|
1 Indications And Usage Saizen Is A Recombinant Human Growth Hormone Indicated For: Pediatric: Treatment Of Children With Growth Failure Due To Growth Hormone Deficiency (Ghd) ( 1.1 ) Adult: Treatment Of Adults With Either Adult Onset Or Childhood Onset Ghd. ( 1.2 ) 1.1 Pediatric Patients Saizen (Somatropin) Is Indicated For The Treatment Of Pediatric Patients With Growth Failure Due To Inadequate Secretion Of Endogenous Growth Hormone. 1.2 Adult Patients Saizen Is Indicated For Replacement Of Endogenous Growth Hormone In Adults With Growth Hormone Deficiency Who Meet Either Of The Following Two Criteria: Adult Onset Patients Who Have Growth Hormone Deficiency, Either Alone Or Associated With Multiple Hormone Deficiencies (Hypopituitarism), As A Result Of Pituitary Disease, Hypothalamic Disease, Surgery, Radiation Therapy, Or Trauma; Or Childhood Onset Patients Who Were Growth Hormone Deficient During Childhood As A Result Of Congenital, Genetic, Acquired, Or Idiopathic Causes. Patients Who Were Treated With Somatropin For Growth Hormone Deficiency In Childhood And Whose Epiphyses Are Closed Should Be Reevaluated Before Continuation Of Somatropin Therapy At The Reduced Dose Level Recommended For Growth Hormone Deficient Adults. Confirmation Of The Diagnosis Of Adult Growth Hormone Deficiency In Both Groups Involves An Appropriate Growth Hormone Provocative Test With Two Exceptions: (1) Patients With Multiple Other Pituitary Hormone Deficiencies Due To Organic Disease; And (2) Patients With Congenital/genetic Growth Hormone Deficiency.
|