MDS
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Questions and Answers

Quel est le rôle principal de l'albumine endogène dans le plasma sanguin?

  • Activation des réponses immunitaires
  • Maintien de la pression oncotique (correct)
  • Transport de l'oxygène dans le sang
  • Production de globules rouges

Quelle est l'indication appropriée pour l'utilisation de l'albumine 20%?

  • Traitement de l'hypertension
  • Réduction du cholestérol
  • Brûlures graves (correct)
  • Traitement de la migraine

Quel est l'effet indésirable le plus fréquent observé avec certains MDS (médicaments dérivés du sang)?

  • Douleurs abdominales
  • Céphalées (correct)
  • Problèmes de vision
  • Maux de dos

Quel est le principal risque associé à un taux de fibrinogène circulant au-delà de 2g/L?

<p>Complications thrombo-emboliques (C)</p> Signup and view all the answers

Quelle est l'utilisation thérapeutique principale du Fibrinogène humain?

<p>Traitement des hémorragies graves (D)</p> Signup and view all the answers

Quel est le rôle des facteurs plasmatiques/recombinants classifiés en 5 catégories?

<p>Coagulation sanguine (D)</p> Signup and view all the answers

Quelle est la méthode de fractionnement du plasma sanguin utilisée pour produire plusieurs lots de médicaments différents?

<p>Précipitations successives des diverses protéines par un apport à froid d'alcool éthylique et la variation du pH (D)</p> Signup and view all the answers

Quel est le principal critère pour la conservation des médicaments dérivés du sang?

<p>Température entre 2 et 8 degrés Celsius (A)</p> Signup and view all the answers

Quelle est l'indication principale pour l'utilisation du PPSB (Complexe prothrombique humain)?

<p>Déficit global et sévère en facteurs vitamine K-dépendants en cas de surdosage en AVK (A)</p> Signup and view all the answers

Quel est le principal risque associé à un taux de fibrinogène circulant au-delà de 2g/L?

<p>Complications thrombo-emboliques (D)</p> Signup and view all the answers

Quelle est l'indication appropriée pour l'utilisation du Fibrinogène humain (Clottafact urgence)?

<p>Traitement des hémorragies graves (B)</p> Signup and view all the answers

Quels sont les principaux effets indésirables observés avec certains MDS (médicaments dérivés du sang)?

<p>Céphalées, fièvre, nausées, vomissements, frissons, réactions cutanées allergiques, myalgie (B)</p> Signup and view all the answers

Quel est l'objectif de la Loi 93-5 du 4 janvier 1993?

<p>Réglementer la fabrication des produits dérivés du sang (D)</p> Signup and view all the answers

Quelle est la responsabilité du pharmacien hospitalier concernant les MDS (médicaments dérivés du sang)?

<p>Traçabilité et pharmacovigilance des MDS (A)</p> Signup and view all the answers

Quel est le principal objectif de la traçabilité ascendante?

<p>Isoler les dons à partir desquels ont été fabriqué un lot donné de MDS (B)</p> Signup and view all the answers

Quel est le rôle des correspondants de pharmacovigilance MDS selon le Décret 95-566 du 6 mai 1995?

<p>Correspondre avec les pharmaciens sur la fabrication des MDS (D)</p> Signup and view all the answers

Qu'est-ce que la traçabilité descendante vise à identifier?

<p>Les lots de MDS fabriqués à partir d’un don donné, encore en stock ou administrés à des patients (D)</p> Signup and view all the answers

Quel est l'un des éléments conservés pendant 40 ans en relation avec la traçabilité?

<p>Les étiquettes de traçabilité (B)</p> Signup and view all the answers

Que représente le code-barre sur les étiquettes de traçabilité?

<p>Le code CIP du médicament dérivé du sang (D)</p> Signup and view all the answers

Quel est le rôle principal de l'albumine endogène dans le plasma sanguin?

<p>Liaison et transport de molécules (B)</p> Signup and view all the answers

Quelle est l'indication appropriée pour l'utilisation du Fibrinogène humain (Clottafact urgence)?

