6C21-10

34-1020/R3
SYSTEM
FINALIDAD DE USO FINALIT D’USO

Total ␤-hCG
Los controles ARCHITECT Total <-hCG se utilizan para la verificaci6n de la exactitud y la precisi6n del sistema I controlli ARCHITECT <-hCG totale vengono utilizzati per la verifica dell’accuratezza e della precisione del Sistema
ARCHITECT i en la determinaci6n cuantitativa y cualitativa de gonadotropina cori6nica humana fracci6n beta (<-hCG) en ARCHITECT i nella determinazione quantitativa e qualitativa della subunitA beta della gonadotropina corionica umana
suero y plasma humanos. Si desea mWs informaci6n, consulte el prospecto del ensayo ARCHITECT correspondiente. (<-hCG) in campioni di siero e plasma umano. Per specifiche piE dettagliate, fare riferimento al relativo foglietto
illustrativo ARCHITECT.
CONTENIDO
3 frascos (8 ml cada uno) de controles ARCHITECT Total <-hCG que contienen hCG preparada en suero humano sin CONTENUTO
reactividad para el HBsAg ni de anticuerpos antiVHC ni VIH-1/VIH-2. Conservante: azida s6dica. 3 flaconi (8 ml ciascuno) di controlli ARCHITECT <-hCG totale contenenti hCG preparata in siero umano, non reattivo per
Los intervalos de concentraci6n siguientes se pueden utilizar para las especificaciones de los replicados individuales l’HBsAg e per gli anticorpi anti-HCV e anti-HIV-1/HIV-2. Conservante: Sodio azoturo.
de estos controles en el sistema ARCHITECT: I seguenti range possono essere utilizzati come specifiche del controllo analizzato in singolo sul Sistema ARCHITECT:

Concentraci6n esperada/ Concentraci6n esperada/ Concentrazione prevista/Range Concentrazione prevista/Range

Control intervalo mIU/ml intervalo IU/I Controllo mIU/ml IU/l
25
750
16 - 34
488 -1 013
25
750
16 - 34
488 -1 013
25
750
16 - 34
488 - 1013
25
750
16 - 34
488 - 1013
Controls
5 000 3 250 -6 750 5 000 3 250 -6 750 5000 3250 - 6750 5000 3250 - 6750
Cada laboratorio debe establecer sus propios intervalos de concentraci6n aceptable para cada lote de controles y para
todos los niveles de los controles. Para ello, se debe analizar un mXnimo de 20 replicados durante varios dXas (de 3 a 5
Ogni laboratorio deve stabilire i propri range di concentrazione per nuovi lotti dei controlli analizzando ciascun livello
come minimo in replicato di 20 per diversi (3-5) giorni. Per essere rappresentativo della futura prestazione del sistema, lo
Kontrollen / Contr les
dXas). Entre las causas de variaciones que se pueden dar y que se deben incluir en este estudio para que sea
representativo del funcionamiento futuro del sistema se incluyen:
studio deve tenere conto delle cause di eventuali variabili, tra cui le seguenti:
• Calibrazioni multiple memorizzate Controles / Controlli
• M"ltiples calibraciones almacenadas • Lotti multipli di reagenti
• M"ltiples lotes de reactivos • Lotti multipli di calibratori
• M"ltiples lotes de calibradores • Moduli multipli di analisi
• M"ltiples m6dulos de procesamiento • Dati raccolti in diversi momenti della giornata
• Datos recogidos en diversos momentos del dXa Questi risultati devono essere inclusi nelle procedure di controllo di qualitA vigenti nel proprio laboratorio.
Estos resultados se deben utilizar en los procesos de control de calidad de su laboratorio.
STANDARDIZZAZIONE
ESTANDARIZACIN La concentrazione dei controlli O calcolata utilizzando calibratori standardizzati in base al Terzo Standard Internazionale
La concentraci6n de los controles se eval"a a trav s de calibradores que se correlacionan con el tercer patr6n WHO 75/537 per la <-hCG.
internacional (3rd IS 75/537) para <-hCG de la Organizaci6n Mundial de la Salud (OMS).
PRECAUZIONI
PRECAUCIONES • Per uso diagnostico in vitro.
