Nazione: Nuova Zelanda
Lingua: inglese
Fonte: Medsafe (Medicines Safety Authority)
Cefaclor monohydrate 27.8 mg/mL equivalent to Cefaclor 25 mg/mL;
Douglas Pharmaceuticals Limited
Cefaclor monohydrate 27.8 mg/mL (=Cefaclor 25 mg/mL)
125 mg/5mL
Granules for oral suspension
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
Bottle, plastic, 100 mL
Prescription
Prescription
Parabolic Drugs Limited
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.
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
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 Leggi il documento completo