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.

Known Adverse Reactions : The most common reactions identified during Axcan's post-marketing experience with VIOKASE are: Bloating, pain in the stomach area, constipation, diarrhoea, upset stomach, gassiness (flatulence), nausea, stomach discomfort, weakness, hypersensitivity, headache, itching, rash and hives. Known Adverse Reactions/Information for Health Care Practitioners: The following adverse reactions, presented by system organ class in alphabetical order, have been identified during Axcan's post-marketing experience with VIOKASE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. It is important to note that several of these reactions may also be attributable to the underlying disease itself. 1. Gastrointestinal disorders: Abdominal distension, Abdominal pain, Constipation, Diarrhoea, Dyspepsia, Flatulence, Nausea, Stomach discomfort. 2. General disorders and administration site conditions: Asthenia. 3. Immune system disorders: Hypersensitivity. 4. Nervous system disorders: Headache. 5. Skin and subcutaneous tissue disorders: Pruritus, Rash, Urticaria

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 : Potential for Allergic Reactions: Caution should be exercised in subjects with a known allergy to proteins of porcine origin. Rarely, severe allergic reactions including anaphylaxis, asthma, hives, and pruritus, have been reported with other pancreatic enzyme products with different formulations of the same active ingredient (pancrelipase). The risks and benefits of continued VIOKASE® treatment in subjects with severe allergy should be taken into consideration with the overall clinical needs of the subject. Potential for Viral Exposure from the Product Source: No cases of transmission of an infectious illness associated with the use of porcine pancreatic extracts have been reported. However, VIOKASE is sourced from pancreatic tissue from pigs used for food consumption. There is a theoretical risk for transmission of viral disease, including diseases caused by novel or unidentified viruses. Thus, the presence of porcine viruses that might infect humans cannot be definitely excluded. Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenicity, genetic toxicology, and animal fertility studies have not been performed with pancreatic enzyme products derived from pigs. Pregnancy: Animal reproduction studies have not been conducted with pancrelipase. It is also not known whether pancrelipase can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. The risks and benefits of pancrelipase should be considered in the context of the need to provide adequate nutritional support to a pregnant woman with exocrine pancreatic insufficiency. Adequate caloric intake during pregnancy is important for normal maternal weight gain and fetal growth. Reduced maternal weight gain and malnutrition can be associated with adverse pregnancy outcomes. Nursing Mothers: It is not known if pancrelipase is excreted in human milk.

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