss an injection, you should have it as soon as possible. However, if it is almost time for the next injection, skip the missed dose. Do not take 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 Ceftazidime Mylan Generics
Do not stop treatment with Ceftazidime Mylan Generics unless your doctor tells you to.
If you have any questions about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact your doctor immediately if you notice any of the following symptoms:

• Reddish patches on the trunk; the patches are target-like or circular macules, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These serious 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, fatigue, facial swelling, increased eosinophils (a type of white blood cell), effects on liver, kidneys, or lungs (DRESS syndrome or drug hypersensitivity syndrome).

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• Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (acute generalized exanthematous pustulosis).

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 known as erythema multiforme with blister formation resembling small targets (a dark spot in the center surrounded by a clear area with a black ring around the edge).
• Nervous system disorders (neurological sequelae): tremors, involuntary muscle contractions, seizures, encephalopathies, and in some cases, coma. These have occurred in people who received too high a dose, especially in those with kidney disease.

→ 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 (phlebitis or thrombophlebitis)
• Raised red rash which may be itchy (urticaria or maculopapular 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 the number of cells that help blood clotting (thrombocytosis)
• Increase in liver enzymes
• Changes in the results of a blood compatibility diagnostic test called the “Coombs test”.

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 (pseudomembranous colitis)
• Candidiasis – fungal infections in the mouth or vagina
• Headache
• Dizziness
• Abdominal pain
• Nausea or vomiting
• Fever 5/7
• Itching. → Inform your doctor if you experience any of these conditions.

Uncommon side effects that may be detected by blood tests include:

• Reduction in the number of white blood cells (neutropenia, leucopenia)
• Reduction in the number of platelets, cells that help blood clotting (thrombocytopenia)
• Increased levels in the blood of urea, blood nitrogen, or serum creatinine.

Rare side effects
These may affect up to 1 in 10,000 patients:

• Inflammation of the kidney (interstitial nephritis) or acute 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 (paresthesia)
• Unpleasant taste in the mouth
• Yellowing of the whites of the eyes or skin (jaundice).

Other side effects that may be detected by blood tests include:

• Too rapid destruction of red blood cells (hemolytic anemia)
• Increase in certain types of white blood cells (lymphocytosis)
• Severe decrease in the number of white blood cells (agranulocytosis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or nurse. You may 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 Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after “Exp.”.
The expiry date refers to the last day of that month.
Before reconstitution, store the vials protected from light and at a temperature not exceeding 25°C.
The reconstituted solution, prepared with water for injections or compatible infusion fluids (e.g. physiological saline, glucose or sodium lactate solutions), 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 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 Ceftazidime Mylan Generics contains
Ceftazidime Mylan Generics 1 g/3 ml powder and solvent for injectable solution for intramuscular use
Ceftazidime Mylan Generics 1 g/10 ml powder and solvent for injectable solution for intravenous use

• The active substance is: 1 g of ceftazidime (as pentahydrate) with sodium carbonate.
• The other components are anhydrous sodium carbonate (in the powder vial); water for injections (in the solvent vial).

Ceftazidime Mylan Generics 2 g powder for solution for infusion

• The active substance is: 2 g of ceftazidime (as pentahydrate) with sodium carbonate.
• The other component is anhydrous sodium carbonate.

Description of the appearance of Ceftazidime Mylan Generics and contents of the pack
Powder and solvent for injectable solution for intramuscular use
Carton containing 1 vial of 1 g powder + 1 solvent vial of 3 ml.
Powder and solvent for injectable solution for intravenous use
Carton containing 1 vial of 1 g powder + 1 solvent vial of 10 ml.
Powder for solution for infusion
Carton containing 1 vial of 2 g powder.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Mylan S.p.A. - Via Vittor Pisani, 20 - 20124 Milan – Italy
Manufacturers
Laboratorio Farmaceutico CT S.r.l., Via Dante Alighieri 71, 18038 Sanremo (IM)
Mitim S.r.l., Via Cacciamali 34, 36, 38, 25125 Brescia
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