KLACID 250MG/5ML GRANULES FOR ORAL SUSPENSION. 250mg/5ml %v/v Granules for Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CLARITHROMYCIN

Available from:

Abbott Laboratories Ireland Ltd

INN (International Name):

CLARITHROMYCIN

Dosage:

250mg/5ml %v/v

Pharmaceutical form:

Granules for Oral Suspension

Prescription type:

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

Authorization status:

Authorised

Authorization date:

0000-00-00

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Klacid 250mg/5ml Granules for Oral Suspension.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution as directed, each 5ml of suspension contains 250mg Clarithromycin.
Excipients: also contain 2.42g of sucrose per 5ml.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Granules for oral suspension.
White to off-white, free-flowing granules with an odour of fruit.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Klacid Suspension 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.
Klacid Suspension 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_.
ANAEROBES:
Macrolide-susceptible
_Bacteroides_
_fragilis_;
_Clostridium_
_perfringens_;
_Peptococcus_
species;
_Peptostreptococcus _species; _Propionibacterium acnes_.
Klacid Suspension has bactericidal activity against several bacterial strains. These organisms include _Haemophilus_
_influenzae, Streptococcus pneumoniae, Streptococcus