MIMETIX

Información principal

  • Denominación comercial:
  • MIMETIX 10 mg COMPRIMIDOS RECUBIERTOS
  • Dosis:
  • 10 mg
  • formulario farmacéutico:
  • COMPRIMIDO RECUBIERTO
  • Usar para:
  • Humanos
  • Tipo de medicina:
  • medicamento alopático
  • Fabricado por:
  • LABORATORIOS RECALCINE, S.A.

Documentos

Localización

  • Disponible en:
  • MIMETIX 10 mg COMPRIMIDOS RECUBIERTOS
    Venezuela
  • Idioma:
  • español

Otros datos

Estado

  • Fuente:
  • Instituto Nacional de Higiene - República Bolivariana de Venezuela
  • Estado de Autorización:
  • VIGENTE
  • Número de autorización:
  • E.F.39.263
  • Fecha de autorización:
  • 20-10-2011
  • última actualización:
  • 03-09-2018

Prospecto

Instituto

Nacional de

Higiene

"Rafael

Rangel"

t"/!f¡lJ

crcceo

Universitaria

UCV.

Los Chaguoramo&.

Caracas - República Boñvariana de Venezuela Codo 1041

....

Teléfono: (0058-0212) 219.1622

-"WL~

htlp:ltwww.inhrr.gob.ve

RIF: G-20000101-1

SISTEMA NACIONAL DE REGISTRO SANITARiO DE PRODUCTOS FARMACÉUTICOS

DM-R·13D4111

Caracas,

Octubre de 2011

Ciudadano(a)

DR. (A).

BElKYS

RUIZ ROJAS,

Farmacéutico Patrocinante

GYNOPHARM DE VENEZUELA

Presente.­

De conformidad con el Oficio DM-R-1303f11

fecha

20/10/2011

mediante

cual

se le notificó la

aprobación del Producto Farmacéutico MIMETIX 10 mg COMPRIMIDOS RECUBIERTOS, W de

Registro

Sanitaria E.F.39.263/11,

según consta en el libro

EF-2011~03,

Pág.

70 usted deberá

cumplir con las condiciones

comercialización siguientes:

1. DEBERÁ comunicar a

PRESCRIPTORES SEGÚN LO ESTABLECIDO EN

MEDICAMENTOS ARTíCULO 35, io siguiente:

Indicación:

Tratamiento coadyuvante de cuadros neurodegenerativos como demencia leve

moderada

a severa

tipo

enfermedad

Alzhefrner.

Posología:

Adultos: Dosis inicial: 5 rng

I

dla durante 1 semana

luego aumento progresivo de la dosis

cada

semana

durante

3 semanas

hasta llegar

a la

dosis de 20 mg

I

día.

Dosis máxima: 20 mg

I

dla.

Advertencias:

En caso

imprescindible

exisfir otra alternativa terapéutica, suspéndase la

lactancia mientras dure el tratamiento.

El uso de

este

producto

puede

generar

confusión, delirio intranquilidad, agitación e insomnio,

debe

evitarse

actividades

impliquen

coordinación

estado

alerta mental.

Este

producto no

debe

administrarse

en pacientes con intolerancia a la lactosa o galactosa

Precauciones:

En pacientes epilépticos.

Contraindicaciones:

Hipersensibilidad a los

componentes

la fórmula.

No se administre

durante

embarazo

o cuando se

sospeche

su existencia.

Estados de confusión

grave,

insuficiencia renal.

Reacciones

adversas:

Gastrointestinales:

Náusea,

estreñimiento, vómito, diarrea.

Neurorógicas: Vértigo, insomnio, intranquilidad, irritabilidad,

delirio

agitación.

Cardiovasculares: Hipertensión,

disnea,

lnsuflciencla Cardiaca.

Trastornos

Respiratorios,

Torácico

Mediastinicos:

Frecuentes·

Disnea,

Interacciones:

Amantadina,

ketamina,

cextrometorfano,

barbitúrlcos,

neuroiéptlcos.

antlcolinérqlccs,

L-dopa,

agonistas

dopaminérgicos,

baclofeno,

inhibidores

anhidrasa

carbónica,

hldroc'cro-tiazfda,

nicotina, quinidina, cimetidina, ranitidina

bicarbonato.

