CIPROXIN IV FLEXIBAG 2 Mg/Ml Solution for Infusion

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

CIPROFLOXACIN LACTATE

Доступно од:

Bayer Limited

АТЦ код:

J01MA02

INN (Међународно име):

CIPROFLOXACIN LACTATE

Дозирање:

2 Mg/Ml

Фармацеутски облик:

Solution for Infusion

Тип рецептора:

Product subject to prescription which may not be renewed (A)

Терапеутска област:

Fluoroquinolones

Статус ауторизације:

Authorised

Датум одобрења:

2007-11-02

Информативни летак

16031 
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 

CIPROXIN IV FLEXIBAG 2MG/ML SOLUTION FOR INFUSION 

Ciprofloxacin  

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT 
INFORMATION FOR YOU. 
 
Keep this leaflet. You may need to read it again. 
 
If you have any further questions,
ask your doctor or pharmacist. 
 
This medicine has been
prescribed for you only. Do not pass it on to others.
It may harm them, even 
if their signs of illness are the same as yours. 
 
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side effects 
not listed in this leaflet. See section 4. 

WHAT IS IN THIS LEAFLET 

1. 
What Ciproxin is and what it is used for 
2. 
What you need to know before you are given Ciproxin 
3. 
How to use Ciproxin 
4. Possible 
side 
effects 
5. 
How to store Ciproxin 
6. 
Contents of the pack and other information 

1. 
WHAT CIPROXIN IS AND WHAT IT IS USED FOR 

Ciproxin contains the active substance ciprofloxacin. Ciprofloxacin
is an antibiotic belonging to the 
fluoroquinolone family. Ciprofloxacin
works by killing bacteria that cause infections. It only works
with 
specific strains of bacteria. 

Adults 
Ciproxin is used in adults to treat the following bacterial
infections: 
 
respiratory tract infections 
 
long lasting or recurring ear or sinus infections 
 
urinary tract infections 
 
genital tract infections in men and women 
 
gastro-intestinal tract
infections and intra-abdominal infections 
 
skin and soft tissue infections 
 
bone and joint infections 
 
anthrax inhalation exposure 

Ciprofloxacin may be used in the management of patients
with low white blood cell counts (neutropenia) 
who have a
fever that is suspected to be due to a bacteri

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ciproxin IV Flexibag 2 mg/ml Solution for Infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each flexible bag with 200 mL solution for infusion contains 400 mg
ciprofloxacin.
Glucose content is 10 g for the 200 mL bag.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear, colourless to slightly yellow solution.
The pH-value of the solution for infusion ranges from 3.6 to 4.5.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ciproxin IV Flexibag 2 mg/ml Solution for Infusion is indicated for
the treatment of the following infections (see sections
4.4 and 5.1). Special attention should be paid to available
information on resistance to ciprofloxacin before commencing
therapy.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
Adults
•
Lower respiratory tract infections due to Gram-negative bacteria
-
exacerbations of chronic obstructive pulmonary disease
-
broncho-pulmonary infections in cystic fibrosis or in bronchiectasis
-
pneumonia
•
Chronic suppurative otitis media
•
Acute exacerbation of chronic sinusitis especially if these are caused
by Gram-negative bacteria
•
Urinary tract infections
•
Genital tract infections
-
epididymo-orchitis including cases due to susceptible_ Neisseria
gonorrhoeae_
-
pelvic inflammatory disease including cases due to susceptible_
Neisseria gonorrhoeae_
•
Infections of the gastro-intestinal tract (e.g. travellers` diarrhoea)
•
Intra-abdominal infections
•
Infections of the skin and soft tissue caused by Gram-negative
bacteria
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