• Para uso en diagn6stico in vitro. • Se trattati e conservati secondo le istruzioni, i controlli ARCHITECT <-hCG totale si mantengono stabili fino alla data
• Si se almacenan y se manejan seg"n las instrucciones, los controles ARCHITECT Total <-hCG se mantienen di scadenza. Non usare oltre tale data.
estables hasta la fecha de caducidad. No se deben utilizar transcurrida dicha fecha. Key to symbols used
• ATTENZIONE: Questo prodotto contiene componenti di origine umana e/o potenzialmente infettivi. Per Erluterung der verwendeten Symbole/Lgende des symboles utiliss/
• ATENCIN: este producto contiene componentes de origen humano y/o potencialmente infecciosos. Si desea un’elencazione specifica, fare riferimento alla sezione “Contenuto” del presente foglietto illustrativo. Nessuno dei
una enumeraci6n mWs detallada consulte el apartado “Contenido” de este prospecto. Al no existir m todos de anWlisis metodi analitici conosciuti puS garantire in modo assoluto che prodotti di origine umana o derivati da microrganismi Clave de los smbolos utilizados/Legenda dei simboli utilizzati
que garanticen la inocuidad de materiales de origen humano o de microorganismos inactivados, todos los materiales inattivati non possano trasmettere infezioni. Pertanto tutti i materiali di origine umana devono essere considerati
de origen humano se deben considerar potencialmente infecciosos. Maneje los reactivos y las muestras de origen potenzialmente infettivi. Si raccomanda di trattare i reagenti ed i campioni dei pazienti in accordo con quanto
humano de acuerdo con las instrucciones espedificadas en la publicaci6n “OSHA Standard on Bloodhorne descritto nella pubblicazione OSHA Standard relativa agli agenti patogeni di origine ematica.1 I materiali contenenti o List Number / Nr. / R f rence / N"mero de Expiration Date / Verwendbar bis / Date d’expiration
Pathogens”. En el caso de materiales que contengan o que pudieran contener agentes infecciosos, se deben seguir sospettati di contenere agenti infettivi devono essere trattati in accordo con quanto descritto nella pubblicazione referencia / Numero di listino Fecha de caducidad / Data di scadenza
las prWcticas de seguridad biol6gica “Biosafety Level 2” u otras normativas equivalentes.3,4 Biosafety Level 2,2 o linee guida equivalenti.3-4
For In Vitro Diagnostic Use /
• Los controles contienen azida s6dica como conservante. Para informaci6n sobre la eliminaci6n correcta de los • I controlli contengono sodio azoturo come conservante. Per informazioni sullo smaltimento dei materiali contenenti In-vitro-Diagnostikum / Pour diagnostic in vitro / Lot Number / Ch.-B./ Num ro de lot
materiales que contienen azida s6dica, consulte el capXtulo 8 del Manual de Operaciones del sistema ARCHITECT. sodio azoturo in conformitA alle norme di sicurezza, fare riferimento alla sezione 8 del Manuale operativo del sistema Para uso en diagn6stico in vitro / N"mero de lote / Numero di lotto
ARCHITECT. Per uso diagnostico in vitro
• Los componentes de este producto contienen azida s6dica y han sido clasificados seg"n las directivas de la
Comunidad Europea (CE) como: nocivo (Xn). A continuaci6n se indican las frases relativas a los riesgos (R) y • I componenti di questo prodotto contengono sodio azoturo e sono classificati secondo le direttive della ComunitA Control Low, Medium, High (L, M, H)
CAUTION: Handle human sourced materials as
medidas de seguridad (S). Europea (CE) nel modo seguente: Nocivo (Xn). Qui di seguito sono elencate le frasi appropriate relative ai rischi (R) Kontrolle Niedrig, Mittel, Hoch (L, M, H)
potentially infectious. Consult instructions for
Contr*le bas, moyen, haut (L, M, H)
R22 Nocivo por ingesti6n. ed alle misure di sicurezza (S). use. (Infection Risk) / ACHTUNG:
Control bajo, medio, alto (L, M, H)
Humanmaterial gilt als potentiell infekti;s und
R32 En contacto con Wcidos libera gases muy t6xicos. R22 Nocivo per ingestione. Controllo basso, medio, alto (L, M, H)
mu< mit der entsprechenden Vorsicht
S35 ElimXnense los residuos del producto y sus recipientes con todas las precauciones posibles. R32 A contatto con acidi libera gas molto tossico. gehandhabt werden. Siehe Packungsbeilage
S36 Ysese indumentaria protectora adecuada. S35 Non disfarsi del prodotto e del recipiente se non con le dovute precauzioni. (Infektionsrisiko) / ATTENTION : Manipuler les
S46 En caso de ingesti6n, acuda inmediatamente al m dico y mu strele la etiqueta o el envase. Authorized Representative
S36 Usare indumenti protettivi adatti. produits d’origine humaine comme s’ils taient Bevollm0chtigter / Mandataire
S46 In caso d’ingestione consultare immediatamente il medico e mostrargli il contenitore o potentiellement infectieux. Consulter les Representante autorizado
l’etichetta. instructions d’utilisation. (Risque d’infection) / Mandatario
ATENCI?N: Maneje los productos de origen
humano como potencialmente infecciosos.
