Ceclor 125mg/5ml

País: Malta

Língua: inglês

Origem: Malta Medicines Authority

Ingredientes ativos:

CEFACLOR

Disponível em:

Phadisco Limited Yiannou Kranidioti Avenue 185, CY-2234 Latsia, Cyprus

Código ATC:

J01DC04

DCI (Denominação Comum Internacional):

CEFACLOR 125 mg/5ml

Forma farmacêutica:

GRANULES FOR ORAL SUSPENSION

Composição:

CEFACLOR 125 mg/5ml

Tipo de prescrição:

POM

Área terapêutica:

ANTIBACTERIALS FOR SYSTEMIC USE

Status de autorização:

Authorised

Data de autorização:

2005-11-10

Folheto informativo - Bula

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PATIENT INFORMATION LEAFLET
1.
MEDICINAL PRODUCT CHARACTERISTICS
1.1
BRAND NAME: C E C L O R
®
1.2
COMPOSITION:
Granules for oral suspension.
Active ingredient: Cefaclor monohydrate.
Excipients:
Sodium Lauryl Sulfate, Dimethicone, Erythrosine Aluminium Lake,
Methylcellulose 15,
Xanthan Gum, Starch Pregelatinised, Artificial Strawberry Flavour,
Sucrose.
1.3
PHARMACEUTICAL FORM
Granules for oral suspension
1.4
CONTENTS IN ACTIVE INGREDIENT
Granules for oral suspension CECLOR
®
Granules for oral suspension cefaclor 125mg/5ml
Granules for oral suspension cefaclor 250mg/5 ml
1.5
DESCRIPTION – PACKAGING
Granules for oral suspension CECLOR
®
Granules for oral suspension 125mg/5 ml: 100ml vial
Granules for oral suspension 250mg/5 ml: 100ml vial
Certain strengths of the pharmaceutical form are not available in some
countries.
1.6
THERAPEUTIC CATEGORY
Antibiotic
1.7
MANUFACTURING/PACKAGING COMPANY
ACS DOBFAR S.P.A
Via Laurentina Km 24, 730
00071 Pomezia (RM), Italy
1.8
MARKETING LICENSE HOLDER
Phadisco Ltd.
185, Yiannou Kranidioti Avenue, CY-2234 Latsia, Cyprus
2.
WHAT YOU SHOULD KNOW ABOUT CECLOR
2.1
GENERAL INFORMATION
Cefaclor is a semisynthetic 2
nd
generation cephalosporin antibiotic, orally administered.
2.2
INDICATIONS
Cefaclor is indicated in the treatment of the following infections
when caused by susceptible
strains of the designated microorganisms:
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OTITIS MEDIA
caused by
_S. pneumoniae_
,
_H. influenzae_
, staphylococci (except for methicillin
resistant strains), and
_S. pyogenes _
(group A ß-hemolytic streptococci) and
_M. catarrhalis_
.
ACUTE BRONCHITIS AND ACUTE EXACERBATIONS OF CHRONIC BRONCHITIS
caused by
_S. pneumoniae_
,
_H. influenzae _
(including beta-lactamase producing strains),
_H. parainfluenzae_
,
_M. catarrhalis _
(including beta-lactamase producing strains),
_S. aureus_
, after their susceptibility is confirmed
_in vitro_
.
PHARYNGITIS AND TONSILLITIS
caused by
_S. pyogenes _
(group A ß-hemolytic streptococci).
(NOTE: Penicillin is generally the first line drug for

Características técnicas

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCTS
Ceclor 125mg/5ml.
Ceclor 250mg/5ml.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of reconstituted 125mg/5ml suspension contains, as the active
ingredient,
cefaclor monohydrate PhEur, equivalent to 125mg of cefaclor base.
Each 5ml of reconstituted 250mg/5ml suspension contains, as the active
ingredient,
cefaclor monohydrate PhEur, equivalent to 250mg of cefaclor base.
3.
PHARMACEUTICAL FORM
Granules for oral suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ceclor is indicated for the treatment of the following infections due
to susceptible micro
organisms:
Respiratory tract infections, including pneumonia, bronchitis,
exacerbations of chronic
bronchitis, pharyngitis and tonsillitis, and as part of the management
of sinusitis
Otitis media
Skin and soft tissue infections
Urinary tract infections, including pyelonephritis and cystitis
Ceclor 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Ceclor is administered orally.
Adults: The usual adult dosage is 250mg every eight hours. For more
severe infections or
those caused by less susceptible organisms, doses may be doubled.
Doses of 4g per day
have been administered safely to normal subjects for 28 days, but the
total daily dosage
should not exceed this amount.
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Ceclor may be administered in the presence of impaired renal function.
Under such
conditions, dosage is usually unchanged (see 'Special warning and
special precautions for
use'). Patients undergoing haemodialysis: Haemodialysis shortens serum
half life by 25
30%. In patients undergoing regular haemodialysis, a loading dose of
250mg 1g
administered prior to dialysis and a therapeutic dose of 250 500mg
ev