Creon 6 Minimicrospheres
Texto original en francés.
Producto de salud natural autorizado en Canadá
- Titular
- Abbott Laboratories Co.
- NPN o DIN-HM
- 80025653
- Estado
- Licencia no activa
- Fecha de licencia
- 7 de junio de 2011
- Fecha de revisión
- 17 de octubre de 2012
- Forma
- Capsule
- Vía de administración
- Orale
- Tipo de solicitud
- Non traditionnelle
Si este producto se vendiera en Francia
No se ha detectado ningún punto según las normas que aplicamos.
Solo se calcula una cantidad diaria para una posología oral explícita para adultos, expresada por día y en una unidad sólida correspondiente a la forma del producto. No se extrapolan las unidades ambiguas, los líquidos, los polvos ni las dosis pediátricas. Una cantidad no calculada no se compara con los límites de dosis. Este análisis no constituye una autorización de venta en Francia ni una evaluación de seguridad o eficacia.
Composición
Composición medicinal no indicada.
Ingredientes no medicinales
Oxyde de fer rouge, Citrate de triéthyle, Dioxyde de titane, Gélatine, Hypromellosephthalate, Macrogol 400, Lauryl sulfate de sodium, Diméthicone, Oxide de fer jaune, FD&C Blue No.2, Alcool cétylique
Dosis recomendadas en Canadá
| Población | Edad | Cantidad por toma | Frecuencia |
|---|---|---|---|
| Adultes et enfants | minimum : 4 ans | Non précisée | Non précisée |
| Adultes | Non précisée | Non précisée | Non précisée |
| Enfants | maximum : 4 ans | Non précisée | Non précisée |
Usos autorizados en Canadá
For replacement therapy where digestion is not adequate due to pancreatic exocrine insufficiency.
Texto original en inglés.
Un uso autorizado en Canadá no es una declaración de propiedades saludables autorizada en la Unión Europea. Consulte el registro de declaraciones de propiedades saludables.
Advertencias en Canadá
Contra-Indications : Patients with known hypersensitivity to porcine proteins, pancreatic enzymes or to any of the ingredients of this product.
Texto original en inglés.
Known Adverse Reactions : In clinical trials, more than 900 patients were exposed to Creon. The most commonly reported adverse reactions were gastrointestinal disorders and were primarily mild or moderate in severity. The following adverse reactions were observed during the clinical trials with the below indicated frequencies. Gastrointestinal disorders: Common (> or = 1/100, <1/10): nausea, vomiting, constipation and abdominal distension. Gastrointestinal disorders are mainly associated with the underlying disease. Similar or lower incidences compared to placebo were reported for diarrhea (common, > or = 1/100, <1/10) and for abdominal pain (very common, > or = 1/10). Frequency not known: Strictures of the ileo-caecum and large bowel (fibrosing colonopathy) have been reported in patients with cystic fibrosis taking high doses of pancreatin preparations. Skin and subcutaneous tissue disorders: Uncommon (> or = 1/1000, <1/100): rash Frequency not known: pruritus, urticaria Immune System disorders: Frequency not known: Hypersensitivity (anaphylactic reactions) Allergic reactions mainly but not exclusively limited to the skin have been observed and additionally identified as adverse reactions during postapproval use. Because these reactions were reported spontaneously from a population of uncertain size, it is not possible to reliably estimate their frequency. Multiple clinical trials were conducted in other patient populations: HIV, acute pancreatitis, diabetes mellitus. No additional adverse drug reactions were identified compared to the above 3 patient groups. Paediatric population: No specific adverse reactions have been identified in the pediatric population. Frequency, type and severity of adverse reactions were similar in children with cystic fibrosis as compared to adults.
Texto original en inglés.
Cautions and Warnings : Very high doses of pancreatic enzymes may increase levels of uric acid in the blood (hyperuricaemia) and/or urine (hyperuricosuria). Fibrosing colonopathy (described as abnormal narrowing of the colon and bowel) has been reported in patients with cystic fibrosis taking high doses of pancreatic enzymes. As a precaution, consult your doctor if you experience any unusual abdominal symptoms or any change in abdominal symptoms, especially if taking in excess of 10,000 units of lipase/kg body weight/day or more than 4,000 units of lipase/gram fat intake. Creon should not be used during pregnancy or lactation unless clearly necessary. If required during pregnancy and lactation Creon should be used in doses sufficient to provide adequate nutritional status. As with all currently marketed porcine pancreatin products, Creon is sourced from pancreatic tissue from swine used for food consumption. Although the risk that Creon will transmit an infectious agent to humans has been reduced by the testing and inactivation of certain viruses during manufacturing, there is a theoretical risk for transmission of viral disease, including diseases caused by novel or unidentified viruses. The presence of porcine viruses that might infect humans cannot be definitely excluded. However, no cases of transmission of an infectious illness associated with the use of porcine pancreatic extracts have been reported, whereas they have been used for a long time.
Texto original en inglés.
Fuente
Ficha oficial de Health Canada, licencia 80025653
Base de datos de productos de salud natural autorizados (BDPSNH), Health Canada: productos autorizados, ingredientes, dosis, usos y advertencias, consultado el 27 de octubre de 2026.
Contient des informations visées par la Licence du gouvernement ouvert – Canada (Santé Canada, BDPSNH)
Texto original en francés.
Texto original en francés.
La fórmula vendida en Europa con el mismo nombre puede ser diferente. Esta información no sustituye el consejo de un médico o farmacéutico.
Lista en la revisión oficial del (registro: Base de datos de productos de salud natural autorizados (BDPSNH), Health Canada: productos autorizados, ingredientes, dosis, usos y advertencias).