Creon 6 Minimicrospheres
Testo originale in francese.
Prodotto naturale per la salute autorizzato in Canada
Se questo prodotto fosse venduto in Francia
Nessun punto rilevato secondo le norme che applichiamo.
Si calcola una quantità giornaliera solo per una posologia orale esplicita per adulti, espressa al giorno e in un’unità solida corrispondente alla forma del prodotto. Unità ambigue, liquidi, polveri e dosi pediatriche non vengono estrapolati. Una quantità non calcolata non viene confrontata con i limiti di dose. Questa analisi non costituisce un’autorizzazione alla vendita in Francia né una valutazione di sicurezza o efficacia.
Composizione
Composizione medicinale non indicata.
Ingredienti non medicinali
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
Dosi raccomandate in Canada
| Popolazione | Età | Quantità per assunzione | Frequenza |
|---|---|---|---|
| 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 |
Usi autorizzati in Canada
For replacement therapy where digestion is not adequate due to pancreatic exocrine insufficiency.
Testo originale in inglese.
Un uso autorizzato in Canada non è un’indicazione sulla salute autorizzata nell’Unione europea. Consulti il registro delle indicazioni sulla salute.
Avvertenze in Canada
Contra-Indications : Patients with known hypersensitivity to porcine proteins, pancreatic enzymes or to any of the ingredients of this product.
Testo originale in inglese.
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.
Testo originale in inglese.
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.
Testo originale in inglese.
Scheda del prodotto
- Titolare
- Abbott Laboratories Co.
- NPN o DIN-HM
- 80025653
- Stato
- Licenza non attiva
- Data della licenza
- 7 giugno 2011
- Data di revisione
- 17 ottobre 2012
- Forma
- Capsule
- Via di somministrazione
- Orale
- Tipo di domanda
- Non traditionnelle
Fonte
Scheda ufficiale Health Canada, licenza 80025653
Banca dati dei prodotti naturali per la salute autorizzati (BDPSNH), Health Canada: prodotti autorizzati, ingredienti, dosi, usi e avvertenze, consultato il 27 ottobre 2026.
Contains information licensed under the Open Government Licence – Canada (Health Canada, LNHPD)
Testo originale in inglese.
Testo originale in francese.
La formula venduta in Europa con lo stesso nome può essere diversa. Queste informazioni non sostituiscono il parere di un medico o farmacista.
Elenco nella revisione ufficiale del (registro: Banca dati dei prodotti naturali per la salute autorizzati (BDPSNH), Health Canada: prodotti autorizzati, ingredienti, dosi, usi e avvertenze).
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