COLOSTRUM BOVIN

Si vous avez besoin d'aide pour accéder aux formats de rechange, tels que Portable Document Format (PDF), Microsoft Word et PowerPoint (PPT), visitez la section d'aide sur les formats de rechange.

La présente monographie vise à servir de guide à l'industrie pour la préparation de demandes de licence de mise en marché (DLMM) et d'étiquettes dans le but d'obtenir une autorisation de mise en marché d'un produit de santé naturel. Elle ne vise pas à être une étude approfondie de l'ingrédient médicinal.

Nota:

Nom(s) propre(s), Nom(s) commun(s), Matière(s) d'origine

Tableau 1. Nom(s) propre(s), Nom(s) commun(s), Matière(s) d'origine
Nom(s) propre(s) Nom(s) commun(s) Matière(s) d'origine
Nom(s) propre(s) Partie(s) Préparation(s)
Colostrum bovin
  • Colostrum bovin
Bos taurus Colostrum Séché et ne provenant pas de bovins hyperimmunisés

Références : Nom propre : Martindale 2010, Kim et al. 2009, Cesarone et al. 2007, Shing et al. 2007; Nom commun : Martindale 2010, Kim et al. 2009, Cesarone et al. 2007, Shing et al. 2007; Matière d’origine : Kim et al. 2009, Cesarone et al. 2007, Shing et al. 2007.

Voie d'administration

Orale

Forme(s) posologique(s)

Cette monographie exclut les aliments et les formes posologiques semblables aux aliments tel qu'indiqué dans le document de référence Compendium des monographies.

Les formes posologiques acceptables pour les catégories d'âge listées dans cette monographie et pour la voie d'administration spécifiée sont indiquées dans le document de référence Compendium des monographies.

Usage(s) ou fin(s)

  • Aide à soutenir la fonction immunitaire des voies respiratoires supérieures (Davison et Diment 2009; Cesarone et al. 2007; Crooks et al. 2006; Patel et Rana 2006; Brinkworth et Buckley 2003; Mero et al. 2002).
  • Aide à soutenir le système immunitaire (Davison et Diment 2009; Cesarone et al. 2007; Crooks et al. 2006; Patel et Rana 2006; Brinkworth et Buckley 2003; Mero et al. 2002).

Dose(s)

Sous-population(s)

Adultes 18 ans et plus

Quantité(s)

0,4 à 10 grammes de colostrum séché, par jour (Kim et al. 2009; Cesarone et al. 2007; Shing et al. 2007; Shing et al. 2006).

Mode(s) d'emploi

Énoncé non requis.

Durée(s) d'utilisation

Consulter un praticien de soins de santé/fournisseur de soins de santé/professionnel de la santé/docteur/médecin pour un usage prolongé (Cesarone et al. 2007; Brinkworth et Buckley 2004; Brinkworth et al. 2004; Coombes et al. 2002; Antonio et al. 2001).

Mention(s) de risque

Précautions et mise en garde

  • Consulter un praticien de soins de santé/fournisseur de soins de santé/professionnel de la santé/docteur/médecin avant d'en faire l'usage si vous êtes enceinte ou si vous allaitez, si vous avez le diabète, des antécédents de cancer, ou souffrez d'une maladie du système immunitaire (par ex., maladie de Crohn, myasthénie, sclérose en plaques, polyarthrite rhumatoïde, lupus érythémateux disséminé, HIV/SIDA, etc.) (Kim et al. 2009; Rowlands 2009; Salvioli et al. 2009; Tripathi et al. 2006; Albers et al. 2005; Mero et al. 2002; Mero et al. 1997).
  • Consulter un praticien de soins de santé/fournisseur de soins de santé/professionnel de la santé/docteur/médecin avant d'en faire l'usage si vous prenez des médicaments qui inhibent le système immunitaire (immunosuppresseurs) (Albers et al. 2005).

Contre-indications(s)

Ne pas utiliser ce produit si vous avez une allergie/hypersensibilité connue au lait de vache (SC 2011).

Réaction(s) indésirable(s) connue(s)

Énoncé non requis.

Ingrédients non médicinaux

Doivent être choisis parmi ceux de la version actuelle de la Base de données des ingrédients des produits de santé naturels (BDIPSN) et respecter les restrictions mentionnées dans cette base de données.

Conditions d'entreposage

Énoncé non requis.

