Ceftazidime 500 mg powder for solution for injection

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Ceftazidime

Dostupno od:

Hikma Farmacêutica (Portugal) S.A.

ATC koda:

J01DD; J01DD02

INN (International ime):

Ceftazidime

Doziranje:

500 milligram(s)

Farmaceutski oblik:

Powder for solution for injection

Tip recepta:

Product subject to prescription which may not be renewed (A)

Područje terapije:

Third-generation cephalosporins; ceftazidime

Status autorizacije:

Not marketed

Datum autorizacije:

2014-09-12

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CEFTAZIDIME 500 MG POWDER FOR SOLUTION FOR INJECTION
CEFTAZIDIME 1 G POWDER FOR SOLUTION FOR INJECTION/INFUSION
CEFTAZIDIME 2 G 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.
PA1217/012/001
PA1217/012/002
PA1217/012/003
WHAT IS IN THIS LEAFLET
1. What Ceftazidime is and what it is used for
2. What you need to know before you use Ceftazidime
3. How to use Ceftazidime
4. Possible side effects
5. How to store Ceftazidime
6. Contents of the pack and other information
1.
WHAT CEFTAZIDIME IS AND WHAT IT IS USED FOR
Ceftazidime is an antibiotic used in adults and children (including
new-born babies). It
works by killing bacteria that cause infections. It belongs to a group
of medicines called
cephalosporins.
Ceftazidime 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 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
DO NOT USE CEFTAZIDIME:
- if you are allergic (hypersensitive) 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
Ceftazidime.
WARNINGS AND PRECAUTIONS
Talk to y

Svojstava lijeka

Health Products Regulatory Authority
01 March 2022
CRN00CQN8
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ceftazidime 500 mg powder for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains ceftazidime 500 mg (as pentahydrate).
Excipient(s) with known effect:
Ceftazidime 500 mg powder for solution for injection contains 26 mg
(1.13 mmol) of sodium per vial.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
500 mg: Powder for solution for injection
White or pale-yellow 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.
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
appropriate use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Health