theboss
27-09-2009, 08:58 PM
just wondering how the dosing works on Sandoz Omnitrope and if anyone has any experience with it........Omnitrope (somatropin) is presented in two dosage forms: a powder for solution (5.8 mg/vial), and solution (5 mg /1.5 mL and 10 mg/1.5 mL.........i guess what i dont understand is in the 5.8mg/vial how many IU would that be? or even the pens..how does that work??
__________________________________________________ ___
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2009_omnitrope_113380-eng.php
Date issued: May 15, 2009
On April 20, 2009, Health Canada issued a Notice of Compliance to Sandoz Canada Inc. for the drug product Omnitrope.
Omnitrope contains the medicinal ingredient somatropin which is a recombinant human growth hormone.
Omnitrope is indicated for:
* Growth Hormone Deficiency (GHD) in Children: Long-term treatment of children with growth failure due to an inadequate secretion of endogenous growth hormone. Other causes of short stature should be excluded.
* Adult Growth Hormone Deficiency (GHD): Long-term replacement therapy in adults with growth hormone deficiency due to underlying hypothalamic or pituitary disease or who were growth deficient during childhood. Growth hormone deficiency should be confirmed by an appropriate growth hormone stimulation test. Patients who were diagnosed as growth hormone deficient during childhood must be retested before treatment starts.
The safety and efficacy of Omnitrope in geriatric (≥65 years of age) and pediatric (<3 years of age) patients have not been evaluated in clinical studies.
Treatment with somatropin stimulates linear growth and normalizes concentrations of Insulin-like Growth Factor-I (IGF-I) in children with GHD. In adults with GHD, treatment with somatropin results in reduced fat mass, increased lean body mass, metabolic alterations that include beneficial changes in lipid metabolism, and normalization of IGF-I concentrations.
The market authorization was based on quality, non-clinical, and clinical information submitted.
Based on the similarity principles for the subsequent entry biologics, a reduced clinical package was accepted. It consists of one repeated-dose toxicity study and six comparative pharmacodynamic (PD) studies in rats (in two of these, Omnitrope was compared with Genotropin®), two local tolerance studies in rabbits, one bioavailability study and four comparative pharmacokinetic (PK)/PD studies in healthy adults, and five Phase III clinical efficacy and safety studies in GHD children. The PK/PD data were comparable between Omnitrope and Genotropin®, and bioequivalence was demonstrated among the different formulations and strengths of Omnitrope. In the treatment of children with GHD, Omnitrope had a clinical efficacy and safety profile that was comparable to the reference product Genotropin®.
The studies also demonstrated that the lyophilized powder and liquid formulations of Omnitrope had comparable clinical efficacy and safety profiles.
Although, there were no clinical studies conducted with Omnitrope in adult GHD patients, Health Canada agreed that the use of Omnitrope in adult GHD patients is supported in consideration of the similar product quality characteristics of Omnitrope and Genotropin® and the similar pathophysiology of adult GHD to GHD in children. In addition, comparative non-clinical, human PK/PD, and clinical efficacy and safety studies in children were conducted to demonstrate comparable clinical profiles between Omnitrope and Genotropin®.
Omnitrope (somatropin) is presented in two dosage forms: a powder for solution (5.8 mg/vial), and solution (5 mg /1.5 mL and 10 mg/1.5 mL). The dosage and administration schedule of Omnitrope should be individualized for each patient. The doses should be given by subcutaneous injections (administered preferably in the evening). Dosing guidelines are available in the Product Monograph.
Omnitrope is contraindicated for patients that show evidence of neoplastic activity, for pediatric patients with closed epiphyses, and for patients with acute critical illness following cardiac surgery, abdominal surgery, multiple trauma, or acute respiratory failure. Omnitrope is also contraindicated in patients with Prader-Willi Syndrome who are severely obese or have severe respiratory impairment.
Omnitrope lyophilized powder when reconstituted with the diluent Bacteriostatic Water for Injection (benzyl alcohol preserved) and Omnitrope 5.0 mg/1.5 mL solution which also contains the preservative benzyl alcohol, should not be administered in newborns or in patients with a known sensitivity to benzyl alcohol. Omnitrope is contraindicated in patients who are hypersensitive to somatropin or to any ingredient in the formulations. Omnitrope should be administered under the conditions stated in the Product Monograph taking into consideration the potential risks associated with the administration of this drug product. Detailed conditions for the use of Omnitrope are described in the Product Monograph.
