Ceftazidime Doc Generici

PACKAGE LEAFLET: INFORMATION FOR THE USER

CEFTAZIDIME DOC

1 g/3 ml powder and solvent for injectable solution for intramuscular use
Equivalent medicine
Read all of this leaflet carefully before 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 experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What CEFTAZIDIME DOC is and what it is used for
CEFTAZIDIME DOC 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 DOC 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 DOC may also be used:

• to prevent infections during surgical procedures on the prostate in men
• to treat patients with low white blood cell counts (neutropenia) who have fever due to a bacterial infection.

2. What you need to know before being given CEFTAZIDIMA DOC

Do not be given CEFTAZIDIMA DOC:

• if you are allergic to ceftazidime or to any of the excipients 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 CEFTAZIDIMA DOC.

➔ Tell your doctor before starting treatment with CEFTAZIDIMA DOC if you think this applies to you.
You must not be given CEFTAZIDIMA DOC.
Warnings and precautions
Serious skin reactions have been reported during treatment with ceftazidime, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Seek immediate medical advice if you notice any of the symptoms related to these serious skin reactions described in section 4.
Be especially careful with CEFTAZIDIMA DOC
Pay attention to certain symptoms such as allergic reactions, nervous system disorders, and gastrointestinal disorders such as diarrhoea while being treated with CEFTAZIDIMA DOC. 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 CEFTAZIDIMA DOC.
If you need blood or urine tests
CEFTAZIDIMA DOC may interfere with test results for sugar in the urine and with a 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 DOC.
Other medicines and CEFTAZIDIMA DOC
Tell 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 DOC 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
  ➔ Tell your doctor if this applies to you.

Pregnancy and breastfeeding
Ask your doctor for advice before being given CEFTAZIDIMA DOC:

• if you are pregnant, think you might be pregnant, or are planning to become pregnant
• if you are breastfeeding.

Your doctor will weigh the benefits of treatment with CEFTAZIDIMA DOC against any possible risks to the baby.
Driving and using machines
CEFTAZIDIMA DOC may cause side effects that could affect your ability to drive, such as dizziness.
Do not drive or operate machinery unless you are certain you are not affected.
CEFTAZIDIMA DOC contains sodium.
You need to take into account the following information if you are on a controlled sodium diet.
This medicine contains 116.4 mg of sodium (the main component of table salt) as anhydrous sodium carbonate per vial. This corresponds to 5.8% of the maximum recommended daily dietary intake of sodium for an adult.

3. How CEFTAZIDIMA DOC is administered

CEFTAZIDIMA DOC is generally administered by a doctor or nurse.
It may be given as an injection directly into the muscle.
CEFTAZIDIMA DOC is prepared by the doctor, pharmacist, or nurse using water for injectable preparations.

Recommended dose
The appropriate dose of CEFTAZIDIMA DOC will be determined 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 CEFTAZIDIMA DOC per day will be administered, divided into two doses.

Children (over 2 months) and children weighing less than 40 kg
For each kg of the infant’s or child’s body weight, 100 to 150 mg of CEFTAZIDIMA DOC 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 CEFTAZIDIMA DOC 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 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 DOC 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 DOC 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 DOC
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; simply take the next dose at the usual time.

If you stop treatment with CEFTAZIDIMA DOC
Do not stop treatment with CEFTAZIDIMA DOC unless your doctor tells you to do so.
If you have any further 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 everybody will get them.
Contact your doctor immediately if you experience any of the following symptoms:

• Reddish patches on the trunk; the patches are target-like or circular macules, often with central blisters, skin peeling, and 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 cells), effects on the liver, kidney, or lungs (DRESS syndrome or drug hypersensitivity syndrome).
• Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (generalized pustular eruption, 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 with blister-like lesions resembling small targets (a dark spot in the center surrounded by a clear area with a dark ring around the edge).
• Nervous system disorders: tremors, seizures, and in some cases coma. These have occurred in people receiving 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
• Raised red rash, which may be itchy
• Pain, burning, swelling, or inflammation at the injection site. ➔ Tell 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. ➔ Tell 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 (BUN), 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 can also report side effects directly via the national reporting system at 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 DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and outer packaging 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 should normally be used within 18 hours if stored at room temperature, and within 7 days 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 in use. This will help protect the environment.

6. Package contents and other information

What CEFTAZIDIMA DOC contains
Each vial of powder contains:

• The active substance: ceftazidime pentahydrate 1.164 g (equivalent to ceftazidime 1 g).
• The other component: anhydrous sodium carbonate.

The solvent vial contains water for injections.
Description of the appearance of CEFTAZIDIMA DOC and package contents
Colorless glass vials type III with elastomeric stoppers and aluminium caps; colorless glass vials type I.
CEFTAZIDIMA DOC 1 g/3 ml, powder and solvent for injectable solution for intramuscular use, 1 vial of powder + 1 solvent vial of 3 ml.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan – Italy.
Manufacturer
Laboratorio Farmaceutico C.T. S.r.l. – Via Dante Alighieri 71 - 18038 Sanremo (Imperia) – Italy.