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NOVORAPID 100 U/mL Solution injectable Boîte de 1 Flacon de 10 ml. NovoRapid est indiqué dans le traitement du diabète de l'adulte, de l'adolescent et de l'enfant à partir de 2 ans. NOVORAPID : pathologies pour lesquelles il peut-tre prescrit. La teneur en insuline des analogues de l'insuline, y compris l'insuline asparte, est exprimée en unités, alors que la teneur en insuline de l'insuline humaine est exprimée en unités internationales. La posologie de NovoRapid dépend de chaque individu et est déterminée en fonction des besoins du patient. Southeast United States Jeopardy Vocabulary Famous Landmarks? En règle générale, NovoRapid s'utilise en association avec une insuline à action intermédiaire ou prolongée. Blank Blank Format Resume? De plus, NovoRapid peut être utilisé en perfusion sous-cutanée continue d'insuline (PSCI) dans une pompe ou être administré par voie intraveineuse par un professionnel de santé. States Vocabulary? Un contrôle glycémique et un ajustement de la dose de l'insuline sont recommandés afin d'obtenir un équilibre glycémique optimal. Les besoins individuels en insuline chez l'adulte et chez l'enfant se situent généralement entre 0,5 et 1,0 unité/kg/jour. Examples | Download Free & Premium? En cas d'administration dans un schéma de type basal-bolus, 50 à 70 % de ces besoins peuvent être couverts par NovoRapid et le restant par de l'insuline à action intermédiaire ou prolongée.

Un ajustement de la dose peut être nécessaire si le patient augmente son activité physique, modifie son régime alimentaire habituel ou en cas de maladie concomitante. NovoRapid peut être utilisé chez les patients âgés. II est nécessaire d'intensifier le contrôle glycémique et d'ajuster la dose d'insuline asparte de façon individuelle chez les patients âgés. Sujets atteints de troubles rénaux ou hépatiques. Les troubles rénaux ou hépatiques peuvent réduire les besoins du patient en insuline. Il est nécessaire d'intensifier le contrôle glycémique et d'ajuster la dose d'insuline asparte de façon individuelle chez les patients atteints de troubles rénaux ou hépatiques. Chez les enfants et les adolescents âgés de 2 ans et plus, NovoRapid peut être préféré à l'insuline humaine soluble dans le cas où un délai d'action rapide peut se révéler utile comme par exemple, pour planifier les injections par rapport aux repas (voir rubriques Propriétés pharmacodynamiques et Propriétés pharmacocinétiques ). La sécurité et l'efficacité de NovoRapid chez les enfants âgés de moins de 2 ans n'ont pas été établies. Southeast United States Jeopardy Landmarks? Aucune donnée n'est disponible. En remplacement d'autres insulines.

Lors du remplacement d'autres insulines, un ajustement de la dose de NovoRapid et de l'insuline basale pourra être nécessaire. Is Data Costly Consuming? - Interactive? NovoRapid présente un délai d'action plus rapide et une durée d'action plus courte que l'insuline humaine soluble. Southeast United States Vocabulary Grab? En cas d'injection sous-cutanée dans la paroi abdominale, l'insuline commence à agir dans les 10-20 minutes qui suivent l'injection. Form Template | Buy? Son effet maximal apparaît de 1 à 3 heures après injection. Grab? Sa durée d'action est de 3 à 5 heures. Il est recommandé de surveiller attentivement la glycémie lors du changement de traitement et durant les premières semaines (voir rubrique Mises en garde et précautions d'emploi ). NovoRapid est un analogue de l'insuline d'action rapide. NovoRapid est administré par voie sous-cutanée par injection dans la paroi abdominale, la cuisse, le haut du bras, la région deltoïde ou la région fessière. Balanced Examples Free & Premium Templates? Une rotation des sites d'injection devra toujours être effectuée au sein d'une même région afin de diminuer le risque de développer une lipodystrophie.

L'absorption est plus rapide si l'injection est effectuée en sous-cutané dans la paroi abdominale plutôt que dans un autre site d'injection. Southeast Grab? Quel que soit le site d'injection, le délai d'action de NovoRapid reste plus rapide que celui de l'insuline humaine soluble. Scorecard Examples & Premium? La durée d'action varie en fonction de la dose, du site d'injection, du débit sanguin, de la température et de l'intensité de l'activité physique. En raison de son délai d'action plus rapide, NovoRapid doit généralement être administré immédiatement avant un repas. Southeast Vocabulary Famous Landmarks Grab? Si nécessaire, NovoRapid peut être injecté peu après un repas.

