Ranbaxy-Cefaclor

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Cefaclor monohydrate 267.5mg equivalent to cefaclor 250 mg (plus 2% overage);  ; Cefaclor monohydrate 267.5mg equivalent to cefaclor 250 mg (plus 2% overage)

Available from:

Douglas Pharmaceuticals Limited

INN (International Name):

Cefaclor monohydrate 267.5 mg (=cefaclor 250 mg; plus 2% overage)

Dosage:

250 mg

Pharmaceutical form:

Capsule

Composition:

Active: Cefaclor monohydrate 267.5mg equivalent to cefaclor 250 mg (plus 2% overage)   Excipient: Brilliant blue FCF Carmoisine Colloidal silicon dioxide Croscarmellose sodium Gelatin   Magnesium stearate Methyl hydroxybenzoate   Ponceau 4R Pregelatinised maize starch Propyl hydroxybenzoate   Titanium dioxide   Water   Active: Cefaclor monohydrate 267.5mg equivalent to cefaclor 250 mg (plus 2% overage) Excipient: Brilliant blue FCF Carmoisine Colloidal silicon dioxide Croscarmellose sodium Gelatin   Magnesium stearate Methyl hydroxybenzoate   Ponceau 4R Pregelatinised maize starch Propyl hydroxybenzoate   Titanium dioxide  

Units in package:

Blister pack, 21 capsules

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Parabolic Drugs Limited

Therapeutic indications:

· 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. Note: Penicillin is the usual medicine of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Amoxicillin has been recommended by The American Heart Association as the standard regimen for the prophylaxis of bacterial endocarditis for dental, oral, and upper respiratory tract procedures, with Penicillin V a rational and acceptable alternative in the prophylaxis against beta-haemolytic streptococcal bacteriaemia in this setting. Cefaclor is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever or bacterial endocarditis are not available at present.

Product summary:

Package - Contents - Shelf Life: Blister pack, - 21 capsules - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, with CRC SAF 38mm cap - 100 capsules - 36 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