Ceftazidime EG Stada

Package leaflet: Information for the user

CEFTAZIDIME EG STADA 1 g/3 ml

powder and solvent for injectable solution for intramuscular use
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.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

1. What CEFTAZIDIME EG STADA is and what it is used for
2. What you need to know before using CEFTAZIDIME EG STADA
3. How to use CEFTAZIDIME EG STADA
4. Possible side effects
5. How to store CEFTAZIDIME EG STADA
6. Contents of the pack and other information

1. What CEFTAZIDIME EG STADA is and what it is used for

CEFTAZIDIME EG STADA 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 EG STADA is used to treat serious bacterial 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 EG STADA may also be used:

• to prevent infections during prostate surgery 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 using CEFTAZIDIME EG STADA

Do not use CEFTAZIDIME EG STADA:

• if you are allergic to ceftazidime 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 EG STADA.

Tell your doctor before starting treatment with CEFTAZIDIME EG STADA if you think
this applies to you. CEFTAZIDIME EG STADA must not be administered to you.
Warnings and precautions
Talk to your doctor or nurse before using CEFTAZIDIME EG STADA.
Exercise particular caution with CEFTAZIDIME EG STADA
Be alert for certain symptoms such as allergic reactions, nervous system disorders, and gastrointestinal disturbances such as diarrhoea while being treated with CEFTAZIDIME EG STADA. 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 CEFTAZIDIME EG STADA.
Serious 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 ceftazidime treatment. Seek immediate medical advice if you notice any of the symptoms related to these serious skin reactions described in section 4.
If you need blood or urine tests
CEFTAZIDIME EG STADA may interfere with test results for glucose in 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 CEFTAZIDIME EG STADA.
Other medicines and CEFTAZIDIME EG STADA
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
You must not be given CEFTAZIDIME EG STADA without first consulting your doctor if you are taking:

• an antibiotic called chloramphenicol
• a type of antibiotics called aminoglycosides, such as gentamicin, tobramycin
• diuretic tablets called furosemide
  Tell your doctor if this applies to you.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or nurse before using this medicine.
Your doctor will assess the benefits of treatment with CEFTAZIDIME EG STADA against any potential risks to the unborn baby.
Driving and using machines
CEFTAZIDIME EG STADA may cause side effects that affect your ability to drive, such as dizziness.
Do not drive or operate machinery unless you are certain you will not be affected.
CEFTAZIDIME EG STADA contains sodium
This medicine contains 50.5 mg of sodium (a main component of table salt) per vial. This is equivalent to 2.5% of the maximum daily dietary intake recommended for an adult.

3. How to use CEFTAZIDIME EG STADA

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
CEFTAZIDIME EG STADA is usually administered by a doctor or nurse.
It may be given as an injection directly into the muscle.
CEFTAZIDIME EG STADA is prepared by the doctor, pharmacist, or nurse using
water for injectable preparations.

Recommended dose
The appropriate dose of CEFTAZIDIME EG STADA 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 baby's body weight, 25 to 60 mg of CEFTAZIDIME EG STADA 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 newborn’s or child’s body weight, 100 to 150 mg of CEFTAZIDIME EG STADA 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 EG STADA three times a day. The maximum dose is 9 g per day.

Elderly 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. Your doctor or nurse will determine the amount of CEFTAZIDIME EG STADA 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 use more CEFTAZIDIME EG STADA 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 EG STADA
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 use a double dose (two injections at the same time) to make up for the missed dose.

If you stop using CEFTAZIDIME EG STADA
Do not stop treatment with CEFTAZIDIME EG STADA unless your doctor tells you to. If you have any doubts, consult your doctor or nurse.

4. Possible side effects

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

Conditions requiring immediate attention
The following serious side effects have occurred in a small number of people, but their exact frequency is unknown:
Seek immediate medical advice if you notice any of the following symptoms:

• severe allergic reaction. Signs include raised, itchy rash, swelling, sometimes affecting the face or mouth, causing difficulty in breathing.
• skin rash with blister-like lesions resembling small targets (a dark spot in the center surrounded by a lighter area with a black ring around the edge).
• widespread rash, reddish patches on the trunk; the patches are target-like or circular macules, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• nervous system disorders: tremors, seizures, and in some cases coma. These have occurred in patients receiving too high a dose, especially in those with kidney disease.
• rare, serious hypersensitivity reactions have been reported, 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 kidneys, liver, and lungs (a reaction known as DRESS or drug hypersensitivity syndrome).
• widespread, red, scaly rash, with lumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized acute exanthematous pustulosis).

