CEFTAZIDIMA 1 G/3 ML Proszek i rozpuszczalnik do roztworu do wstrzykiwań

Treść ulotki

1. Ceftazidima Mylan Generics 1 g/3 ml powder and solvent for injectable solution for use
2. Ceftazidima Mylan Generics 1 g/10 ml powder and solvent for injectable solution for use
   1. What is Ceftazidima Mylan Generics and what is it used for
   2. What you need to know before you are given Ceftazidima Mylan Generics
   3. How Ceftazidima Mylan Generics is administered
   4. Possible side effects
   5. How to store Ceftazidima Mylan Generics
   6. Contents of the pack and other information

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

intramuscular

Ceftazidima Mylan Generics 1 g/10 ml powder and solvent for injectable solution for use

intravenous
Ceftazidima Mylan Generics 2 g powder for infusion solution
ceftazidima

Generic medicine
Read this leaflet carefully before 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.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

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

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

Ceftazidima 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.
Ceftazidima Mylan Generics is used to treat severe bacterial infections of:

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

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Ceftazidima Mylan Generics can 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 a fever due to a bacterial infection.

2. What you need to know before you are given Ceftazidima Mylan Generics

You must not be given Ceftazidima Mylan Generics:

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

→Tell your doctor before starting treatment with Ceftazidima Mylan Generics if you think this applies to you. You must not be given Ceftazidima Mylan Generics.

Warnings and precautions
Talk to your doctor before using Ceftazidima Mylan Generics.
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 in association with treatment with ceftazidime. Contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Be careful with Ceftazidima Mylan Generics
Pay attention to some symptoms such as allergic reactions, nervous system disorders and gastrointestinal disorders like diarrhoea while being treated with Ceftazidima Mylan Generics. This will reduce the risk of possible problems. See “Conditions for which you should be careful” in section 4. If you have had an allergic reaction to other antibiotics, you may also be allergic to Ceftazidima Mylan Generics.

If you need blood or urine tests
Ceftazidima Mylan Generics may interfere with the results of tests for the presence of sugar in the urine and a blood test known as the Coombs test. If you are undergoing these tests:
→ Inform the person taking the sample that you are being treated with Ceftazidima Mylan Generics.

Other medicines and Ceftazidima Mylan Generics
Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes medicines you can get without a prescription.
You must not be given Ceftazidima Mylan Generics without consulting your doctor if you are taking:

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

Pregnancy and breastfeeding
Tell your doctor before you are given Ceftazidima Mylan Generics:

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

The doctor will assess the benefit of treatment with Ceftazidima Mylan Generics against the risk to the baby.

Driving and using machines
Ceftazidima Mylan Generics can cause side effects that affect your ability to drive, such as dizziness (see section 4. “Possible side effects”).
Do not drive or use machines unless you are sure you are not experiencing any effects.

Ceftazidima Mylan Generics contains sodium
Ceftazidima Mylan Generics 1 g/3 ml powder and solvent for solution for injection for intramuscular use and Ceftazidima Mylan Generics 1 g/10 ml powder and solvent for solution for injection for intravenous use contain 50.5 mg of sodium (the main component of table salt) per vial. This is equivalent to 2.5% of the maximum recommended daily intake of sodium with the diet for an adult.
Ceftazidima Mylan Generics 2 g powder for solution for infusion contains 101 mg of sodium (the main component of table salt) per vial. This is equivalent to 5.05% of the maximum recommended daily intake of sodium with the diet for an adult.
You need to take this into account if you are on a sodium-controlled diet.

3. How Ceftazidima Mylan Generics is administered

Ceftazidima Mylan Generics is generally administered by a doctor or a nurse. It may be
administered as an intravenous infusion or as an injection directly into a
vein or into the muscle.
Ceftazidima Mylan Generics is prepared by the doctor, pharmacist or nurse using
water for injectable preparations or appropriate infusion fluids.

Recommended dose
The appropriate dose of Ceftazidima Mylan Generics will be decided by the doctor and depends on: the
severity and type of infection; whether you are being treated with other antibiotics; your body weight and age;
your kidney function.

Newborn babies (0-2 months)
For each kg of the baby’s body weight, 25 to 60 mg of Ceftazidima
Mylan Generics will be administered per day divided into two doses.
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Children (over 2 months) and children weighing less than 40 kg
For each kg of the newborn or child’s body weight, 100 to 150 mg
of Ceftazidima Mylan Generics will be administered per day 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 Mylan Generics three times a day. 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 you are 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 Ceftazidima Mylan Generics you need based on the severity of your kidney disease. The doctor
will monitor you carefully and may have kidney function tests at more frequent intervals.

