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ASPEN CIPROFLOXACIN Injection for Intravenous Infusion – CMI
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ASPEN CIPROFLOXACIN
INJECTION FOR INTRAVENOUS INFUSION
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ASPEN
CIPROFLOXACIN Injection for
Intravenous Infusion. It does not
contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given ASPEN
CIPROFLOXACIN Injection for
Intravenous Infusion against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE._ _
_ _
You may need to read it again.
WHAT ASPEN
CIPROFLOXACIN
INJECTION FOR
INTRAVENOUS INFUSION IS
USED FOR
ASPEN CIPROFLOXACIN Injection
for Intravenous Infusion contains
ciprofloxacin (as ciprofloxacin
lactate) as the active ingredient. It
belongs to a group of antibiotics
called fluoroquinolones.
_ _
This medicine is used to treat many
different conditions including:
lung infections
infections of skin
infections of bone and joints
kidney and bladder infections
infections in the blood
inhalation of anthrax (post-
exposure).
It works by killing many kinds of
bacteria which cause infections in
the body.
Ciprofloxacin will not work against
infections caused by viruses such
as cold and flu.
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.
It is available only with a doctor’s
prescription.
There is no evidence t
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제품 특성 요약
ASPEN CIPROFLOXACIN Injection for Intravenous Infusion
– PI
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PRODUCT INFORMATION
ASPEN CIPROFLOXACIN
INJECTION FOR INTRAVENOUS INFUSION
NAME OF THE MEDICINE
Ciprofloxacin
The chemical structure is shown below:
DESCRIPTION
Aspen Ciprofloxacin Injection for Intravenous Infusion is a synthetic carboxyquinolone derivative with broad
spectrum antimicrobial activity for intravenous (IV) administration.
Ciprofloxacin, a fluoroquinolone, is a 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-
quinolinecarboxylic acid. Its empirical formula is C
17
H
18
FN
3
O
3
and it has a molecular weight of 331.4 (CAS
registry number 85721-33-1). Ciprofloxacin is a faint
to light yellow crystalline powder.
Aspen Ciprofloxacin Injection for Intravenous Infusion is available as
a ciprofloxacin (as lactate) 100 mg/50
mL and a 200 mg/100 mL infusion solution. It
also contains the excipients lactic acid (as a solubilising agent),
glucose (55 mg/mL) and water for injections. Aspen Ciprofloxacin Injection for Intravenous Infusion is a clear,
colourless to a slightly yellowish solution.
PHARMACOLOGY
PHARMACOKINETICS
_Distribution _
Immediately following a 30 minute intravenous infusion of 200 mg ciprofloxacin, serum concentrations average
3 microgram/mL. During the first hour after completion of infusion, serum concentration decreases
to
approximately 30% of the peak value, but
thereafter serum concentrations decline with a half life of
approximately four hours. Mean concentrations observed after a 200 mg dose are given below:
CIPROFLOXACIN
SERUM CONCENTRATIONS (MICROGRAM/ML) AFTER A 30 MINUTE INFUSION
DOSE
END OF INFUSION
0.5 HR
1 HR
3 HR
6 HR
8 HR
12 HR
200 mg
3.18
1.4
1.0
0.5
0.3
0.2
0.1
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