<p>Traitement des hémorragies graves (A)</p> Signup and view all the answers

Quel est le principal risque associé à un taux de fibrinogène circulant au-delà de 2g/L?

<p>Thrombose (C)</p> Signup and view all the answers

Quelle est la méthode de fractionnement du plasma sanguin utilisée pour produire plusieurs lots de médicaments différents?

<p>Méthode de précipitations successives (C)</p> Signup and view all the answers

Quel est le principal critère pour la conservation des médicaments dérivés du sang?

<p>Température réfrigérée (C)</p> Signup and view all the answers

Quel est l'un des rôles de l'albumine endogène dans le plasma sanguin?

<p>Capteur de radicaux libres (C)</p> Signup and view all the answers

Quel est l'effet indésirable le plus fréquent observé avec certains MDS (médicaments dérivés du sang)?

<p>Nausées (B)</p> Signup and view all the answers

Quel est le principal objectif de la Loi 93-5 du 4 janvier 1993?

<p>Garantir la traçabilité des médicaments dérivés du sang (A)</p> Signup and view all the answers

Quel est le rôle des facteurs plasmatiques/recombinants classifiés en 5 catégories?

<p>Amélioration de la coagulation sanguine (A)</p> Signup and view all the answers

Quels sont les principaux effets indésirables observés avec certains MDS (médicaments dérivés du sang)?

<p>Nausées, fièvre, vomissements, réactions cutanées allergiques, myalgie. (B)</p> Signup and view all the answers

Quels sont les principaux composants fractionnés du plasma sanguin?

<p>Fibrinogène, albumine, facteurs de coagulation. (C)</p> Signup and view all the answers

Quel est le principal objectif de la Loi 93-5 du 4 janvier 1993?

<p>Assurer la fabrication sécurisée des produits dérivés du sang (A)</p> Signup and view all the answers

Quel est le rôle des facteurs de coagulation plasmatiques/recombinants classifiés en 5 catégories?

<p>Contribuer à la fabrication des médicaments dérivés du sang (A)</p> Signup and view all the answers

Quelle est l'indication appropriée pour l'utilisation du PPSB (Complexe prothrombique humain)?

<p>Carence en facteur II (C)</p> Signup and view all the answers

Quel est le rôle principal de l'albumine endogène dans le plasma sanguin?

<p>Maintenir la pression oncotique dans les vaisseaux sanguins (C)</p> Signup and view all the answers

Quel est le principal risque associé à un taux de fibrinogène circulant au-delà de 2g/L?

<p>Thrombose (B)</p> Signup and view all the answers

Quelle est l'indication appropriée pour l'utilisation du Fibrinogène humain (Clottafact urgence)?

<p>Hémorragie sévère chez les patients sous anticoagulants (C)</p> Signup and view all the answers

Quelle est la responsabilité du pharmacien hospitalier concernant les MDS (médicaments dérivés du sang)?

<p>Assurer la pharmacovigilance des MDS (A)</p> Signup and view all the answers

Quel est le rôle des correspondants de pharmacovigilance MDS selon le Décret 95-566 du 6 mai 1995?

<p>Surveiller les effets indésirables des MDS chez les patients (C)</p> Signup and view all the answers

Que représente le code-barre sur les étiquettes de traçabilité?

<p>Le numéro de lot du médicament dérivé du sang (A)</p> Signup and view all the answers

Quel est le principal critère pour la conservation des médicaments dérivés du sang?

<p>La durée maximale de conservation autorisée par lot (B)</p> Signup and view all the answers

Quelle est l'utilité principale des étiquettes de traçabilité avec code-barre sur les boîtes de médicaments dérivés du sang?

<p>Favoriser l'identification rapide et précise des médicaments dérivés du sang dans une pharmacie hospitalière. (D)</p> Signup and view all the answers

Quel est l'objectif principal de la Loi 93-5 du 4 janvier 1993?

<p>Assurer la sécurité de la fabrication des produits dérivés du sang (D)</p> Signup and view all the answers

Quel est le rôle des correspondants de pharmacovigilance MDS selon le Décret 95-566 du 6 mai 1995?

