Ceftazidime 2g Powder for solution for injection or infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ceftazidime

Available from:

Wockhardt UK Limited

ATC code:

J01DD; J01DD02

INN (International Name):

Ceftazidime

Dosage:

2 gram(s)

Pharmaceutical form:

Powder for solution for injection/infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Third-generation cephalosporins; ceftazidime

Authorization status:

Marketed

Authorization date:

2004-12-17

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CEFTAZIDIME 1 G POWDER FOR SOLUTION FOR INJECTION
CEFTAZIDIME 2 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION
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 further questions, ask your doctor or nurse.
- This medicine has been prescribed to you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
The name of the medicine is ceftazidime 1g powder for solution for
injection and ceftazidime 2g
powder for solution for injection or infusion. In the rest of this
leaflet it is called ceftazidime for
injection.
WHAT IS IN THIS LEAFLET
1. What ceftazidime for injection is and what it is used for
2. What you need to know before you take ceftazidime for injection
3. How to take ceftazidime for injection
4. Possible side effects
5. How to store ceftazidime for injection
6. Contents of the pack and other information
1. WHAT CEFTAZIDIME IS AND WHAT IT IS USED FOR
Ceftazidime is an antibiotic used in adults and children (including
newborn babies). It works by
killing bacteria that cause infections. It belongs to a group of
medicines called cephalosporins.
CEFTAZIDIME IS USED TO TREAT SEVERE BACTERIAL INFECTIONS OF:
• the lungs or chest
• the lungs and bronchi in patients suffering from cystic fibrosis
• the brain (_meningitis_)
• the ear
• the urinary tract
• the skin and soft tissues
• the abdomen and abdominal wall (_peritonitis_)
• the bones and joints.
Ceftazidime can also be used:
• to prevent infections during prostate surgery in men
• to treat patients with low white blood cell counts (_neutropenia_)
who have a fever due to a bacterial
infection.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CEFTAZIDIME FOR INJECTION
DO N

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ceftazidime 2g Powder for solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains ceftazidime 2g (as pentahydrate)
Excipient with known effect
Each gram of ceftazidime contains approximately 52mg (2.26mmol) of
sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection or infusion (Powder for
injection/infusion).
White to cream coloured, crystalline powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ceftazidime is indicated for the treatment of the infections listed
below in adults and children including neonates (from
birth).
Nosocomial pneumonia
Broncho-pulmonary infections in cystic fibrosis
Bacterial meningitis
Chronic suppurative otitis media
Malignant otitis externa
Complicated urinary tract infections
Complicated skin and soft tissue infections
Complicated intra-abdominal infections
Bone and joint infections
Peritonitis associated with dialysis in patients on CAPD.
Treatment of patients with bacteraemia that occurs in association
with, or is suspected to be associated with, any of the
infections listed above.
Ceftazidime may be used in the management of neutropenic patients with
fever that is suspected to be due to a bacterial
infection.
Ceftazidime may be used in the peri-operative prophylaxis of urinary
tract infections for patients undergoing trans-
urethral resection of the prostate (TURP).
The selection of ceftazidime should take into account its
antibacterial spectrum, which is mainly restricted to aerobic
Gram negative bacteria (see sections 4.4 and 5.1).
Ceftazidime should be co-administered with other antibacterial agents
whenever the possible range of causative
bacteria would not fall within its spectrum of activity.
Consideration should be given to official guidelines on the
appropriate use of antibacterial agents.
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