ASPEN CIPROFLOXACIN ciprofloxacin injection for intravenous infusion 100mg/50mL bag

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ciprofloxacin, Quantity: 2 mg/mL

Available from:

Aspen Pharmacare Australia Pty Ltd

INN (International Name):

Ciprofloxacin

Pharmaceutical form:

Injection, intravenous infusion

Composition:

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

Administration route:

Intravenous Infusion

Units in package:

10 x 50 mL bags

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Aspen Ciprofloxacin Injection for Intravenous Infusion is indicated for use in the following. Hospitalised adult patients in whom oral ciprofloxacin is indicated but cannot be administered or where the oral form is inappropriate. 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. Inhalational anthrax (post exposure): To reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. Ciprofloxacin serum concentrations achieved in humans serve as a 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, such as pneumonia due to Streptococcus pneumoniae. If anaerobic organisms are suspected of contributing to the infection, use of other suitable drugs should be considered. Strains 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 aetiological agents, additional therapy should be considered.

Product summary:

Visual Identification: Clear solution free from visible particles; Container Type: Bag; Container Material: Other composite material; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2006-01-23

Patient Information leaflet

ASPEN CIPROFLOXACIN Injection for Intravenous Infusion – CMI
Page 1 of 3
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 that it is
addictive.
BEFORE YOU ARE GIVEN IT
_WHEN YOU MUST NOT BE GIVEN IT _
YOU MUST NOT BE GIVEN THIS
MEDICINE IF YOU HAVE AN ALLERGY
TO:
•
ciprofloxacin
•
any other quinolone antibiotics
such as grepafloxacin,
moxifloxacin, nalidixic acid or
norfloxacin
•
any of the ingredients listed at
the end of this leaflet.
Symptoms of an allergic reaction
may in

Summary of Product characteristics

aspen-ciprofloxacin-iv-pi-5dec19
AUSTRALIAN PRODUCT INFORMATION
ASPEN CIPROFLOXACIN INJECTION FOR INTRAVENOUS INFUSION
1
NAME OF THE MEDICINE
Ciprofloxacin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
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 monohydrate
(55 mg/mL) and
water for injections.
3
PHARMACEUTICAL FORM
Aspen Ciprofloxacin Injection for Intravenous Infusion is a synthetic
carboxyquinolone
derivative with broad spectrum antimicrobial activity for intravenous
(IV) administration.
Ciprofloxacin is a faint to light yellow crystalline powder.
Aspen Ciprofloxacin Injection for Intravenous Infusion is a clear,
colourless to a slightly
yellowish solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Aspen 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
aerosolized
_Bacillus _
_anthracis. _
Ciprofloxacin
serum
concentrations achieved in humans serve as a surrogate endpoint
reasonably likely to
predict clinical benefit and provide the basis for this indication.
aspen-ciprofloxacin-iv-pi-5dec19
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 suitabl