Spécifications

  • Les spécifications du produit fini doivent être établies conformément aux exigences décrites dans le Guide de référence sur la qualité des produits de santé naturels de la Direction des produits de santé naturels et sans ordonnance (DPSNSO).
  • L'ingrédient médicinal doit être conforme aux exigences mentionnées dans la BDIPSN

Références citées

  • Albers R, Antoine JM, Bourdet-Sicard R, Calder PC, Gleeson M, Lesourd B, Samartín S, Sanderson IR, Van Loo J, Vas Dias FW, Watzl B. Markers to measure immunomodulation in human nutrition intervention studies. British Journal of Nutrition 2005;94(3):452-458.
  • Antonio J, Sanders MS, Gammeren VD. The effects of bovine colostrum supplementation on body composition and exercise performance in active men and women. Nutrition 2001;17(3):243-247.
  • Brinkworth GD, Buckley JD. Bovine colostrum supplementation does not affect plasma buffer capacity or haemoglobin content in elite female rowers. European Journal of Applied Physiology 2004;91(2-3):353-6
  • Brinkworth, GD, Buckley JD. Concentrated bovine colostrum protein supplementation reduces the incidence of self-reported symptoms of upper respiratory tract infection in adult males. European Journal of Nutrition 2003;42(4):228-232.
  • Brinkworth GD, Buckley JD, Slavotinek JP, Kurmis AP. Effects of bovine colostrum supplementation on the composition of resistance trained and untrained limbs in healthy young men. European Journal of Applied Physiology 2004;91(1):53-60.
  • Cesarone MR, Belcaro G, Di Renzo A, Dugall M, Cacchio M, Ruffini I, Pellegrini L, Del Boccio G, Fano F, Ledda A, Bottari A, Ricci A, Stuard S, Vinciguerra G. Prevention of influenza episodes with colostrum compared with vaccination in healthy and high-risk cardiovascular subjects: The epidemiologic study in San Valentino. Clinical and Applied Thrombosis/Hemostasis 2007;13(2):130-136.
  • Coombes JS, Conacher M, Austen SK, Marshall PA. Dose effects of oral bovine colostrum on physical work capacity in cyclists. Medicine and Science in Sports and Exercise 2002;34(7):1184-1188.
  • Crooks CV, Wall CR, Cross ML, Rutherfurd-Markwick KJ. The effect of bovine colostrum supplementation on salivary IgA in distance runners. International Journal of Sport Nutrition and Exercise Metabolism 2006;16(1):47-64.
  • Davison G, Diment BC. Bovine colostrum supplementation attenuates the decrease of salivary lysozyme and enhances the recovery of neutrophil function after prolonged exercise. British Journal of Nutrition 2009;103(10):1425-1432.
  • HC 2011: Health Canada, The Use of Food Allergen Precautionary Statements on Prepackaged Foods. [Accessed 2018 June 15]. Available from:Next link will take you to another Web site  https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/fn-an/alt_formats/pdf/label-etiquet/allergen/precaution_label-etiquette-eng.pdf
  • Kim JH, Jung WS, Choi NJ, Kim DO, Shin DH, Kim YJ. Health-promoting effects of bovine colostrum in Type 2 diabetic patients can reduce blood glucose, cholesterol, triglyceride and ketones. Journal of Nutritional Biochemistry 2009;20(4):298-303.
  • Martindale 2010: Sweetman SC, editor. Martindale: The Complete Drug Reference. 37th edition [Internet]. London (GB): Pharmaceutical Press; 2012. [Bovine colostrum: Date of monograph revision 2010-10-01; Accessed 2018 June 15]. Available from:Next link will take you to another Web site  http://ovidsp.tx.ovid.com/
  • Mero A, Miikkulainen H, Riski J, Pakkanen R, Aalto J, Takala T. Effects of bovine colostrum supplementation on serum IGF-I, IgG hormone, and saliva IgA during training. Journal of Applied Physiology 1997;83(4):1144-1151
  • Mero A, Kahkonen J, Nykanen T, Parviainen T, Jokinen I, Takala T, Nikula T, Rasi S, Leppaluoto J. IGF-I, IgA, and IgG responses to bovine colostrum supplementation during training. Journal of Applied Physiology 2002;93(2):732-739.
  • Patel K, Rana R. Pedimune in recurrent respiratory infection and diarrhea- the Indian Experience - the PRIDE study. Indian Journal of Pediatrics 2006;73(7):585-591.
  • Rowlands MA, Gunnell D, Harris R, Vatten LJ, Holly JM, Martin RM. Circulating insulin-like growth factor peptides and prostate cancer risk: a systematic review and meta-analysis. International Journal of Cancer 2009;124(10):2416-2429.
  • Salvioli S, Capri M, Bucci L, Lanni C, Racchi M, Uberti D, Memo M, Mari D, Govoni S, Franceschi C. Why do centenarians escape or postpone cancer? The role of IGF-1, inflammation and p53. Cancer Immunology, Immunotherapy 2009;58(12):1909-1917.
  • SC 2011: Santé Canada. L'utilisation des mises en garde relatives aux allergènes alimentaires sur l'étiquette des aliments préemballés. [Consulté le 3 juillet 2018]. Disponible à : Next link will take you to another Web site  https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/fn-an/alt_formats/pdf/label-etiquet/allergen/precaution_label-etiquette-eng.pdf
  • Shing CM, Jenkins DG, Stevenson L, Coombes JS. The influence of bovinen colostrum supplementation on exercise performance in highly trained cyclists. British Journal of Sports Medicine 2006;40:797-801.
  • Shing CM, Peake J, Suzuki K. Effects of bovine colostrums supplementation on immune variables in highly trained cyclists. Journal of Applied. Physiology 2007;102(3):1113-1122.
  • Tripathi V, Vashishtha B. Bioactive compounds of colostrum and its application. Food Reviews International 2006;22(3):225-244.

Références consultées

  • Bolke E, Jehle PM, Hausmann F. Preoperative oral application of immunoglobulin-enriched colostrum milk and mediator response during abdominal surgery. Shock 2002;17(1):9-12.
  • Brinkworth GD, Buckley JD, Bourdon PC, Gulbin JP, David AZ. Oral bovine colostrum supplementation enhances buffer capacity but not rowing performance in elite female rowers. International Journal of Sport Nutrition and Exercise Metabolism 2002;12:349-363.
  • Buckley JD, Abbot MJ, Brinkworth GD, Whyte PBD. Bovine colostrum supplementation during endurance running training improves recovery, but not performance. Journal of Science and Medicine in Sport 2002;5(2):65-79.
  • Buckley JD, Brinkworth GD, Abbot MJ. Effect of bovine colostrum on anaerobic exercise performance and plasma insulin-like growth factor I. Journal of Sports Sciences 2003;21(7):577588.
  • Caccavo D, Pellegrino NM, Altamura M, Rigon A, Amati L, Amoroso A, Jirillo E. Antimicrobial and immunoregulatory functions of lactoferrin and its potential therapeutic application. Journal of Endotoxin Research 2002;8(6):403-417.
  • Cross ML, Gill HS. Immunomodulatory properties of milk. British Journal of Nutrition 2000;84(S1):S81-S89.
  • El-Loly, MM. Bovine milk immunoglobulins in relation to human health. International Journal of Dietary Science 2007;2(3):183-195.
  • EMA 1994: Specific Requirements for the production of and control of immunosera and colostrum substitutes. 7BIm12a. [Accessed 2011 April 23]. Available from: Next link will take you to another Web site  http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500 004623.pdf
  • Farke C, Rattenberger E, Roiger SU, Meyer HH. Bovine colostrum: determination of naturally occurring steroid hormones by Liquid Chromatography-Tandem Mass spectrometry (LCMS/MS). Journal of Agricultural and Food Chemistry 2011;59(4):1423-1427.
  • Gopal PK, Gill HS. Oligosaccharides and glycoconjugates in bovine milk and colostrum. British Journal of Nutrition 2000;84(S1): S69-S74.
  • Greenberg PD, Cello JP. Treatment of severe diarrhea caused by Cryptosporidium parvum with oral bovine immunoglobin concentrate in patients with AIDS. Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology 1996;13(4):348-354.
  • Hammarstrom L, Weiner CK. Targeted antibodies in dairy-based products. Advances in Experimental Medicine and Biology 2008;606:321-343.
  • Health Canada, Report of the Royal College of Physicians and Surgeons of Canada Expert Panel on Human safety of RBST. [Accessed 2012 April 23]. Available from: Next link will take you to another Web site  http://www.hcsc.gc.ca/dhp-mps/vet/issues-enjeux/rbst-stbr/rep_rcpsc-rap_crmcc-eng.php
  • He F, Tuomola E, Arvilommi H, Salminen S. Modulation of human humoral immune response through orally administered bovine colostrum. FEMS Immunology and Medical Microbiology 2001;31(2):93-96.
  • Huppertz HI, Rutkowski R, Busch DH, Eisebit R, Lissner R, Karch H. Bovine colostrum ameliorates diarrhea infestion with diarrheagic Escherichia coli, shiga toxin-producing E. coli, and E. coli expressing intimin and hemolysin. Journal of Pediatric Gastroenterology and Nutrition 1999;29(4):452-456
  • Kelly GS. Bovine Colostrums: A review of clinical uses. Alternative Medicine Review 2003;8(4):378-394.
  • Korhonen H, Marnila P, Gill HS. Milk immunoglobulins and complement factors. British Journal of Nutrition 2000;84(S1):S75-S80.
  • Mero A, Nykanen T, Keinanen O, Knuutinen J, Lahti K, Alen M, Rasi S, Leppaluoto J. Protein metabolism and strength performance after bovine colostrum supplementation. Amino Acids 2005;28(3):327-335.
  • Mitra AK, Mahalanabis D, Ashraf H, Unicomb L, Eeckls R, Tzipori S. Hyperimmune cow colostrum reduces diarrhoea due to rotovirus: a double-bind, controlled clinical trial. Acta Paediatrica 1995;84(9):996-1001
  • Natural Standard. Bovine colostrum Copyright © 2012 [Internet]. [Accessed 2012 August 15]. Available from: Next link will take you to another Web site  http://www.naturalstandard.com
  • Pakkanen R, Aalto J. Growth factors and antimicrobial factors of bovine colostrum. International Dairy Journal 1997;7(5):285-297
  • Playford RJ, Macdonald CE, Johnson WS. Colostrum and milk-derived peptide growth factors for the treatment of gastrointestinal disorders. American Journal of Clinical Nutrition 2000;72(1):5-14.
  • Plettenberg A, Stoehr A, Stellbrink HJ, Albrecht H, Meigel W. A preparation from bovine colostrum in the treatment of HIV-positive patients with chronic diarrhea. The Clinical Investigator 1993;71(1):42-45.
  • Poke GS, Roy JH. The oestrogenic activity of bovine colostrum. The Biochemical Journal 1953;53(3):427-430.
  • Przybylska J, Albera E, Kankofer M. Antioxidants in bovine colostrum. Reproduction in Domestic Animals 2007;42(4):402-409.
  • Ragab SS, Afifi EAA. Bovine Colostrum: its dietary supplementation role in improvement and modulation of human immune indices. [Accessed 2012 April 23] Available from: Next link will take you to another Web site  http://www.firstmilking.com/bovinecolostrumresearch.htm
  • Roos N, Mahe S, Benamouzig R, Sick H, Rautureau J, Tome D. 15N-labeled immunoglobulins from bovine colostrum are partially resistant to digestion in the human intestine. The Journal of Nutrition 1995;125(5):1238-1244.
  • Rump JA, Arndt R, Arnold A, Bendick C, Dichtelmuller H, Franke M, Helm EB, Jager H, Kampmann B, Kolb P, Kreuz W, Lissner R, Meigel W, Ostendorf P, Peter HH, Plettenberg A, Schedel I, Stellbrink HW, Stephan W. Treatment of diarrhoea in human immunodeficiency virus-infected patients with immunoglobulins from bovine colostrum. The Clinical Investigator 1992;70(7):588-594.
  • Solomons NW. Modulation of the immune system and the response against pathogens with bovine colostrums concentrates. European Journal of Clinical Nutrition 2002; 56(S3): S24-S28.
  • Struff, WG, Sprotte G. Bovine colostrum as a biologic in clinical medicine: a review. Part II: clinical studies. International Journal of Clinical Pharmacology and Therapeutics 2008;46(5):211-225.
  • Thapa BR. Health factors in colostrum. Indian Journal of Pediatrics 2005;72(7):579-581.
  • Thapa, BR. Therapeutic potentials of bovine colostrums. Indian Journal of Pediatrics 2005;72 (10):849-852.
  • Uruakpa FO, Ismond MAH, Akobundu ENT. Colostrum and its benefits: a review. Nutrition Research 2002;22(6):755-767.
  • van Hooijdonk, ACM, Kussendrager KD, Steijns JM. In vivo antimicrobial and antiviral activity of components in bovne milk and colostrum involved in non-specific defence. British Journal of Nutrition 2000;84(S1):S127-S134.
  • Weiner C, Pan Q, Hurtig M, Boren T, Bostwick E, Hammarstrom L. Passive immunity against human pathogens using bovine antibodies. Clinical and Experimental Immunology 1999;116:193-205.
  • Wolvers DAW, van Herpen-Broekmans WMR, Logman MHGM van der Wielen RPJ, Albers R. Effect of a mixture of micronutrients, but not of bovine colostrum concentrate, on immune function parameters in healthy volunteers: a randomized placebo-controlled study. Nutrition Journal 2006;5:28-39.
  • Xu L, Zhang L, Zhang Y, Sheng Q, Zhao A. Qualitative and quantitative comparison of hormone contents between bovine and human colostrums. International Dairy Journal 2011;21(1):54-57.