Ranbaxy-Cefaclor

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

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

Available from:

Douglas Pharmaceuticals Limited

INN (International Name):

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

Dosage:

125 mg/5mL

Pharmaceutical form:

Granules for oral suspension

Composition:

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

Units in package:

Bottle, plastic, 100 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Parabolic Drugs Limited

Therapeutic indications:

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 produc

Product summary:

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

Authorization date:

1997-06-26

Summary of Product characteristics

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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