Almacnese entre 2 °C y 8 °C Consulte las instrucciones de uso.(Riesgo de Legal Manufacturer
infecci6n) / ATTENZIONE:Trattare i materiali Hersteller
BIBLIOGRAFA Conservare a 2-8 °C di origine umana come potenzialmente infettivi. Fabricant
Consultare le istruzioni per l’uso. Fabricante legal
1. US Department of Labor, Occupational Safety and Health Administration, 29 CFR Part 1910.1030, Occupational (Rischio di infezione)
Exposure to Bloodborne Pathogens; Final Rule. Federal Register 1991;56(235):64175-82. BIBLIOGRAFIA Fabbricante

2. US Department of Health and Human Services. Biosafety in Microbiological and Biomedical Laboratories. HHS 1. US Department of Labor, Occupational Safety and Health Administration, 29 CFR Part 1910.1030, Occupational Store at / Lagerung bei
Publication No. (CDC)93-8395. Washington, DC: US Government Printing Office, May 1999. Exposure to Bloodborne Pathogens; Final Rule. Federal Register 1991;56(235):64175-82. Conserver A / Almac nese entre
3. World Health Organization. Laboratory Biosafety Manual. Geneva: World Health Organization, 1993. 2. US Department of Health and Human Services. Biosafety in Microbiological and Biomedical Laboratories. HHS Conservare a 2-8°C
4. National Committee for Clinical Laboratory Standards. Protection of Laboratory Workers from Instrument Biohazards Publication No. (CDC)93-8395. Washington, DC: US Government Printing Office, May 1999.
and Infectious Disease Transmitted by Blood, Body Fluids, and Tissue: Approved Guideline. NCCLS Document 3. World Health Organization. Laboratory Biosafety Manual. Geneva: World Health Organization, 1993.
M29-A. Wayne (PA): NCCLS, 1997. 4. National Committee for Clinical Laboratory Standards. Protection of Laboratory Workers from Instrument Biohazards
and Infectious Disease Transmitted by Blood, Body Fluids, and Tissue: Approved Guideline. NCCLS Document ABBOTT
M29-A. Wayne (PA): NCCLS, 1997. Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580 ©2002, Abbott Laboratories

6C21-1C-10_Multilingual.p65 1 10/25/2002, 3:15 PM

COMMONPLATE NONE
COLOR: PMS 329 CVC
SIZE: 14” x 8.5”
SIZE: 12.59 x 35.56 cm
CONTROL VERSION 2 TEMPLATE, Human-Sourced Controls
Template: archconins2 R2
 INTENDED USE VERWENDUNGSZWECK DOMAINE D’APPLICATION
The ARCHITECT Total ␤-hCG Controls are for the verification of the accuracy and precision of the ARCHITECT i System Die ARCHITECT Gesamt-<-hCG Kontrollen dienen zur Zberpr[fung der Genauigkeit und Pr0zision des ARCHITECT i Les contr*les ARCHITECT ␤-hCG totale sont utilis s pour la v rification de l’exactitude et de la reproductibilit du
when used for the quantitative and qualitative determination of beta human chorionic gonadotropin (␤-hCG) in human Systems bei der quantitativen Bestimmung oder dem qualitativen Nachweis von humanem Beta-Choriongonadotropin in systOme ARCHITECT i lors de la d termination quantitative et qualitative de la gonadotrophine chorionique humaine
serum and plasma. Refer to the ARCHITECT assay-specific reagent package insert for additional information. Humanserum und -plasma. Weitere Informationen entnehmen Sie bitte der entsprechenden ARCHITECT (mol cule entiOre et sous-unit s b]ta libres) dans le s rum ou le plasma humain. Pour de plus amples informations, se
Packungsbeilage. r f rer A la notice du dosage.
