Ranbaxy-Cefaclor

Land: Neuseeland

Sprache: Englisch

Quelle: Medsafe (Medicines Safety Authority)

Wirkstoff:

Cefaclor monohydrate 27.8 mg/mL equivalent to Cefaclor 25 mg/mL;  

Verfügbar ab:

Douglas Pharmaceuticals Limited

INN (Internationale Bezeichnung):

Cefaclor monohydrate 27.8 mg/mL (=Cefaclor 25 mg/mL)

Dosierung:

125 mg/5mL

Darreichungsform:

Granules for oral suspension

Zusammensetzung:

Active: Cefaclor monohydrate 27.8 mg/mL equivalent to Cefaclor 25 mg/mL   Excipient: Allura red AC Citric acid Colloidal silicon dioxide Simeticone Sodium benzoate Sodium citrate dihydrate Strawberry flavour 052311 AP0551 Sucrose Xanthan gum

Einheiten im Paket:

Bottle, plastic, 100 mL

Klasse:

Prescription

Verschreibungstyp:

Prescription

Hergestellt von:

Parabolic Drugs Limited

Anwendungsgebiete:

Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated micro-organisms: Lower respiratory infections, including pneumonia caused by S. pneumoniae, H. influenzae (including both ampicillin-sensitive and ampicillin-resistant strains), and S. pyogenes (Group A beta- haemolytic streptococci), M.catarrhalis, acute bronchitis, and acute exacerbations of chronic bronchitis. Upper respiratory infections, including pharyngitis and tonsillitis caused by S. pyogenes (Group A beta-haemolytic streptococci) and M. catarrhalis. Otitis media caused by S. pneumoniae, H. influenzae (including both ampicillin-sensitive and ampicillin-resistant strains) staphylococci, and S. pyogenes (Group A beta-haemolytic streptococci), and M. catarrhalis. Skin and soft-tissue infections caused by Staphylococcus aureus (including ?-lactamase producing strains), S. pyogenes (Group A beta-haemolytic streptococci) and Staphylococcus epidermidis (including ?-lactamase producing strains). Urinary tract infections, including pyelonephritis and cystitis caused by E. coli, P, mirabilis, Klebsiella sp" and coagulase-negative staphylococci. Note: Cefaclor has been found to be effective in both acute and chronic urinary tract infections; sinusitis; gonococcal urethritis. Skin and skin structure infections caused by Staphylococcus aureus and S. pyogenes (group A beta-haemolytic streptococci). Sinusitis. Gonococcal urethritis, but appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor. Therapy may be started while awaiting the results of these studies. Once these results become available, antimicrobial therapy should be adjusted accordingly.

Produktbesonderheiten:

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

Berechtigungsdatum:

1997-06-26

Fachinformation

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NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Ranbaxy-Cefaclor 250 mg capsules
Ranbaxy-Cefaclor 500 mg capsules
Ranbaxy-Cefaclor 125 mg/5 mL granules for oral suspension
Ranbaxy-Cefaclor 250 mg/5 mL granules for oral suspension
Ranbaxy-Cefaclor SR 375 mg modified release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Ranbaxy-Cefaclor 250 mg capsule contains cefaclor monohydrate
267.5 mg (equivalent to
cefaclor 250 mg).
Each Ranbaxy-Cefaclor 500 mg capsule contains cefaclor monohydrate 535
mg (equivalent to
cefaclor 500 mg).
Each mL of Ranbaxy-Cefaclor 125 mg/5 mL oral suspension contains
cefaclor monohydrate 27.8
mg (equivalent to cefaclor 25 mg).
Each mL of Ranbaxy-Cefaclor 250 mg/5 mL oral suspension contains
cefaclor monohydrate 55.6
mg (equivalent to cefaclor 50 mg).
Each Ranbaxy-Cefaclor SR 375 mg modified release tablet contains
cefaclor 405.27 mg
(equivalent to cefaclor 375 mg).
EXCIPIENT(S) WITH KNOWN EFFECT
Ranbaxy-Cefaclor oral suspension contains sucrose.
Ranbaxy-Cefaclor modified release tablet contains lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule 250 mg: Purple/white size 2 gelatine capsule imprinted with
“CEFACLOR 250’ on both
the cap and body of the capsule.
Capsule 500 mg: Purple/grey size OEL gelatine capsule imprinted with
“CEFACLOR 500’ on both
the cap and body of the capsule.
Oral suspension 125 mg/5 ml: White to off-white granular powder, which
upon reconstitution
with water forms a red strawberry, flavoured suspension with a sweet
taste.
Oral suspension 250 mg/5 ml: White to off-white granular powder, which
upon reconstitution
with water forms a red strawberry, flavoured suspension with a sweet
taste.
Modified release tablets: Capsule shaped, biconvex, unscored, blue
film-coated tablet, imprinted
with "Cefaclor CD 375mg" in black.
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4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Cefaclor is indicated in the treatment of the following infections
when caused by susceptible
strains of the designated micro-organi