VITAMIN C-

Información principal

  • Denominación comercial:
  • VITAMIN C-500 MG
  • Dosis:
  • 500 mg
  • formulario farmacéutico:
  • Tableta
  • Usar para:
  • Humanos
  • Tipo de medicina:
  • medicamento alopático

Documentos

  • para el público en general:
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Localización

  • Disponible en:
  • VITAMIN C-500 MG
    Cuba
  • Idioma:
  • español

Otros datos

Estado

  • Fuente:
  • CECMED - Autoridad Reguladora de Medicamentos, Equipos y Dispositivos Médicos - Cuba
  • Número de autorización:
  • 051-15d3
  • última actualización:
  • 10-05-2018

Ficha Técnica

RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO.

Nombre del producto:

VITAMIN C-500 MG

(Ácido ascórbico)

Forma farmacéutica:

Tableta

Fortaleza:

500 mg

Presentación:

Frasco de PEAD con 100 tabletas.

Titular del Registro Sanitario, país:

MEDICARIBE S.A., LA HABANA, CUBA.

Fabricante, país:

MAJOR PHARMACEUTICALS, MÍCHIGAN,

ESTADOS UNIDOS DE AMÉRICA.

Número de Registro Sanitario:

051-15D3

Fecha de Inscripción:

25 de septiembre de 2015

Composición:

Cada tableta contiene:

Ácido ascórbico

500,0 mg

Plazo de validez:

36 meses

Condiciones de almacenamiento:

Almacenar por debajo de 30 °C. Protéjase de la

humedad.

Indicaciones terapéuticas:

El acido ascórbico se usa para prevenir y tratar el escorbuto, una enfermedad provocada por

la carencia de vitamina C en el cuerpo. Mejora la visión y ejerce funciones preventivas ante

la aparición de cataratas y glaucomas. Dada su capacidad antioxidante hace que la misma

elimine sustancias toxicas del organismo como son los nitritos y nitratos presentes en los

productos

cárnicos,

preparados

embutidos.

nitratos

nitritos

aumentan

probabilidad de desarrollar cáncer. Es antibacteriana por lo que disminuye el crecimiento de

ciertas bacterias dañinas para el organismo. Reduce las complicaciones derivadas de la

diabetes tipo II. Disminuye los niveles de tensión arterial y previene la aparición de

enfermedades vasculares. Tiene propiedades antihistamínicas, por lo que se utiliza en

tratamientos alérgicos contra el asma y la sinusitis. Ayuda a prevenir o mejorar afecciones

de la piel como eccemas o soriasis. Es cicatrizante de heridas y quemaduras ya que es

imprescindible en la formación de colágeno. Aumenta la producción de estrógenos durante

la menopausia por lo que es utilizada para reducir o aliviar los síntomas de sofocos y

demás.

Mejora

estreñimiento por

sus propiedades laxantes.

Repara

mantiene

cartílagos, huesos y dientes.

Contraindicaciones:

Pacientes que tienen o tuvieron cálculos renales, deben consultar con su médico. Las

personas diabéticas si ingieren grandes cantidades de acido ascórbico deben consultar

como examinar su orina.

Precauciones:

Evite tomar más de una multivitamínicas al mismo tiempo. Algunas formas de ácido

ascórbico contienen sodio y deben evitarse si usted mantiene una régimen bajo de

contenido de sal y de sodio.

Advertencias especiales y precauciones de uso:

No use más ni menos de la dosis indicada, ni tampoco más seguido de lo prescrito.

Efectos indeseables:

Aunque los efectos indeseables no son comunes, pueden producir diarreas y malestar

estomacal.

Posología y modo de administración:

Adultos: Una tableta diaria, preferentemente con un alimento

Interacciones con otros productos medicinales y otras formas de interacción:

Ácido acetilsalicílico: en administración concomitante con vitamina C aumenta la excreción

urinaria de ácido ascórbico y se reduce la excreción del ácido acetilsalicílico.

Barbitúricos: aumentan la excreción de ácido ascórbico a través de la orina.

Tetraciclinas: aumentan la excreción de ácido ascórbico a través de la orina.

Deferoxamina: el ácido ascórbico (en altas dosis) no debería administrarse durante el primer

mes de un tratamiento con deferoxamina ya que podría agravar la toxicidad por hierro.

Contraconceptivos hormonales con estrógenos: la vitamina C a dosis elevadas aumenta la

biodisponibilidad de los estrógenos en sangre.

Fenotiazinas como flufenazina: posible disminución de su concentración plasmática

Anticoagulantes orales como warfarina y acenocumarol: podría verse modificada su acción

por el ácido ascórbico.

