Ranbaxy-Cefaclor

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Cefaclor monohydrate 55.6 mg/mL equivalent to Cefaclor 50 mg/mL

Disponible depuis:

Douglas Pharmaceuticals Limited

DCI (Dénomination commune internationale):

Cefaclor monohydrate 55.6 mg/mL (=Cefaclor 50 mg/mL)

Dosage:

250 mg/5mL

forme pharmaceutique:

Granules for oral suspension

Composition:

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

Unités en paquet:

Bottle, plastic, 75ml, 75 mL

classe:

Prescription

Type d'ordonnance:

Prescription

Fabriqué par:

Parabolic Drugs Limited

Descriptif du produit:

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)

Date de l'autorisation:

1997-06-26

Résumé des caractéristiques du produit

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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.
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