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by: ViiV Healthcare ViiV Healthcare GlaxoSmithKline GlaxoSmithKline Research Research Triangle Park, Triangle NC 27709 Park, NC 27709 Research Research Triangle Park, Triangle NC 27709 Park, NC 27709 TRM:3BRSTRM:3BRS Revised: September Revised: September 2015 2015 Lamivudine Lamivudine is manufactured is manufactured under agreement under agreement from Shirefrom Pharmaceuticals Shire Pharmaceuticals Group plc,Group Basingstoke, plc, Basingstoke, UK UK EPIVIR, EPZICOM, EPIVIR, EPZICOM, TIVICAY, TRIUMEQ, TIVICAY, TRIUMEQ, and ZIAGEN andare ZIAGEN registered are registered trademarks trademarks of the ViiVofHealthcare the ViiV Healthcare group of group of companies. companies. The other The brands other listed brands are trademarks listed are trademarks of their respective of their respective owners and owners are notandtrademarks are not trademarks of the ViiVofHealthcare the ViiV Healthcare group of companies. group of companies. The makers Theofmakers these brands of thesearebrands not affiliated are not with affiliated and do with notand endorse do notthe endorse ViiV Healthcare the ViiV Healthcare group of companies group of companies or its products. or its products. ©2016 ViiV ©2016 Healthcare ViiV Healthcare Healthcare groupof of group companies. companies. ©2015, ViiV ©2015, Healthcare ViiV group companies. group of of companies. Allrights rightsreserved. All reserved. rightsreserved. reserved. Printed inPrinted USA. in 629501R0 USA. 629501R0 February February 2016 2016 All All rights Printed inPrinted USA. [code in USA. TBD] [code [dateTBD] TBD] [date TBD] Traductora Médica Certificada Presidenta, Atabex Translations Ex-Catedrática Programa Graduado de Traducción, UPR cdiaz@atabextranslations.com 787.756.6763 Comprimido 1: Paro vs arresto Es posible que haya oído frases como estas: “el paciente se arrestó” o “el paciente tuvo un arresto respiratorio”. Sea cardiaco o respiratorio, el paciente no suf re un arresto, sino un paro. Recuerde, arrest en inglés y paro en español. Deje los arrestos a los oficiales de l y y orden. Comprimido 2: Virus vs viruses Son innumerables las veces que oímos usar el plural anómalo viruses en español. La razón: El inglés añade “es” para formar el plural del sustantivo singular virus. El español usa el artículo para marcar el singular o el plural: “el virus”, “los virus”. Pero aun si no lleva el artículo, virus en singular y virus en plural. Son muchos los virus que atacan al español, protéjase de este. Comprimido 3: Sistema inmunológico Por def inici n, inmunológico signif i a “perteneciente o relativo a la inmunología” y la inmunología es el “estudio de la inmunidad biológica y sus aplicaciones”. Si partimos del latín, el elemento compositivo “logo” signifi a 'versado' o 'especialista' en el elemento que lo antecede: por ejemplo, cardiólogo, inmunólogo y sus adjetivos, cardiológico e inmunológico, respectivamente. Por eso es más correcto hablar del “sistema inmunitario” pues inmunitario signifi a “perteneciente o relativo a la inmunidad”. No obstante, la amplia difusión y aceptación del término “sistema inmunológico” hace que muchas personas estén renuentes a corregirlo. ¡Usted decide! C. 4: Sistema inmune, enfermedad inmune ¿Alguna vez han pensado en la contradicción que representan frases como estas? Si el sistema fuera inmune nada lo afectaría. Si la enfermedad fuera inmune, no se podría combatir. En realidad, “inmune” en estos y otros casos es una traducción literal del inglés que se podría subsanar usando la frase preposicional “de inmunidad” o, mejor aún, el adjetivo inmunitario. Dígalo correctamente: Sistema inmunitario, enfermedad inmunitaria. 13856-57-Galenus int r1.indd 47 9/2/16 8:44 AM T:10.5” B:12” S:10” T:10.5” by: Carmen E. Díaz-Zayas, M.A. S:10” Manufactured Manufactured for: for: Comprimidos lingüísticos 47 NONCLINICAL NONCLINICAL TOXICOLOGY TOXICOLOGY Carcinogenesis, Carcinogenesis, Mutagenesis, Mutagenesis, Impairment Impairment of Fertility: of Fertility: Carcinogenicity: Carcinogenicity: Dolutegravir: Dolutegravir: Two-yearTwo-year carcinogenicity carcinogenicity studies instudies mice and in mice rats and wererats conducted were conducted with dolutegravir. with dolutegravir. Mice were Mice were administered administered doses of doses up to 500 of upmg to per 500kg, mgand perrats kg, and wererats administered were administered doses of doses up to 50 of up mgtoper 50 mg per kg. In mice, kg. Innomice, significant no significant increasesincreases in the incidence in the incidence of drug-related of drug-related neoplasms neoplasms were observed were observed at the highest at the highest doses tested, doses resulting tested, resulting in dolutegravir in dolutegravir AUC exposures AUC exposures approximately approximately 26-fold 26-fold higher than higher those than in humans those in at humans the recommended at the recommended dose of 50 dose mgofonce 50 mg daily. once In rats, daily.noInincreases rats, no increases in in the incidence the incidence of drug-related of drug-related neoplasms neoplasms were observed were