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Somatropin (Genotropin) (0.15 mg/day to 0.3 mg/day): Replacement of Endogenous Growth Hormone in Adults with Growth Hormone Deficiency [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2014 Jan.

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Somatropin (Genotropin) (0.15 mg/day to 0.3 mg/day): Replacement of Endogenous Growth Hormone in Adults with Growth Hormone Deficiency [Internet].

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1.: National Institute for Clinical Excellence. Human growth hormone (somatropin) for the treatment of growth failure in children [Internet]. London: NICE; 2010. [cited 2013 Aug 23]. Technology appraisal guidance; 188). Available from: http://www.nice.org.uk/guidance/TA188.
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4.: Ho KKY. on behalf of the 2007 GH Deficiency Consensus Workshop Participants. Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II: a statement of the GH Research Society in association with the European Society for Pediatric Endocrinology, Lawson Wilkins Society, European Society of Endocrinology, Japan Endocrine Society, and Endocrine Society of Australia. Eur J Endocrinol [Internet] 2007;157(6):695–700. [cited 2013 Aug 13]; Available from: http://www.eje-online.org/content/157/6/695.full.pdf+html. [PubMed: 18057375]
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11.: Svensson J, Bengtsson BA. Safety aspects of GH replacement. Eur J Endocrinol [Internet] 2009 Nov;161 Suppl 1:S65–S74. [cited 2013 Aug 8]; Available from: http://eje-online.org/content/161/suppl_1/S65.full.pdf+html. [PubMed: 19684054]
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13.: Drugs & health products. Ottawa: Therapeutic Products Directorate, Health Canada; Feb, 2013. Notice of compliance information: Genotropin.
14.: Company: Pfizer Canada Inc. [CONFIDENTIAL manufacturer's submission]. Kirkland (QC): Pfizer Canada Inc.; May, 2013. CDR submission binder: Genotropin (somatropin [rDNA] for injection).
15.: Appelman-Dijkstra NM, Claessen KM, Roelfsema F, Pereira AM, Biermasz NR. Long-term effects of recombinant human GH replacement in adults with GH deficiency: a systematic review. Eur J Endocrinol [Internet] 2013 Jul;169(1):R1–R14. [cited 2013 Aug 9]; Available from: http://www.eje-online.org/content/169/1/R1.full.pdf+html. [PubMed: 23572082]
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19.: Rubeck KZ, Bertelsen S, Vestergaard P, Jorgensen JO. Impact of GH substitution on exercise capacity and muscle strength in GH-deficient adults: a meta-analysis of blinded, placebo-controlled trials. Clin Endocrinol (Oxf). 2009 Dec;71(6):860–866. [PubMed: 19508603]
20.: Widdowson WM, Gibney J. The effect of growth hormone (GH) replacement on muscle strength in patients with GH-deficiency: a meta-analysis. Clin Endocrinol (Oxf). 2010 Jun;72(6):787–792. [PubMed: 19769614]
21.: Widdowson WM, Gibney J. The effect of growth hormone replacement on exercise capacity in patients with GH deficiency: a metaanalysis. J Clin Endocrinol Metab [Internet] 2008 Nov;93(11):4413–4417. Available from: http://jcem.endojournals.org/content/93/11/4413.full.pdf+html. [PubMed: 18697875]
22.: Maison P, Griffin S, Nicoue-Beglah M, Haddad N, Balkau B, Chanson P, et al. Impact of growth hormone (GH) treatment on cardiovascular risk factors in GH-deficient adults: a metaanalysis of blinded, randomized, placebo-controlled trials. J Clin Endocrinol Metab [Internet] 2004 May;89(5):2192–2199. [cited 2013 Aug 13]; Available from: http://jcem.endojournals.org/content/89/5/2192.full.pdf+html. [PubMed: 15126541]
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24.: McKenna SP, Doward LC, Alonso J, Kohlmann T, Niero M, Prieto L, et al. The QoL-AGHDA: an instrument for the assessment of quality of life in adults with growth hormone deficiency. Qual Life Res. 1999 Jun;8(4):373–383. [PubMed: 10472170]
25.: Hunt SM, McKenna SP, McEwen J, Backett EM, Williams J, Papp E. A quantitative approach to perceived health status: a validation study. J Epidemiol Community Health [Internet] 1980 Dec;34(4):281–286. [cited 2013 Sep 13]; Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1052092. [PMC free article: PMC1052092] [PubMed: 7241028]
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28.: Rovet J, Holland J. Psychological aspects of the Canadian randomized controlled trial of human growth hormone and low-dose ethinyl oestradiol in children with Turner syndrome. The Canadian Growth Hormone Advisory Group. Horm Res. 1993;39 Suppl 2:60–4. [PubMed: 8359791]
29.: Biosynthetic human growth hormone of recombinant DNA origin: 5 mg vial; 6, 12, 24 mg cartridges [product monograph]. Toronto: Eli Lilly Canada; Oct 16, 2012. Humatrope (somatropin for injection).
