CLARITHYROMYCIN Granules for Oral Suspension 250/5 Mg/Ml
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
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(SPC)
25-05-2024
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Virkt innihaldsefni:
CLARITHROMYCIN
Fáanlegur frá:
Rowex Ltd
Skammtar:
250/5 Mg/Ml
Lyfjaform:
Granules for Oral Suspension
Leyfisdagur:
2012-02-03
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clarithromycin 250mg/5ml Granules for Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution 1 ml oral suspension contains 50 mg clarithromycin, 5 ml oral suspension contains 250 mg
clarithromycin.
The product contains 2.4 g sucrose per 5 ml ready- for- use suspension.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Granules for oral suspension.
White to beige granules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clarithromycin 50 mg/ml granules for oral suspension is indicated in adults, adolescents and children, 6 months to 12
years, for the treatment of the following acute and chronic infections, when caused by clarithromycin susceptible
organisms.
•
Infections of the upper respiratory tract such as tonsillitis/pharyngitis, as an alternative when beta lactam
antibiotics are not appropriate.
•
Acute otitis media in children.
•
Infections of the lower respiratory tract such as community acquired pneumonia.
•
Sinusitis and acute exacerbation of chronic bronchitis in adults and adolescents over 12 years of age
•
Skin infections and soft tissue infections of mild to moderate severity.
In appropriate combination with antibacterial therapeutic regimens and an appropriate ulcer healing medicinal product
for the eradication of _Helicobacter pylori _in adult patients with _H. pylori _associated ulcers. See section 4.2.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dosage of Clarithromycin 50 mg/ml granules for oral suspension depends on the clinical condition of the patient
and has to be defined in any case by the physician.
_Adults and adolescents:_
Standard dosage:
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