Dexmedetomidine Hydrochloride Injection
【CONTENTS】Dexmedetomidine Hydrochloride and Dexmedetomidine Hydrochloride Injections(Precedex™)
【SPECIFICATIONS】2ml:200ug, 100ml:400ug
【INDICATIONS】 Intensive Care Unit Sedation(Precedex™ is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting.)
【DOSAGE AND ADMINISTRATION】
For adult patients: a loading infusion of one mcg/kg over 10 minutes.
Precedex must be diluted with 0.9% sodium chloride injection to achieve required concentration (4 mcg/mL) prior to administration. Strict aseptic technique must always be maintained during handling of Precedex.
【REGISTRY CLASSIFICATION】6+6
【INTRODUCTION】
Dexmedetomidine Hydrochloride Injections(Precedex™)was first developed by HOSPIRA and Orion Corporation,which was first approved by FDA in May 2000.
Dexmedetomidine is the only one both analgesic and anesthetic sedative. Its main characteristic is to wake up in time and convenient operation communication with patients. Dexmedetomidine excited alpha 2A receptor, inhibition of sympathetic activity, reducing the concentration of norepinephrine and cortisol. It may be one of the most satisfactory drugs of extubation management currently. Dexmedetomidine has stable hemodynamics and can reduce the incidence of cardiovascular events and death during cardiovascular operation anesthesia.It can reduce the drug consumption, improve the quality of anesthesia and reduce the overall cost of patients.
Anesthesia drugs in the size of the domestic market is six billions in 2010. The rapid growth of dexmedetomidine hydrochloride Injections is more than 100% since listing. As the increase in domestic application of operation and ICU sedation and fewer competitors, dexmedetomidine hydrochloride will has a high growth in the future.
【INTELLECTUAL PROPERTY】
There is no risk of infringement.
【TRANSFER TARGETS】
Process of active pharmaceutical ingredients
Process of tablets production
Data for declaring
【RESEARCH PROGRESS】
Active pharmaceutical ingredients
Enlarge production has completed. The size of enlarge production is 50g each batch and single impurity is less than 0.1%.
Injections
Enlarge production has completed. The size of enlarge production is 10 thousand each batch.
Study of test methods has completed.