Source: Health Products and Food Branch (CA)
SYNERCID.
Quinupristin, 150 mg.
Dalfopristin, 350 mg.
Powder for injection.
For intravenous infusion only.
Therapeutic classification: Antibacterial agent.
SYNERCID (quinupristin/dalfopristin) I.V., a streptogramin antibacterial agent for intravenous administration, is a sterile freeze-dried formulation of two semisynthetic pristinamycin derivatives, quinupristin (derived from pristinamycin I) and dalfopristin (derived from pristinamycin IIA) in the ratio of 30:70 (w/w).
Each 10 mL glass vial, with a gray rubber closure and an aluminum seal with a dark blue flipoff cap contains sufficient quinupristin/dalfopristin to deliver 500 mg (150 mg of quinupristin and 350 mg of dalfopristin).
Non medicinal ingredients: methane sulfonic acid and NaOH for pH adjustment.
SYNERCID (quinupristin and dalfopristin in the ratio of 30:70) is supplied as a sterile lyophilized pyrogen-free preparation of quinupristin and dalfopristin for intravenous administration in single-dose glass vials. Each vial contains 500 mg (150 mg of quinupristin and 350 mg of dalfopristin).
| Marketing Informations | Authorization Dates |
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Authorization holder:
Monarch Pharmaceuticals Ireland Limited (Subsidiary of King Pharmaceuticals, Inc., Bristol, Tennesee), Alexandra House, The Sweepstakes, Ballsbridge, Dublin 4, Ireland 101819 |
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