Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: Pfizer Laboratories (Pty) Ltd, 85 Bute Lane, Sandton 2196, South Africa Tel: +27(0)11 320 6000 / 0860 734 937 (Toll-free South Africa)
CYTOSAR 100 mg Powder for solution for injection.
CYTOSAR 500 mg Powder for solution for injection.
Bacteriostatic water for injection plus benzyl alcohol 0,9% m/v.
| Pharmaceutical Form |
|---|
|
Powder for solution for injection. CYTOSAR is available as a freeze-dried preparation. |
CYTOSAR 100 mg contains 100 mg cytarabine per vial.
CYTOSAR 500 mg contains 500 mg cytarabine per vial.
CYTOSAR is packed with Bacteriostatic water for injection plus benzyl alcohol 0,9% m/v and must be reconstituted before use.
Sugar free.
Excipients with known effect:
One 5 mL ampoule of Bacteriostatic water for injection plus benzyl alcohol 0,9% m/v contains 45 mg benzyl alcohol.
One 10 mL ampoule of Bacteriostatic water for injection plus benzyl alcohol 0,9% m/v contains 90 mg benzyl alcohol.
DO NOT USE THIS DILUENT CONTAINING BENZYL ALCOHOL FOR INTRATHECAL USE OR FOR HIGH DOSE THERAPY (see sections 4.3, 4.4 and 4.2).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Cytarabine |
Cytarabine (ARA-C) is metabolised in vivo to ARA-CTP phosphorylated compound. This competitively inhibits DNA polymerase and may also inhibit certain acid kinase enzymes. |
| List of Excipients |
|---|
|
CYTOSAR 100 mg and 500 mg: Hydrochloric acid for pH adjustment |
CYTOSAR 100 mg: 100 mg vial plus 5 mL water for injection (with benzyl alcohol 0,9% m/v).
CYTOSAR 500 mg: 500 mg vial plus 10 mL water for injection (with benzyl alcohol 0,9% m/v).
CYTOSAR 100 mg and 500 mg are in multidose vials.
Bacteriostatic water for injection plus benzyl alcohol 0,9% m/v is available in ampoules of 5 mL and 10 mL.
Not all pack sizes may be marketed.
Pfizer Laboratories (Pty) Ltd, 85 Bute Lane, Sandton 2196, South Africa
Tel: +27(0)11 320 6000 / 0860 734 937 (Toll-free South Africa)
CYTOSTAR 100 mg: H2757 (Act 101/1965)
CYTOSTAR 500 mg: T/26/47
Bacteriostatic water for injection plus benzyl alcohol 0,9% m/v: H/34/60
CYTOSAR 100 mg: N/A (Old medicine)
CYTOSAR 500 mg: 18 November 1987
Bacteriostatic water for injection plus benzyl alcohol 0,9% m/v: 20 October 1975
| Drug | Countries | |
|---|---|---|
| CYTOSAR | Estonia, Hong Kong, Croatia, Mexico, Poland, South Africa |
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