Ceftazidime Hospira Pdr for Soln Inj/Inf 1g

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CEFTAZIDIME PENTAHYDRATE

Available from:

Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom

ATC code:

J01DD02

INN (International Name):

CEFTAZIDIME PENTAHYDRATE 1.165 g

Pharmaceutical form:

POWDER FOR SOLUTION FOR INFUSION OR INJECTION

Composition:

CEFTAZIDIME PENTAHYDRATE 1.165 g

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2016-01-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CEFTAZIDIME 250 MG POWDER FOR SOLUTION FOR INJECTION
CEFTAZIDIME 500 MG POWDER FOR SOLUTION FOR INJECTION
CEFTAZIDIME 1 G POWDER FOR SOLUTION FOR INJECTION/INFUSION
CEFTAZIDIME 2 G POWDER FOR SOLUTION FOR INJECTION/INFUSION
CEFTAZIDIME
The name of your medicine is Ceftazidime 250 mg and 500 mg powder for
solution for injection and
Ceftazidime 1g and 2g powder for solution for injection/infusion,
which will be referred to as
‘Ceftazidime’ throughout the rest of this document.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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.

If you get any side effects, talk to your doctor. This includes any
possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Ceftazidime is and what it is used for
2.
What you need to know before you are given Ceftazidime
3.
How to take Ceftazidime
4.
Possible side effects
5.
How to store Ceftazidime
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 ARE GIVEN CEFTAZIDIME
YOU MUST NOT BE GIVEN CEFTAZIDIME:
• If you are allergic

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ceftazidime 1 g powder for solution for injection/infusion
Ceftazidime 2 g powder for solution for injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1.165 g of ceftazidime pentahydrate, equivalent to
1 g of ceftazidime.
Each vial contains 2.330 g of ceftazidime pentahydrate, equivalent to
2 g of ceftazidime.
Excipient with known effect:
1 g vial contains 2.2 mmol (or 51 mg) of sodium per vial
2 g vial contains 4.5 mmol (or 102 mg) of sodium per vial
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
1 g - Powder for solution for injection/infusion
2g - Powder for solution 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.
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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
whe