CONTENTS
3 Bottles (8 mL each) of ARCHITECT Total ␤-hCG Controls contain hCG prepared in human serum nonreactive for HBsAg INHALT COMPOSITION
and antibodies to HCV and HIV-1/HIV-2. Preservative: Sodium Azide. 3 Fl0schchen (je 8 ml) ARCHITECT Gesamt-<-hCG Kontrollen enthalten hCG in Humanserum, nicht reaktiv f[r HBsAg und 3 flacons (8 ml chacun) de contr*les ARCHITECT ␤-hCG totale contenant de l’hCG pr par e dans du s rum humain non
The following concentration ranges may be used for individual replicate control specifications on the ARCHITECT Antik;rper gegen HCV und HIV-1/HIV-2. Konservierungsmittel: Natriumazid. r actif pour l’AgHBs et les anticorps anti-VHC et anti-VIH-1/VIH-2. Conservateur : Azide de sodium.
System: Die folgenden Konzentrationsbereiche k;nnen f[r das ARCHITECT System als Kontrollspezifikationen f[r Les limites de concentration suivantes peuvent servir de sp cifications pour chaque r plique des contr*les sur le
Einzelbestimmungen verwendet werden: systOme ARCHITECT:
Target Concentration/Range Target Concentration/Range
Control mIU/mL IU/L Richtkonzentration/ Bereich Richtkonzentration/ Bereich Concentration cible / Limites Concentration cible / Limites
Kontrolle mIU/ml IU/l Contr*le mIU/ml IU/l
25 16 - 34 25 16 - 34
750 488 - 1013 750 488 - 1013 25 16 - 34 25 16 - 34 25 16 A 34 25 16 A 34
5000 3250 - 6750 5000 3250 - 6750 750 488 - 1013 750 488 - 1013 750 488 A 1013 750 488 A 1013
5000 3250 - 6750 5000 3250 - 6750 5000 3250 A 6750 5000 3250 A 6750
Each laboratory should establish its own concentration ranges for new control lots at each control level. This can be
accomplished by assaying a minimum of 20 replicates over several (3-5) days. Sources of variation that can be expected Jedes Labor sollte seine eigenen Konzentrationsbereiche f[r neue Kontrollchargen und jede Kontrollkonzentration durch Chaque laboratoire doit tablir ses propres limites de concentration pour chaque contr*le provenant d’un nouveau lot.
should be included in this study in order to be representative of future system performance. These may include: mindestens Zwanzigfachbestimmung [ber mehrere (3 - 5) Tage hinweg bestimmen. Die Ursachen f[r m;gliche Variationen Ceci peut ]tre effectu en analysant un minimum de 20 r pliques sur plusieurs jours (3 A 5). Cette tude devra prendre en
• Multiple stored calibrations sollten in dieser Untersuchung ber[cksichtigt werden, damit sie repr0sentativ f[r die k[nftige Leistung des Systems ist. compte les sources de variation potentielles afin de rendre compte de la future performance du systOme. Ces variations
Dies k;nnen folgende Ursachen sein: peuvent ]tre dues entre autres aux facteurs suivants :
• Multiple reagent lots
• Mehrfach gespeicherte Kalibrierungen • Calibrations m moris es multiples
• Multiple calibrator lots
• Verschiedene Reagenzienchargen • Lots de r actifs multiples
• Multiple processing modules
• Verschiedene Kalibratorchargen • Lots de calibrateurs multiples
• Data points collected at different times of the day
• Mehrfach-Bearbeitungsmodule • Modules de traitement multiples
These results should be applied to your laboratory’s quality control practices.
• Datenpunkte von verschiedenen Zeitpunkten des Tages • Donn es obtenues A diff rents moments de la journ e
STANDARDIZATION Diese Ergebnisse sollten in die Verfahren zur Qualit0tskontrolle Ihres Labors eingehen. Ces r sultats doivent ]tre utilis s pour le contr*le de qualit dans votre laboratoire.
