Drug Name
Trade Name:Vaccae®
General Name:Mycobacterium vaccae for Injection
Pronunciation in Chinese: Zhusheyong Muniu Fenzhiganjun
Vaccae® is a sterile, white to pale yellow, preservative free lyophilized powder for deep intramuscular administration.
Each vial of Vaccae® contains 0.5milligram heat-killed Mycobacterium vaccae mass (or counted as 22.5microgram total bacterial proteins), 1.25 milligram sucrose, 1.25milligram sodium glutamate,1.25milligram sodium chloride, 0.725milligram NaH2PO3 and 3.05milligram Na2HPO3. When dissolved with water for injection, the reconstituted solution should be clear and transparent, at a pH approximately 7.0, and has no insoluble substance visible to naked eyes.
Vaccae® is indicated for treatment of pulmonary tuberculosis. 
Vaccae® is contraindicated in patients who develop or have known hypersensitivity to Mycobacterium vaccae vaccine. Vaccae® is also contraindicated in pregnant women and patients with severe cardiac disease or extreme debility.
Dosage and administration
Vaccae® should be administrated by deeply intramuscular injection at dosage of 22.5microgram (one vial) every two weeks for 3 to 6 months. Treatment course could be prolonged according to the advice of experienced doctor for the subsequent therapy of refractory tuberculosis. There was no report about over dosage of Vaccae® administration.
Adverse reactions
No any serious adverse reaction had been observed in patients receiving Vaccae® therapy. Slight local indurations at injection site, rash or fever rarely occurred.
Storage and stability
Vials of Vaccae® must be kept in dark place under 2~8℃(36~46℉). DO NOT FREEZE.
Reconstituted solution of Vaccae® should not be left at room temperature for a total time exceeding 12 hours prior to use.
Do not use beyond the expiration date stamped on the vial.
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