Ceftazidime Fresenius 2000 mg powder for solution for injection/infusion

País: Malta

Idioma: anglès

Font: Malta Medicines Authority

Disponible des:

Fresenius Kabi Italia S.r.l Via Camagre 41, 37063 Isola della Scala (Vr) , Italy

Codi ATC:

J01DD02

Designació comuna internacional (DCI):

CEFTAZIDIME 2000 mg

formulario farmacéutico:

POWDER FOR SOLUTION FOR INJECTION/INFUSION

Composición:

CEFTAZIDIME 2000 mg

tipo de receta:

POM

Área terapéutica:

ANTIBACTERIALS FOR SYSTEMIC USE

Estat d'Autorització:

Authorised

Data d'autorització:

2023-09-20

Informació per a l'usuari

1
Package Leaflet: Information for the user
Ceftazidime Fresenius 1000 mg powder for solution for injection
Ceftazidime Fresenius 2000 mg powder for solution for
injection/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 Ceftazidime Fresenius is and what it is used for
2.
What you need to know before you use Ceftazidime Fresenius
3.
How to use Ceftazidime Fresenius
4.
Possible side effects
5.
How to store Ceftazidime Fresenius
6.
Contents of the pack and other information
1. WHAT CEFTAZIDIME FRESENIUS IS AND WHAT IT IS USED FOR
Ceftazidime Fresenius 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. _
_ _
CEFTAZIDIME FRESENIUS 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 Fresenius 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 USE
CEFTAZIDIME FRESENIUS
DO NOT USE CEFTAZIDIME
FRESENIUS
:
•
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
C

Fitxa tècnica

1
SUMMARY OF PRODUCTS CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Ceftazidime Fresenius
1000 mg powder for solution for injection
Ceftazidime Fresenius
2000 mg powder for solution for injection/infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Ceftazidime Fresenius
1000 mg powder for solution for injection
Each vial contains 1000 mg of ceftazidime (as Ceftazidime
pentahydrate)
Ceftazidime Fresenius
2000 mg powder for solution for injection or infusion
Each bottle contains 2000 mg of ceftazidime (as Ceftazidime
pentahydrate)
Excipient: This medicinal product contains 2.3 mmol (52 mg) sodium for
1000 mg Ceftazidime.
Excipient: This medicinal product contains 4.6 mmol (104 mg) sodium
for 2000 mg Ceftazidime.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for solution for injection.
Powder for solution for injection or infusion.
_White to yellowish 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.
2
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 neg