MICROFERRUM

Información principal

  • Denominación comercial:
  • MICROFERRUM 100 mg CAPSULAS CON MICROGRANULOS DE LIBERACION RETARDADA
  • Dosis:
  • 100mg
  • formulario farmacéutico:
  • C
  • Usar para:
  • Humanos
  • Tipo de medicina:
  • medicamento alopático
  • Fabricado por:
  • VIFOR INTERNATIONAL INC

Documentos

Localización

  • Disponible en:
  • MICROFERRUM 100 mg CAPSULAS CON MICROGRANULOS DE LIBERACION RETARDADA
    Venezuela
  • Idioma:
  • español

Otros datos

Estado

  • Fuente:
  • Instituto Nacional de Higiene - República Bolivariana de Venezuela
  • Estado de Autorización:
  • VIGENTE
  • Número de autorización:
  • E.F.34.430
  • Fecha de autorización:
  • 17-08-2005
  • última actualización:
  • 03-09-2018

Prospecto

República

Bolivariana

de Venezuela

Ministerio

Salud

I)esarrollo

Social

Instituto

Nacional

de Higiene

ttRafael

Rangeltt

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s.A.

Presente.

acuerdo

dictamen

Junta

Revisora

Productos

Farmacéuticos,

sesión

74 Acta

8851

f e c h a

L7/08/A5,

se aprueba

producto:

MICROFERRUN

CAPSULAS

CON MICROGRANT'LOS

DE LIBERACION

RETARDADA

SR-04-O763.

No. DE REGTSTRO

E.F.

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Igualmente

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dispone

quince

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d i a s

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para

solicitar

Junta

Revisora

? r o d u c t o s

Farmacéuticos,

reconsideración

exigencias

s e ñ a l a d a s

c o n t i n u a c i ó n :

Compromiso

de comunicar

Gremio Médico

1o siguiente:

producto

aceptable

siguientes

condicj-ones

restricciones

de uso:

Indicación:

Tratamiento

de la

anemia

f e r r o p é n i c a .

Posología:

Niños

mg-6 mg

hierro

el-emental/kq

peso

c o r p o r a l

una vez

d i a .

Adu1tos:.

20A mg

hj-erro

elemental

al- día.

Advertencias:

administre

durante

embarazo

cuando

sospeche

existencia/

durante

lactancia

menos

criterio

médico,

balance

riesgo

beneficio

s e a

favorable.

Durante

tratamiento

este

p r o d u c t o

deben

realj-zarse

controles

periódicos

í n d i c e s

hematimétricos

hasta

normalización

l-os

mismos.

duración

tratamiento

debe ser

menor

s e m a n a s .

caso

obtenerse

respuesta

satísfactoria

d u r a n t e

este lapso,

deben reafizarse

exploraciones

c o m p l e m e n t a r i a s .

Precaucionee¡:

caso

náusea,

vómito,

constipación

diarrea,

recomendable

disminuir

dosis

administrarlo

l a s

comidas.En

pacientes

enfermedad ulceropéptica.

Contraindicaciones:

Hipersensibil-idad

componentes

fórmula.

Pacientes

hemocromatosis,

hemosiderosi-s,

anemia

hemolítica-drepanoci

aplasia

e r i t r o c i i u a r i - a ,

insuficiencia

hepática

y,/o

r e n a l .

Reacciones

Adversas:

Gastrointestina

náusea,

v ó m j - t o ,

constipaciéR,

diarrea,

dolor

a b d o m i n a l .

"Prevenir

eI Dengue

es larea

de todas

todos,

p i r ó s i s ,

República

Bolivariana

de Venezuela

Ministerio

Salud

Desarrollo

Social

Instituto

Nacional

de Higiene

"Rafael

Rangeltt

REGISTRO

NACIONAT

PRODUCTOS

F'ARIÍACEUTICOS

Interaeciones:

T e t r a c i c l i n a s ,

f e n i l b u t a z o n a .

a n t i á c i d o s ,

p e n í c í l a m i n a ,

s a l i c i l a t o s ,

asigna

producto

periodo

validez

t e n t a t i v o

(O2)

años,

envasado

BLISTER

PVC-PVDC

t O t f

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compromiso

remitir

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anal-iticos

estabilidad

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primeros

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comercial-ización

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meses

durante

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c o n d i c i o n e s

c l i m á t i c a s

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( 3 A "

C + 2 "

c / l O % + S % H R )

nombre

correcto

producto

MICROFERRUN

CAPSUI,AS

MICROGRANULOS

DE LIBERACION

RETARDADA.

reitera

soli-citado

puntos

o f i c i o

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s o l i c i t ó .

