Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Pfizer Laboratories (Pty) Ltd, 85 Bute Lane, Sandton, 2196, South Africa
ZYVOXID 400 mg (Tablets).
ZYVOXID 600 mg (Tablets).
ZYVOXID 200 mg/100 ml (Solution for Infusion).
ZYVOXID 600 mg/300 ml (Solution for Infusion).
ZYVOXID 20 mg/ml (Granules for Suspension).
| Pharmaceutical Form |
|---|
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ZYVOXID 400 mg Tablets: A white to off-white, ovaloid tablet, imprinted on one side with black ink “ZYVOXID 400 mg”. ZYVOXID 600 mg Tablets: A white to off-white coated tablet with ‘ZYV’ debossed on one side and ‘600’ debossed on the other side. ZYVOXID Solution for Infusion: A ready-to-use infusion bag containing a clear, colourless to yellow solution free of visible particles. ZYVOXID Granules for Suspension: A white to yellow-orange granule/powder, may contain white to yellow-orange lumps. The constituted suspension appears as a white to yellow-orange homogeneous suspension. |
ZYVOXID 400 mg Tablets: Each film-coated tablet contains 400 mg linezolid.
ZYVOXID 600 mg Tablets: Each film-coated tablet contains 600 mg linezolid.
ZYVOXID 200 mg/100 ml Solution for Infusion: Each 1 ml contains 2 mg linezolid. The 100 ml infusion bag contains 200 mg linezolid.
ZYVOXID 600 mg/300 ml Solution for Infusion: Each 1 ml contains 2 mg linezolid. The 300 ml infusion bag contains 600 mg linezolid.
ZYVOXID 20 mg/ml Granules for Suspension: Following reconstitution with 123 ml water, each 1 ml contains 20 mg linezolid. Preservative content: Sodium benzoate 0,2% m/v.
ZYVOXID film-coated tablets contain the following inactive ingredients: maize starch, microcrystalline cellulose, hydroxypropylcellulose, sodium starch glycollate, and magnesium stearate. The film coating contains opadry white and carnauba wax. The printing ink contains black iron oxide (400 mg tablets).
ZYVOXID 200 mg/100 ml and ZYVOXID 600 mg/300 ml Solution for Infusion contain the following inactive ingredients: sodium citrate dihydrate, citric acid anhydrous, dextrose monohydrate, hydrochloric acid or sodium hydroxide and water for injections.
ZYVOXID 20 mg/ml Granules for Suspension contains the following inactive ingredients: sucrose, citric acid anhydrous, sodium citrate hydrous, microcrystalline cellulose, carboxymethylcellulose sodium, aspartame, xanthan gum, mannitol, sodium benzoate, flavourings (orange, orange cream, peppermint, vanilla), colloidal silicon dioxide anhydrous, sodium chloride, sweeteners (fructose, maltodextrin, monoammonium glycyrrhizinate, sorbitol).
| Active Ingredient | Description | |
|---|---|---|
| Linezolid |
Linezolid is a synthetic, antibacterial agent that belongs to a new class of antimicrobials, the oxazolidinones. It has in vitro activity against aerobic Gram-positive bacteria and anaerobic micro-organisms. Linezolid selectively inhibits bacterial protein synthesis via a unique mechanism of action. |
| List of Excipients |
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ZYVOXID 400 mg Tablets: White HDPE bottles of 10 or 30 tablets or PVC/foil blisters of 10 or 30 tablets.
ZYVOXID 600 mg Tablets: White HDPE bottles of 10 or 30 tablets or PVC/foil blisters of 10 or 30 tablets.
ZYVOXID 200 mg/100 ml Solution for infusion: Single-use infusion bags packaged in a foil overwrap available in a pack size of 100 ml (200 mg linezolid).
ZYVOXID 600 mg/300 ml Solution for infusion: Single-use infusion bags packaged in a foil overwrap available in a pack size of 300 ml (600 mg linezolid).
ZYVOXID Granules for Suspension: Granules for suspension in 240 ml amber glass bottles. Once constituted, the volume of suspension is 150 ml.
Pfizer Laboratories (Pty) Ltd, 85 Bute Lane, Sandton, 2196, South Africa
ZYVOXID 400 mg Tablets: 35/20.1.1/0309
ZYVOXID 600 mg Tablets: 35/20.1.1/0310
ZYVOXID 20 mg/ml Granules for Suspension: 35/20.1.1/0311
ZYVOXID 200 mg/100 ml Solution for Infusion: 35/20.1.1/0312
ZYVOXID 600 mg/300 ml Solution for Infusion: 35/20.1.1/0313
| Drug | Countries | |
|---|---|---|
| ZYVOXID | Austria, Cyprus, Germany, Estonia, Spain, France, Croatia, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Tunisia, Turkey, South Africa |
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