<p>Pharmaciens responsables de la sécurité des médicaments dérivés du sang (A)</p> Signup and view all the answers

Qu'est-ce que la traçabilité descendante vise à identifier?

<p>Les patients ayant reçu un médicament dérivé du sang (C)</p> Signup and view all the answers

Quel est l'un des rôles de l'albumine endogène dans le plasma sanguin?

<p>Transport de nutriments et de déchets métaboliques (B)</p> Signup and view all the answers

Quelle est l'utilisation thérapeutique principale du Fibrinogène humain?

<p>Traitement des hémorragies sévères chez les patients atteints d'hémophilie (C)</p> Signup and view all the answers

Quel est le principal critère pour la conservation des médicaments dérivés du sang?

<p>Degré d'intégrité et d'activité biologique des composants sanguins (B)</p> Signup and view all the answers

Qu'est-ce que la pharmacovigilance ascendante implique?

<p>Traçabilité ascendante des dons à partir desquels ont été fabriqué un lot donné de MDS (A)</p> Signup and view all the answers

Quelle est l'utilité principale des étiquettes de traçabilité avec code-barre sur les boîtes de médicaments dérivés du sang?

<p>Identification rapide des lots en cas d'urgence médicale (B)</p> Signup and view all the answers

Qu'est-ce que la traçabilité descendante vise à identifier?

<p>Les patients ayant reçu un médicament dérivé du sang (B)</p> Signup and view all the answers

Quelle méthode est utilisée pour produire plusieurs lots de médicaments différents?

<p>Fractionnement par filtration membranaire du plasma sanguin (D)</p> Signup and view all the answers

Quel est le rôle principal de l'albumine endogène dans le plasma sanguin?

<p>Liaison et transport de molécules (C)</p> Signup and view all the answers

Quelle est l'indication appropriée pour l'utilisation de l'albumine 20%?

<p>Remplissage vasculaire en réanimation (A)</p> Signup and view all the answers

Quelle est l'indication appropriée pour l'utilisation du PPSB (Complexe prothrombique humain)?

<p>Déficit global et sévère en facteurs vitamine K-dépendants (D)</p> Signup and view all the answers

Quel est le rôle des facteurs plasmatiques/recombinants classifiés en 5 catégories?

<p>Traitement des troubles de la coagulation (C)</p> Signup and view all the answers

Quel est le rôle des correspondants de pharmacovigilance MDS selon le Décret 95-566 du 6 mai 1995?

<p>Surveiller et rapporter les effets indésirables des médicaments dérivés du sang (D)</p> Signup and view all the answers

Quel est le principal risque associé à un taux de fibrinogène circulant au-delà de 2g/L?

<p>Complications thrombo-emboliques (B)</p> Signup and view all the answers

Quelle est la méthode de fractionnement du plasma sanguin utilisée pour produire plusieurs lots de médicaments différents?

<p>Fractionnement par précipitations successives des protéines (B)</p> Signup and view all the answers

Quel est le rôle des facteurs de coagulation plasmatiques/recombinants classifiés en 5 catégories?

<p>Traitement des troubles liés à la coagulation sanguine (D)</p> Signup and view all the answers

Quel est l'un des rôles de l'albumine endogène dans le plasma sanguin?

<p>Capteur de radicaux libres et propriétés antioxydantes (A)</p> Signup and view all the answers

Quel est le principal objectif de la traçabilité ascendante?

<p>Identifier l'origine des composants fractionnés du plasma sanguin (C)</p> Signup and view all the answers

Quelle est l'utilité principale des étiquettes de traçabilité avec code-barre sur les boîtes de médicaments dérivés du sang?

<p>Suivre l'administration des médicaments dérivés du sang aux patients (B)</p> Signup and view all the answers

Flashcards

What is the main function of albumin in plasma?

Albumin's primary role in blood plasma is to maintain the oncotic pressure, which helps regulate the movement of fluids between blood vessels and surrounding tissues.

What is Albumin 20% used for?

Albumin 20% is used to treat severe burns, as it helps to restore blood volume and prevent fluid loss.

What is the most frequent side effect of blood-derived medications?

