Aspen Ciprofloxacin

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ciprofloxacin 2 mg/mL;  

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Ciprofloxacin 2 mg/mL

Dosage:

2 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Ciprofloxacin 2 mg/mL   Excipient: Glucose monohydrate Lactic acid Water for injection

Units in package:

Bag, plastic, 100 mL PVC infusion bag with HDPE and polycarbonate stopper pack of 10, 10 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Quimica Sintetica SA

Therapeutic indications:

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 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:

Package - Contents - Shelf Life: Bag, plastic, 100 mL PVC infusion bag with HDPE and polycarbonate stopper pack of 10 - 10 dose units - 36 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

2006-08-07

Patient Information leaflet

ASPEN CIPROFLOXACIN Injection for Intravenous Infusion – CMI
Page 1 of 4
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 – New Zealand Data Sheet
Page 1 of 23
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Aspen Ciprofloxacin Injection (for intravenous infusion)
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.
Ciprofloxacin, a fluoroquinolone, is a
1-cyclopropyl-6-fluoro-1,4-dihydro-4-
oxo-7-(1-piperazinyl)-3-quinolinecarboxylic
acid.
Its
empirical
formula
is
C17H18FN3O3 and it has a molecular weight of 331.4 (CAS registry
number
85721-33-1). Ciprofloxacin is a faint to light yellow crystalline
powder.
3.
PHARMACEUTICAL FORM
Aspen Ciprofloxacin injection for intravenous infusion is a clear,
colourless to
a slightly yellowish solution.
Aspen
Ciprofloxacin
injection
for
intravenous
infusion
is
a
synthetic
carboxyquinolone derivative with broad spectrum antimicrobial activity
for
intravenous (IV) administration.
4.
CLINICAL PARTICULARS
4.1 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
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 – New Zealand Data Sheet
Page 2 of 23
Note: Because gram-positive organisms are generally less sensitive to
ciprofloxacin, it may not be the drug of choice in cases with
gram-positive
infecti