Tirabicin Tablet, film coated 150mg

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

ROXITHROMYCIN

Tilgængelig fra:

Kleva S.A. 189 Parnithos Avenue, 13671 Acharnai, Attiki, Greece

ATC-kode:

J01FA06

INN (International Name):

ROXITHROMYCIN 150 mg

Lægemiddelform:

FILM-COATED TABLET

Sammensætning:

ROXITHROMYCIN 150 mg

Recept type:

POM

Terapeutisk område:

ANTIBACTERIALS FOR SYSTEMIC USE

Autorisation status:

Authorised

Autorisation dato:

2006-03-29

Indlægsseddel

PATIENT INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
‐ Keep this leaflet. You may need to read it again.
‐ If you have further questions, please ask your doctor or your
pharmacist.
‐ This medicine has been prescribed for you personally and you
should not
pass it on to
others. It may harm, them, even if their symptoms are the same as
yours.
IN THIS LEAFLET:
1. What Tirabicin is and what it is used for
2. Before you take Tirabicin
3. How to take Tirabicin
4. Possible side effects
5. Storing Tirabicin
6.
Further information
TIRABICIN 150MG FILM COATED TABLETS
ROXITHROMYCIN
‐ The active substance is: Roxithromycin 150 mg.
‐ The other ingredients are: Excipients: Hyprolose, Poloxalcol,
Povidone K30, Colloidal
anhydrous silica, Magnesium stearate, Talc, Maize starch, Coating:
Hypromellose, Glucose
anhydrous, Titanium dioxide E171, Propylene glycol.
The Marketing Authorisation Holder and Manufacturing Authorisation
Holder for
Tirabicin is:
Kleva SA 189, PArnithos Ave. 13671, Athens‐Greece.
1. WHAT TIRABICIN IS AND WHAT IT IS USED FOR
Tirabicin is available as white, round, film coated tablets in
PVC/aluminium blisters. Each box
contains one blister strip of 10 tablets and a patient information
leaflet.
Tirabicin is a broad
‐spectrum antibiotic. Roxithromycin is a semisynthetic antibacterial
substance. It is a macrolide antimicrobial with a broad spectrum of
action against Gram‐
positive and Gram‐negative microorganisms. Tirabicin is indicated
for the treatment of the
following infections due to microorganisms sensitive to roxithromycin:
‐ Upper respiratory tract infections: pharyngitis and tonsillitis
due
to _Streptococcus _
_pyogenes_. Acute nasosinusitis due to _Streptococcus pneumonia _
_‐ _Lower respiratory tract infections: acute bacterial aggravation
of chronic bronchitis due to
_Haemophilus influnzae,_ _Moraxella catarrhalis_ of _Streptococcus
pneumonia _and_ Chlamydia _
_pneumonia _
_‐ _Genital tract infections except gonococcal infections

Produktets egenskaber

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1.  
   NAME OF THE MEDICINAL PRODUCT 

   TIRABICIN
® 

2.          QUALITATIVE AND QUANTITATIVE COMPOSITION  
Roxithromycin                       150 mg / tab 

  Roxithromycin                      C
41
H
76
N
2
O
15

 (3R, 4S, 5S, 6R, 7R, 9R, 11S, 12R, 13S, 14R) - 4-
[(2,6-dideoxy-3-C, 3-O-dimethl -a-L-
ribo-hexopyranosyl) oxy] -14
-ethyl -7,12,13 -trihydroxy -10 -[(E)- [(2-methoxyethoxy) 
methoxy] imino]- 3,5,7,9,11,13 -hexamethyl- 6-[(3,4,6
-trideoxy -3-dimethylamino -β-D-
xylo- hexopyranosyl) -oxy] oxacyclo tetradecan-2-one. 

3.  
PHARMACEUTICAL FORM 

Film coated tablets  

4.  
CLINICAL PARTICULARS  

4.1.  
INDICATIONS 

TIRABICIN
®
  is indicated for the treatment of infections due to
microorganisms 
sensitive to roxithromycin , especially the following: 
•  Upper respiratory tract infections: pharyngitis and
tonsilitis due to Streptococcus 
pyogenes. Acute nasosinusitis due to Streptococcus pneumoniae. 
•  Low respiratory tract infections: acute
bacterial aggravation of chronic bronchitis due 
to _Haemophilus influenzae_, _Moraxella
catarrhalis_ or _Streptococcus pneumoniae_. For 
patients with respiratory tract infections, when there
is suspicion for infection due to 
H. influenzae, empirical therapy is not recommended. 

Pneumonia  due  to  Mycoplasma  pneumoniae,  Streptococcus  pneumoniae  and 
Chlamydia pneumoniae.  
•  Genital tract infections except gonococcal ones 
•  Non-complicated skin and soft tissues infections
due to Streptococcus pyogenes or 
Staphylococcus aureus.  
      Abscesses usually need surgical drainage. 

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4.2.  
POSOLGY AND METHOD OF ADMINISTRATION 
ADMINISTRATION : For oral admi