CEFTAZIDIMA 250 mg Powder And Solvent For Injectable Solution

Зміст інструкції

1. Ceftazidima Biopharma 250 mg/1 ml powder and solvent for injectable solution for use
2. Ceftazidima Biopharma 500 mg/1.5 ml powder and solvent for injectable solution for use
   1. WHAT CEFTAZIDIMA BIOPHARMA IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CEFTAZIDIMA BIOPHARMA
   3. HOW CEFTAZIDIMA BIOPHARMA IS ADMINISTERED
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE CEFTAZIDIMA BIOPHARMA
   6. PACKAGE CONTENTS AND OTHER INFORMATION
3. CEFTAZIDIMA BIOPHARMA 500 mg/1.5 ml powder and solvent for injectable solution for use

Ceftazidima Biopharma 250 mg/1 ml powder and solvent for injectable solution for use

intramuscular

Ceftazidima Biopharma 500 mg/1.5 ml powder and solvent for injectable solution for use

intramuscular
Ceftazidima Biopharma 1 g/3 ml powder and solvent for injectable solution for use
intramuscular
Ceftazidima Biopharma 1 g/10 ml powder and solvent for injectable solution for use
intravenous
Ceftazidima Biopharma 2 g powder for infusion solution
Ceftazidima
Equivalent medicinal product

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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. WHAT CEFTAZIDIMA BIOPHARMA IS AND WHAT IT IS USED FOR

Ceftazidima Biopharma 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 Biopharmais 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.

Ceftazidima Biopharma 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 BIOPHARMA

You must not be given Ceftazidima Biopharma:

• if you are allergic ( hypersensitive) to ceftazidime, to cephalosporins or to any of the other components 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 Biopharma.
• Tell your doctor before starting treatment with Ceftazidima Biopharma if you think this applies to you. You must not be given Ceftazidima Biopharma.

Warnings and precautions
Take special care with Ceftazidima Biopharma
Severe skin reactions, including
Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and
systemic symptoms (DRESS), 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.
Pay attention to some symptoms such as allergic reactions, nervous system disorders and
gastrointestinal disorders such as diarrhoea while being treated with Ceftazidima Biopharma. 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 Biopharma.

If you need blood or urine tests
Ceftazidima Biopharma can 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:
tell the person taking the sample that you are being treated with Ceftazidima Biopharma.

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

• an antibiotic called chloramphenicol
• a type of antibiotics called aminoglycosidesfor example gentamicin, tobramycindiuretic tablets called furosemide. Tell your doctor if this applies to you.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy or if you are
breastfeeding with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.
The doctor will assess the benefit of treatment with Ceftazidima Biopharma against the risk to the
child.

Driving and operating machinery
Ceftazidima Biopharma can cause side effects that affect the ability to drive
such as dizziness.
Do not drive or operate machinery unless you are sure you are not experiencing any effects.

Important information about the excipients of Ceftazidima Biopharma
Ceftazidima Biopharma contains sodium
Ceftazidima Biopharma 250 mg contains less than 1 mmol (23 mg) of sodium per vial, which is
essentially ‘sodium-free’.
Ceftazidima Biopharma 500 mg contains 26 mg of sodium (the main component of table salt)
per vial. This is equivalent to 1.3% of the maximum recommended daily intake with the
diet of an adult.
Ceftazidima Biopharma 1 g contains 52 mg of sodium (the main component of table salt) per
vial. This is equivalent to 2.6% of the maximum recommended daily intake with the
diet of an adult.
Ceftazidima Biopharma 2 g contains 104 mg of sodium (the main component of table salt) per
vial. This is equivalent to 5.2% of the maximum recommended daily intake with the
diet of an adult.

3. HOW CEFTAZIDIMA BIOPHARMA IS ADMINISTERED

Ceftazidima Biopharma 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 Biopharma is prepared by the doctor, pharmacist or nurse using water
for injectable preparations or appropriate infusion fluids.

Usual dose
The appropriate dose of Ceftazidima Biopharma 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; the
condition of your kidneys.

Newborns (0-2 months)
For each kg of the baby's body weight, 25 to 60 mg of Ceftazidima
Biopharma will be administered per day divided into two doses.

Children (over 2 months) and childrenweighing less than 40 kg
For each kg of the newborn or child's body weight, 100 to 150 mg of
Ceftazidima Biopharma will be administered per day divided into three doses. The maximum dose is 6 g per day.