The concentration of the controls are evaluated using calibrators referenced to the World Health Organization (W.H.O.)
3rd International Standard 75/537 for ␤-hCG. STANDARDISIERUNG STANDARDISATION
Die Kontrollkonzentrationen wurden mittels Kalibratoren [berpr[ft, die auf den “3rd International Standard 75/537” der La concentration des contr*les est valu e A l’aide de calibrateurs correspondant au 3Ome Standard International de
PRECAUTIONS Weltgesundheitsorganisation (WHO) f[r <-hCG eingestellt sind. l’Organisation Mondiale de la Sant (OMS) 75/537 relatif A la ␤-hCG.
• For In Vitro Diagnostic Use.
VORSICHTSMASSNAHMEN PRECAUTIONS
• ARCHITECT Total ␤-hCG Controls are stable until the expiration date when stored and handled as directed. Do not use
past expiration date. • In-vitro-Diagnostikum. • Pour diagnostic in vitro.
• Die ARCHITECT Gesamt-<-hCG Kontrollen sind bis zum Verfallsdatum haltbar, sofern sie vorschriftsgem0< gelagert • Les contr*les ARCHITECT ␤-hCG totale sont stables jusqu’A la date d’expiration s’ils sont conserv s et manipul s
und gehandhabt werden. Nicht [ber das Verfallsdatum hinaus verwenden. selon les indications du fabricant. Ne pas utiliser au-delA de la date d’expiration.
• CAUTION: This product contains human sourced and/or potentially infectious components. For a specific
listing, refer to the CONTENTS section of this package insert. No known test method can offer complete assurance
that products derived from human sources or inactivated microorganisms will not transmit infection. Therefore, all • ACHTUNG: Dieses Produkt enth0lt Humanmaterial und/oder potentiell infekti;se Komponenten. Eine • ATTENTION : Ce produit contient des composants d’origine humaine et/ou potentiellement infectieux. Se
human sourced materials should be considered potentially infectious. It is recommended that these reagents and detaillierte Auflistung entnehmen Sie bitte dem Abschnitt “Inhalt” in dieser Packungsbeilage. Keine derzeit bekannte r f rer au paragraphe “Composition” de cette notice pour une liste d taill e. Aucune des m thodes d’analyse
human specimens be handled in accordance with the OSHA Standard on Bloodborne Pathogens1. Biosafety Level 22 Testmethode kann mit absoluter Sicherheit ausschlie<en, da< Infektionen durch Humanmaterial oder inaktivierte actuellement connues ne peut garantir de fa^on absolue que les composants d’origine humaine ou d riv s de
or other appropriate biosafety practices3,4 should be used for materials that contain or are suspected of containing Mikroorganisamen [bertragen werden k;nnen. Daher gelten alle Humanproben und Reagenzien als potentiell infekti;s microorganismes inactiv s ne transmettront pas d’infections. En cons quence, tous les mat riaux d’origine humaine
infectious agents. und m[ssen gem0< den entsprechenden Sicherheitsvorschriften gehandhabt werden.1-4 devront ]tre consid r s comme potentiellement infectieux. Il est recommand de manipuler ces r actifs et les
• Controls contain sodium azide as a preservative. For information on safe disposal of sodium azide containing • Die Kontrollen enthalten Natriumazid als Konservierungsmittel. Weitere Informationen zur sicheren Entsorgung chantillons humains selon les rOgles “OSHA Standard on Bloodborne Pathogens”.1 Les mat riaux contenant ou
materials, refer to the ARCHITECT System Operations Manual, Section 8. Natriumazid-haltiger Materialien entnehmen Sie bitte Kapitel 8 der ARCHITECT Bedienungsanleitung. susceptibles de contenir des agents infectieux doivent ]tre manipul s selon les rOgles biologiques de s curit de
niveau 22 ou autres rOgles biologiques en vigueur.3,4
• Components of this product contain sodium azide and are classified per applicable European Community (EC) • Die Komponenten dieses Produktes enthalten Natriumazid und werden gem0< den Richtlinien der Europ0ischen
Directives as: Harmful (Xn). The following are the appropriate Risk (R) and Safety (S) phrases. Gemeinschaft (EG) wie folgt eingestuft: Gesundheitssch0dlich (Xn). Nachfolgend sind die entsprechenden Risiko- (R) • Les contr*les contiennent de l’azide de sodium comme conservateur. Pour de plus amples informations sur
R22 Harmful if swallowed. und Sicherheitss0tze (S) aufgef[hrt. l’ limination appropri e des produits contenant de l’azide de sodium, se r f rer au chapitre 8 du Manuel Technique
R32 Contact with acids liberates very toxic gas. R22 Gesundheitssch0dlich beim Verschlucken.
