Ranbaxy-Cefaclor SR

Country: নিউ জিলণ্ড

ভাষা: ইংরেজি

সূত্র: Medsafe (Medicines Safety Authority)

সক্রিয় উপাদান:

Cefaclor monohydrate 405.27mg equivalent to cefaclor 375 mg

থেকে পাওয়া:

Douglas Pharmaceuticals Limited

INN (International Name):

Cefaclor monohydrate 405.27 mg (=cefaclor 375 mg)

ডোজ:

375 mg

ফার্মাসিউটিকাল ফর্ম:

Modified release tablet

রচনা:

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

প্যাকেজ ইউনিট:

Blister pack, PVC/DC & alumin, 14 tablets

শ্রেণী:

Prescription

প্রেসক্রিপশন টাইপ:

Prescription

Manufactured by:

Parabolic Drugs Limited

পণ্য সারাংশ:

Package - Contents - Shelf Life: Blister pack, PVC/DC & alumin - 14 tablets - 24 months from date of manufacture stored at or below 25°C

অনুমোদন তারিখ:

1997-11-21

পণ্য বৈশিষ্ট্য

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