E.F.39.263/11

f_PERC_007

/"~'"1

( ..

....1

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1,--

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Instituto

Nacional

lene

"Rafael

Rangel"

Ciudad

Ul1ive¡~i!aria

UCV.

cheoueremcs.

Caracas . República Bolivariana de

veoeaceta

Teléfono:

(oo58·0n2)

'19.1

[;22

hllp:flw\'{w,inhrr.gob.ve

RIF: G·20000101·1

2. Se le asigna al producto un período de validez tentativo de

(02) años en el envase BLISTER

DE PVC TRANSPARENTE E INCOLORO

I

FOIL DE ALUMINIO.

el compromiso de (emitir

los resultados analltlccs de estabilidad para

tres (03) primeros lotes comerciales, cada tres

(03)

meses

durante el primer año

y

cada seis (06) meses durante el segundo año

el perIodo

de validez asignado al producto, almacenado bajo

las condiciones

cnrnéucas

Venezuela

(30°C±2°C/70%±5% HR)

3. Remitir anexo a la notificación del inicio de la comercialización del primer lote del producto, el

Certificado del Producto Farmacéutico, original

vigente o en su defecto copia compulsada del

mismo.

4. Corregir textos de empaque, etiqueta

prospecto interno según modelos anexos.

5. Mantener actualizado el expediente del producto en referencia en lo que respecta a la vigencia

de los Certificados de Producto Farmacéutico,

libre

Venta

ylo

Buenas Prácticas de Manufactura.

S. Los textos de empaque, etiqueta, unidad posológica

prospecto Interno deben adecuarse, según

caso,

establecido

OfICio

Aprobación,

Oficio

Condiciones

Comercialización, las Normas

Boletines de la Junta Revisora de Productos Farmacéutico.

7. Comunicar al Instituto Nacional de Higiene "Rafael Rangel", a través del Centro Nacional de

Farmacovigilancia (CENAVIF), cualquier efecto no descrito durante el proceso de evaluación del

Registro Sanitario

derive

de la actividad farmacológica del mismo o de alguno de sus

ingredientes

y

del cual se tenga conocimiento después de aprobado el producto.

8. Debe indicar

Despacho

cuatro

(04)

meses

anticipación,

la fecha

probable

ccmerdaüzación

producto

farmacéutico.

este

lapso

tiempo

procederá

EVALUACIÓN de la metodoloqla analítica utilizada en el control de calidad del producto y a la

programación respectiva.

9. A los fines

del estricto cumplimiento del ArtIculo

del Reglamento de la Ley del Ejercicio de la

Farmacia vigente, publicado en Gaceta Oficial

NI>

4.582 extraordinario de fecha 21 de mayo de

1.993, se informa

están obligados a participar al

Instituto

Nacional de Higiene "Rafael

Rangel" la fecha en la cual se inicie la comercialización del primer lote elaborado, de manera

que los funcionarios

acreditados del Instituto

Nacional

de Higiene "Rafael

Rangel", puedan

proceder

a captar

muestras

correspondientes

el

propio

sitio

de fabricación,

distribución en el caso de los productos importados.

Igualmente se le informa que dispone de quince (15) días hábiles, para solicitar a esta GERENCIA,

reconsideración

de las exigencias ANTERIORMENTE señaladas. Transcurrido dicho lapso queda

usted en la obligación

cumplir con las condiciones de

uso bajo las cuales fue aprobado el

producto.

El incumplimiento

alguna

condiciones de

comercialización

será

sancionado

CANCELACiÓN del producto.

DRA. MARIA TE

ESA\l1\4

GERENTE

SECTORIAL DE REG

..¡J~

d919gaet6n d91ConS9Jo

S9S161\

1_'7"m

MPM/nnr.­

E.F.39.263/11

F-PERC'001

Marzo

2010

Página z

Revisión

4-6-2018

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira, Inc., a Pfizer company, is voluntarily recalling lots 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69), to the hospital/institution level due to the potential presence of embedded and loose particulate matter on the syringe plunger.

FDA - U.S. Food and Drug Administration

4-6-2018

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System   by Hospira: Recall - Due to the Potential Presence of Particulate Matter

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System by Hospira: Recall - Due to the Potential Presence of Particulate Matter

The patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity.