ARCHITECT.
S35 This material and its container must be disposed of in a safe way. R32 Entwickelt bei Ber[hrung mit S0ure sehr giftige Gase. • Les composants de ce produit contiennent de l’azide de sodium et sont classifi s, selon les directives de la
S36 Wear suitable protective clothing. S35 Abf0lle und Beh0lter m[ssen in gesicherter Weise beseitigt werden. Communaut Europ enne (CE), comme : nocifs (Xn). La nature des risques particuliers (R) et les conseils de
S46 If swallowed, seek medical advice immediately and show this container or label. S36 Bei der Arbeit geeignete Schutzkleidung tragen. prudence (S) attribu s aux pr parations dangereuses sont les suivants :
S46 Bei Verschlucken sofort 0rztlichen Rat einholen und Verpackung oder Etikett vorzeigen. R22 Nocif en cas d’ingestion.
R32 Au contact d’un acide, d gage un gaz trOs toxique.
S35 Ne se d barrasser de ce produit et de son r cipient qu’en prenant toutes pr cautions d’usage.
S36 Porter un v]tement de protection appropri .
Store at 2-8°C. S46 En cas d’ingestion, consulter imm diatement un m decin et lui montrer l’emballage ou
Lagerung bei 2 - 8 °C. l’ tiquette.
BIBLIOGRAPHY
1. US Department of Labor, Occupational Safety and Health Administration, 29 CFR Part 1910.1030, Occupational LITERATUR
Exposure to Bloodborne Pathogens; Final Rule. Federal Register 1991;56(235):64175-82. 1. US Department of Labor, Occupational Safety and Health Administration, 29 CFR Part 1910.1030, Occupational
2. US Department of Health and Human Services. Biosafety in Microbiological and Biomedical Laboratories. HHS Exposure to Bloodborne Pathogens; Final Rule. Federal Register 1991;56(235):64175-82.
Publication No. (CDC)93-8395. Washington, DC: US Government Printing Office, May 1999. 2. US Department of Health and Human Services. Biosafety in Microbiological and Biomedical Laboratories. HHS Conserver entre 2 et 8 °C
3. World Health Organization. Laboratory Biosafety Manual. Geneva: World Health Organization, 1993. Publication No. (CDC)93-8395. Washington, DC: US Government Printing Office, May 1999.
4. National Committee for Clinical Laboratory Standards. Protection of Laboratory Workers from Instrument Biohazards 3. World Health Organization. Laboratory Biosafety Manual. Geneva: World Health Organization, 1993. BIBLIOGRAPHIE
and Infectious Disease Transmitted by Blood, Body Fluids, and Tissue: Approved Guideline. NCCLS Document 4. National Committee for Clinical Laboratory Standards. Protection of Laboratory Workers from Instrument Biohazards 1. US Department of Labor, Occupational Safety and Health Administration, 29 CFR Part 1910.1030, Occupational
M29-A. Wayne (PA): NCCLS, 1997. and Infectious Disease Transmitted by Blood, Body Fluids, and Tissue: Approved Guideline. NCCLS Document Exposure to Bloodborne Pathogens; Final Rule. Federal Register 1991;56(235):64175-82.
M29-A. Wayne (PA): NCCLS, 1997. 2. US Department of Health and Human Services. Biosafety in Microbiological and Biomedical Laboratories. HHS
Publication No. (CDC)93-8395. Washington, DC: US Government Printing Office, May 1999.
3. World Health Organization. Laboratory Biosafety Manual. Geneva: World Health Organization, 1993.
4. National Committee for Clinical Laboratory Standards. Protection of Laboratory Workers from Instrument Biohazards
and Infectious Disease Transmitted by Blood, Body Fluids, and Tissue: Approved Guideline. NCCLS Document
M29-A. Wayne (PA): NCCLS, 1997.

6C21-1C-10_Multilingual.p65 2 10/25/2002, 3:15 PM