Fribat

Package leaflet: Information for the user

FRIBAT 1g/3 ml powder and solvent for injectable solution for intramuscular use

Ceftazidime
Equivalent medicine
Please read 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, consult your doctor or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• 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 FRIBAT is and what it is used for
2. What you need to know before using FRIBAT
3. How to use FRIBAT
4. Possible side effects
5. How to store FRIBAT
6. Contents of the pack and other information

1. What FRIBAT is and what it is used for

FRIBAT is an antibiotic used in adults and children (including newborns).
It works by killing bacteria that cause infections and belongs to a group of medicines called
cephalosporins.
FRIBAT is used to treat severe 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.

FRIBAT may also be used:

• to prevent infections during surgical procedures of the prostate 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 using FRIBAT

Do not use FRIBAT:

• 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 FRIBAT.

Tell your doctor before starting treatment with FRIBAT if you think this applies to you.
FRIBAT must not be administered to you.

Warnings and precautions

Talk to your doctor or nurse before using FRIBAT.

Be especially careful with FRIBAT

Pay attention to certain symptoms such as allergic reactions, nervous system disorders, and gastrointestinal disorders such as diarrhoea while being treated with FRIBAT. 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 FRIBAT.

Severe 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). Contact your doctor immediately if you notice any symptoms related to these severe skin reactions described in section 4.

If you need blood or urine tests

FRIBAT may interfere with test results for glucose in the 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 FRIBAT.

Other medicines and FRIBAT

Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.

FRIBAT must not be administered to you 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, breastfeeding and fertility

If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or nurse for advice before using this medicine.
Your doctor will evaluate the benefit of treatment with FRIBAT against the potential risk to the baby.

Driving and using machines

FRIBAT may cause side effects that affect your ability to drive, such as dizziness.
Do not drive or operate machinery unless you are certain you are not affected.

FRIBAT contains sodium

This medicine contains 50.5 mg of sodium (a key component of table salt) per vial. This is equivalent to 2.5% of the maximum daily recommended dietary intake of sodium for an adult.

3. How to use FRIBAT

Use this medicine exactly as prescribed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
FRIBAT is generally administered by a doctor or nurse.
FRIBAT may be given as an injection directly into the muscle.
FRIBAT is prepared by the doctor, pharmacist, or nurse using water for
injections.
Recommended dose
The appropriate dose of FRIBAT 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 your kidney function.
Newborn infants (0–2 months)
For each kg of the infant's body weight, 25 to 60 mg of FRIBAT per
day will be administered, 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 FRIBAT 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 FRIBAT three times daily. 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 decide how much FRIBAT 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 FRIBAT 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 FRIBAT
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 a forgotten dose.
If you stop using FRIBAT
Do not stop treatment with FRIBAT 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 attention
The following serious side effects have occurred in a small number of people, but their exact frequency is unknown:
Contact your doctor immediately if you notice any of the following symptoms:

• severe allergic reaction. Signs include raised, itchy rash, swelling, sometimes affecting the face or mouth, causing breathing difficulties.
• skin rash with blister-like lesions resembling small targets (a dark spot in the center surrounded by a pale area and a dark ring around the edge).
• widespread rash, reddish patches on the trunk, the patches being 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 people 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 cells), 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 occur at the beginning of treatment (acute generalized 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.

Tell 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 intestine, which may cause pain or diarrhoea, possibly containing 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 are:

• decrease in the number of white blood cells
• decrease in the number of platelets (cells that help blood clotting)
• increase in blood urea, blood nitrogen or serum creatinine levels.

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

• 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 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 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 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 FRIBAT

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 vial and the 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 below 25°C.
The reconstituted 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What FRIBAT 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 FRIBAT and contents of the pack
Colorless glass vial type III with a stopper made of elastomeric material and aluminum cap; colorless glass vial type I.

FRIBAT 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
Epifarma 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
21 months
Special precautions for storage
Before reconstitution, store vials protected from light and at a temperature below 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 refrigerated (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 FRIBAT vials are supplied 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 volumes to be added and the resulting solution concentrations, 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 injection
• sodium lactate M/6 for injection
• sodium lactate compound for injection (Hartmann's solution)
• dextrose 5% for injection
• sodium chloride 0.225% and dextrose 5% for injection
• sodium chloride 0.45% and dextrose 5% for injection
• sodium chloride 0.9% and dextrose 5% for injection
• sodium chloride 0.18% and dextrose 4% for injection
• dextrose 10% for injection
• Dextran 40 10% for injection in sodium chloride 0.9% for injection
• Dextran 40 10% for injection in dextrose 5% for injection
• Dextran 70 6% for injection in sodium chloride 0.9% for injection
• Dextran 70 6% for injection in dextrose 5% for injection

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