Ceftazidime DALI Pharma 500 mg Powder for Solution for Injection

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CEFTAZIDIME PENTAHYDRATE

Available from:

DALI Pharma GmbH Brehmstrasse 56, 40239, Dusseldorf,, Germany

ATC code:

J01DD02

INN (International Name):

CEFTAZIDIME PENTAHYDRATE 500 mg

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION

Composition:

CEFTAZIDIME PENTAHYDRATE 500 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2021-01-05

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CEFTAZIDIME DALI PHARMA 500 MG POWDER FOR SOLUTION FOR INJECTION
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, pharmacist or
nurse.
▪
If you get any side effects, talk to your doctor, pharmacist or
nurse.This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ceftazidime DALI Pharma is and what it is used for
2.
What you need to know before you are given Ceftazidime DALI Pharma
3.
How Ceftazidime DALI Pharma is given
4.
Possible side effects
5.
How to store Ceftazidime DALI Pharma
6.
Contents of the pack and other information
1.
WHAT CEFTAZIDIME DALI PHARMA IS AND WHAT IT IS USED FOR
Ceftazidime DALI Pharma contains the active substance ceftazidime and
is an antibiotic given to
adults, adolescents and children (including newborn babies). It works
by killing bacteria that cause
infections. It belongs to a group of medicines called Cephalosporins
_. _
_ _
Ceftazidime DALI Pharma is 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 DALI Pharma 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.
Consideration should be given to official guidelines on the
appropriate use of antibacterial agents.
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2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CEFTAZIDIME DALI PHARMA
YOU MUST NOT BE GIVEN CEFTAZIDIME DALI PHARMA:

If you are allergic to ceftazidime, to any other cephalosporins or any
of the other ingre

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ceftazidime DALI Pharma 500 mg Powder for Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 500 mg of ceftazidime (as pentahydrate).
Excipients with known effects:
Each vial contains 25.6 mg (1.11 mmol) of sodium.
This medicinal product contains maximum 0.29 mg sodium metabisulfite
per vial.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection.
White or pale yellow powder
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ceftazidime DALI Pharma is indicated for the treatment of the
infections listed below in adults,
adolescents and children including neonates (from birth):
▪
Nosocomial pneumonia
▪
Broncho-pulmonary infections in cystic fibrosis
▪
Bacterial meningitis
▪
Chronic suppurative otitis media (otitis media suppurativa chronica)
▪
Malignant inflammation of the external auditory canal (otitis externa
maligna)
▪
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 DALI Pharma may be used:
▪
in the management of neutropenic patients with fever that is suspected
to be due to a
bacterial infection;
▪
in the peri-operative prophylaxis of urinary tract infections for
patients undergoing trans-
urethral resection of the prostate (TURP).;
The selection of Ceftazidime DALI Pharma should take into account its
antibacterial spectrum,
which is mainly restricted to aerobic Gram negative bacteria (see
sections 4.4 and 5.1).
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Ceftazidime DALI Pharma should be co-administered with other
antibacterial agents whenever the
possible range of causative bacteria would not fall within its
spectrum of activity.
C