Ceftazidime PharmSol 1 g Powder for Solution for Injection/Infusion

Nchi: Malta

Lugha: Kiingereza

Chanzo: Medicines Authority

Viambatanisho vya kazi:

CEFTAZIDIME PENTAHYDRATE

Inapatikana kutoka:

PharmSol Europe Limited The Victoria Centre Unit 2, Lower Ground Floor, Valletta Road, Mosta MST 9012 , Malta

ATC kanuni:

J01DD02

INN (Jina la Kimataifa):

CEFTAZIDIME PENTAHYDRATE

Dawa fomu:

SOLUTION FOR INJECTION/INFUSION

Tungo:

CEFTAZIDIME PENTAHYDRATE 1 gram(s)

Dawa ya aina:

POM

Eneo la matibabu:

ANTIBACTERIALS FOR SYSTEMIC USE

Bidhaa muhtasari:

Licence number in the source country: NOT APPLICAPABLE

Idhini hali ya:

Authorised

Idhini ya tarehe:

2021-01-05

Taarifa za kipeperushi

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CEFTAZIDIME PHARMSOL 1 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, 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 PharmSol is and what it is used for
2.
What you need to know before you are given Ceftazidime PharmSol
3.
How Ceftazidime PharmSol is given
4.
Possible side effects
5.
How to store Ceftazidime PharmSol
6.
Contents of the pack and other information
1.
WHAT CEFTAZIDIME PHARMSOL IS AND WHAT IT IS USED FOR
Ceftazidime PharmSol 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 PharmSol 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 PharmSol 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.
2
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CEFTAZIDIME PHARMSOL
YOU MUST NOT BE GIVEN CEFTAZIDIME PHARMSOL:

If you are allergic to ceftazidime to any other cephalosporins or any
of the other
ingredients of this medicine (listed in section 6);

Tabia za bidhaa

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ceftazidime PharmSol 1 g Powder for Solution for Injection/Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1 g of ceftazidime (as pentahydrate).
Excipients with known effects:
Each vial contains 51.2 mg (2.23 mmol) of sodium.
This medicinal product contains maximum 0.58 mg sodium metabisulfite
per vial.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
White or pale yellow powder
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ceftazidime PharmSol 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 PharmSol 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).;
2
The selection of Ceftazidime PharmSol should take into account its
antibacterial spectrum,
which is mainly restricted to aerobic Gram negative bacteria (see
sections 4.4 and 5.1).
Ceftazidime PharmSol 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 giv