Cefaclor Sandoz

Kraj: Nowa Zelandia

Język: angielski

Źródło: Medsafe (Medicines Safety Authority)

Składnik aktywny:

Cefaclor monohydrate 52.45 mg/mL equivalent to Cefaclor 50 mg/mL (with 2.5% overage)

Dostępny od:

Novartis New Zealand Ltd

INN (International Nazwa):

Cefaclor monohydrate 52.45 mg/mL (=Cefaclor 50 mg/mL; with 2.5% overage)

Dawkowanie:

250 mg/5mL

Forma farmaceutyczna:

Granules for oral suspension

Skład:

Active: Cefaclor monohydrate 52.45 mg/mL equivalent to Cefaclor 50 mg/mL (with 2.5% overage) Excipient: Dimeticone Iron oxide yellow Maize starch Methylcellulose Sodium laurilsulfate Strawberry flavour 052312 AP0551 Sucrose Xanthan gum

Sztuk w opakowaniu:

Bottle, glass, 60 mL

Klasa:

Prescription

Typ recepty:

Prescription

Wyprodukowano przez:

ACS Dobfar SpA

Podsumowanie produktu:

Package - Contents - Shelf Life: Bottle, glass, - 60 mL - 24 months from date of manufacture stored at or below 25°C 14 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Bottle, glass, - 100 mL - 24 months from date of manufacture stored at or below 25°C 14 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Data autoryzacji:

2000-04-19

Charakterystyka produktu

NEW ZEALAND DATASHEET
CEFACLOR SANDOZ
_CEFACLOR MONOHYDRATE PH EUR, POWDER FILLED CAPSULE, 250 MG AND 500
MG, _
_GRANULES FOR ORAL SUSPENSION 125 MG/5 ML AND 250 MG/5 ML (AS
CEFACLOR) _
PRESENTATION
_CEFACLOR SANDOZ CAPSULES _
250 MG
Capsule, powder filled, Size 2, reddish brown opaque cap and body.
Each capsule contains cefaclor
monohydrate equivalent to cefaclor 250 mg.
500 MG
Capsule, powder filled, Size 0, reddish brown opaque cap and body.
Each capsule contains cefaclor
monohydrate equivalent to cefaclor 500 mg.
_CEFACLOR SANDOZ GRANULES FOR ORAL SUSPENSION _
125 MG/5 ML
Suspension, oral, granules for, light yellow to orange yellow
coloured. Reconstituted suspension
contains in 5 ml, cefaclor monohydrate equivalent to cefaclor 125 mg.
250 MG/5 ML
Suspension, oral, granules for, light yellow to orange yellow
coloured. Reconstituted suspension
contains in 5 ml, cefaclor monohydrate equivalent to cefaclor 250 mg.
USES
_ACTIONS _
PHARMACOTHERAPEUTIC GROUP
J01DC04 – Second generation cephalosporins, cefaclor.
MECHANISM OF ACTION
Beta-lactam antibiotic.
PHARMACODYNAMIC EFFECTS
Inhibition of bacterial cell wall synthesis.
ANTIBIOTIC CLASS
Cefaclor monohydrate is a semi-synthetic cephalosporin for oral
administration.
ANTIBIOTIC NATURE AND MODE OF ACTION
_In vitro _tests demonstrate that the bactericidal action of
cephalosporins results from inhibition of cell-
wall synthesis.
SUSCEPTIBILITY DATA
While _in vitro _studies have demonstrated the susceptibility of most
strains of the following organisms
to cefaclor, clinical efficacy for infections other than those
included in the Indications section is
unknown.
Aerobes, Gram-positive: Staphylococci, including coagulase-positive,
coagulase-negative, and
penicillinase-producing strains; _Streptococcus pyogenes_ (Group A
beta-haemolytic streptococci);
_Streptococcus pneumoniae_;_ Corynebacterium_ spp.
Aerobes, Gram-negative: _Moraxella (Branhamella) catarrhalis_;
_Haemophilus influenzae_, including
beta-lactamase-producing ampicillin-resistant strains; _Escherichia
coli