Pinaclor Granules for Oral Suspension 125mg/5ml

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Anhydrous Cefaclor

Available from:

Pinewood Laboratories Ltd,

ATC code:

J01DC; J01DC04

INN (International Name):

Anhydrous Cefaclor

Dosage:

125 mg/5ml

Pharmaceutical form:

Granules for oral suspension

Prescription type:

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

Therapeutic area:

Second-generation cephalosporins; cefaclor

Authorization status:

Not marketed

Authorization date:

1999-05-14

Summary of Product characteristics

Health Products Regulatory Authority
27 May 2019
CRN0092T6
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pinaclor Granules for Oral Suspension 125mg/5ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of the constituted suspension contains Cefaclor monohydrate
131.1mg equivalent to anhydrous Cefaclor 125mg.
Excipients: Each 5ml of constituted suspension contains 2.29g of
sucrose, 2.695mg of sodium, and 0.625mg of Allura Red AC
(E129).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Granules for oral suspension.
White to off-white granule powder forming a red suspension on
constitution with water, having a strawberry flavour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cefaclor is indicated for the treatment of the following infections
due to susceptible microorganisms including _Streptococcus _
_pyogenes_ (group A beta haemolytic streptococci) and _Branhamella
catarrhalis._
Respiratory tract infections, including pneumonia, bronchitis,
exacerbations of chronic bronchitis, pharyngitis and tonsillitis and
as part of the management of sinusitis
Otis media
Skin and soft tissue infections.
Urinary tract infections including pyelonephritis and cystitis.
Cefaclor has been found to be effective in both acute and chronic
urinary tract infections.
Cefaclor is generally effective in the eradication of streptococci
from the nasopharynx, however, data establishing efficacy in
the subsequent prevention of either rheumatic fever or bacterial
endocarditis are not available.
Consideration should be given to the local guidance regarding the
appropriate use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Cefaclor is administered orally.
_Adults:_ The usual adult dosage is 250 mg every eight hours. For more
severe infections or those caused by less susceptible
organisms, doses may be doubled. Doses of 4 g per day have been
administered safely to normal subjects for 28 days but the
total daily dosage should not exceed this amount.
Cefaclor may be adm