VIOKASE

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VIOKASE (pancrelipase, USP) is indicated for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis, cystic fibrosis or other conditions.

Banca dati dei prodotti naturali per la salute autorizzati (BDPSNH), Health Canada: prodotti autorizzati, ingredienti, dosi, usi e avvertenze · 2012-11-01

Traduzione non disponibile. Testo originale, lingua: inglese.

Cautions and Warnings : VIOKASE and other pancreatic enzyme products are made from pancreatic organs of pigs used for food. The following risks are present with all pancreatic enzyme products including VIOKASE. Potential for Fibrosing Colonopathy: VIOKASE increases the chance of having a rare bowel disorder called fibrosing colonopathy. The condition is serious and may require surgery. The risk of having this condition may be reduced by following the dosing. Tell your health care practitioner if you have a history of intestinal blockage or fibrosing colonopathy. Potential for Irritation to the Mouth: Do not retain VIOKASE in the mouth. VIOKASE should not be crushed or chewed. Potential for Hyperuricemia: Increase in blood uric acid levels, which for example, may be associated with worsening of gout, or painful, swollen joints. Tell your health care practitioner if you have gout, kidney disease, or a condition called hyperuricemia. Potential for Allergic Reactions: Symptoms of an allergic reaction include: Trouble with breathing, skin rashes, or swollen lips. Tell your health care practitioner if you are allergic to pork (pig) products. Potential for Viral Exposure from the Product Source: There is a theoretical risk of contracting a viral infection from pig-derived medicines but no human illness has been reported. Contact your health care practitioner right away if you have any of the symptoms listed above. Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenicity, genetic toxicology, and animal fertility studies have not been performed with pancreatic enzyme products derived from pigs. Pregnancy: Tell your health care practitioner if you are pregnant or planning to become pregnant. It is not known if VIOKASE will harm your unborn baby. Nursing Mothers: Tell your health care practitioner if you are breast-feeding or plan to breast-feed. It is not known if VIOKASE passes into your breast milk.

Banca dati dei prodotti naturali per la salute autorizzati (BDPSNH), Health Canada: prodotti autorizzati, ingredienti, dosi, usi e avvertenze · 2012-11-01

Traduzione non disponibile. Testo originale, lingua: inglese.

Cautions and Warnings : Cautions and Warnings/Information for Health Care Practitioners: VIOKASE and other pancreatic enzyme products are made from pancreatic organs of pigs used for food. The following risks are present with all pancreatic enzyme products including VIOKASE. Potential for Fibrosing Colonopathy: Fibrosing colonopathy has been reported following treatment with different pancreatic enzyme products. Fibrosing colonopathy is a rare, serious adverse reaction initially described in association with high-dose pancreatic enzyme use, usually over a prolonged period of time and most commonly reported in pediatric subjects with cystic fibrosis. The underlying mechanism of fibrosing colonopathy remains unknown. Doses of pancreatic enzyme products exceeding 6,000 lipase units/Kg of body weight per meal have been associated with colonic stricture in children less than 12 years of age. Subjects with fibrosing colonopathy should be closely monitored because some subjects may be at risk of progressing to stricture formation. It is uncertain whether regression of fibrosing colonopathy occurs. It is generally recommended, unless clinically indicated, that enzyme doses should be less than 2,500 lipase units/Kg of body weight per meal (or less than 10,000 lipase units/Kg of body weight per day) or less than 4,000 lipase units/g fat ingested per day. Doses greater than 2,500 lipase units/Kg of body weight per meal (or greater than 10,000 lipase units/Kg of body weight per day) should be used with caution and only if they are documented to be effective by 3-day fecal fat measures that indicate a significantly improved coefficient of fat absorption. Subjects receiving higher doses than 6,000 lipase units/Kg of body weight per meal should be examined and the dosage either immediately decreased or titrated downward to a lower range. Potential for Irritation to Oral Mucosa: Care should be taken to ensure that no drug is retained in the mouth. VIOKASE® should not be crushed or chewed. These actions can cause early release of enzymes, irritation of oral mucosa, and/or loss or enzyme activity. Potential for Hyperuricemia: Caution should be exercised in subjects with gout, renal impairment, or hyperuricemia. Porcine-derived pancreatic enzyme products contain purines that may increase blood uric acid levels.

Banca dati dei prodotti naturali per la salute autorizzati (BDPSNH), Health Canada: prodotti autorizzati, ingredienti, dosi, usi e avvertenze · 2012-11-01