Headaches are a common side effect of some blood-derived medications, possibly due to reactions within the body.

What risk is associated with high fibrinogen levels?

A fibrinogen level higher than 2 g/L increases the risk of developing blood clots, potentially leading to serious complications.

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What is Human Fibrinogen used for?

Human fibrinogen is primarily used to treat severe bleeding, especially when a clotting factor deficiency exists.

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What is the function of plasma-derived clotting factors?

Plasma-derived or recombinant clotting factors, grouped into five categories, play a crucial role in the coagulation cascade process.

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How is plasma fractionated to produce various medications?

Fractionation of plasma involves various steps, but the primary method used to create many different medications is the gradual precipitation of proteins through controlled cooling and pH manipulation.

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What is the most important factor for storing blood-derived medications?

Blood-derived medications should be kept at a temperature range of 2 to 8 degrees Celsius to preserve their effectiveness and prevent degradation.

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What is PPSB used for?

PPSB, or human prothrombin complex, is used to treat severe deficiencies in Vitamin K-dependent clotting factors when an overdose of anticoagulant medication has occurred.

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What risk is associated with high fibrinogen levels?

High levels of fibrinogen in the bloodstream increase the risk of blood clots forming, known as thromboembolic complications.

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What is Human Fibrinogen (Clottafact urgency) used for?

Human fibrinogen, specifically Clottafact urgency, is a vital treatment for severe bleeding episodes.

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What are the most common side effects of blood-derived medications?

Common side effects associated with blood-derived medications include headaches, fever, nausea, vomiting, chills, allergic skin reactions, and muscle aches.

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What is the purpose of Law 93-5?

Law 93-5, implemented in 1993, is designed to regulate the manufacturing processes of blood-derived products.

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What is the responsibility of hospital pharmacists regarding blood-derived medications?

Hospital pharmacists play a crucial role in ensuring the traceability and pharmacovigilance of blood-derived medications, which involves tracking and monitoring their use and effects.

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What is the goal of upward traceability?

The goal of upward traceability is to pinpoint the specific blood donations used to produce a particular batch of blood-derived medications.

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What is the role of pharmacovigilance correspondents?

Pharmacovigilance correspondents, as outlined in Decree 95-566, are responsible for communicating with pharmacists regarding the manufacturing processes of blood-derived medications.

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What does downward traceability identify?

Downward traceability aims to identify all batches of blood-derived medications that were produced from a specific blood donation, whether they are in stock or have been administered to patients.

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What information related to traceability is kept for 40 years?

Traceability information, such as labels, must be kept for a minimum of 40 years to ensure transparency and accountability.

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What is the barcode on traceability labels?

The barcode on traceability labels represents the unique CIP code of the blood-derived medication, facilitating identification and tracking.

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What is the main role of albumin in plasma?

Endogenous albumin plays a critical role in binding and transporting molecules throughout the body, contributing to various essential functions.

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What is Human Fibrinogen (Clottafact urgency) used for?

Human fibrinogen (Clottafact urgency) is employed to treat critical bleeding episodes, particularly in patients undergoing anticoagulant therapy.

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What risk is associated with high fibrinogen levels?

Elevated levels of fibrinogen in the blood directly contribute to the formation of blood clots, known as thrombosis.

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What is the main method of plasma fractionation?

Plasma fractionation is a complex process that utilizes various methods, but the most common technique involves successive precipitations of proteins to isolate different components.

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What is the crucial aspect of storing blood-derived medications?

Maintaining a refrigerated temperature is essential for preserving the quality and effectiveness of blood-derived medications.

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What is another role of albumin in plasma?

In addition to its role in fluid balance, albumin also acts as a protector against harmful free radicals in the bloodstream, contributing to overall health.

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What is the most common side effect associated with blood-derived medications?

Nausea is a frequent side effect experienced by individuals taking blood-derived medications.

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What is the main goal of Law 93-5?

Law 93-5, enacted in 1992, is designed to ensure the complete traceability of blood-derived medications, guaranteeing their safe and controlled use.

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What is the role of clotting factors?

