Source: Health Products Regulatory Authority (ZA) Publisher: sanofi-aventis south africa (pty) ltd., 2 Bond Street, Midrand, 1685, South Africa
ORELOX 100 (tablets).
ORELOX 200 (tablets).
ORELOX JUNIOR (granules for oral suspension).
| Pharmaceutical Form |
|---|
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ORELOX 100: Biconvex, cylindrical practically white tablets, 9 mm in diameter with “208” and beneath “A” engraved on one side. A broken tablet shows a pale yellow core surrounded by a white film-coating. ORELOX 200: Biconvex, cylindrical, practically white tablets, 11 mm in diameter with “208” and beneath “C” engraved on one side. A broken tablet shows a pale yellow core surrounded by a white film-coating. ORELOX JUNIOR: Pale, yellow granules for reconstitution. The reconstituted suspension is pale yellow in colour and has a banana flavour and odour. |
Each film-coated tablet contains 130,45 mg of cefpodoxime proxetil equivalent to 100 mg of cefpodoxime.
Contains sugar (lactose monohydrate): 21,55 mg.
Excipients: Carboxymethylcellulose calcium, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate.
Film-coating: Hydroxypropyl methyl-cellulose, talc, titanium dioxide.
Each film-coated tablet contains 260,90 mg of cefpodoxime proxetil equivalent to 200 mg of cefpodoxime.
Contains sugar (lactose monohydrate): 43,10 mg.
Excipients: Carboxymethylcellulose calcium, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate.
Film-coating: Hydroxypropyl methyl-cellulose, talc, titanium dioxide.
Each 5 ml of suspension contains 52,18 mg of cefpodoxime proxetil equivalent to 40 mg of cefpodoxime.
Preservative: Potassium sorbate 0,17%.
Contains sugar: Lactose monohydrate 14,56 mg/5 ml; Sucrose 601,33 mg/5 ml.
Contains aspartame: 20 mg/5 ml.
Excipients: Anhydrous colloidal silica, aspartame, banana flavour, carboxymethylcellulose calcium, carboxymethylcellulose sodium, citric acid monohydrate, hydroxypropylcellulose, iron oxide yellow, lactose monohydrate, monosodium glutamate, potassium sorbate, sodium chloride, sorbitan trioleate, sucrose, talc.
| Active Ingredient | Description | |
|---|---|---|
| Cefpodoxime |
Like other beta-lactam drugs, cefpodoxime exerts antibacterial activity by binding to and inhibiting the action of certain bacterial cell wall synthetic enzymes, namely the penicillin binding proteins. |
| List of Excipients |
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ORELOX 100: film-coated tablets are available in polyamide/aluminium/polyvinyl chloride/aluminium blister packs, inserted into an outer printed cardboard carton containing 10 tablets (1 strip x 10 tablets).
ORELOX 200: film-coated tablets are available in polyamide/aluminium/polyvinyl chloride/aluminium blister packs, inserted into an outer printed cardboard carton containing 10 tablets (1 strip x 10 tablets) or 20 tablets (2 strips x 10 tablets).
ORELOX JUNIOR: is packed into a 75 ml or 150 ml type lll amber glass bottle, fitted with a dehydrating capsule. The closure is a child-proof white opaque plastic screw-cap fitted with a white polyethylene joint and a pilfer proof ring.
The bottle is inserted into an outer printed cardboard carton.
The 75 ml or 150 ml bottles contain granules for reconstitution up to 50 ml or 100 ml of suspension, respectively.
sanofi-aventis south africa (pty) ltd., 2 Bond Street, Midrand, 1685, South Africa
ORELOX 100: Z/20.1.1/7
ORELOX 200: A38/20.1.1/0406
ORELOX JUNIOR: 27/20.1.1/0564
Date on the registration certificates (original registration):
ORELOX 100: 9 September 1991
ORELOX 200: 12 June 2009
ORELOX JUNIOR: 10 November 1993
| Drug | Countries | |
|---|---|---|
| ORELOX | Germany, France, Italy, Malta, Mexico, Nigeria, Tunisia, South Africa |
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