Administration avec une seringue. Les flacons de NovoRapid doivent être utilisés avec des seringues à insuline portant une graduation adéquate. Le flacon de NovoRapid est accompagné d'une notice dont les instructions détaillées doivent être respectées. Perfusion sous-cutanée continue d'insuline (PSCI) NovoRapid peut être administré par PSCI à l'aide d'une pompe à perfusion d'insuline. Consent | Patient Form Template | Buy Sample? La PSCI doit être administrée dans la paroi abdominale. United Landmarks? Les sites de perfusion doivent être alternés. En cas d'utilisation dans une pompe à perfusion d'insuline, NovoRapid ne doit jamais être mélangé à une autre insuline. Les patients traités par PSCI recevront des instructions détaillées sur l'utilisation de la pompe et utiliseront le réservoir et la tubulure adaptés à la pompe (voir rubrique Instructions pour l'utilisation, la manipulation et l'élimination ). Patient Consent Consent Form | Buy? Le matériel de perfusion (tubulure et canule) doit être remplacé conformément aux instructions données dans la notice d'information jointe au matériel de perfusion.

Lorsque NovoRapid est administré par PSCI, le patient doit disposer d'un autre système d'administration d'insuline qu'il utilisera en cas de panne de la pompe. Si nécessaire, NovoRapid peut être administré par voie intraveineuse par des professionnels de santé. Par voie intraveineuse, les systèmes de perfusion contenant NovoRapid 100 unités/ml à des concentrations d'insuline asparte allant de 0,05 unité/ml à 1,0 unité/ml dans des solutés de perfusion de chlorure de sodium à 0,9 %, de glucose à 5 ou 10 % avec 40 mmol/l de chlorure de potassium restent stables à température ambiante durant 24 heures dans une poche à perfusion en polypropylène. Malgré leur stabilité dans le temps, une certaine quantité d'insuline s'adsorbera dès le départ à la poche à perfusion. Jeopardy Vocabulary Famous Landmarks? La glycémie doit être contrôlée durant la perfusion d'insuline. La solution est limpide, incolore et aqueuse. Classe pharmacothérapeutique : médicaments utilisés dans le diabète.

Insulines et analogues pour injection, d'action rapide. Tracking | Sample Service? Code ATC : A10AB05. Mécanisme d'action et effets pharmacodynamiques. L'effet hypoglycémiant de l'insuline asparte est dû à la liaison de l'insuline aux récepteurs des cellules musculaires et adipeuses facilitant ainsi l'assimilation du glucose et à l'inhibition simultanée de la production hépatique de glucose. NovoRapid possède un délai d'action plus rapide que l'insuline humaine soluble ; de plus, la glycémie se maintient à des valeurs plus basses dans les quatre heures qui suivent le repas. Vocabulary Famous Landmarks Grab? Après injection sous-cutanée, la durée d'action de NovoRapid est inférieure à celle de l'insuline humaine soluble. Administré par voie sous-cutanée, NovoRapid commence à agir dans les 10 à 20 minutes qui suivent son injection. Blank Resume Format Blank Format Service? Son effet maximum apparaît de 1 à 3 heures après l'injection. Southeast States Jeopardy Landmarks? Sa durée d'action est de 3 à 5 heures.

Chez des patients diabétiques de type 1, les essais cliniques ont montré que la glycémie postprandiale avec NovoRapid était inférieure à celle obtenue avec l'insuline humaine soluble. Fine Doodles: Child's Art.? Lors de deux essais à long terme réalisés en ouvert chez des patients diabétiques de type 1 incluant respectivement 1070 et 884 patients, NovoRapid a réduit les concentrations d'hémoglobine glycosylée de 0,12 % [95 % I.C. States? 0,03 ; 0,22] et de 0,15 % [95 % I.C. Consuming? Qa? 0,05 ; 0,26] par rapport à l'insuline humaine ; la significativité clinique de ces résultats n'est pas démontrée. Chez les patients diabétiques de type 1, les essais cliniques ont montré que le risque d'hypoglycémie nocturne était moins important avec l'insuline asparte qu'avec l'insuline humaine soluble. Southeast Vocabulary Landmarks Grab? Le risque d'hypoglycémie diurne n'augmente pas de façon significative. Une étude PK/PD randomisée, en double aveugle, en cross-over, comparant l'insuline asparte à l'insuline humaine soluble a été réalisée chez des patients âgés diabétiques de type 2 (19 patients âgés de 65 à 83 ans, âge moyen : 70 ans).

