RINOLAST

Información principal

  • Denominación comercial:
  • RINOLAST 30mg/5ml SUSPENSION
  • Dosis:
  • 30mg/5ml(A7)
  • formulario farmacéutico:
  • SUSPENSI
  • Usar para:
  • Humanos
  • Tipo de medicina:
  • medicamento alopático
  • Fabricado por:
  • LABORATORIOS FARMA S.A.

Documentos

Localización

  • Disponible en:
  • RINOLAST 30mg/5ml SUSPENSION
    Venezuela
  • Idioma:
  • español

Otros datos

Estado

  • Fuente:
  • Instituto Nacional de Higiene - República Bolivariana de Venezuela
  • Estado de Autorización:
  • VIGENTE
  • Número de autorización:
  • E.F.36.581
  • Fecha de autorización:
  • 26-09-2007
  • última actualización:
  • 03-09-2018

Prospecto

4 Gobierno BolIvariano

1

Ministerio del Poder Popular' Instituto Nacional

1

de Higiene

-

de Venezuela

para la Salud

i

Rangel"

REGISTRO NACIONAL DE PRODUCTOS

FARMACEUTICOS

074464

2 9 OCT 2007

Caracas /

Ciudadana.

DRA. ARACELIS ORTEGA

RIOS.

FARNA

S.A.

Presente.

De acuerdo con dictamen de 1.a Junta R evisorade Eroduc

t:c•s

Farmacéuticos, en sesión N° 73 Acta W>

9055

de fecha

26/09/2007,

se aprueba el producto

RINOLAST 30rng/5m1 SUSPENSION

SREF-07-0043.

No. DE REGISTRO E.F. 36.581.

Igualmente se le informa que dispone de quince (15) días

Iid1,)J1eH,

)eic

SOLIO

.1 a

J.nta Revisor a de Pr

0I1ç

Farmacéuticos, ia reconsideración de las exicencias señaladas

a nunt;. Lnuación:

C2omprem.iso de comunrcar al Gremio Médico lo sícuiente

E 1. oroduoto es

cptal

en 1. as sigui.ntscondrc. ícnesv

restricciones de uso:

Indicaciones:

Tratamiento sintomático de la rinitis alérgica, urticaria y

otras afecciones dermato Lógicas de origen aJ erLLco, como

dermatitis atdpica.

Posologia:

Adultos y niños mayores de 12 años: 60 - 180 mg una vez al

Advertencias:

No se administre durante el embarazo o cuando se sospeche

su existencia, ni durante la lactancia, a menos

que a

criterio médico el. balance riesgo/beneficio sea favor ah.:Le.

De ser imprescindible su uso por no existir

otra alter-

m t e

materna mientras dure el tratamiento.

SO (tOfll.LLLStLO OIL HL

incrlorO; Oo 12 siTas.

Contraindicaciones:

1Jí

Reacciones Adversas:

fr t.: i go

GisLio ntestd nal : Nauses, id H:tacjio

Interacciones:

7PTa ocids

conLenqja

hiW.:oxas

lItO

"2006, AÑO BICENTENARIO DEL JURAMENTO DEL GENERALISIMO FRANCISCO DE MIRANDA

Y DE

LA PARTICIPACIÓN PROTAGÓN PCA

Y DEL PODER POPULAR"

Gobierno BolIvariano Ministerio del Poder Popular inst,tuto Nacional

de Higiene

de Venezuela

para la Salud

i "Rafael Rangel"

REGISTRO NACIONAL DE PRODUCTOS

FARMPCEUTICOS

Si desea mantener la solicitud del pro.d oto para su uso

en niños menores de 12 años de

edad deberá consienar

estudios cl ni cos donde se evalúe la e ficada y seguridad

en este

grupo etáreo.

Se Le asigne al producto un par lodo de validez tentativo

de dos

(02)

años envasado en

FRASCO

DE VIDRIO COLOR A1AR

CON TAPA DE ALUMINIO PILFER PROOF,

con el

compromiso.

remitir

resultados analíticos de

estabilidad para los

tres

primeros

lotes comerciales cada

tres (3)

meses

durante el primer

año

y cada

seis

meses durante el

segundo año

del período de validez asignado,

almacenado

bajo

condiciones climáticas de

Venezuela (30°C±2°C/

5IHR)

Antes del primer lote de comercialización

debe remitir Lo

siguiente:

4.1. Certificado

Buenas

Prácticas

Manufactura

origina .1

vigente

en su

defecto la copia compulsada

del mismo.

4.2. Tipo

vidrIo

uti 1 izado

a i st,ems

envase

ci erre.

El

producto es aceptable en principio en las presen-

taciones de 60, 120, 150

180 ml para la venta al

púbí ico

Corregir texto de empaque y etiqueta según modelo anexo.

Corregir texto de prospecto interno según modelo anexo y

agregar lo siguiente:

Indicaciones:

Tratamiento sintomático de la rinitis alérgica, urticaria

y otras afecciones dermatológcas de origen alérgico,

como dermatitis atóp.ica"

Posología:

Adtil tos

y fllhO5

mayores de 12 años: 60 - 180 mg una vez

a i d 1 a

Advertencias:

No se administre en niños menores de Ti atoo

Interacciones:

ile t 1 3c1 des

cori eng a.e

ñ íd r óxido

a 1 em]

macínes lo

A 1.os fines del estricto

rimplim:i.erito del Artício 60 dei.

Oe4lC1CI i tO

de La Le

del Ej ercido de la

Farmacia

(1

.Jf

' LC1

-

"2006, AÑO BICENTENARIO DEL JURAMENTO DEL GENERALISIMO FRANCISCO DE MIRANDA

Y DE

LA PARTICIPACIÓN PROTAGÓNICA Y DEL PODER POPULAR"

Gobierno BolIvariano Ministerio del Poder Popular Instituto Nacional

1

de Higiene

de Venezuela

para la Salud

1 "Rafael Rangel"

REGISTRO NACIONAL DE PRODUCTOS

FARMACEUTICOS

dinar.Lo de lecho 21 de mayo de 1

, se informa que es tón

obliqedos a participar a la Junta Revisoo de Productos

Farrriaoéut: 1 cos, la fecha en 1a ocal se ini ci e 1a ccmerc ja-

lización del primer lote elaborado, de manera que los

1 luU cu

ac redi.tados

N a cio

Higiene " Rafael Rangel ", puedan proceder a captar las

muestras correspondientes en el propio sitio de fabri-

cación, 6 de distribución en el caso de los productos

importados. El incumplimiento del mencionado compromiso

será sancionado con la prohibición del producto.

Transcurrido dicho lapso queda usted en la obligación de

cumplir, con las condiciones de uso bajo las cuales fue

aprobado el producto.

POR LA JUNTA REV,TQR, DE PRODUCTOS FARMACÉUTICOS

STILLO

"20 AÑO BICENTENARIO DEL JURAMENTO DEL GENERALISIMO FRANCISCO DE MIRANDA

Y DE LA

PARTICIPACIÓN PROTAGÓNICA Y DEL PODER POPULAR"

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Votrient (Novartis Europharm Limited)

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