Adults and adolescentsweighing 40 kg or more
1 to 2 g of Ceftazidima Biopharma 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 Biopharma you need based on the severity of the kidney disease. The doctor will
monitor you carefully and may have kidney function tests at more regular intervals.

If you are given more Ceftazidima Biopharma 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 Biopharma
If you forget an injection, 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.

If you stop treatment with Ceftazidima Biopharma
Do not stop treatment with Ceftazidima Biopharma unless your doctor tells you to do so. 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 everybody gets them.
Seek immediate medical attention if you notice any of the following symptoms:

• reddish patches on the trunk, the patches are target or circular macules, 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 enlarged lymph nodes, fatigue, facial swelling, increased eosinophils (a type of white blood cells), effects on the kidneys, liver or lungs (DRESS syndrome or drug hypersensitivity syndrome)
• 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 pay 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 a raised, itchy rash, swelling, sometimes on the face or mouth causing difficulty breathing
• rashwith formations of blisterssimilar to small targets(a dark spot in the center surrounded by a clear area with a black ring around the edge)
• nervous system disorders: tremors, convulsions 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 may affect up to 1in 10patients:

• diarrhea
• swelling and redness along the vein
• raised, itchy red rash
• pain, burning, swelling or inflammation at the injection site.

Tell your doctor if any of these conditions worries 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
• an increase in liver enzymes.

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

• inflammation of the intestine which can cause pain or diarrhea which 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 can be detected by blood tests are:

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

Very rare side effects
These may affect up to 1patient in 10,000:

• inflammation or kidney 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
• unpleasant taste in the mouth
• yellowing of the whites of the eyes or skin.

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

• too fast destruction of red blood cells
• an increase in some types of white blood cells
• severe decrease in the number of white blood cells.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist 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 BIOPHARMA

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 packaging after “Exp.”.
The expiry date refers to the last day of that month, in intact packaging,
correctly stored.
Before reconstitution, store the vials at a temperature not exceeding 25 °C and protected
from light.
The product in solution, after reconstitution with water for injectable preparations or with compatible
infusion fluids (e.g. saline solution, glucose or Sodium Lactate) should normally be
used within 12 hours if stored at a temperature below 25 °C.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Ceftazidima Biopharma contains

CEFTAZIDIMA BIOPHARMA 250 mg/1 ml powder and solvent for injectable solution for use

intramuscular
One vial of powder contains:
Active ingredient: ceftazidime pentahydrate 291 mg (equivalent to ceftazidime 250 mg)
Excipients: powder vial: sodium carbonate; solvent vial: water for injections

CEFTAZIDIMA BIOPHARMA 500 mg/1.5 ml powder and solvent for injectable solution for use

intramuscular
One vial of powder contains:
Active ingredient: ceftazidime pentahydrate 582 mg (equivalent to ceftazidime 500 mg)
Excipients: powder vial: sodium carbonate; solvent vial: water for injections

CEFTAZIDIMA BIOPHARMA 1 g/3 ml powder and solvent for injectable solution for use

intramuscular
One vial of powder contains:
Active ingredient: ceftazidime pentahydrate 1.164 g (equivalent to ceftazidime 1 g)
Excipients: powder vial: sodium carbonate; solvent vial: water for injections

CEFTAZIDIMA BIOPHARMA 1 g/10 ml powder and solvent for injectable solution for use

intravenous
One vial of powder contains:
Active ingredient: ceftazidime pentahydrate 1.164 g (equivalent to ceftazidime 1 g)
Excipients: powder vial: sodium carbonate; solvent vial: water for injections

CEFTAZIDIMA BIOPHARMA 2 g powder for solution for infusion
One vial contains:
Active ingredient: ceftazidime pentahydrate 2.328 g (equivalent to ceftazidime 2 g)
Excipients: sodium carbonate

Description of the appearance of Ceftazidima Biopharma and package contents

Powder and solvent for injectable solution for intramuscular use
Pack of 1 vial of 250 mg + 1 solvent vial of 1 ml
Pack of 1 vial of 500 mg + 1 solvent vial of 1.5 ml
Pack of 1 vial of 1 g + 1 solvent vial of 3 ml

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

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

Marketing Authorisation Holder and Manufacturer
Biopharma S.r.l. - Via Paolo Mercuri 8 – 00193 Rome

Manufacturer Responsible for Batch Release
Biopharma S.r.l. – Via delle Gerbere 22/30 – 00134 Santa Palomba Rome