Ceftazidime 1g, powder for solution for injection/infusion

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

ceftazidime

Available from:

MIP Pharma GmbH

ATC code:

J01DD02

INN (International Name):

ceftazidime

Dosage:

1g

Pharmaceutical form:

Powder for solution for injection/infusion

Administration route:

intravenous intermittent injection or intravenous continuous infusion

Units in package:

Pack sizes: Packages with 1, 5 or 10 vials

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

MIP Pharma GmbH

Therapeutic group:

Antibacterials for systemic use. Third-generation cephalosporins

Therapeutic indications:

It 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

Authorization status:

Authorised

Authorization date:

2015-03-03

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 Ceftazidime is given 
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 (inclu-
ding newborn babies). It works by killing bacteria that cause 
infections. It belongs to a group of medicines called _cephalo-_
_sporins_. 
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 _(neutro-_
_penia)_ 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 _(hypersensitive)_ to CEFTAZIDIME or any 
of the other ingredients 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 Ceftazidime. 


 TELL YOUR DOCTOR BEFORE you start on Ceftazidime if you 
think that this applies to you. You must not be given Cefta-
zidime. 
TAKE SPECIAL CARE WITH CEFTAZIDIME 
You must look out for certain symptoms such as allergic 
reactions, nervous system disorders and gastrointestinal 
disorders such as diarrhoea while you are being given Cef-
tazidime. This will reduce the risk of possible problems. See 
_(“Conditions you need to look out for”)_ in section 4. If you 
have had an allerg

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Ceftazidime 1 g, powder for solution for injection/infusion 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
1 vial contains 1 g ceftazidime (as pentahydrate). 
Excipient with known effect:  
Sodium carbonate, corresponding to about 52 mg sodium per vial 
For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 
Powder for solution for injection/infusion  
White or pale yellow 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 act