Based on the Health Canada review of data on quality, safety, and efficacy, Health Canada considers that the benefit/risk profile of Omnitrope is favourable for the indications stated above.
__________________________________________________ ___
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2009_omnitrope_113380-eng.php
Date issued: May 15, 2009
On April 20, 2009, Health Canada issued a Notice of Compliance to Sandoz Canada Inc. for the drug product Omnitrope.
Omnitrope contains the medicinal ingredient somatropin which is a recombinant human growth hormone.
Omnitrope is indicated for:
* Growth Hormone Deficiency (GHD) in Children: Long-term treatment of children with growth failure due to an inadequate secretion of endogenous growth hormone. Other causes of short stature should be excluded.
* Adult Growth Hormone Deficiency (GHD): Long-term replacement therapy in adults with growth hormone deficiency due to underlying hypothalamic or pituitary disease or who were growth deficient during childhood. Growth hormone deficiency should be confirmed by an appropriate growth hormone stimulation test. Patients who were diagnosed as growth hormone deficient during childhood must be retested before treatment starts.
The safety and efficacy of Omnitrope in geriatric (≥65 years of age) and pediatric (<3 years of age) patients have not been evaluated in clinical studies.
Treatment with somatropin stimulates linear growth and normalizes concentrations of Insulin-like Growth Factor-I (IGF-I) in children with GHD. In adults with GHD, treatment with somatropin results in reduced fat mass, increased lean body mass, metabolic alterations that include beneficial changes in lipid metabolism, and normalization of IGF-I concentrations.
The market authorization was based on quality, non-clinical, and clinical information submitted.
Based on the similarity principles for the subsequent entry biologics, a reduced clinical package was accepted. It consists of one repeated-dose toxicity study and six comparative pharmacodynamic (PD) studies in rats (in two of these, Omnitrope was compared with Genotropin®), two local tolerance studies in rabbits, one bioavailability study and four comparative pharmacokinetic (PK)/PD studies in healthy adults, and five Phase III clinical efficacy and safety studies in GHD children. The PK/PD data were comparable between Omnitrope and Genotropin®, and bioequivalence was demonstrated among the different formulations and strengths of Omnitrope. In the treatment of children with GHD, Omnitrope had a clinical efficacy and safety profile that was comparable to the reference product Genotropin®.
The studies also demonstrated that the lyophilized powder and liquid formulations of Omnitrope had comparable clinical efficacy and safety profiles.
Although, there were no clinical studies conducted with Omnitrope in adult GHD patients, Health Canada agreed that the use of Omnitrope in adult GHD patients is supported in consideration of the similar product quality characteristics of Omnitrope and Genotropin® and the similar pathophysiology of adult GHD to GHD in children. In addition, comparative non-clinical, human PK/PD, and clinical efficacy and safety studies in children were conducted to demonstrate comparable clinical profiles between Omnitrope and Genotropin®.
Omnitrope (somatropin) is presented in two dosage forms: a powder for solution (5.8 mg/vial), and solution (5 mg /1.5 mL and 10 mg/1.5 mL). The dosage and administration schedule of Omnitrope should be individualized for each patient. The doses should be given by subcutaneous injections (administered preferably in the evening). Dosing guidelines are available in the Product Monograph.
Omnitrope is contraindicated for patients that show evidence of neoplastic activity, for pediatric patients with closed epiphyses, and for patients with acute critical illness following cardiac surgery, abdominal surgery, multiple trauma, or acute respiratory failure. Omnitrope is also contraindicated in patients with Prader-Willi Syndrome who are severely obese or have severe respiratory impairment.
Omnitrope lyophilized powder when reconstituted with the diluent Bacteriostatic Water for Injection (benzyl alcohol preserved) and Omnitrope 5.0 mg/1.5 mL solution which also contains the preservative benzyl alcohol, should not be administered in newborns or in patients with a known sensitivity to benzyl alcohol. Omnitrope is contraindicated in patients who are hypersensitive to somatropin or to any ingredient in the formulations. Omnitrope should be administered under the conditions stated in the Product Monograph taking into consideration the potential risks associated with the administration of this drug product. Detailed conditions for the use of Omnitrope are described in the Product Monograph.
Based on the Health Canada review of data on quality, safety, and efficacy, Health Canada considers that the benefit/risk profile of Omnitrope is favourable for the indications stated above.