CIPROFLOXACIN TEVA 2 Mg/Ml Solution for Infusion

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

CIPROFLOXACIN

Prieinama:

Teva Pharma B.V.

ATC kodas:

J01MA02

INN (Tarptautinis Pavadinimas):

CIPROFLOXACIN

Dozė:

2 Mg/Ml

Vaisto forma:

Solution for Infusion

Recepto tipas:

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

Gydymo sritis:

Fluoroquinolones

Autorizacija statusas:

Authorised

Leidimo data:

2010-01-08

Pakuotės lapelis

1 

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 

Ciprofloxacin Teva 2 mg/ml Solution for Infusion  
Ciprofloxacin  

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 pharmacist or nurse.  
- 
If you get any side
effects, talk to your doctor, pharmacist or nurse. This
includes any possible side 
effects not listed in this leaflet.  See section 4. 

WHAT IS IN THIS LEAFLET:  
1. 
What Ciprofloxacin Teva 2 mg/ml Solution for Infusion is and
what it is used for  
2. 
What you need to know before you are given Ciprofloxacin Teva 2
mg/ml Solution for Infusion 
3. 
How Ciprofloxacin Teva 2 mg/ml Solution for Infusion is given 
4. 
Possible side effects  
5. 
How to store Ciprofloxacin Teva 2 mg/ml Solution for Infusion 
6. 
Contents of the pack and other information 

1.  
WHAT CIPROFLOXACIN TEVA 2 MG/ML SOLUTION FOR INFUSION IS AND WHAT
IT IS USED FOR  

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

_Adults _
Ciprofloxacin Teva is used in adults to treat the
following bacterial infections: 


respiratory tract infections 


long lasting or recurring ear or sinus infections 


urinary tract infections 


infections of the testicles 


genital organ infections in women 


gastro-intestinal tract infections and intra-abdominal infections 


skin and soft tissue infections 


bone and joint infections 


to treat infections in patients with a very low white blood
cell count (neutropenia) 


to prevent infections in patien

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ciprofloxacin Teva 2 mg/ml Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for infusion contains 2 mg ciprofloxacin (as ciprofloxacin lactate*).
100 ml infusion bag contains 200 mg ciprofloxacin as 254.4 mg ciprofloxacin lactate*.
200 ml infusion bag contains 400 mg ciprofloxacin as 508.8 mg ciprofloxacin lactate*.
*Ciprofloxacin lactate is formed from ciprofloxacin and lactic acid _in situ _during the manufacturing process.
Excipient with known effect:
100 ml of Solution for Infusion contains 5 g glucose
200 ml of Solution for Infusion contains 10 g glucose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear, colourless or slightly yellow solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ciprofloxacin 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 _Neisseria gonorrhoeae_
-
Pelvic inflammatory disease including cases due to _Neisseria gonorrhoeae_
In the above genital tract infections when thought or known to be due to _Neisser