Ceftazidime 2g powder for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ceftazidime pentahydrate

Available from:

Wockhardt UK Ltd

ATC code:

J01DD02

INN (International Name):

Ceftazidime pentahydrate

Dosage:

2gram

Pharmaceutical form:

Powder for solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010201; GTIN: 5012727904290 5012727909233

Patient Information leaflet

FPO
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

Summary of Product characteristics

OBJECT 1
CEFTAZIDIME 2G POWDER FOR SOLUTION FOR INJECTION
OR INFUSION
Summary of Product Characteristics Updated 31-Oct-2017 | Wockhardt UK
Ltd
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
appro