Remitir

tipo

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Ensayo

Disolución

mét.odo

detección

para

l - a

cuantificación

del- Hierro

dicho

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Corregir

l-os

textos

empaque,

oil-

aluminio

prospecto

interno

según

modelos

a n e x o s .

l-os

fines

del-

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cumplimiento

Art.ícul-o

Reglamento

Ejercicio

F a r m a c i a

v í g e n t e ,

p u b l i c a d o

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N o .

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Extraordinario

fecha

mayo

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están

obligados

participar

Junta

Revisora

Productos

Farmacéuticos,

fecha

cual

i n i c i e

comercialización

primer

l-ote

elaborado,

m a n e r a

l-os

funcionarios

acreditados

Instituto

N a c i o n a l -

Higiene

"Rafael

Rangel",

puedan

proceder

captar

l a s

muestras

correspondientes

propio

sitio

fabricación,

distribución

caso

l - o s

productos

importados.

incumplimiento

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29-5-2018

TAYTULLA (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) by Allergan: Recall - Due to Out of Sequence Capsules

TAYTULLA (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) by Allergan: Recall - Due to Out of Sequence Capsules

Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules. As a result of this packaging error, oral contraceptive capsules, that are taken out of sequence, may place the user at risk for contraceptive failure and unintended pregnancy. The reversing of the order may not be apparent to either new users or previous ...

FDA - U.S. Food and Drug Administration

29-5-2018

Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules

Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules

Allergan plc (NYSE:AGN) today issued a voluntary recall in the US market of one lot (Lot# 5620706, Expiry May-2019) of TAYTULLA® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6x28 physicians sample pack, indicated for use by women to prevent pregnancy. Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal...

FDA - U.S. Food and Drug Administration

29-8-2018

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Active substance: aliskiren hemifumarate / hydrochlorothiazide) - Centralised - Renewal - Commission Decision (2018)5769 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/964/R/87

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Active substance: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt) - Orphan designation - Commission Decision (2018)5729 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/051/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2055 (IQVIA RDS Ireland Limited)

EU/3/18/2055 (IQVIA RDS Ireland Limited)

EU/3/18/2055 (Active substance: (3R,3aS,9R,9aS,9bS)-3-((dimethylamino)methyl)-9-hydroxy-6,9-dimethyl-3,3a,4,5,7,8,9,9a-octahydroazuleno[4,5-b]furan-2(9bH)-one fumarate) - Orphan designation - Commission Decision (2018)5727 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/060/18

Europe -DG Health and Food Safety

7-8-2018

Duaklir Genuair (AstraZeneca AB)

Duaklir Genuair (AstraZeneca AB)

Duaklir Genuair (Active substance: aclidinium bromide / formoterol fumarate dihydrate) - Centralised - Yearly update - Commission Decision (2018)5419 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

7-8-2018

Brimica Genuair (AstraZeneca AB)

Brimica Genuair (AstraZeneca AB)

Brimica Genuair (Active substance: aclidinium bromide / formoterol fumarate dihydrate) - Centralised - Yearly update - Commission Decision (2018)5420 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

25-7-2018

Viread (Gilead Sciences Ireland UC)

Viread (Gilead Sciences Ireland UC)

Viread (Active substance: tenofovir disoproxil fumarate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4980 of Wed, 25 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/419/T/187

Europe -DG Health and Food Safety

6-6-2018

Truvada (Gilead Sciences Ireland UC)

Truvada (Gilead Sciences Ireland UC)

Truvada (Active substance: emtricitabine / tenofovir disoproxil fumarate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3690 of Wed, 06 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/594/T/148

Europe -DG Health and Food Safety

6-6-2018

Stribild (Gilead Sciences Ireland UC)

Stribild (Gilead Sciences Ireland UC)

Stribild (Active substance: elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil (as fumarate)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3691 of Wed, 06 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2574/T/93

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

Tecfidera (Biogen Idec Limited)

Tecfidera (Biogen Idec Limited)

Tecfidera (Active substance: Dimethyl fumarate) - Centralised - Yearly update - Commission Decision (2018)3458 of Wed, 30 May 2018

Europe -DG Health and Food Safety

24-5-2018

Stribild (Gilead Sciences International Limited)

Stribild (Gilead Sciences International Limited)

Stribild (Active substance: elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil (as fumarate)) - PSUSA - Modification - Commission Decision (2018)3277 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2574/PSUSA/10082/201708

Europe -DG Health and Food Safety

26-3-2018

EU/3/18/1990 (PharmaBio Consulting)

EU/3/18/1990 (PharmaBio Consulting)

EU/3/18/1990 (Active substance: Dimethyl fumarate) - Orphan designation - Commission Decision (2018)1879 of Mon, 26 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/219/17

Europe -DG Health and Food Safety