CEFTAZIDIME MYLAN ceftazidime (as pentahydrate) 2 g powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ceftazidime pentahydrate

Available from:

Alphapharm Pty Ltd

INN (International Name):

ceftazidime pentahydrate

Authorization status:

Registered

Patient Information leaflet

CEFTAZIDIME MYLAN
_contains the active ingredient Ceftazidime pentahydrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CEFTAZIDIME
MYLAN.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking CEFTAZIDIME
MYLAN against the benefits
expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT CEFTAZIDIME
MYLAN IS USED FOR
CEFTAZIDIME MYLAN contains
ceftazidime (as pentahydrate) as the
active ingredient. It belongs to a
group of antibiotics called
cephalosporins.
It is used to treat a wide range of
infections caused by bacteria. These
infections may affect the chest
(bronchitis or pneumonia), ears,
nose, throat, bladder and urinary
tract, skin and soft tissue, stomach or
bones.
It works by killing the bacteria that
cause these.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine/It is available only
with a doctor's prescription.
This medicine is not addictive.
BEFORE YOU ARE GIVEN IT
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN
CEFTAZIDIME MYLAN IF YOU
HAVE OR HAVE HAD AN ALLERGY TO:
•
any medicine containing
ceftazidime
•
any other cephalosporin antibiotic
•
major allergy to penicillin
If you are allergic to cephalosporin or
penicillin you may have an increased
chance of being allergic to
CEFTAZIDIME MYLAN.
•
Any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an allergic
reaction may include;
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
CEFTAZIDIME MYLAN SHOULD
NOT BE MIXED WITH LIGNOCAINE AND
GIVEN TO YOU IF YOU

Summary of Product characteristics

PRODUCT INFORMATION
CEFTAZIDIME MYLAN
_Ceftazidime (as pentahydrate) _
NAME OF THE MEDICINE
Active ingredient
:
Ceftazidime (as pentahydrate)
Chemical name
:
(6R,7R)-7-[[(2Z)-2-(2-aminothiazol-4-yl)-2-[(1-carboxyl-1-
methylethoxy)imino]acetyl]amino]-8-oxo-3-[(1-pyridinio)methyl]-5-thia-1-
azabicyclo[4.2.0]oct-2-ene-2-carboxylate pentahydrate
Structural formula
:
Molecular weight
:
637.0
CAS Registry no.
:
78439-06-2
DESCRIPTION
Ceftazidine is a cephalosporin antibiotic for use by injection only.
CEFTAZIDIME MYLAN powder
for injection is a white or almost white crystalline powder of
ceftazidime pentahydrate (sterile and
buffered with sodium carbonate) equivalent to 1 g or 2 g ceftazidime
(on dried and sodium carbonate
free basis). On the addition of water for injections, CEFTAZIDIME
MYLAN powder for injection
dissolves with effervescence to produce a solution for injection.
CEFTAZIDIME MYLAN powder for
injection contains approximately 50.5 mg (2.2 mEq) of sodium per gram
of ceftazidime.
For laboratory
tests associated with ceftazidime administration, ceftazidime
pentahydrate should be used.
PHARMACOLOGY
PHARMACOKINETICS
Absorption of ceftazidime after oral administration is negligible,
therefore CEFTAZIDIME MYLAN is
intended for parenteral use only.
In humans, after a single intramuscular administration of 500 mg and 1
g, mean peak serum levels of
18 mg/L and 37 mg/L respectively are achieved at 1 hour, falling to 8
mg/L and 2 mg/L (500 mg) and
20 mg/L and 5 mg/L (1 g) at four hours and eight hours respectively
for the two doses.
Five minutes after an intravenous bolus injection of 500 mg, 1 g and 2
g, mean serum levels are
respectively 46 mg/L, 87 mg/L and 170 mg/L, falling to 17 mg/L and 6
mg/L (500 mg), 32 mg/L and
10 mg/L (1 g) and 85 mg/L and 15 mg/L (2 g) at one and four hours
respectively with the three doses.
The serum half-life in adults with normal renal function is about 1.8
hours (1.2-2.9 hours). This may
be prolonged to 20-35 hours in anuric patients. In neonates, the serum
half-life of ceftazidime ca