Fungentin

Riik: Malta

keel: inglise

Allikas: Medicines Authority

Toimeaine:

AMOXICILLIN, CLAVULANIC ACID

Saadav alates:

Elpen Pharmaceutical Co. Inc. 95 Marathonos Ave., 190 09 Pikermi, Attica, Greece

ATC kood:

J01CR02

INN (Rahvusvaheline Nimetus):

AMOXICILLIN 125 mg/5ml CLAVULANIC ACID 31.25 mg/5ml

Ravimvorm:

POWDER FOR ORAL SUSPENSION

Koostis:

AMOXICILLIN 125 mg/5ml CLAVULANIC ACID 31.25 mg/5ml

Retsepti tüüp:

POM

Terapeutiline ala:

ANTIBACTERIALS FOR SYSTEMIC USE

Volitamisolek:

Withdrawn

Loa andmise kuupäev:

2006-11-14

Infovoldik

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SUMMARY OF PRODUCT CHARACTERISTICS 

1.  TRADE NAME OF THE MEDICINAL PRODUCT 

FUGENTIN
®

2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 

FUGENTIN
®
  film-coated tablets (500 + 125) mg/tab:
Each tablet contains 500 mg amoxicillin (as 
amoxicillin trihydrate) and 125 mg clavulanic acid
(as potassium clavulanate).  
FUGENTIN
®
  powder for oral suspension (125 + 31.25) mg/5 ml: Each
dosimetric spoonful (5 ml of 
the suspension) contain 125 mg amoxicillin (as amoxicillin
trihydrate) and 31.25 mg clavulanic acid 
(as potassium clavulanate)._ _
FUGENTIN
®
  powder for oral suspension (250 + 62.5) mg/5 ml:
Each dosimetric spoonful (5 ml of 
the suspension) contain 250 mg amoxicillin
(as amoxicillin trihydrate) and 62.5 mg clavulanic acid 
(as potassium clavulanate)._ _

3.  PHARMACEUTICAL FORM 

A. 
Film-coated tablets 
B. 
Powder for oral suspension 

4.  CLINICAL PARTICULARS 

4.1. 
 THERAPEUTIC INDICATIONS 

FUGENTIN
®
 is indicated for short period treatment of bacterial
infections, caused by beta-lactamase 
producing organisms, which are susceptible to this drug. The
duration of treatment depends on the 
therapeutic indication and it must not exceed 14 days. 
•  Upper Respiratory Tract Infections (including ear, nose and
throat infections), i.e. recurrent 
tonsillitis, sinusitis, otitis media (especially in recurrence
or in severe cases). 
•  Lower Respiratory Tract Infections i.e.
acute exacerbations of chronic bronchitis, lobar 
pneumonia and bronchopneumonia.  
•  Genitourinary Tract Infections i.e. cystitis,
urethritis (not prostatitis), pyelonephritis, infections 
of the female genital organs (excluding infections caused
by chlamydia). 
•  Skin and Soft Tissue Infections. 
•  Bone and Joint Infections i.e. osteomyelitis. 
•  Other Infections i.e. septic abortion, puerperal sepsis,