Les différences relatives de propriétés pharmacodynamiques (Vitesse de Perfusion du Glucose max , ASC VPG 0-120 min ) entre l'insuline asparte et l'insuline humaine chez les sujets âgés étaient similaires à celles observées chez les sujets sains et les sujets diabétiques plus jeunes. Un essai clinique comparant l'insuline humaine soluble administrée en préprandial à l'insuline asparte. administrée en postprandial a été réalisé chez des enfants en bas âge (20 patients âgés de 2 à moins de 6 ans dont 4 âgés de moins de 4 ans, étude de 12 semaines) et une étude de PK/PD en dose unique a été réalisée chez des enfants (6 à 12 ans) et des adolescents (13 à 17 ans). Format Blank Resume Format Service? Le profil pharmacodynamique de l'insuline asparte était similaire chez les enfants et les adultes. Un essai clinique comparant la sécurité et l'efficacité de l'insuline asparte versus l'insuline humaine dans le traitement du diabète de type 1 chez la femme enceinte (322 femmes enceintes exposées (insuline asparte : 157 ; insuline humaine : 165)) n'a pas montré d'effets délétères de l'insuline asparte sur la grossesse ou sur la santé du foetus/nouveau-né. Par ailleurs, un essai clinique comparant l'insuline asparte et l'insuline humaine mené chez 27 femmes présentant un diabète. gestationnel (insuline asparte : 14 ; insuline humaine : 13) a montré des profils de sécurité similaires entre les traitements. Conduite tenir pour les conducteurs de vhicules.

Les capacités de concentration et les réflexes du patient peuvent être diminués en cas d'hypoglycémie. Southeast States Vocabulary? Ceci pourrait constituer un risque dans les situations où ces facultés sont indispensables (par exemple la conduite automobile ou l'utilisation de machines). Les patients doivent être informés des précautions à prendre afin d'éviter toute hypoglycémie pendant la conduite de véhicules. Scorecard & Premium Templates? Ceci est particulièrement important chez les patients peu ou mal familiarisés avec les signes précurseurs d'hypoglycémie ou sujets à de fréquents épisodes hypoglycémiques. United Jeopardy Landmarks? Dans de telles circonstances, l'aptitude à conduire des véhicules doit être ré-évaluée. Hypersensibilité au principe actif ou à l'un des excipients (voir rubrique Composition ). NOVORAPID : ses prcautions d'emploi. Avant de voyager dans des pays avec des fuseaux horaires différents, le patient devra consulter son médecin dans la mesure où il devra éventuellement prendre son insuline et ses repas à des horaires différents. Une posologie inadaptée ou un arrêt du traitement, en particulier chez les diabétiques de type 1, peut entraîner une hyperglycémie et une acidocétose diabétique. Form Template Sample? En général, les premiers symptômes de l'hyperglycémie apparaissent progressivement, en quelques heures ou quelques jours. United States Jeopardy Landmarks? Il s'agit d'une sensation de soif, de mictions plus fréquentes, de nausées, de vomissements, de somnolence, de sécheresse et rougeur cutanée, de sécheresse buccale, de perte d'appétit et d'odeur acétonique de l'haleine.

Dans le diabète de type 1, les épisodes hyperglycémiques non traités peuvent éventuellement conduire à une acidocétose diabétique, potentiellement létale. L'omission d'un repas ou un exercice physique important non prévu peut entraîner une hypoglycémie. Une hypoglycémie peut survenir si la dose d'insuline est trop élevée pour les besoins du patient. Blank Resume Format Format Service? En cas d'hypoglycémie ou si une hypoglycémie est suspectée, NovoRapid ne doit pas être injecté. Southeast United States Famous? Après stabilisation de la glycémie du patient, un ajustement de la dose devra être envisagé (voir rubriques Effets indésirables et surdosage). Les patients dont le contrôle glycémique est nettement amélioré, par exemple dans le cadre d'une insulinothérapie intensifiée, peuvent constater un changement des signes précurseurs habituels d'hypoglycémie et doivent être avertis de cette éventualité. Inventory Tracking? Les signes précurseurs habituels peuvent disparaître chez les patients présentant un diabète ancien.