If you are given more Ceftazidima Mylan Generics than you should
If you accidentally receive a dose higher than the prescribed one, contact
your doctor or the nearest hospital immediately.

If you forget to use Ceftazidima Mylan Generics
If you forget an injection, you should administer it as soon as possible. However, if it is almost time for
the next injection, skip the forgotten injection. Do not take a double dose (two injections
at the same time) to make up for the missed dose, just take the next dose
at the usual time.

If you stop treatment with Ceftazidima Mylan Generics
Do not stop treatment with Ceftazidima Mylan Generics unless your doctor tells you to
do so.
If you have any questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

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

Seek immediate medical attention if you notice any of the following symptoms:

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

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• widespread, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Conditions for which you should be careful
The following serious side effects have occurred in a small number of people, but their
exact frequency is unknown:

• severe allergic reaction. Signs include a raised, itchy rash, swelling, sometimes on the face or mouth causing difficulty breathing
• rash known as erythema multiforme with the formation of blisters 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, convulsions, encephalopathies and, in some cases, coma. These have occurred in people in whom the dose administered to them was too high, especially in people with kidney disease.

→ Contact your doctor or nurse urgently if you experience any of these symptoms.
Common side effects
These can affect up to 1 in 10 patients:

• diarrhea
• swelling and redness along the vein (phlebitis or thrombophlebitis)
• raised red rash that may be itchy (urticaria or maculo-papular rash)
• pain, burning, swelling or inflammation at the injection site. → Tell your doctor if any of these conditions worry you.

Common side effects that can be detected by blood tests are:

• an increase in a type of white blood cells (eosinophilia)
• an increase in the number of cells that help blood clotting (thrombocytosis)
• an increase in liver enzymes
• alteration of the outcome of a diagnostic test for blood compatibility called “Coombs’ test”.

Uncommon side effects
These can affect up to 1 in 100 patients:

• inflammation of the intestine that can 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. → Tell your doctor if you experience any of these conditions.

Uncommon side effects that can be detected by blood tests are:

• a reduction in the number of white blood cells (neutropenia, leukopenia)
• a reduction in the number of platelets, cells that help blood clotting (thrombocytopenia)
• an increase in the level in the blood of urea, azotemia or serum creatinine.

Very rare side effects
These can affect up to 1 in 10,000 patients:

• inflammation of the kidney (interstitial nephritis) or acute renal failure

Other side effects
Other side effects have occurred in a small number of people, but their exact
frequency is unknown:

• pins and needles sensation (paresthesia)
• unpleasant taste in the mouth
• yellowing of the whites of the eyes or skin (jaundice).

Other side effects that can be detected by blood tests are:

• too fast destruction of red blood cells (hemolytic anemia)
• an increase in some types of white blood cells (lymphocytosis)
• severe decrease in the number of white blood cells (agranulocytosis).

Reporting of side effects
If you get any side effect, even if not listed in this leaflet, please tell your doctor or
nurse. You can also report side effects directly through 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 Ceftazidima Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack 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 product in solution, after reconstitution with water for injections or with compatible infusion fluids
(e.g. sodium chloride solution, glucose solution or sodium lactate solution) should be
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normally used within 6 hours if stored at room temperature and within 1 day if stored
at 4°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ceftazidima Mylan Generics contains
Ceftazidima Mylan Generics 1 g/3 ml powder and solvent for injectable solution for
intramuscular use
Ceftazidima Mylan Generics 1 g/10 ml powder and solvent for injectable solution for
intravenous use

• The active ingredient is: 1 g of ceftazidime (as penta hydrate) with sodium carbonate.
• The other ingredients are anhydrous sodium carbonate (vial of powder); water for injections (solvent vial).

Ceftazidima Mylan Generics 2 g powder for solution for infusion

• The active ingredient is: 2 g of ceftazidime (as penta hydrate) with sodium carbonate.
• The other ingredient is anhydrous sodium carbonate.

Description of the appearance of Ceftazidima Mylan Generics and contents of the pack

Powder and solvent for injectable solution for intramuscular use
Pack containing 1 vial of 1 g + solvent vial of 3 ml.

Powder and solvent for injectable solution for intravenous use
Pack containing 1 vial of 1 g + solvent vial of 10 ml.

Powder for solution for infusion
Pack containing 1 vial of 2 g powder.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan S.p.A. - Via Vittor Pisani, 20 - 20124 Milano – Italy
Manufacturer
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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