Ufexil

Држава: Малта

Језик: Енглески

Извор: Medicines Authority

Активни састојак:

CIPROFLOXACIN

Доступно од:

DEMO S.A. Pharmaceutical Industry 21st km National Road Athens - Lamia 14568 Krioneri, Greece

АТЦ код:

J01MA02

INN (Међународно име):

CIPROFLOXACIN 2 mg/ml

Фармацеутски облик:

SOLUTION FOR INFUSION

Састав:

CIPROFLOXACIN 2 mg/ml

Тип рецептора:

POM

Терапеутска област:

ANTIBACTERIALS FOR SYSTEMIC USE

Статус ауторизације:

Withdrawn

Датум одобрења:

2007-04-04

Информативни летак

 
UFEXIL 
100MG/50ML, 200MG/100ML, 400MG/200ML 
(CIPROFLOXACIN) 

1.  NAME OF THE MEDICINAL PRODUCT   
UFEXIL 100mg/50ml, UFEXIL 200mg/100ml, UFEXIL 400mg/200ml. 
2.  QUALITATIVE AND QUANTITATIVE COMPOSITION (IN ACTIVE 
INGREDIENT) 
Ciprofloxacin Lactate  2.55 mg 
equivalent to Ciprofloxacin             2 mg 
Ciprofloxacin Lactate: C
17
H
18
FN
3
O
3
C
3
H
6
O
3 
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline-carbo- 
xylic acid lactate. 
3.  PHARMACEUTICAL FORM  
Solution for intravenous infusion. 
4. CLINICAL 
PARTICULARS 
4.1 THERAPEUTIC INDICATIONS 
Ciprofloxacin is indicated for the treatment of infections
caused by 
susceptible organism strains in the following conditions: 
Lower respiratory tract infections:_  _Caused by _Escherichia
coli, Klebsiella _
_pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas _
_aeruginosa_
. It is not effective in pneumonia caused by pneumococcus. 
Ciprofloxacin is particularly effective against _Pseudomonas
aeruginosa _in 
cystic fibrosis. Prevention of pulmonary anthrax development after
possible 
or certain inhalation of anthrax bacillus seeds. Skin and skin
structure 
infections:_ _Caused by _Escherichia coli, Klebsiella
pneumoniae, Enterobacter _
_cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii,
Morganella _
_morganii, Citrobacter freundii, Pseudomonas
aeruginosa, Staphylococcus _
_aureus _
and_ Staphylococcus epidermidis_ (methicillin resistant strains). In
the 
last case, concomitant treatment with another antibiotic (e.g.
rifampicin) is 
suggested, in order to prevent organism resistance to ciprofloxacin.
Bone 
and joint infections:  Caused by _Enterobacter
cloacae,_  _Serratia marcescens_, 
_Pseudomonas aeruginosa_
 and _Enterobacter spp_. in general. Urinary tract 
infections: Caused by_ Escherichia coli, Klebsiella
pneumoniae, Enterobacter _
_cloacae, Serratia marcescens, Proteus mirabilis, Providencia
rettgeri,�

Карактеристике производа

Page 1 of 11 

SUMMARY OF PRODUCT CHARACTERISTICS 

1.  NAME OF THE MEDICINAL PRODUCT 

UFEXIL 

2.  QUALITATIVE
AND QUANTITATIVE COMPOSITION (IN ACTIVE INGREDIENT)  

Ciprofloxacin Lactate             2.55 mg 
equivalent to Ciprofloxacin    2 mg
/ml

Ciprofloxacin Lactate: C
17
H
18
FN
3
O
3
C
3
H
6
O
3 
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline-carbo-xylic
acid lactate. 

3.  PHARMACEUTICAL FORM  
Solution for intravenous infusion. 

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
Ciprofloxacin is indicated for the treatment of infections caused by
susceptible organism strains in 
the following conditions: 
Lower respiratory tract
infections:_  _Caused by _Escherichia coli, Klebsiella
pneumoniae, _
_Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa_. It
is not effective in 
pneumonia from pneumococcus. Ciprofloxacin is particularly
effective against _Pseudomonas _
_aeruginosa  _in cystic fibrosis. Prevention of pulmonary anthrax
development after possible or 
certain inhalation of anthrax bacillus seeds. Skin and
skin structure infections:_  _Caused by 
_Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae,
Proteus mirabilis, Proteus _
_vulgaris, Providencia stuartii, Morganella morganii, Citrobacter
freundii, Pseudomonas _
_aeruginosa, Staphylococcus aureus _and_ Staphylococcus
epidermidis_ (methicillin resistant strains). 
In the last case, concomitant treatment with another antibiotic
(e.g. rifampicin) is suggested, in 
order to prevent organism resistance to ciprofloxacin. Bone and
joint infections:  Caused by 
_Enterobacter cloacae,_  _Serratia marcescens_,  _Pseudomonas
aeruginosa_ and _Enterobacter spp_. in 
general. Urinary tract infections:  Caused by_ Escherichia coli,
Klebsiella pneumoniae, _
_Enterobacter cloacae, Serratia marcescens, Proteus
mirabilis, Providencia rettgeri, Morganella