País: Nova Zelanda
Idioma: anglès
Font: Medsafe (Medicines Safety Authority)
Cefaclor monohydrate 405.27mg equivalent to cefaclor 375 mg
Douglas Pharmaceuticals Limited
Cefaclor monohydrate 405.27 mg (=cefaclor 375 mg)
375 mg
Modified release tablet
Active: Cefaclor monohydrate 405.27mg equivalent to cefaclor 375 mg Excipient: Colloidal silicon dioxide Hyprolose Hypromellose Lactose monohydrate Magnesium stearate Opacode Opadry Blue Purified talc
Blister pack, PVC/DC & alumin, 14 tablets
Prescription
Prescription
Parabolic Drugs Limited
Package - Contents - Shelf Life: Blister pack, PVC/DC & alumin - 14 tablets - 24 months from date of manufacture stored at or below 25°C
1997-11-21
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 Llegiu el document complet