observed at the highest at the dose highest tested, doseresulting tested, resulting in dolutegravir in dolutegravir AUC exposures AUC exposures 17-fold and 17-fold 30-fold and higher 30-foldinhigher malesinand males females, and females, respectively, respectively, than those thanin those humans in humans at the recommended at the recommended dose of 50 dosemgofonce 50 mg daily. once Abacavir: daily. Abacavir: AbacavirAbacavir was was administered administered orally atorally 3 dosage at 3 dosage levels tolevels separate to separate groups of groups mice ofand mice ratsand in rats 2-yearin 2-year carcinogenicity carcinogenicity studies. studies. Results Results showed showed an increase an increase in the incidence in the incidence of malignant of malignant and and non-malignant non-malignant tumors. Malignant tumors. Malignant tumors occurred tumors occurred in the preputial in the preputial gland of gland malesofand males the clitoral and the clitoral gland ofgland females of females of both species, of both species, and in the andliver in the of female liver of rats. female In addition, rats. In addition, non-malignant non-malignant tumors also tumors occurred also occurred in the liver in the andliver thyroid andgland thyroid of gland femaleofrats. female These rats.observations These observations were made were made at systemic at systemic exposures exposures in the range in theof range 7 to 28 of times 7 to 28thetimes human theexposure human exposure at the recommended at the recommended dose of 600 dosemg. of 600 Lamivudine: mg. Lamivudine: Long-term Long-term carcinogenicity carcinogenicity studies with studies lamivudine with lamivudine in mice and in mice rats and rats showed showed no evidence no evidence of carcinogenic of carcinogenic potentialpotential at exposures at exposures up to 12up times to 12(mice) timesand (mice) 57 times and 57 times (rats) the(rats) human the exposures human exposures at the recommended at the recommended dose of dose 300 mg. of 300 Mutagenicity: mg. Mutagenicity: Dolutegravir: Dolutegravir: Dolutegravir Dolutegravir was not genotoxic was not genotoxic in the bacterial in the bacterial reverse mutation reverse mutation assay, mouse assay,lymphoma mouse lymphoma assay, assay, or in the or inin vivo the inrodent vivo micronucleus rodent micronucleus assay. Abacavir: assay. Abacavir: AbacavirAbacavir induced induced chromosomal chromosomal aberrations aberrations both in the bothpresence in the presence and absence and absence of metabolic of metabolic activationactivation in an in vitro in ancytogenetic in vitro cytogenetic study in study humaninlymphocytes. human lymphocytes. AbacavirAbacavir was mutagenic was mutagenic in the absence in the absence of metabolic of metabolic activation, activation, althoughalthough it was not it was mutagenic not mutagenic in the presence in the presence of metabolic of metabolic activationactivation in an L5178Y in an L5178Y mouse mouse lymphoma lymphoma assay. Abacavir assay. Abacavir was clastogenic was clastogenic in malesinand males not and clastogenic not clastogenic in females in females in an in an in vivo mouse in vivo bone mousemarrow bone marrow micronucleus micronucleus assay. Abacavir assay. Abacavir was notwas mutagenic not mutagenic in bacterial in bacterial mutagenicity mutagenicity assays in assays the presence in the presence and absence and absence of metabolic of metabolic activation. activation. Lamivudine: Lamivudine: Lamivudine Lamivudine was mutagenic was mutagenic in an L5178Y in an L5178Y mouse lymphoma mouse lymphoma assay and assay clastogenic and clastogenic in a in a cytogenetic cytogenetic assay using assaycultured using cultured human lymphocytes. human lymphocytes. Lamivudine Lamivudine was notwas mutagenic not mutagenic in a in a microbialmicrobial mutagenicity mutagenicity assay, inassay, an in invitro an cell in vitro transformation cell transformation assay, inassay, a rat inmicronucleus a rat micronucleus test, in atest, rat bone in a rat marrow bone marrow cytogenetic cytogenetic assay, and assay, in anand assay in anforassay unscheduled for unscheduled DNA synthesis DNA synthesis in rat liver. in rat Impairment liver. Impairment of Fertility: of Fertility: Dolutegravir, Dolutegravir, abacavir,abacavir, or lamivudine or lamivudine did not affect did notmale affect or male or female fertility female infertility rats atindoses rats atassociated doses associated with exposures with exposures approximately approximately 44, 9, or44, 1129,times or 112 times (respectively) (respectively) higher than higher thethan exposures the exposures in humans in humans at the doses at theofdoses 50 mg, of 50 600mg, mg,600 andmg, and 300 mg 300 (respectively). mg (respectively). PATIENTPATIENT COUNSELING COUNSELING INFORMATION INFORMATION See FDA-Approved See FDA-Approved Patient Labeling Patient Labeling (Medication (Medication Guide). Guide). GALENUS / COMPRIMIDOS LINGÜÍSTICOS ® ® BRIEF SUMMARY BRIEF SUMMARY for TRIUMEQ for TRIUMEQ (abacavir, (abacavir, dolutegravir, dolutegravir, and lamivudine) and lamivudine) Tablets (cont’d) Tablets (cont’d)
