DBL CIPROFLOXACIN

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Nunua Sasa

Shusha Taarifa za kipeperushi (PIL)
11-06-2024
Shusha Tabia za bidhaa (SPC)
11-06-2024

Viambatanisho vya kazi:

Ciprofloxacin

Inapatikana kutoka:

Hospira Australia Pty Ltd

Darasa:

Medicine Registered

Taarifa za kipeperushi

                                 
DBL
™ 
Ciprofloxacin Injection for Intravenous Infusion CMI 
 
page 1 
 
DBL
™ 
CIPROFLOXACIN INJECTION FOR 
INTRAVENOUS INFUSION  
 
Ciprofloxacin _(Sip-roe-FLOX-a-sin)_ 
 
CONSUMER MEDICINE INFORMATION 
_Date of dispensing _
_Consumer Name _
_Pharmacist Name _
_Consumer Address _
_Pharmacist Address _
 
 
WHAT IS IN THIS LEAFLET 
 
This leaflet answers some 
common questions about DBL
™ 
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 DBL
™ 
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._  _
You may need to read it again. 
 
 
 
WHAT DBL
™ 
CIPROFLOXACIN INJECTION 
FOR INTRAVENOUS 
INFUSION IS USED FOR 
 
This medicine is used to treat: 
•   lung infections 
•  infections of skin 
•  infections of bone and joints 
•  kidney and bladder infections 
•  infections in the blood 
•  inhalation of anthrax (post-
exposure) 
 
This medicine belongs to a group 
of medicines called 
fluoroquinolones. 
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.   
 
This medicine is not addictive. 
 
It is available only with a doctor’s 
prescription. 
 
 
 
 
BEFORE YOU ARE GIVEN  
DBL
™ 
CIPROFLOXACIN 
INJECTION FOR 
INTRAVENOUS INFUSION 
 
_WHEN YOU MUST NOT BE _
_GIVEN IT _
 
YOU MUST NOT BE 
                                
                                Soma hati kamili
                                
                            

Tabia za bidhaa

                                Product Information - Australia 
 
Version 5.0 
Page  1
 
 
DBL™ CIPROFLOXACIN INJECTION FOR INTRAVENOUS INFUSION 
 
 
NAME OF THE MEDICINE 
Ciprofloxacin 
 
The chemical structure is shown below: 
 
 
Molecular formula: 
 
C
17
H
18
FN
3
O
3 
Molecular weight: 
 
331.35 
CAS Registry Number:   
85721-33-1 
 
 
DESCRIPTION 
DBL™ 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.  Ciprofloxacin is a white to pale yellow
crystalline powder. 
 
DBL™ Ciprofloxacin Injection for Intravenous Infusion is available
as a ciprofloxacin (as lactate) 
100 mg/50 mL, 200 mg/100 mL and 400mg/200mL infusion solution.  It
also contains the excipients 
lactic acid (as a solubilising agent), glucose (as monohydrate, 50
mg/mL) and water for injections.  
Hydrochloric acid is added as necessary to adjust the pH.  DBL™
Ciprofloxacin Injection for 
Intravenous Infusion is a clear, colourless or slightly yellow
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 
 
The pharmacokinetics of
intravenously administered ciprofloxacin are near linear over the
dosage 
range of 100 mg to 300 mg, 
                                
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