Uso en embarazo y lactancia:

Ingiera las cantidades de acido ascórbico indicadas por el médico si está embarazada o

lactando.

Efectos sobre la conducción de vehículos/ maquinarias:

No se han reportado hasta la fecha.

Sobredosis:

Es poco probable que exista una intoxicación por vitamina C, puesto que es una vitamina

hidrosoluble y los excesos son eliminados a través de la orina. Pero si la dosis diaria supera

los 2000mg/día pueden aparecer molestias gastrointestinales, diarreas, malestar en el

estomago, cálculos renales, insomnio y exceso de absorción de hierro. Entonces acuda a

su médico.

Propiedades farmacodinámicas:

El acido ascórbico se usa para prevenir y tratar el escorbuto, una enfermedad provocada por

la carencia de vitamina C en el cuerpo. Mejora la visión y ejerce funciones preventivas ante

la aparición de cataratas y glaucomas. Dada su capacidad antioxidante hace que la misma

elimine sustancias toxicas del organismo como son los nitritos y nitratos presentes en los

productos cárnicos, preparados o embutidos. Los nitratos y nitritos aumentan la

probabilidad de desarrollar cáncer.

Propiedades farmacocinéticas (Absorción, distribución, biotransformación,

eliminación):

El acido ascórbico es absorbido en el cuerpo por transporte activo y difusión simple.

Dependiente activo transporte de

sodio-ascorbato de

socioCo-Transporters

(SVCTs) y

transportadores de hexosa (superabundancia) son los dos transportadores necesarios para

la absorción. SVCT1 y SCVT2 importan la forma reducida de ascorbato a través de la

membrana plasmática. GLUY1 y GLUT3 son los dos transportadores de glucosa y transferir

solo forma acido dehidroascórbico de vitamina C Aunque el acido dehidroascórbico es

absorbido en la tasa más alta que el ascorbato, la cantidad de acido dehidroascórbico que

se encuentra en el plasma y tejidos en condiciones normales es baja, como las células

rápidamente reducen acido dehidroascórbico ascorbato. Así SVCTs parecen ser el sistema

predominante para el transporte de la vitamina C en el cuerpo. SVCT2 participa en el

transporte de la vitamina C en casi todos los tejidos, animales Knockout para SVCT2

mueren poco después del nacimiento, sugiriendo que el transporte medido por SVCT2

vitamina C es necesaria para la vida.

Con la ingesta regular la tasa de absorción varía entre 70 y 95%. Sin embargo, el grado de

absorción disminuye a medida que aumenta el consumo. El alto consumo (12 g), absorción

humana fraccional dl acido ascórbico puede ser tan bajo como el 16% en baja ingesta (˂ 20

mg) la tasa de absorción puede alcanzar hasta el 98%. Las concentraciones de ascorbato

en el umbral de reabsorción renal pasan libremente en la orina y son excretadas. Las altas

dosis dietéticas (correspondientes a varios cientos de mg/día en los seres humanos)

ascorbato se acumula en el cuerpo los niveles de plasma hasta el umbral de reabsorción

renal,

aproximadamente

1,5mg/dL

hombres

mg/dL

mujeres.

Concentraciones en el plasma superior a este valor (pensado para representar la saturación

del cuerpo) son rápidamente excretadas en la orina con una vida media de 30 minutos;

Concentraciones inferiores a esta cantidad umbral activamente son retenido por los riñones,

Half-Life

para

resto

tienda

vitamina

cuerpo

aumentan

considerablemente,

la prolongación

Half-Life como

cuerpo almacena

están

agotadas.

Aunque la tienda máxima de vitamina C en el cuerpo es determinado principalmente por el

umbral renal en la sangre, hay muchos tejidos que mantienen concentraciones de vitamina

C mucho mayores que en sangre. Tejidos biológicos que acumulan más de 100 veces el

nivel en el plasma sanguíneo de vitamina C son las glándulas suprarrenales, pituitaria, timo,

cuerpo lúteo y retina. Aquellas con 10 a 50 veces la concentración presente en el plasma

sanguíneo incluyen el cerebro, bazo, pulmón, testículos, ganglios linfáticos, hígado, tiroides,

pequeña mucosa intestinal, leucocitos, páncreas, riñón y glándulas salivales.

El acido ascórbico puede ser oxidado (desglosado) en el cuerpo humano por la enzima L-

ascorbato oxidasa que directamente no es excretado en la orina como consecuencia de la

saturación del cuerpo o destruido en el metabolismo de otro cuerpo y es oxidado por esta

enzima y eliminado.

Instrucciones de uso, manipulación y destrucción del remanente no utilizable del

producto:

No se ha reportado hasta la fecha.

