CLERON 125MG/5ML POWDER FOR ORAL SUSPENSION

Χώρα: Κύπρος

Γλώσσα: Ελληνικά

Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Δραστική ουσία:

ΚΛΑΡΙΘΡΟΜΥΚΊΝΗ

Διαθέσιμο από:

DELORBIS PHARMACEUTICALS LTD

Φαρμακολογική κατηγορία (ATC):

J01FA09

INN (Διεθνής Όνομα):

CLARITHROMYCIN

Δοσολογία:

125MG/5ML

Φαρμακοτεχνική μορφή:

POWDER FOR ORAL SUSPENSION

Σύνθεση:

8000001318 - CLARITHROMYCIN - 125 MG

Οδός χορήγησης:

ORAL USE

Τρόπος διάθεσης:

Με Ιατρική Συνταγή

Θεραπευτική περιοχή:

CLARITHROMYCIN

Περίληψη προϊόντος:

01 - 1 BOTTLE X 100ML - 100 - MILLILITRE - 990014601 - Εγκεκριμένο

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
CLERON 125 MG/5 ML POWDER FOR ORAL SUSPENSION
Clarithromycin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU GIVE THIS MEDICINE TO
YOUR CHILD BECAUSE IT
CONTAINS IMPORTANT INFORMATION.

Keep this leaflet. You may need to read it again.

If you have further questions, ask your doctor or your pharmacist.

This medicine has been prescribed for your child only. Do not pass it
on to others. It might
harm them, even if their symptoms are the same as your child’s.

If your child gets 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 Cleron powder for oral suspension 125 mg/5 ml is and what it is
used for
2.
What you need to know before giving Cleron powder for oral suspension
125 mg/5 ml
3.
How to give Cleron powder for oral suspension 125 mg/5 ml
4.
Possible side effects
5.
How to store Cleron powder for oral suspension 125 mg/5 ml
6.
Contents of the pack and other information
1.
WHAT CLERON POWDER FOR ORAL SUSPENSION 125 MG/5 ML IS AND WHAT IT IS
USED FOR
Each 5 ml spoonful of Cleron powder for oral suspension 125 mg/5 ml
contains 125 mg of the
active ingredient clarithromycin.
Cleron belongs to a group of medicines called macrolides antibiotics.
Antibiotics stop the growth
of bacteria (bugs) that cause infections.
It is used to treat infections such as:
1.
Chest infections, such as bronchitis and pneumonia
2.
Throat and sinus infections
3.
Skin and tissue infections
4.
Ear infections particularly inflammation of the middle ear (acute
otitis media).
Cleron powder for oral suspension 125 mg/5 ml is used in children 6
months to 12 years old.
2.
WHAT YOU NEED TO KNOW BEFORE GIVING CLERON POWDER FOR ORAL SUSPENSION
125 MG/5 ML
DO NOT GIVE CLERON POWDER FOR ORAL SUSPENSION 125 MG/5 ML TO YOUR
CHILD IF THEY:
•
are ALLERGIC
to clarithromycin, other macrolide antibiotics such as erythromycin or
azithromycin, or any of the other ingredients of Cleron powd

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cleron 125 mg/5 ml Powder for oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of reconstituted suspension contains 125 mg of the active
ingredient Clarithromycin.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral suspension.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Consideration should be given to official quidance on the appropriate
use of antibacterial agents.
Cleron powder for oral suspension 125 mg/5 ml is indicated in children
6 months to 12 years.
Cleron powder for oral suspension 125 mg/5 ml is indicated for the
treatment of infections caused by
susceptible organisms. Indications include:

Lower respiratory tract infections.

Upper respiratory tract infections.

Skin and skin structure infections.

Acute otitis media.
Cleron powder for oral suspension 125 mg/5 ml is usually active
against the following organisms _in vitro_:
GRAM-POSITIVE BACTERIA:
_Staphylococcus aureus_
(methicillin susceptible);
_Streptococcus pyogenes_
(Group A beta-haemolytic streptococci); alpha-haemolytic streptococci
(viridans group); _Streptococcus_
_(Diplococcus) pneumoniae_; _Streptococcus agalactiae_; _Listeria
monocytogenes_.
GRAM-NEGATIVE
BACTERIA:
_Haemophilus _
_influenzae_,
_Haemophilus _
_parainfluenzae_,
_Moraxella_
(_Branhamella_)
_catarrhalis_,
_Neisseria gonorrhoeae_;
_Legionella pneumophila_,
_Bordetella pertussis_,
_Helicobacter pylori_; _Campylobacter jejuni_.
MYCOPLASMA:_ Mycoplasma pneumoniae_; _Ureaplasma urealyticum_.
OTHER ORGANISMS: _ Chlamydia trachomatis_; _Mycobacterium avium_;
_Mycobacterium leprae_; _Chlamydia_
_pneumoniae_.
1
ANAEROBES: Macrolide-susceptible _Bacteroides fragilis_; _Clostridium
perfringens_; _Peptococcus_ species;
_Peptostreptococcus_ species; _Propionibacterium acnes_.
Cleron powder for oral suspension 125 mg/5 ml has bactericidal
activity against several bacterial strains.
These
organisms
include
_H._
_ _
_influenzae,_
_ _
_Streptococcus