Plasma-derived or recombinant clotting factors play a vital role in promoting and enhancing the coagulation process, halting bleeding episodes.

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What are the most common side effects of blood-derived medications?

Common side effects associated with blood-derived medications include nausea, fever, vomiting, allergic skin reactions, and muscle aches.

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What are the main components fractionated from plasma?

Key components separated from plasma include fibrinogen, albumin, and coagulation factors, each playing vital roles in maintaining blood health.

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What is the main objective of Law 93-5?

Law 93-5, enacted in 1993, aims to guarantee the safe and controlled production of all blood-derived products, prioritizing patient safety.

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What is the role of clotting factors in blood-derived medication production?

Plasma-derived clotting factors, classified into five categories, play a crucial role in the production of blood-derived medications.

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What is PPSB used for?

PPSB, or human prothrombin complex, is essential for treating deficiencies in Factor II, a crucial clotting factor, often stemming from anticoagulant treatment complications.

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What is the main function of albumin in plasma?

Albumin's primary role in plasma is to help regulate the fluid pressure within blood vessels, which is crucial for proper blood circulation and tissue health.

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What risk is associated with high fibrinogen levels?

High levels of fibrinogen contribute directly to the formation of blood clots, which can block blood vessels and lead to serious health problems.

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What is Human Fibrinogen (Clottafact urgency) used for?

Human fibrinogen, especially Clottafact urgency, is used to treat severe bleeding episodes, particularly in patients who are on anticoagulant medications.

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What is the responsibility of hospital pharmacists regarding blood-derived medications?

Hospital pharmacists are responsible for ensuring the safety and effective use of blood-derived medications by monitoring their usage and any adverse effects.

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What is the role of pharmacovigilance correspondents?

Pharmacovigilance correspondents, as outlined in the decree, play a crucial role in monitoring adverse effects (side effects) of blood-derived medications in patients, contributing to medication safety.

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What does the barcode on traceability labels represent?

The barcode on traceability labels represents the unique lot number of the blood-derived medication, allowing for quick and accurate identification.

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What is the main criterion for storing blood-derived medications?

The primary criterion for storing blood-derived medications is the maximum shelf life allowed for each specific lot, ensuring its viability and effectiveness.

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What is the main utility of traceability labels with barcodes on blood-derived medication boxes?

The barcode on traceability labels attached to blood-derived medication boxes allows for swift and precise identification of these medications within a hospital pharmacy, particularly in urgent situations.

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What is the main objective of Law 93-5?

Law 93-5, enacted in 1993, primarily addresses the manufacturing process of blood-derived products, aiming to ensure the safety and quality of these essential medications.

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What is the role of pharmacovigilance correspondents?

Pharmacovigilance correspondents, as outlined in the decree, are pharmacists who are specifically tasked with ensuring the safe and effective use of blood-derived medications, acting as guardians of patient health.

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What does downward traceability identify?

Downward traceability aims to identify all individuals who have received a specific blood-derived medication, ensuring complete transparency in the blood product supply chain.

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What is another role of albumin in plasma?

Albumin plays an important role in transporting nutrients throughout the body, delivering them to cells, and also helps remove waste products from the bloodstream.

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What is the main therapeutic use of Human Fibrinogen?

Human fibrinogen is a critical treatment for severe bleeding events, especially in patients with hemophilia, who often experience a deficiency in clotting factors.

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What is the main criterion for storing blood-derived medications?

The most important criterion for storing blood-derived medications is to ensure that the biological activity of the blood components remains intact and effective throughout the storage period.

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What does upward pharmacovigilance involve?

Upward pharmacovigilance involves tracing blood products back to the original donations, ensuring the safety of the blood donation process and the manufacturing of blood-derived medications.

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What is the main utility of traceability labels with barcodes on blood-derived medication boxes?

The traceability labels with barcodes on blood-derived medication boxes allow for quick and accurate identification of specific lots in emergency situations, ensuring efficient and effective medication administration.

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What is the main objective of Law 93-5?

The main objective of Law 93-5 is to prioritize the safety and quality of the entire blood-derived product manufacturing process, assuring the safety of patients.

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