Contact your doctor or nurse urgently if you experience any of these symptoms.

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

• diarrhoea
• 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 are:

• 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 (may affect up to 1 in 100 people)

• inflammation of the bowel, which may cause pain or diarrhoea 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 are:

• 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, nitrogen, or serum creatinine.

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

• 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
• yellowing of the whites of the eyes or of the skin

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

• 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 get any side effects, 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 EG STADA

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 product in solution, after reconstitution with water for injections, should normally be used within 8 hours if stored at room temperature (25°C) and within 48 hours if stored in the refrigerator (2°–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 EG STADA contains
One vial of powder contains:
Active substance: ceftazidime 1 g (as pentahydrate) with sodium carbonate.
Excipients: anhydrous sodium carbonate
Solvent vial contains:
Excipients: water for injections

Description of the appearance of CEFTAZIDIME EG STADA and package contents
Colorless type III glass vial with a stopper made of elastomeric material and an aluminum cap; colorless type I glass vial.

CEFTAZIDIME EG STADA 1 g/3 ml powder and solvent for injectable solution for intramuscular use
1 vial of powder + 1 solvent vial of 3 ml

Marketing Authorization Holder
FG S.r.l. – Via San Rocco, 6 – 85033 Episcopia (Potenza)

Manufacturer
Laboratorio Farmaceutico C.T. S.r.l.
Via Dante Alighieri, 71 - 18038 Sanremo (IM)

The following information is intended for healthcare professionals only

Please refer to the Summary of Product Characteristics for further
information
Shelf life
2 years
Special precautions for storage
Before reconstitution, store vials protected from light and at a temperature below 25°C.
The solution after reconstitution with water for injections should normally be used within 8 hours if stored at room temperature (25°C), and within 48 hours if stored in the refrigerator (2°–4°C).
Incompatibilities
Ceftazidime must not be mixed in the same infusion set or syringe with aminoglycosides. Precipitate formation has been reported when vancomycin is added to ceftazidime solutions.
Special precautions for disposal and handling
All types of CEFTAZIDIMA EG STADA vials are provided under reduced pressure. As the product dissolves, carbon dioxide is released and positive pressure develops.
Small bubbles of carbon dioxide in the reconstituted solution may be disregarded.
Instructions for reconstitution
See the table for added volumes and concentrations of the solution, which may be useful when fractional doses are required.

The colour of solutions may vary from pale yellow to amber depending on the
concentration, type of diluent and storage conditions used. Within the established
recommendations, the product's activity is not impaired by such colour variations.
Ceftazidime at concentrations between 1 mg/ml and 40 mg/ml is compatible with:

• sodium chloride 9 mg/ml (0.9%) for injectable preparations
• sodium lactate M/6 for injectable preparations
• compound sodium lactate for injectable preparations (Hartmann's solution)
• dextrose 5% for injectable preparations
• sodium chloride 0.225% and dextrose 5% for injectable preparations
• sodium chloride 0.45% and dextrose 5% for injectable preparations
• sodium chloride 0.9% and dextrose 5% for injectable preparations
• sodium chloride 0.18% and dextrose 4% for injectable preparations
• dextrose 10% for injectable preparations
• Dextran 40 10% for injectable preparations in sodium chloride 0.9% for injectable preparations
• Dextran 40 10% for injectable preparations in dextrose 5% for injectable preparations
• Dextran 70 6% for injectable preparations in sodium chloride 0.9% for injectable preparations
• Dextran 70 6% for injectable preparations in dextrose 5% for injectable preparations

Ceftazidime at concentrations between 0.05 mg/ml and 0.25 mg/ml is compatible with lactate
dialysis solution for intraperitoneal use.
Ceftazidime may be reconstituted for intramuscular use with 0.5% or 1% lidocaine hydrochloride
for injectable preparations.
Any unused medicinal product and waste material derived from this medicinal product must be
disposed of in accordance with local applicable regulations.