Fortum 2 g powder for solution - for injection or infusion, vial - for infusion, monovial

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ceftazidime

Available from:

GlaxoSmithKline (Ireland) 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:

1984-09-24

Patient Information leaflet

Reason for update: Type IAin Divestment of GSK Verona manufacturing
site to ACS Dobfar – Project
Chestnut
Agency Approval Date: TBC
Text Date: 20/01/2020
Text Issue and Draft No.: issue6draft2
SPC Issue and Draft No.: issue5draft3 (No change in SPC with this
submission)
[GSK Logo]
PACKAGE LEAFLET: INFORMATION FOR THE USER
FORTUM
® 500 MG POWDER FOR SOLUTION FOR INJECTION
FORTUM
® 1 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION, VIAL
FORTUM
® 2 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION, VIAL
FORTUM
® 2 G POWDER FOR SOLUTION FOR INFUSION, MONOVIAL TM
ceftazidime
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.
-
If you get any side effects talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Fortum is and what it is used for
2.
What you need to know before you are given Fortum
3.
How Fortum is given
4.
Possible side effects
5.
How to store Fortum
6.
Contents of the pack and other information
1.
WHAT FORTUM IS AND WHAT IT IS USED FOR
Fortum 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._
FORTUM 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.
Fortum 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.
Reason for update: Type IAin Divestment of GSK Verona manufacturing
site to ACS Dobfar �

Summary of Product characteristics

Health Products Regulatory Authority
09 October 2019
CRN009D2L
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fortum 2 g powder for solution - for injection or infusion, vial - for
infusion, monovial
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 2 g ceftazidime (as pentahydrate) with sodium
carbonate (118 mg per gram of ceftazidime).
Excipient with known effect
Each vial contains 104 mg (4.6 mmol) of sodium per vial.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Powder for solution for injection or infusion
Vials containing white to cream sterile powder.
Powder for solution for infusion
Monovial containing white to cream sterile powder.
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 transurethral
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).
Health Products Regulatory Authority
09 October 2019
CRN009D2L
Page 2 of 17
Ceftazidime should be co-administered with other antibacterial agents
whenever the possi