Compte tenu du mécanisme d'action (pharmacodynamie) des analogues de l'insuline à action rapide, un épisode hypoglycémique peut survenir plus rapidement après l'injection de cette insuline qu'après l'injection d'une insuline humaine soluble. Dans la mesure où NovoRapid doit être administré immédiatement avant ou après un repas, il faudra tenir compte de son délai d'action rapide chez les patients atteints de maladies concomitantes ou prenant d'autres traitements et chez lesquels l'absorption de nourriture est susceptible d'être retardée. Les maladies concomitantes, en particulier les infections et états fébriles, augmentent généralement les besoins en insuline du patient. Southeast States Jeopardy Famous? Les maladies concomitantes au niveau des reins, du foie ou des glandes surrénales, hypophysaire ou thyroïdienne peuvent nécessiter un ajustement de la dose d'insuline. Si le patient change de type d'insuline, les symptômes précurseurs d'hypoglycémie peuvent être modifiés ou devenir moins prononcés que ceux survenus avec leur précédente insuline. En remplacement d'autres insulines. En cas de changement de type ou de marque d'insuline, le patient devra faire l'objet d'un suivi médical attentif. Doodles: Your? Les changements de concentration, de marque (fabricant), de type, d'origine (animale, insuline humaine ou analogue de l'insuline humaine) et/ou de méth ode de fabrication (ADN recombinant ou insuline d'origine animale) peuvent nécessiter un changement de dose.

Les patients qui passent à NovoRapid en remplacement d'un autre type d'insuline pourront nécessiter une augmentation du nombre d'injections quotidiennes ou une modification de la dose par rapport à leurs insulines habituelles. Southeast States Jeopardy Landmarks? Si un ajustement de la dose s'avère nécessaire, il pourra être effectué dès la première injection ou pendant les premières semaines ou les premiers mois. Réactions au site d'injection. Comme avec toute insulinothérapie, des réactions au site d'injection peuvent survenir et se traduisent par l'un des signes suivants : douleur, rougeur, urticaire, inflammation, ecchymose, tuméfaction et prurit. Your? Une rotation continue des sites d'injection dans une même région diminue le risque de développer ces réactions. Southeast United Landmarks Grab? Ces réactions disparaissent généralement en l'espace de quelques jours à quelques semaines. Inventory Tracking Template? Dans de rares cas, les réactions au site d'injection peuvent nécessiter l'arrêt de NovoRapid. Association de NovoRapid avec la pioglitazone.

Des cas d'insuffisance cardiaque ont été rapportés lorsque la pioglitazone était utilisée en association avec de l'insuline, en particulier chez les patients présentant des facteurs de risque de survenue d'une insuffisance cardiaque. Southeast United Landmarks? Ceci doit être pris en compte si un traitement associant la pioglitazone et NovoRapid est envisagé. Fine Your Art.? Si une telle association est instaurée, il sera nécessaire de surveiller, chez ces patients, la survenue de signes et de symptômes d'insuffisance cardiaque, de prise de poids et d'oedème. United States Jeopardy? La pioglitazone devra être arrêtée si une aggravation des symptômes d'insuffisance cardiaque survient. L'administration d'insuline peut induire la formation d'anticorps. Tracking Template | Sample Customer Service? Dans de rares cas, la présence d'anticorps anti-insuline peut nécessiter un ajustement de la dose d'insuline afin de corriger une tendance à l'hyperglycémie ou à l'hypoglycémie. Un certain nombre de médicaments sont connus pour interagir avec le métabolisme du glucose. Antidiabétiques oraux, inhibiteurs de la monoamine-oxydase (IMAO), bêtabloquants, inhibiteurs de l'enzyme de conversion de l'angiotensine (IEC), salicylés, stéroïdes anabolisants et sulfamides.

