Ciproxin

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ciprofloxacin 2 mg/mL (Equates to ciprofloxacin lactate 2.54 mg/mL in the final formulation)

Available from:

Bayer New Zealand Limited

INN (International Name):

Ciprofloxacin 2 mg/mL (Equates to ciprofloxacin lactate 2.54 mg/mL in the final formulation)

Dosage:

2 mg/mL

Pharmaceutical form:

Solution for infusion

Composition:

Active: Ciprofloxacin 2 mg/mL (Equates to ciprofloxacin lactate 2.54 mg/mL in the final formulation) Excipient: Hydrochloric acid Lactic acid Sodium chloride Water for injection

Units in package:

Vial, glass, with Type I bromobutyl stopper, 50 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Bayer AG

Therapeutic indications:

Infections of the lower respiratory tract. In the treatment of outpatients with pneumonia due to Pneumococcus, ciprofloxacin should not be used as a medicine of first choice. Ciprofloxacin can be regarded as a suitable treatment for pneumonias caused by Klebsiella, Enterobacter, Proteus, E. coli, Pseudomonas, Haemophilus, Branhamella, Legionella, and Staphylococcus.

Product summary:

Package - Contents - Shelf Life: Vial, glass, with Type I bromobutyl stopper - 50 mL - 48 months from date of manufacture stored at or below 30°C - Vial, glass, with chlorobutyl stopper - 50 mL - 48 months from date of manufacture stored at or below 30°C - Vial, glass, with Type I bromobutyl stopper - 100 mL - 48 months from date of manufacture stored at or below 30°C - Vial, glass, with chlorobutyl stopper - 100 mL - 48 months from date of manufacture stored at or below 30°C - Vial, glass, with Type I bromobutyl stopper - 200 mL - 48 months from date of manufacture stored at or below 30°C - Vial, glass, with chlorobutyl stopper - 200 mL - 48 months from date of manufacture stored at or below 30°C

Authorization date:

1990-12-18

Patient Information leaflet

CIPROXIN
®
 IV CMI 

1 
CIPROXIN
®
 IV 
(CI

PROX

IN)

_ciprofloxacin _

CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS 
LEAFLET 
This leaflet answers some common 
questions about Ciproxin IV. It does 
not contain all the available 
information. It does not take the 
place of talking to your doctor or 
your pharmacist. 

All medicines have risks and 
benefits.  Your doctor has weighed 
the risks of you taking Ciproxin IV 
against the benefits they expect it 
will have for you. 

IF YOU HAVE ANY CONCERNS ABOUT 
TAKING THIS MEDICINE, ASK YOUR 
DOCTOR OR PHARMACIST. 

KEEP THIS LEAFLET WITH THE 
MEDICINE. 
You may need to read it again.

WHAT CIPROXIN IV IS 
USED FOR 
Ciproxin IV is used to treat serious 
infections in the lungs, skin, blood, 
bone, joints, kidneys, and bowel. 
Ciproxin IV is also used to treat 
inhalational anthrax (an infection 
caused by breathing in the spores of 
bacteria). 

Ciproxin IV contains the active 
ingredient, CIPROFLOXACIN, which is 
an antibiotic belonging to a group of 
medicines called quinolones 
(pronounced kwin-o-lones). These 
antibiotics work by killing the 
bacteria that are causing your 
infection.  

Ciproxin IV is used in hospitalised 
patients where use of Ciproxin 
tablets is inappropriate. 

Ciproxin IV will not work against 
infections caused by viruses such as 
colds or the 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. 
BEFORE YOU ARE 
GIVEN CIPROXIN IV 
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU MUST NOT BE GIVEN CIPROXIN 
IV IF YOU HAVE AN ALLERGY TO: 

  ciprofloxacin, the active 
ingredient in Ciproxin IV 

  any of the ingredients listed at 
the end of this leaflet 

  

Summary of Product characteristics

191001 Ciproxin DS
Page 1 of 31
NEW ZEALAND DATA SHEET
1.
CIPROXIN
®
Ciproxin 250 mg, film-coated tablets*
Ciproxin 500 mg, film-coated tablets*
Ciproxin 750 mg, film-coated tablets*
Ciproxin 50 mg/mL, oral suspension*
Ciproxin 100 mg/mL, oral suspension**
Ciproxin 2 mg/mL, solution for infusion*
*currently unavailable
** currently available
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
FILM-COATED TABLETS
Ciproxin 250 mg:
1 tablet contains 291 mg ciprofloxacin hydrochloride, corresp. to 250
mg ciprofloxacin as
monohydrate
Ciproxin 500 mg:
1 tablet contains 582 mg ciprofloxacin hydrochloride, corresp. to 500
mg ciprofloxacin as
monohydrate
Ciproxin 750 mg:
1 tablet contains 873 mg ciprofloxacin hydrochloride, corresp. to 750
mg ciprofloxacin as
monohydrate
2.2
ORAL SUSPENSION
Ciproxin 50 mg/mL:
1 bottle consists of 7.95 g of microcapsules which contain 5.0 g
ciprofloxacin
1 bottle with 99.2 g suspension diluent to prepare 100 mL of Ciproxin
Suspension 5 %
1 measuring spoonful (approx. 5.0 mL) contains approx. 250 mg
ciprofloxacin
One measuring spoon (5.0 mL suspension) contains approx. 1.4 g of
sucrose
Ciproxin 100 mg/mL:
1 bottle consists of 15.9 g of microcapsules which contain 10.0 g
ciprofloxacin
191001 Ciproxin DS
Page 2 of 31
1 bottle with 91.7 g suspension diluent to prepare 100 mL of Ciproxin
Suspension 10 %
1 measuring spoonful (approx. 5.0 mL) contains approx. 500mg
ciprofloxacin
One measuring spoon (5.0 mL suspension) contains approx. 1.3 g of
sucrose
2.3
SOLUTION FOR INFUSION
Ciproxin 2 mg/mL:
1 glass bottle of 100 mL infusion solution contains 254.4 mg
ciprofloxacin lactate, corresp. to
200 mg ciprofloxacin. Sodium chloride content is 900 mg .
For the full list of excipients, see _section 6.1 List of excipients.
_
3.
PHARMACEUTICAL FORM
3.1
FILM-COATED TABLET
Ciproxin 250 mg:
Round, nearly white to slightly yellowish film-coated scored tablets
marked with “CIP 250” on
one side and a “Bayer cross” on the reverse side. The tablet can
be divided into equal
halves.
Ciproxin 500 mg:
Oblong, nea