CLONOCID Granules for Oral Suspension 25 Mg/Ml
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
02-04-2023
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
CLARITHROMYCIN
Available from:
Clonmel Healthcare Ltd
Dosage:
25 Mg/Ml
Pharmaceutical form:
Granules for Oral Suspension
Authorization date:
2005-04-15
Summary of Product characteristics
License
Part II
Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Clonocid 125mg/5ml granules for oral suspension.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml reconstituted oral suspension contains 25 mg clarithromycin.
5 ml reconstituted oral suspension contains 125 mg clarithromycin.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Granules for oral suspension.
White to off-white granules.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
Streptococcal tonsillitis, otitis media, skin and soft tissue infections of mild to moderate severity in penicillin
hypersensitive patients or in cases where penicillin is inappropriate for other reasons. Available data on
epidemiological resistance to macrolide antibiotics should be considered.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
4.2 Posology and method of administration
General:
The dosage of Clarithromycin depends on the clinical condition of the patient and has to be defined in any case by the
physician.
The usual dose in children aged 6 months or older is 7.5 mg/kg twice daily.
Recommendations for dosage:
“Children < 8 kg should be dosed on a per kg basis (approx. 7.5mg/kg twice daily) which is equal to
Read the complete document
