Ciprofloxacin (AFT)

Country: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Ciprofloxacin lactate 2.653 mg/mL equivalent to Ciprofloxacin 2 mg/mL

Fáanlegur frá:

Baxter Healthcare Ltd

INN (Alþjóðlegt nafn):

Ciprofloxacin lactate 2.653 mg/mL (equivalent to Ciprofloxacin 2 mg/mL)

Skammtar:

0.2% w/v

Lyfjaform:

Solution for infusion

Samsetning:

Active: Ciprofloxacin lactate 2.653 mg/mL equivalent to Ciprofloxacin 2 mg/mL Excipient: Hydrochloric acid Lactic acid Sodium chloride Water for injection

Einingar í pakka:

Bottle, glass, Clear Type II colourless bottle with grey bromobutyl rubber closure 50 mL, 50 mL

Tegund:

Prescription

Gerð lyfseðils:

Prescription

Framleitt af:

Mylan Laboratories Limited

Vörulýsing:

Package - Contents - Shelf Life: Bottle, glass, Clear Type II colourless bottle with grey bromobutyl rubber closure 50 mL - 50 mL - 36 months from date of manufacture stored at or below 30°C protect from light. do not freeze - Bottle, glass, Clear Type II colourless bottle with grey bromobutyl rubber closure 100 mL - 100 mL - 36 months from date of manufacture stored at or below 30°C protect from light. do not freeze - Bottle, glass, Clear Type II colourless bottle with grey bromobutyl rubber closure 200 mL - 200 mL - 36 months from date of manufacture stored at or below 30°C protect from light. do not freeze

Leyfisdagur:

2006-07-13

Vara einkenni

NEW ZEALAND DATA SHEET
CIPROFLOXACIN Data Sheet 14 March 2018 Page 1 of 12
Baxter Healthcare Ltd
1 CIPROFLOXACIN (0.2%w/v, solution for infusion)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient _
Ciprofloxacin lactate 2.653mg/mL (equivalent to ciprofloxacin 2mg/mL).
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
CIPROFLOXACIN 2mg/mL is a clear, colourless to slightly yellow
infusion solution containing
ciprofloxacin lactate equivalent to 2mg of ciprofloxacin per mL.
The pH of CIPROFLOXACIN solution for infusion is 3.9 ‐ 4.5.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
_Adults _
_Uncomplicated and complicated infections caused by ciprofloxacin
sensitive pathogens _

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._

Infections of the kidneys and/or the efferent urinary tract.

Infections of the genital organs, including adnexitis, gonorrhoea and
prostatitis.

Infections of the abdominal cavity (e.g. infections of the
gastrointestinal tract or the biliary tract,
peritonitis).

Infections of the skin and soft tissue.

Infections of the bones and joints.

Sepsis.

Inhalation 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.
_Children _

For the treatment
of acute pulmonary exacerbation of cystic fibrosis associated with_ _
_P. aeruginosa _infection in paediatric patients aged 5 ‐ 17 years.

For the indication of inhalational anthrax (post