30.: Norditropin SimpleXx: somatropin solution for injection, cartridge: 5 mg/1.5 mL, 10 mg/1.5 mL and 15 mg/1.5 mL. Norditropin NordiFlex: somatropin solution for injection pre-filled disposable pen: 5 mg/1.5 mL, 10 mg/1.5 mL and 15 mg/1.5 mL [product monograph]. Mississauga (ON): Novo Nordisk Canada Inc.; Sep 14, 2012.
31.: Nutropin: somatropin for injection, lyophilized powder for injection; 10 mg/vial. Nutropin AQ: somatropin injection, solution; 10 mg/2 mL vial. Nutropin AQ Pen, cartridge, somatropin injection, solution; 10 mg/2 mL pen cartridge. Nutropin AQ NuSpin: somatropin injection, solution; NuSpin injection device prefilled with cartridge: Nutropin AQ NuSpin 5 (5 mg/2 mL). Nutropin AQ NuSpin 10 (10 mg/2 mL). Nutropin AQ NuSpin 20 (20 mg/2 mL) [product monograph]. Mississauga (ON): Hoffmann-La Roche Limited; Dec 21, 2012.
32.: Omnitrope: somatropin (rDNA origin) for injection. Lyophilized powder for injection: 5.8 mg/vial. Solution for injection: 5 mg/1.5 mL, 10 mg/1.5 mL [product monograph]. Boucherville (QC): Sandoz Canada Inc.; Jun 12, 2013.
33.: Saizen: somatropin for injection. Lyophilized powder for reconstitution: 1.33 mg/vial, 3.33 mg/vial, 5 mg/vial, 8.8 mg/vial. Saizen click.easy: somatropin for injection. Lyophilized powder for reconstitution: 8.8 mg (8.0 mg/mL), 8.8 mg (5.83 mg/mL), 4 mg (1.5 mg/mL). Saizen: somatropin. Solution for injection in a cartridge: 6 mg (5.83 mg/mL), 12 mg (8 mg/mL). 20 mg (8 mg/mL) [product monograph]. Mississauga (ON): EMD Serono, A Division of EMD Inc.; Aug 22, 2012. Canada.
34.: e-CPS [Internet]. Ottawa: Canadian Pharmacists Association; 2013. [cited 2013 Sep 4]. Available from: https://www.e-therapeutics.ca Subscription required.
35.: Clinical study report:CTN 92-8124-011. The effect of somatropin (Genotropin^®) replacement therapy in GH-deficient adults on body composition, hand grip strength, quality of life, serum IGF-1, lipid metabolism and safety [CONFIDENTIAL internal manufacturer's report]. Stockholm: Pharmacia AB; Mar 12, 1996.
36.: Clinical study report:TRN 91-001. The effect of somatropin (Genotropin) replacement therapy in growth hormone deficiency adults on body composition, quality of life, bone mineral density, muscle strength, exercise capacity, serum IGF-1, plasma lipids and safety. A report of a randomised, double-blind, 6-month placebo-controlled study and 24-month somatropin replacement therapy [CONFIDENTIAL internal manufacturer's report]. Stockholm: Pharmacia & Upjohn AB; Jun 18, 1997.
37.: Clinical study report: TRN 91-081-01. The effect of somatropin (Genotropin^®) replacement therapy in GH-deficient adults on body composition, quality of life, bone mineral density, respiratory muscle strength, serum lipids, immune function, serum IGF-1 and safety [CONFIDENTIAL internal manufacturer's report]. Stockholm: Kabi Pharmacia AB; Jan 14, 1993.
38.: Clinical study report: TRN 91-081-02. The effect of somatropin (Genotropin^®) replacement therapy in GH-deficient adults on body composition, quality of life, bone mineral density, cardiovascular function, serum lipids, coagulation factors, serum IGF-1, insulin sensitivity and safety. A final report of randomized, double-blind, placebo-controlled study. [CONFIDENTIAL internal manufacturer's report]. Stockholm: Kabi Pharmacia AB; Oct 20, 1993.
39.: Clinical study report:TRN 91-131-04. The effect of somatropin (Genotropin^®) replacement therapy in GH-deficient adults on body composition, bone mineral content, bone mineral density, serum IGF-1, serum IGFBP-3 and safety. A final report of a randomized, double blind, placebo-controlled study [CONFIDENTIAL internal manufacturer's report]. Stockholm: Pharmacia AB; Aug 30, 1996.
40.: Claessen KMJA, Appelman-Dijkstra NM, Adoptie DMMM, Roelfsema F, Smit JWA, Biermasz NR, et al. Metabolic profile in growth hormone-deficient (GHD) adults after long-term recombinant human growth hormone (rhGH) therapy. J Clin Endocrinol Metab. 2013;98(1):352–361. [PubMed: 23162104]
41.: Clinical study report TRN 91-131-08. The effect of somatropin (Genotropin^®) replacement therapy in GH-deficient adults on body composition, quality of life, bone mineral density, serum IGF-1, exercise and safety. A final report of a randomized, double blind, placebo-controlled study (6 months) followed by open somatropin replacement (6 months) [CONFIDENTIAL internal manufacturer's report]. Stockholm: Pharmacia AB; Jan 31, 1996.

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Somatropin (Genotropin) (0.15 mg/day to 0.3 mg/day): Replacement of Endogenous Growth Hormone in Adults with Growth Hormone Deficiency [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2014 Jan. REFERENCE.