FDA - U.S. Food and Drug Administration

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

1-11-2018

Dexdomitor (Orion Corporation)

Dexdomitor (Orion Corporation)

Dexdomitor (Active substance: dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7380 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

31-10-2018

Evista (Daiichi Sankyo Europe GmbH)

Evista (Daiichi Sankyo Europe GmbH)

Evista (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7342 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

26-9-2018

Sileo (Orion Corporation)

Sileo (Orion Corporation)

Sileo (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018

Europe -DG Health and Food Safety

19-9-2018

Memantine Mylan (Mylan S.A.S.)

Memantine Mylan (Mylan S.A.S.)

Memantine Mylan (Active substance: Memantine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5972 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2660/T/12

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Active substance: memantine) - Centralised - Renewal - Commission Decision (2018)5421 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2766/R/10

Europe -DG Health and Food Safety

30-7-2018

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Active substance: ertugliflozin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5103 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4314/T/2

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety

23-7-2018

Optruma (Eli Lilly Nederland B.V.)

Optruma (Eli Lilly Nederland B.V.)

Optruma (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4893 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

12-7-2018

Econor (Elanco Europe Ltd)

Econor (Elanco Europe Ltd)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4580 of Thu, 12 Jul 2018

Europe -DG Health and Food Safety

11-7-2018

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Active substance: duloxetine hydrochloride) - Centralised - Withdrawal - Commission Decision (2018)4515 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Scientific guideline:  Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.

Europe - EMA - European Medicines Agency

3-7-2018

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4254 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/896/T/90

Europe -DG Health and Food Safety

3-7-2018

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4249 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1235/T/77

Europe -DG Health and Food Safety

3-7-2018

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4252 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/862/T/93

Europe -DG Health and Food Safety

3-7-2018

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4251 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/861/T/90

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (Active substance: (R)-1-(3-(aminomethyl) phenyl)-N-(5-((3-cyanophenyl)(cyclopropylmethylamino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide dihydrochloride) - Orphan designation - Commission Decision (2018)4173 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/003/18

Europe -DG Health and Food Safety

14-6-2018

Kuvan (BioMarin International Limited)

Kuvan (BioMarin International Limited)

Kuvan (Active substance: sapropterin dihydrochloride) - Centralised - Yearly update - Commission Decision (2018)3859 of Thu, 14 Jun 2018

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3809 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3808 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3802 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/152/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3801 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/020/11/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3799 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/11/T/03

Europe -DG Health and Food Safety

30-5-2018

Eviplera (Gilead Sciences Ireland UC)

Eviplera (Gilead Sciences Ireland UC)

Eviplera (Active substance: emtricitabine / rilpivirine (as hydrochloride) / tenofovir disoproxil (as fumarate)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3453 of Wed, 30 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2312/T/91

Europe -DG Health and Food Safety

30-5-2018

Vokanamet (Janssen-Cilag International NV)

Vokanamet (Janssen-Cilag International NV)

Vokanamet (Active substance: canagliflozin / metformin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)3463 of Wed, 30 May 2018

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2017 (Spedding Research Solutions SAS)

EU/3/18/2017 (Spedding Research Solutions SAS)

EU/3/18/2017 (Active substance: Ambroxol hydrochloride) - Orphan designation - Commission Decision (2018)3384 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/236/17

Europe -DG Health and Food Safety

24-5-2018

Velmetia (Merck Sharp and Dohme Limited)

Velmetia (Merck Sharp and Dohme Limited)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3261 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Ristfor (Merck Sharp and Dohme Limited)

Ristfor (Merck Sharp and Dohme Limited)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3262 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Janumet (Merck Sharp and Dohme Limited)

Janumet (Merck Sharp and Dohme Limited)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3260 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Efficib (Merck Sharp and Dohme Limited)

Efficib (Merck Sharp and Dohme Limited)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3276 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

21-5-2018

EU/3/14/1353 (Lupin Europe GmbH)

EU/3/14/1353 (Lupin Europe GmbH)

EU/3/14/1353 (Active substance: Mexiletine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)3134 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/074/14/T/03

Europe -DG Health and Food Safety