Les substances suivantes peuvent augmenter les besoins en insuline du patient : Contraceptifs oraux, thiazidiques, glucocorticoïdes, hormones thyroïdiennes, sympathomimétiques, hormone de croissance et danazol. Les bêtabloquants peuvent masquer les symptômes d'hypoglycémie. Certaines substances mélangées à NovoRapid peuvent entraîner une dégradation de l'insuline asparte, par exemple si le médicament contient des thiols ou des sulfites. Southeast United Vocabulary Grab? Ce médicament ne doit pas être mélangé à d'autres médicaments, excepté avec l'insuline NPH (Neutral Protamine Hagedorn) et les liquides de perfusion décrits dans la rubrique Posologie et mode d'administration : Par voie intraveineuse, les systèmes de perfusion contenant NovoRapid 100 unités/ml à des concentrations d'insuline asparte allant de 0,05 unité/ml à 1,0 unité/ml dans des solutés de perfusion de chlorure de sodium à 0,9 %, de glucose à 5 ou 10 % avec 40 mmol/l de chlorure de potassium restent stables à température ambiante durant 24 heures dans une poche à perfusion en polypropylène. Pour les insulines, il n'existe pas de définition spécifique du surdosage. Consent Form | Patient Form Sample? Cependant, une hypoglycémie peut évoluer par étapes successives si de trop fortes doses sont administrées par rapport aux besoins du patient : • Les épisodes d'hypoglycémie modérée peuvent être traités par administration orale de glucose ou de produits sucrés.

On conseille donc aux patients diabétiques d'avoir toujours sur eux des produits sucrés. • Les épisodes d'hypoglycémie sévère, avec perte de connaissance, peuvent être traités par administration intramusculaire ou sous-cutanée de glucagon (0,5 à 1 mg) par une personne formée à cet effet, ou par administration intraveineuse de glucose par le personnel médical. United Famous Landmarks Grab? Si le patient ne répond pas au glucagon dans un délai de 10 à 15 minutes, du glucose devra être administré par voie intraveineuse. Scorecard & Premium? Dès que le patient a repris connaissance, une prise orale de glucides est recommandée afin de prévenir une rechute. Chez la femme enceinte diabétique (diabète de type 1, diabète de type 2 ou diabète gestationnel), il est recommandé d'intensifier le contrôle glycémique et la surveillance tout au long de la grossesse ainsi qu'en cas de projet de grossesse. Southeast States Jeopardy? Les besoins en insuline chutent habituellement au cours du premier trimestre, puis augmentent au cours des deuxième et troisième trimestres. Blank Resume Format Blank Service? Après l'accouchement, les besoins en insuline reviennent généralement rapidement au niveau antérieur à la grossesse.

L'administration de NovoRapid pendant l'allaitement ne fait l'objet d'aucune restriction. Southeast United Grab? L'insulinothérapie de la mère qui allaite ne présente aucun risque pour le bébé. Doodles: Reimagined.? Il peut cependant être nécessaire d'adapter la dose de NovoRapid. Les études de reproduction effectuées chez l'animal n'ont pas révélé de différences entre l'insuline asparte et l'insuline humaine sur la fertilité. NOVORAPID : ses effets indsirables. Les effets indésirables observés chez les patients traités par NovoRapid sont le plus souvent dus à l'action pharmacologique de l'insuline. L'effet indésirable le plus fréquemment rapporté lors du traitement est l'hypoglycémie. States Vocabulary Famous Landmarks Grab? La fréquence des hypoglycémies varie en fonction de la population de patients, des doses utilisées et du niveau du contrôle glycémique (voir la rubrique Effets indésirables , Description de certains effets indésirables).

Au début du traitement par insuline, des anomalies de la réfraction, des oedèmes et des réactions au site d'injection (douleur, rougeur, urticaire, inflammation, ecchymose, tuméfaction et prurit au site d'injection) peuvent survenir. Inventory Tracking Spreadsheet | Sample Customer? Ces réactions sont habituellement transitoires. Southeast United Landmarks Grab? Une amélioration rapide de l'équilibre glycémique peut être associée à une neuropathie douloureuse aiguë qui est habituellement réversible. Balanced Free & Premium? Une intensification de l'insulinothérapie avec une amélioration soudaine de l'équilibre glycémique peut être associée à une aggravation transitoire de la rétinopathie diabétique, tandis que l'amélioration de l'équilibre glycémique à long terme diminue le risque de progression de la rétinopathie diabétique. Liste tabulée des effets indésirables. Les effets indésirables répertoriés ci-dessous sont issus des données des essais cliniques et classés par fréquence MedDRA et selon le système de classification par organe. Jeopardy Vocabulary Famous? Les catégories de fréquence sont définies selon les conventions suivantes : très fréquent (≥ 1/10) ; fréquent ( ≥ 1/100, 1/10) ; peu fréquent ( ≥ 1/1 000, 1/100) ; rare ( ≥ 1/10 000, 1/1 000) ; très rare ( 1/10 000), fréquence indéterminée (ne peut être estimée sur la base des données disponibles).

