Fortum powder for solution for injection/infusion

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

ceftazidime (ceftazidime pentahydrate)

Available from:

ACS Dobfar S.p.A.

ATC code:

J01DD02

INN (International Name):

ceftazidime (ceftazidime pentahydrate)

Dosage:

500mg

Pharmaceutical form:

powder for solution for injection/infusion

Units in package:

(1) glass vial

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2021-10-08

Patient Information leaflet

Reason for update: Project Cleo – MAH Change – Stockley Park to
Brentford
Market: UK
Agency Approval Date: N/A as Type 1AIN so implemented before agency
approval_ _
Text Date: 23-Mar-2020
Text Issue and Draft No.: Issue 7 Draft 2
[GSK Logo]
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.
Reason for update: Project Cleo – MAH Change – Stockley Park to
Brentford
Market: UK
Agency Approval Date: N/A as Type 1AIN so implemented before agency
approval_ _
Text Date: 23-Mar-2020
Text Issue and Draft No.: Issue 7 Draft 2
2.
WHAT YOU NEED TO KNOW B

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fortum 500 mg powder for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 500 mg ceftazidime (as pentahydrate) with sodium
carbonate (118 mg per
gram of ceftazidime).
Excipient with known effect
Each vial contains 26 mg (1.15 mmol) of sodium per vial.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection
Vials containing white to cream sterile powder.
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.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Table 1: Adults and children ≥ 40 kg
_Inter