Fortum for Injection 2g

Country: Միացյալ Թագավորություն

language: անգլերեն

source: myHealthbox

active_ingredient:

ceftazidime

MAH:

Glaxo Operations UK Ltd

ATC_code:

J01DD02

INN:

ceftazidime

dosage:

2g

pharmaceutical_form:

Powder for solution for injection or infusion

administration_route:

intravenous injection or infusion

units_in_package:

packs of 1 or 5

prescription_type:

POM - Prescription Only Medicine

manufactured_by:

GlaxoSmithKline Manufacturing

therapeutic_group:

Anti-bacterials for systemic use. Third-generation cephalosporins

therapeutic_indication:

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:

2015-03-06

PIL

INFORMATION FOR THE HEALTHCARE PROFESSIONAL 
FORTUM
®

FOR INJECTION 3 G, 2 G, 1 G AND 500 MG
CEFTAZIDIME

DOSAGE AND ADMINISTRATION INFORMATION ONLY
Please refer to the Summary of Product Characteristics for further
information
DON’T STOP TAKING FORTUM
Don’t stop taking Fortum unless your doctor tells you 
to. If you have any further questions on the use of this 
medicine ask your doctor or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, 
although not everybody gets them. 
CONDITIONS YOU NEED TO LOOK OUT FOR
The following serious side effects have occurred in a 
small number of people but their exact frequency is 
unknown:
•  SEVERE ALLERGIC REACTION. Signs include RAISED 
AND ITCHY RASH, SWELLING, sometimes of the face or 
mouth causing DIFFICULTY IN BREATHING.
•  SKIN RASH, which may BLISTER, and looks like SMALL 
TARGETS (central dark spot surrounded by a paler 
area, with a dark ring around the edge).
•  A WIDESPREAD RASH with BLISTERS and PEELING SKIN. 
(These may be signs of _Stevens-Johnson syndrome _or_ _
_toxic epidermal necrolysis)._
•  NERVOUS SYSTEM DISORDERS: tremors, fits and, in 
some cases coma. These have occurred in people 
when the dose they are given is too high, particularly 
in people with kidney disease.
•  There have been rare reports of severe
hypersensitivity reactions with severe rash, which 
may be accompanied by fever, fatigue, swelling of 
the face or lymph glands, increase of eosinophils 
(type of white blood cells), effects on liver, kidney or 
lung (a reaction called DRESS).
➔
  CONTACT A DOCTOR OR NURSE IMMEDIATELY IF YOU 
GET ANY OF THESE SYMPTOMS.
COMMON SIDE EFFECTS
These may affect UP TO 1 IN 10 people:
•  diarrhoea
•  swelling and redness along a vein
•  red raised skin rash which may be itchy
•  pain, burning, swelling or inflammation at the
injection site.
➔
  TELL YOUR DOCTOR if any of these are troubling you.
Common side effects

SPC

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Fortum for Injection 2g 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Fortum for Injection: Vials contain 2g ceftazidime (as
pentahydrate) with sodium 
carbonate (118mg per gram of ceftazidime). 
Fortum Monovial in a vial containing 2g ceftazidime
pentahydrate. 

3 PHARMACEUTICAL 
FORM 
Powder for solution for injection or infusion 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
Fortum 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 a