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HSA Approval

CLAMOVID GRANULES 156.25 mg/5 ml

SIN12027P

CLAMOVID GRANULES 156.25 mg/5 ml

CLAMOVID GRANULES 156.25 mg/5 ml

July 17, 2002

GOLDPLUS UNIVERSAL PTE LTD

GOLDPLUS UNIVERSAL PTE LTD

Regulatory Information

GOLDPLUS UNIVERSAL PTE LTD

GOLDPLUS UNIVERSAL PTE LTD

Therapeutic

Prescription Only

Formulation Information

GRANULE, FOR SUSPENSION

**Dosage and Administration** _**CLAMOVID 625 TABLET**_ **Adults and Children Over 12 years old:** Severe infections:Oral, one tablet, three times a day.Other infections:Oral, one tablet, two times a day. _**Dosage in Renal Impairment:**_ Adults:Mild impairment (Creatinine clearance > 30ml/min): No change in dosage.:Moderate impairment (Creatinine clearance 10–30 ml/min): One tablet, 12 hourly.:Severe impairment (Creatinine clearance < 10ml/min): Not recommended. _**Dosage in Hepatic Impairment:**_ Dose with caution; monitor hepatic function at regular intervals. There are, as yet, insufficient data on which to base a dosage recommendation. Note: Not recommended in children of 12 years and under. _**CLAMOVID GRANULES**_ The usual recommended daily dosage is 25 mg/Kg/day in divided doses every 8 hours. In more serious infections the dosage may be increased up to 50 mg/Kg/day in divided doses every eight hours. Children: 1 to 6 years (10 to 18kg):Oral, 5ml (approximately 125mg of Amoxycillin and 31.25mg of Clavulanic Acid every eight hour.7 to 12 hours (18 to 40kg):Oral, 10ml (approximately 250mg of Amoxycillin and 62.5mg of Clavulanic Acid) every eight hours. _**Duration of therapy should be appropriate to the indication and should not exceed 14 days without review.**_

ORAL

Medical Information

**Indications** For treatment of acute otitis media, sinusitis, pneumonia, skin and soft tissue infections, urinary tract infections caused by betalactamase-producing strains of bacteria.

**Contraindications** - Contraindicated in patients known to be hypersensitive to penicillin. Attention should be paid to possible cross-sensitivity with other beta-lactam antibiotics e.g. cephalosporins. - Contraindicated in patients with a previous history of penicillin-associated jaundice/hepatic dysfunction - Contraindicated in patients with infectious mononucleosis

J01CR02

amoxicillin and beta-lactamase inhibitor

Manufacturer Information

GOLDPLUS UNIVERSAL PTE LTD

Bilim Ilac Sanayi Ve Ticaret Anonim Sirketi

Active Ingredients

AMOXYCILLIN TRIHYDRATE

125 mg/5 ml

Amoxicillin

CLAVULANATE POTASSIUM

31.25 mg/5 ml

Clavulanic acid

Documents

Package Inserts

Proposed clean PI - Clamovid.pdf

Approved: May 6, 2022

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