DBL CIPROFLOXACIN 200 mg/100 mL injection for intravenous infusion bag

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ciprofloxacin, Quantity: 200 mg

Available from:

Pfizer Australia Pty Ltd

INN (International Name):

Ciprofloxacin

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: hydrochloric acid; lactic acid; water for injections; glucose monohydrate

Administration route:

Intravenous

Units in package:

50 pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Ciprofloxacin Injection for Intravenous Infusion is indicated for use in the following: 1. Hospitalised adult patients in whom oral ciprofloxacin is indicated but cannot be administered or where the oral form is inappropriate. 2. For the treatment of serious or life-threatening infections due to sensitive organisms involving the following organ systems: - Lower respiratory tract infections (gram-negative organisms). Skin and skin structure. Septicaemia. Bone and joint. Urinary tract. 3. Inhalational anthrax (post-exposure): To reduce the incidence or progression of disease following exposure to aerolized Bacillus anthracis. Ciprofloxacin serum concentrations achieved in humans serve as surrogate endpoint reasonably likely to predict clinical benefit and provide the basis for this indication. Note: Because gram-positive organisms are generally less sensitive to ciprofloxacin, it may not be the drug of choice in cases with gram positive infections due to Streptococcus pneumoniae. If anaerobic organisms are suspected of contributing to the infection, use of other suitable drugs should be considered. Strains of Neisseria gonorrhoea resistant to ciprofloxacin have been reported in Australia. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin. Therapy with ciprofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued. Ciprofloxacin is suitable to treat mixed infections caused by susceptible strains of both gram-negative and gram positive aerobic bacteria. If anaerobic organisms are suspected as accompanying aetiologic agents, additional therapy should be considered.

Product summary:

Visual Identification: Clear, colourless or slightly yellow solution; Container Type: Bag; Container Material: Plastic; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2006-12-15

Patient Information leaflet

DBL™ CIPROFLOXACIN
INJECTION FOR
INTRAVENOUS INFUSION
_Ciprofloxacin_
CONSUMER MEDICINE INFORMATION
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.
DBL Ciprofloxacin Injection for
Intravenous Infusion 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 GIVEN DBL
CIPROFLOXACIN INJECTION FOR
INTRAVENOUS INFUSION IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
ciprofloxacin
•
any of the ingredients listed at the
end of this leaflet
•
any other quinolone antibiotics
such as moxifloxacin, nalidixic
acid or norfloxacin.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or othe

Summary of Product characteristics

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Supersedes: pfpcipdi11020
Page 1 of 24
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL™
CIPROFLOXACIN
INJECTION
FOR
INTRAVENOUS INFUSION BAG (CIPROFLOXACIN)
1.
NAME OF THE MEDICINE
Ciprofloxacin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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-quinoline-carboxylic 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 400 mg/200 mL infusion solution. It
also contains the
excipients lactic acid (as a solubilising agent), glucose monohydrate
50 mg/mL and water for
injections. Hydrochloric acid is added as necessary to adjust the pH.
EXCIPIENT(S) WITH KNOWN EFFECT
•
Glucose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
DBL Ciprofloxacin Injection for Intravenous Infusion is a clear,
colourless, or slightly yellow
solution, available in infusion bags.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DBL Ciprofloxacin Injection for Intravenous Infusion is indicated for
use in the following:
1.
Hospitalised adult patients in whom oral ciprofloxacin is indicated
but cannot be
administered or where the oral form is inappropriate.
2.
For the treatment of serious or life-threatening infections due to
sensitive organisms
involving the following organ systems:
- Lower respiratory tract infections (gram-negative organisms)
- Skin and skin structure
- Septicaemia
Version: pfpcipdi11121
Supersedes: pfpcipdi11020
Page 2 of 24
- Bone and joint
- Urinary tract
3.
Inhalational anthrax (post-exposure): To reduce the incidence or
progression of disease
following exposure to aerosolized
_Bacillus anthracis._
Ciprofloxacin serum concentrations
achieved