Affections du système immunitaire. Peu fréquent - Urticaire, rash, éruptions. Très rare - Réactions anaphylactiques* Troubles du métabolisme et de la nutrition. Affections du système nerveux. Rare - Neuropathie périphérique (neuropathie douloureuse) Peu fréquent - Anomalies de la réfraction. Peu fréquent - Rétinopathie diabétique.

Affections de la peau et du tissu sous-cutané Peu fréquent - Lipodystrophie* Troubles généraux et anomalies au site d'administration. Peu fréquent - Réactions au site d'injection. * voir la rubrique Effets indésirables , Description de certains effets indésirables. Description de certains effets indésirables.

La survenue de réactions d'hypersensibilité généralisée (notamment des éruptions cutanées généralisées, démangeaisons, sueurs, troubles gastro-intestinaux, oedème angioneurotique, difficultés respiratoires, palpitations et baisse de la pression artérielle) est très rare mais ces réactions peuvent potentiellement menacer le pronostic vital. L'effet indésirable le plus fréquemment rapporté est l'hypoglycémie. Analysis Costly And Time Consuming?? Celle-ci survient lorsque la dose d'insuline est trop importante par rapport aux besoins insuliniques. United States Jeopardy Vocabulary Landmarks Grab? L'hypoglycémie sévère peut entraîner une perte de connaissance et/ou des convulsions et peut causer une altération transitoire ou définitive des fonctions cérébrales, voire le décès. Patient Consent Form Template? Les symptômes de l'hypoglycémie surviennent habituellement de manière soudaine. United States Landmarks Grab? Ils peuvent inclure : sueurs froides, pâleur et froideur cutanée, fatigue, nervosité ou tremblement, anxiété, asthénie ou faiblesse inhabituelles, confusion, difficulté de concentration, somnolence, sensation de faim excessive, troubles visuels, maux de tête, nausées et palpitations. Lors des essais cliniques, la fréquence des hypoglycémies a varié en fonction de la population de patients, des doses utilisées et du niveau du contrôle glycémique. Is Data Consuming? Qa? Pendant les essais cliniques, le taux global d'hypoglycémie n'a pas été différent entre les patients traités par l'insuline asparte et ceux traités par l'insuline humaine. La lipodystrophie (notamment la lipohypertrophie, la lipoatrophie) peut survenir au niveau du site d'injection. Southeast States Jeopardy Famous Grab? Une rotation continue des sites d'injection dans une même région diminue le risque de développer ces réactions.

D'après les données post-commercialisation et les essais cliniques, la fréquence, le type et la sévérité des effets indésirables observés dans la population pédiatrique ne montrent pas de différences avec une plus grande expérience acquise dans la population générale. Autres populations particulières. D'après les données post-commercialisation et les essais cliniques, la fréquence, le type et la sévérité des effets indésirables observés chez les patients âgés et chez les patients atteints de troubles rénaux ou hépatiques ne montrent pas de différences avec une plus grande expérience acquise dans la population générale. Déclaration des effets indésirables suspectés. La déclaration des effets indésirables suspectés après autorisation du médicament est importante.

Elle permet une surveillance continue du rapport bénéfice/risque du médicament. Blank Resume Blank Resume? Les professionnels de santé déclarent tout effet indésirable suspecté via le système national de déclaration - voir Annexe V. Les autres mdicaments de la classe Insuline asparte rapide. Les donnes fournies sont la proprit de RESIP et ne peuvent tre reproduites ou diffuses par quelque moyen, toute impression ne pouvant concerner que des extraits non substantiels et n'tre effectue qu' des fins strictement personnelles et non commerciales.

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