Country: New Zealand
Bahasa: Inggeris
Sumber: Medsafe (Medicines Safety Authority)
Cefaclor monohydrate 55.6 mg/mL equivalent to Cefaclor 50 mg/mL
Douglas Pharmaceuticals Limited
Cefaclor monohydrate 55.6 mg/mL (=Cefaclor 50 mg/mL)
250 mg/5mL
Granules for oral suspension
Active: Cefaclor monohydrate 55.6 mg/mL equivalent to Cefaclor 50 mg/mL Excipient: Allura red AC Citric acid Colloidal silicon dioxide Simeticone Sodium benzoate Sodium citrate dihydrate Strawberry flavour 052311 AP0551 Sucrose Xanthan gum
Bottle, plastic, 75ml, 75 mL
Prescription
Prescription
Parabolic Drugs Limited
Package - Contents - Shelf Life: Bottle, plastic, 75ml - 75 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)
1997-06-26
1 | P a g e 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. 2 | P a g e 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 Baca dokumen lengkap