Aristin-C

Krajina: Malta

Jazyk: angličtina

Zdroj: Malta Medicines Authority

Aktívna zložka:

CIPROFLOXACIN

Dostupné z:

Anfarm Hellas S.A. 4 Achaias Str. & Trizinias 14564 Kifissia, Attiki, Greece

ATC kód:

J01MA02

INN (Medzinárodný Name):

CIPROFLOXACIN 200 mg

Forma lieku:

SOLUTION FOR INFUSION

Zloženie:

CIPROFLOXACIN 200 mg

Typ predpisu:

POM

Terapeutické oblasti:

ANTIBACTERIALS FOR SYSTEMIC USE

Stav Autorizácia:

Withdrawn

Dátum Autorizácia:

2007-02-09

Príbalový leták

 
1
INSTRUCTION LEAFLET 

1.1 
TRADENAME 

ARISTIN-C Inj.Sol.Inf. 200mg/100ml 

1.2 
COMPOSITION 

Active Ingredient: 
Ciprofloxacin 
Excipients: 
 Lactic Acid (90% W/W), Sodium Chloride, Hydrochloric Acid, Water 
for Injections 

1.3 
PHARMACEUTICAL FORM 

Sterile solution for intravenous infusion 

1.4 
STRENGTH 

Each presentation of ARISTIN-C Infusion in glass
bottles contains the following:  
200mg Ciprofloxacin Ph.Eur. as 254.4mg ciprofloxacin lactate. 

1.5 
DESCRIPTION OF PACKAGING 

Type II, internally siliconised,
colourless glass infusion bottles with a matt
grey teflon-coated 
chlorobutyl rubber stopper, containing 100ml
of ARISTIN-C Infusion solution, with a 
cardboard outer. 

1.6 
PHARMACOTHERAPEUTICAL CATEGORY 

Antibacterial 

1.7 
MARKETING AUTHORIZATION HOLDER 

ANFARM HELLAS S.A. 
K. Paleologou & 27, Perikleous str. 
Halandri 152 32 
Athens - GREECE 

1.8 
MANUFACTURER 

ANFARM HELLAS S.A. 
Schimatari Viotias 

2. 
INFORMATION ABOUT THE DRUG YOUR PHYSICIAN HAS PRESCRIBED YOU 
2.1 
INDICATIONS 
Ciprofloxacin is indicated for the treatment of the
following infections caused by sensitive 
bacteria:  
_ADULTS:_ 
Respiratory tract infections: e.g. lobar and bronchopneumonia,
acute and chronic bronchitis, 
acute exacerbation of cystic fibrosis, bronchiectasis,
empyema. Ciprofloxacin is not 
recommended as first-line therapy for the
treatment of pneumococcal pneumonia. 
Ciprofloxacin may be used for treating
Gram-negative pneumonia.  

2
Ear, nose and throat infections: e.g. mastoiditis, otitis
media and sinusitis, especially if due to 
Gram-negative
bacteria (including Pseudomonas spp.). Ciprofloxacin is not
recommended for 
the treatment of acute tonsillitis.  
Eye infections: e.g. bacterial conjunctivitis.  
Urinary tract infections: e.g. uncomplicated and complicated
urethritis, cystitis, pyelonephritis, 
prostati

Súhrn charakteristických

Page 1 of 13 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 
ARISTIN-C 

2. QUALITATIVE 
AND 
QUANTITATIVE 
COMPOSITION 
Qualitative composition: Ciprofloxacin (INN)  
Quantitative composition:  
Each presentation of ARISTIN-C
Infusion in glass bottles contains the following:  
200mg Ciprofloxacin Ph.Eur. as 254.4mg ciprofloxacin lactate.  
For excipients see Section 6.1 

3.  
PHARMACEUTICAL FORM 
Sterile solution for intravenous infusion 

4.  
CLINICAL 
PARTICULARS 

4.1  
THERAPEUTIC INDICATIONS 
Ciprofloxacin is indicated for the treatment of the
following infections caused by sensitive 
bacteria:  
ADULTS: 
Severe systemic infections: e.g. septicaemia, bacteraemia,
peritonitis, infections in 
immunosuppressed patients with
haematological or solid tumours and in patients in 
intensive care units with specific problems such as infected
burns.  
Respiratory tract infections: e.g. lobar and
bronchopneumonia, acute and chronic bronchitis, 
acute exacerbation of cystic fibrosis, bronchiectasis,
empyema. Ciprofloxacin is not 
recommended as first-line therapy for the
treatment of pneumococcal pneumonia. 
Ciprofloxacin may be used for treating Gram-negative pneumonia.  
Ear, nose and throat infections: e.g.
mastoiditis, otitis media and sinusitis, especially if due 
to Gram-negative bacteria (including Pseudomonas spp.).
Ciprofloxacin is not 
recommended for the treatment of acute tonsillitis.  
Eye infections: e.g. bacterial conjunctivitis.  
Urinary tract infections: e.g. uncomplicated
and complicated urethritis, cystitis, 
pyelonephritis, prostatitis, epididymitis.  
Skin and soft tissue infections: e.g.
infected ulcers, wound infections, abscesses, cellulitis, 
otitis externa, erysipelas, infected burns.  
Bone and joint infections: e.g. osteomyelitis, septic arthritis  
Intra-abdominal infections: e.g. peritonitis,
intra-abdominal ab