Fecha de aprobación/ revisión del texto: 25 de septiembre de 2015.

  • El prospecto de información de este producto no está disponible actualmente, puede enviar una petición a nuestro servicio al cliente y le notificaremos tan pronto como nos sea posible para conseguirlo.

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Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) soybean BPS‐CV127‐9. This soybean was found to be as safe and nutritious as its conventional counterpart and commercial soybean varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 16 February 2018, European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soy...

Europe - EFSA - European Food Safety Authority Publications

10-9-2018

Kangaroo Manufacturing Inc. recalls Kangaroo's Super Cool Slime

Kangaroo Manufacturing Inc. recalls Kangaroo's Super Cool Slime

Health Canada's sampling and evaluation program has determined the Super Cool Slime products donot meet the Canadian toy safety requirements related to boric acid content.

Health Canada

29-8-2018

Update of the tolerable upper intake level for vitamin D for infants

Update of the tolerable upper intake level for vitamin D for infants

Published on: Tue, 07 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on the draft Scientific Opinion on the update of the tolerable upper intake level for vitamin D for infants. This draft Scientific Opinion was prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) and endorsed by the Panel for public consultation by written procedure on 9 April 20...

Europe - EFSA - European Food Safety Authority Publications

27-8-2018

Several unauthorized products seized from Vitality Health Foods in Drayton Valley, AB, may pose serious health risks

Several unauthorized products seized from Vitality Health Foods in Drayton Valley, AB, may pose serious health risks

Health Canada is advising Canadians that several unauthorized products seized from Vitality Health Foods in Drayton Valley, AB, may pose serious health risks. The 11products include vitamins, dietary supplements, workout supplements and decongestants. Seized products were labelled to contain various ingredients, including prescription drugs and controlled substances.

Health Canada

14-8-2018

Genius Premium Craft Boxes recalls Do-It-Yourself Slime Kits

Genius Premium Craft Boxes recalls Do-It-Yourself Slime Kits

Health Canada’s sampling and evaluation program has determined the Do-It-Yourself Slime Kits do not meet the Canadian toy safety requirements related to boric acid content.

Health Canada

10-8-2018

FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

FDA approves new drug for treatment of polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR). This is the first FDA-approved treatment for this rare, debilitating and often fatal genetic disease and the first FDA approval of a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

18-7-2018

Sodium glucose co-transporter 2 inhibitors

Sodium glucose co-transporter 2 inhibitors

Safety advisory - diabetic ketoacidosis and surgical procedures

Therapeutic Goods Administration - Australia

5-11-2018

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Active substance: (6aR,10aR)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid) - Orphan designation - Commission Decision (2018)7271 of Mon, 05 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/114/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

29-10-2018

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7249 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1144/WS1433/0051

Europe -DG Health and Food Safety

29-10-2018

DuoPlavin (Sanofi Clir SNC)

DuoPlavin (Sanofi Clir SNC)

DuoPlavin (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7255 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1143/WS/1433/0050

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Actavis (Actavis Group PTC ehf.)

Zoledronic acid Actavis (Actavis Group PTC ehf.)

Zoledronic acid Actavis (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6488 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)6427 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/183/16/T/02

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Mylan (Mylan S.A.S.)

Zoledronic acid Mylan (Mylan S.A.S.)

Zoledronic acid Mylan (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6486 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Teva (Teva B.V.)

Zoledronic acid Teva (Teva B.V.)

Zoledronic acid Teva (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6466 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

1-10-2018

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

Europe -DG Health and Food Safety

24-9-2018

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Active substance: zoledronic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6243 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2365/T/33

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Active substance: (S)-(-)-3-(4-aminophenyl)-2-methoxypropanoic acid) - Orphan designation - Commission Decision (2018)5728 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/075/18

Europe -DG Health and Food Safety

15-8-2018

Watched Vitamania? Here’s how the TGA regulates vitamins in Australia

Watched Vitamania? Here’s how the TGA regulates vitamins in Australia

Find out how the TGA regulates vitamins in Australia

Therapeutic Goods Administration - Australia

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)5386 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

1-8-2018

Ucedane (Lucane Pharma)

Ucedane (Lucane Pharma)

Ucedane (Active substance: carglumic acid) - Centralised - Yearly update - Commission Decision (2018)5230 of Wed, 01 Aug 2018

Europe -DG Health and Food Safety

27-7-2018

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Active substance: Synthetic cyclic 8 amino acid analogue of human unacylated ghrelin) - Transfer of orphan designation - Commission Decision (2018)5049 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/066/17/T/01

Europe -DG Health and Food Safety