I believe the FDA had some standardization requirements for all the enzymes. Not surprised because when DS was in the hospital they gave him pancreacarb MT8s and they had more units of the last two ingredients than his normal pancrease MT10s. Probably just a consistency issue between brands.
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I believe the FDA had some standardization requirements for all the enzymes. