L-ARGININE

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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.

Notes

Date

28 mars 2024

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

Tableau 1. Nom(s) propre(s), Nom commun(s), Information(s) d'origine
Nom(s) propre(s) Nom(s) commun(s) Information(s) d'origine
Matière(s) d'origine Préparation
  • Acide (S)-2-amino-5-[(aminoiminométhyl) amino] pentanoïque
  • L-Arginine

L-Arginine

  • Acide cétoisocaproïque de L-arginine
  • Alpha-cétoglutarate de L-arginine
  • DL-Arginine
  • L-Arginine
  • Monochlorhydrate de L-arginine
Synthétique

Références : Noms propres : NIH 2023, RSC 2023; Nom commun : NIH 2023, RSC 2023; Informations d'origine : NIH 2023, BP 2009, USP 32 2009, Ph. Eur. 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 la voie d'administration orale sont indiquées dans la liste déroulante dans le formulaire web de demande de licence de mise en marché pour les demandes officinales.

Usage(s) ou fin(s)

Dose(s)

Sous-population(s)

Adultes 18 ans et plus

Quantité(s)

Amélioration de la capacité à faire de l'exercice physique chez les individus atteints d'une MCV stable

6 à 21 grammes de L-arginine, par jour; Ne pas dépasser 8 grammes par dose unique (Doutreleau et al. 2010; Shao et Hathcock 2008; Doutreleau et al. 2006; Evans et al. 2004; Lim et al. 2004; Palloshi et al. 2004; Bode-Bogër et al. 2003; Bednarz et al. 2000; Hambrecht et al. 2000; Lerman et al. 1998; Adams et al. 1997; Ceremuzynski et al. 1997; Clarkson et al. 1996; Rector et al. 1996)

Synthèse des protéines

0,21 à 21 grammes de L-arginine, par jour; Ne pas dépasser 8 grammes par dose unique (Shao et Hathcock 2008; IOM 2005; Evans et al. 2004; Bode-Bogër et al. 2003; Sydow et al. 2002

Mode(s) d'emploi

Énoncé non requis.

Durée(s) d'utilisation

Produits fournissant de 3 g à 9 g de L-arginine, par jour

Consulter un praticien de soins de santé/fournisseur de soins de santé/professionnel de la santé/docteur/médecin si l'usage se prolonge au-delà de 6 semaines si vous avez une maladie cardiovasculaire (Salmani et al. 2021; Shao et Hathcock 2008; Sydow et al. 2002; Hambrecht et al. 2000; Clarkson et al. 1996; Rector et al. 1996).

Produits fournissant plus de 9 g et jusqu'à 14 g de L-arginine, par jour

Consulter un praticien de soins de santé/fournisseur de soins de santé/professionnel de la santé/docteur/médecin si l'usage se prolonge au-delà de 6 mois pour les personnes en santé (Alexander et al. 2005; De Nicola et al. 1999).

Produits fournissant plus de 14 g de L-arginine, par jour

Consulter un praticien de soins de santé/fournisseur de soins de santé/professionnel de la santé/docteur/médecin si l'usage se prolonge au-delà de 12 semaines pour les personnes en santé (Tangphao et al. 1999).

Mention(s) de risque

Précaution(s) et mise(s) en garde

Tous les produits

Consultez un praticien de soins de santé/fournisseur de soins de santé/professionnel de la santé/docteur/médecin avant l'utilisation si vous êtes enceinte ou si vous allaitez.

Amélioration de la capacité à faire de l'exercice physique chez les individus atteints d'une MCV stable

Consultez un praticien de soins de santé/fournisseur de soins de santé/professionnel de la santé/docteur/médecin si les symptômes s'aggravent.

Produits fournissant plus de 0,42 g de L-arginine, par jour

Contre-indications(s)

Produits fournissant plus de 9 g de L-arginine, par jour

Ne pas utiliser si vous avez subi une crise cardiaque/un infarctus du myocarde (Sun et al. 2009; Schulman et al. 2006; Bednarz et al. 2005).

Réaction(s) indésirable(s) connue(s)

Produits fournissant plus de 9 g de L-arginine, par jour

Lorsque vous utilisez ce produit, vous pourriez souffrir d'inconfort gastro-intestinal/de troubles gastro-intestinaux (Grimble 2007; Evans et al. 2004; IOM 2005; Clarkson et al. 1996).

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

Doivent être établies conformément aux exigences décrites dans le Règlement sur les produits de santé naturels.

Spécifications

EXEMPLE D'INFO-PRODUIT :

Veuillez consulter la ligne directrice, Étiquetage des produits de santé naturels pour plus de détails.

Info-Produit

Références citées

Adams MR, McCredie R, Jessup W, Robinson J, Sullivan D, Celermajer DS. 1997. Oral L-arginine improves endothelium-dependent dilatation and reduces monocyte adhesion to the endothelial cells in young men with coronary artery disease. Atherosclerosis 129(2):261-269.

Adams MR, Forsyth CJ, Jessup W, Robinson J, Celermajer DS. 1995. Oral L-arginine inhibits platelet aggregation but does not enhance endothelium-dependent dilation in healthy young men. Journal of the American College of Cardiology 26(4):1054-1061.

Alexander JW, Metze TJ, McIntosh MJ, Goodman HR, First MR, Munda R, Cardi MA, Austin JN, Goel S, Safdar S, Greenberg N, Chen X, Woodle ES. 2005. The influence of immunomodulatory diets on transplant success and complications. Transplantation 79:460-465. 

Bednarz B, Jaxa-Chamiec T, Maciejewski P, Szpajer M, Janik K, Gniot J, Kawka-Urbanek T, Drozdowska D, Gessek J, Laskowski H. 2005. Efficacy and safety of oral l-arginine in acute myocardial infarction. Results of the multicenter, randomized, double-blind, placebo-controlled ARAMI pilot trial. Kardiol Pol. 62(5):421-7.

Bednarz B, Wolk R, Chamiec T, Herbaczynska-Cedro K, Winek D, Ceremuzynski L. 2000. Effects of oral L-arginine supplementation on exercise-induced QT dispersion and exercise tolerance in stable angina pectoris. International Journal of Cardiology 75(2-3):205-210.

Bode-Böger SM, Muke J, Surdacki A, Brobant G, Böger RH, Frölich J. 2003. Oral L-arginine improves endothelial function in healthy individuals older than 70 years. Vascular Medicine 8(2):77-81.

BP 2009: British Pharmacopoeia Commission. 2008. British Pharmacopoeia 2009, Volume II. London (GB): The Stationary Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA).

Ceremuzynski L, Chamiec T, Herbaczynska-Cedro K. 1997. Effect of supplemental oral L-arginine on exercise capacity in patients with stable angina pectoris. The American Journal of Cardiology 80(3):331-333.

Clarkson P, Adams MR, Powe AJ, Donald AE, McCredie R, Robinson J, McCarthy SN, Keech A, Celermajer DS, Deanfield JE. 1996. Oral L-arginine endothelium-dependent dilation in hypercholesterolemic young adults. Journal of Clinical Investigation 97(8):1989-1994.

De Nicola L, Bellizzi V, Minutolo R, Andreucci M, Capuano A, Garibotto G, Corso G, Andreucci VE, Cianciaruso B. 1999. Randomized, double-blind, placebo-controlled study of arginine supplementation in chronic renal failure. Kidney International 56:674-684.

Doutreleau S, Rouyer O, Di Marco P, Lonsdorfer E, Richard R, Piquard F, Geny B. 2010. L-Arginine supplementation improves exercise capacity after a heart transplant. American Journal of Clinical Nutrition. Doi: 10.3945/ajcn.2009.27881.

Doutreleau S, Mettauer B, Piquard F, Rouyer O, Schaefer A, Lonsdorfer J., Beny B. 2006. Chronic L-Arginine Supplementation Enhances Endurance Exercise Tolerance in Heart Failure Patients. International Journal of Sports Medicine 27(7):567-572.

Evans WR, Fernstrom JD, Thompson J, Morris SM Jr, Kuller LH. 2004. Biochemical responses of healthy subjects during dietary supplementation with L-arginine. Journal of Nutritional Biochemistry 15(9):534-539.

Grimble GK. 2007. Adverse gastrointestinal effects of arginine and related amino acids. The Journal of Nutrition 137(6 Suppl 2):1693S-1701S.

Groff J, Gropper S. 2000. Advanced Nutrition and Human Metabolism, 3rd edition. Belmont (CA): Wadsworth/Thomson Learning. 

Hambrecht R, Hilbrich L, Erbs S, Gielen S, Fiehn E, Schoene N, Schuler. 2000. Correction of endothelial dysfunction in chronic heart failure: additional effects of exercise training and oral L-arginine supplementation. Journal of the American College of Cardiology 35(3):706-713.

Huynh NT, Tayek JA. 2002. Oral arginine reduces systemic blood pressure in type 2 diabetes: Its potential role in nitric oxide generation. American College of Nutrition 21(5):422-427.

IOM 2006: Otten JJ, Pitzi Hellwig J, Meyers LD, editors. 2006. Institute of Medicine Dietary Reference Intakes: The Essential Guide to Nutrient Requirements. Washington (DC): National Academies Press.

IOM 2005: Institute of Medicine. Panel on Dietary Reference Intakes for Electrolytes and Water, and the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine. 2005. Dietary Reference Intakes for Water, Potassium, Sodium, Chloride, and Sulfate. Washington (DC): National Academies Press.

Lekakis JP, Papathanassiou S, Papaioannou TG, Papamichael CM, Zakopoulos N, Kotsis V, Dagre AG, Stamatelopoulos K, Protogerou A, Stamatelopoulos SF. 2002. Oral L-arginine improves endothelial dysfunction in patients with essential hypertension. International Journal of Cardiology 86(2-3):317-323.

Lerman A, Burnett JC, Higano ST, McKinley LJ, Holmes Jr DR. 1998. Long-term L-arginine supplementation improves small-vessel coronary endothelial function in humans. Circulation 97(21):2123-2128.

Lim SD, Mooradian SJ, Goldberg CS, Gomez C, Crowley DC, Rocchini AP, Charpie JR. 2004. Effect of oral L-arginine on oxidant stress, endothelial dysfunction, and systemic arterial pressure in young cardiac transplant recipients. The American Journal of Cardiology 94(6):828-831.

Nagaya N, Uematsu M, Oya H, Sato N, Sakamaki F, Kyotani S, Ueno K, Nakanishi N, Yamagishi M, Miyatake K. 2001. Short-term oral administration of L-arginine improves hemodynamics and exercise capacity in patients with precapillary pulmonary hypertension. American Journal of Respiratory and Critical Care Medicine 163(4):887-891.

NIH 2023: National Institutes of Health. PubChem. Bethesda (MD): National Library of Medicine, US Department of Health & Human Services. [Consulté le 23 octobre 2023]. Disponible à : https://pubchem.ncbi.nlm.nih.gov/

Palloshi A, Fragasso G, Piatti P, Monti LD, Setola E, Valsecchi G, Galluccio E, Chierchia SL, Morgonato A. 2004. Effect of oral L-arginine on blood pressure and symptoms and endothelial function in patients with systemic hypertension, positive exercise tests, and normal coronary arteries. The American Journal of Cardiology 93(7):933-935.

Parker JO, Parker JD, Caldwell RW, Farrell B, Kaesemeyer WH. 2002. The effect of supplemental L-arginine on tolerance development during continuous transdermal nitroglycerin therapy. Journal of the American College of Cardiology 39(7):1199-1203.

Ph. Eur. 2007: European Pharmacopoeia Commission. 2007. European Pharmacopoeia, 6th edition, Volume 1. Strasbourg (FR): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).

Rector TS, Bank AJ, Mullen KA, Tschumperlin LK, Sih R, Pillai K, Kubo SH. 1996. Randomized, double-blind, placebo-controlled study of supplemental oral –arginine in patients with heart failure. Circulation 93(12):2135-2141.

RSC 2023: Royal Society of Chemistry: The Merck Index Online [Accessed 2023 August 14]. Available from: https://merckindex.rsc.org/

Salmani M, Alipoor E, Navid H, Farahbakhsh P, Yaseri M, Imani H. 2021. Effect of l-arginine on cardiac reverse remodeling and quality of life in patients with heart failure. Clin Nutr. 40(5):3037-3044.

Shao A, Hathcock JN. 2008. Risk assessment for the amino acids taurine, L-glutamine and Larginine. Regulatory Toxicology and Pharmacology 50:376-399.

Shils ME, Olson JA, Shike M, Ross AC, editors. Modern Nutrition in Health and Disease, 10th edition. Philadelphia (PA): Lippincott Williams and Wilkins; 2006.

Schulman SP, Becker LC, Kass DA, Champion HC, Terrin ML, Forman S, Ernst KV, Kelemen MD, Townsend SN, Capriotti A, Hare JM, Gerstenblith G. 2006. L-Arginine therapy in acute myocardial infarction: the vascular interaction with age in myocardial infarction (VINTAGE MI) randomised clinical trial. Journal of American Medical Association 295(1):58-64.

Siani A, Pagano E, Iacone R, Iacoviello L, Scopacasa F, Strazzullo P. 2000. Blood pressure and metabolic changes during dietary L-arginine supplementation in humans. American Journal of Hypertension 13(5):547-551.

Sun T, Zhou WB, Luo XP, Tang YL, Shi HM. 2009. Oral L-arginine supplementation in acute myocardial infarction therapy: a meta-analysis of randomized controlled trials. Clin Cardiol. 32(11):649-52.

Sydow K, Schwedhelm E, Arakawa N, Bode-Böger SM, Tsikas D, Hornig B, Frölich, Böger RH. ADMA and oxidative stress are responsible for endothelial dysfunction in hyperhomocyst(e)inemia: effects of L-arginine and B vitamins. Cardiovascular Research 57(1):244-252.

Tangphao O, Chalon S, Moreno HJr, Hoffman BB, Blaschke TF. Pharmacokinetics of L-arginine during chronic administration to patients with hypercholesterolaemia. Clinical Science 96:199-207.

USP-NF 2023: United States Pharmacopeial Convention. United States Pharmacopeia and the National Formulary. Rockville (MD): United States Pharmacopeial Convention, Inc.; 2023.

Références consultées

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Andrés A, Morales JM, Prega M, Campo C, Lahera V, García-Robles R, Rodicio JL, Ruilope LM. 1997. L-arginine reverses the antinatriuretic effect of cyclosporine in renal transplant patients. Nephrology Dialysis Transplantation 12(7):1437-1440.

Becker Y, Olshevsky U, Levitt J. 1967. The role of arginine in the replication of Herpes simplex virus. The Journal of General Virology 1(4):471-478.

Bednarz B, Jaxa-Chamiec T, Gebalska J, Herbaczynska-Cedro K, Ceremuzynski L. 2004. L-

Arginine supplementation prolongs duration of exercise in congestive heart failure. Kardiologia Polska 60(4):348-353.

Bednarz B, Jaxa-Chamiec T, Maciejewski P, Szpajer M, Janik K, Gniot J, Kawka-Urbanek T, Drozdowska D, Gessek J, Laskowski H. 2005. Efficacy and safety of oral L-arginine in acute myocardial infarction. Results of multicenter, randomised, double-blind, placebo-controlled ARAMI pilot trial. Kardiologia Polska 62(5):421-427.

Blum A, Cannon III RO, Costello R, Schenke WH, Csako G. 2000. Endocrine and lipid effects of oral L-arginine treatment in healthy postmenopausal women. The Journal of Laboratory and Clinical Medicine 135(3):231-237.

Blum A, Hathaway L, Mincemoyer RN, Schenke WH Kirby M, Csako G, Waclawiw MA, Panza JA, Cannon III RO. 1999. Oral L-arginine in patients with coronary artery disease on medical management. Circulation 101(18):2160-2464. 

Blum A, Porat R, Rosenchein Uri, Keren G, Roth A, Laniado S, Miller H. 1999. Clinical and inflammatory effects of dietary L-arginine in patients with intractable angina pectoris. American Journal of Cardiology 83(10):1488-1490.

Cannon RA III. 2002. Oral L-arginine (and other active ingredients) for ischemic heart disease? Journal of the American College of Cardiology 39(1):46-48.

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Carrier M, Pellerin M, Perrault LP, Bouchard D, Pagé P, Searle N, Lavoie J. 2002. Cardioplegic arrest with L-arginine improves myocardial protection: results of a prospective randomized clinical trial. The Annals of Thoracic Surgery 73(3):837-842.

Cartledge JJ, Davies AM, Eardley I. 2000. A randomized double-blind placebo-controlled crossover trial of the efficacy of L-arginine in the treatment of interstitial cystitis. BJU International 85(4):421-426.

Chen J, Wollman Y, Chernichovsky T, Iaina A, Sofer M, Matzkin H. 1999. Effect of oral administration of high-dose nitric oxide donor L-arginine in men with organic erectile dysfunction: results of a double-blind, randomized, placebo-controlled study. BJU International 83(3):269-273.

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Facchinetti F, Saade GR, Neri I, Pizzi C, Longo M, Volpe A. 2007. L-Arginine supplementation in patients with gestational hypertension: a pilot study. Hypertension in Pregnancy 26(1):121-130.

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Jahangir E, Handy D, Palmisano J, Loscalzo J. 2009. The effect of L-arginine and creatine on vascular function and homocysteine metabolism. Vascular Medicine 14(3): 239-248.

Kiziltepe U, Tunçtan B, Eyileten ZB, Sirlak M, Arikbuku M, Tasoz R, Uysalel A, Ozyurda U. 2004. Efficiency of L-arginine enriched cardioplegia and non-cardioplegic reperfusion in ischemic hearts. International Journal of Cardiology 97(1):93-100.

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Lauer T, Kleinbongart P, Rath J, Schultz R, Kelm M, Rassaf T. 2008. L-Arginine preferentially dilates stenotic segments of coronary arteries thereby increasing coronary flow. Journal of Internal Medicine 264(3):237-244.

Lebret T, Hervé JM, Gorny P, Worcel M, Botto H. 2002. Efficacy and safety of a novel combination of L-arginine glutamate and yohimbine hydrochloride: a new oral therapy for erectile dysfunction. European Urology 41(6):608-613.

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Loscalzo J. 2003. Adverse effects of supplemental L-arginine in atherosclerosis: Consequences of methylation stress in a complex catabolism? Arteriosclerosis & thrombosis and Vascular Biology 23(1):3-5.

Lucotti P, Setola E, Monti LD, Galluccio E, Costa S, Sandoli EP, Fermo I, Rabaiotti G, Gatti R, Piatti PM. 2006. Beneficial effects of long-term oral L-arginine treatment added to a hypocaloric diet and exercise training program in obese, insulin-resistant type 2 diabetic patients. American Journal of Physiology, Endocrinology and Metabolism 291(5):906-912.

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Morris CR, Kuypers FA, Larkin S, Sweeters N, Simon J, Vichinsky EP, Styles LA. 2000.

Arginine therapy: a novel strategy to induce nitric oxide production in sickle cell disease. British Journal of Haematology 111(2):498-500.

Morris CR, Morris SM, Hagar W, van Warmerdam J, Claster SKepka-Lenhart D, Machado L, Kuypers FA, Vichinsky EP. 2003. Arginine therapy: a new treatment for pulmonary hypertension in sickle cell disease? American Journal of Respiratory and Critical Care Medicine 168(1):63-69.

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Napoli C, Farzati B, Sica V, Iannuzzi E, Coppola G, Silvestroni A, Balestrieri ML, Florio A, Matarazzo A. 2008. Beneficial effects of autologous bone marrow cell infusion and antioxidants/L-arginine in patients with chronic critical limb ischemia. European Journal of Cardiovascular Prevention and Rehabilitation 15(6):709-718.

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Oomen CM, van Erk J, Feskens EJM, Kok FJ, Kromhout D. 2007. Arginine intake and risk of coronary heart disease mortality in elderly men. Arteriosclerosis, Thrombosis and Vascular Biology 20(9):2134-2139.

Palloshi A, Fragasso G, Piatti P, Monti LD, Setola E, Valsecchi G, Galluccio E, Chierchia SL, Morgonato A. 2004. Effect of oral L-arginine on blood pressure and symptoms and endothelial function in patients with systemic hypertension, positive exercise tests, and normal coronary arteries. The American Journal of Cardiology 93(7):933-935.

Parnell MM, Holst DP, Kaye DM. 2005. Augmentation of endothelial function following exercise training is associated with increased L-arginine transport in human heart failure. Clinical Science 109(6):523-530.

Perusquía M, Villalón, Navarrete E, García GA, Pérez-Palacios G, Lemus AE. 2003.

Vasodilating effect of norethisterone and its 5α metabolites: a novel nongenomic action. European Journal of Pharmacology 475(1-3):161-169.

Peters N, Freilinger T, Opherk C, Pfefferkorn T, Dichgans M. 2008. Enhanced L-arginine-induced vasoreactivity suggests endothelial dysfunction in CADASIL. Journal of Neurology 255(8):1203-1208.

Polan ML, Hochberg RB, Trant AS, Wuh HCK. 2004. Estrogen bioassay of ginseng extract and

Arginmax, a nutritional supplement for the enhancement of female sexual function. Journal of Women’s Health 13(4):427-430.

Preli RB, Potvin Klein K, Herrington DM. 2002. Vascular effects of dietary L-arginine supplementation. Atherosclerosis 162(1):1-15.

Pretnar-Oblak J, Sabovic M, Zaletel M. 2007. Associations between systemic and cerebral endothelial impairment determined by cerebrovascular reactivity to L-arginine. Endothelium 14(2):73-80.

Rajapakse NW, Mattson DL. 2009. Role of L-arginine in nitric oxide production in health and hypertension. Clinical and Experimental Pharmacology and Physiology 36(3):249-255.

Ruel M, Beanlands RS, Lortie M, Chan V, Camack N, deKemp RA, Suuronen EJ, Rubens FD, DeSilva JN, Sellke FW, Steward DJ, Mesana TG. 2008. Concomitant treatment with oral L-arginine improves the efficacy of surgical angiogenesis in patients with severe diffuse coronary artery disease: The Endothelial Modulation in Angiogenic Therapy randomized clinical trial. The Journal of Thoracic and Cardiovascular Surgery 135(4):762-770.

Rytlewski K, Olszanecki R, Lauterbach R, Grzyb A, Basta A. 2006. Effects of oral L-arginine on the foetal condition and neonatal outcome in preeclampsia: A preliminary study. Basic & Clinical Pharmacology & Toxicology 99(2):146-152.

Rytlewski K, Olszanecki R, Lauterbach R, Grzyb A, Kiec-Wilk B, Dembinska-Kiec, Basta A. 2008. Effects of oral L-arginine on the pulsatility indices of umbilical artery and middle cerebral artery in preterm labor. European Journal of Obstetrics & Gynecology and Reproductive Biology 138(1):23-28.

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