Fortum 1g powder for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ceftazidime pentahydrate

Available from:

Sandoz Ltd

ATC code:

J01DD02

INN (International Name):

Ceftazidime pentahydrate

Dosage:

1gram

Pharmaceutical form:

Powder for solution for injection

Administration route:

Intramuscular; Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010201; GTIN: 5000123108176

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FORTUM® 500 MG POWDER FOR SOLUTION FOR INJECTION
FORTUM® 1 G, 2 G, 3 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN FORTUM
YOU MUST NOT BE GIVEN FORTUM:
•
IF YOU ARE ALLERGIC 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 Fortum.
→ TELL YOUR DOCTOR BEFORE you start on Fortum if you think that this
applies to
you. You must not be given Fortum.
TAKE SPECIAL CARE WITH FORTUM
You must lo

Summary of Product characteristics

OBJECT 1
FORTUM 1G INJECTION
Summary of Product Characteristics Updated 15-Jun-2016 |
GlaxoSmithKline UK
1. Name of the medicinal product
Fortum
®
1 g powder for solution for injection or infusion
2. Qualitative and quantitative composition
Each vial contains 1 g ceftazidime (as pentahydrate) with sodium
carbonate (118 mg per gram of
ceftazidime).
Excipient with known effect
Each vial contains 52 mg (2.3 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.
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 patient 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).
Ceftazidime should be co-administered with other antibacterial agents
whenever the possible range of
causive bacteria would not fall within its spectrum of activity.
Consideration should be given to official guidelines on the
appropriate use of antibacterial agents.
4.2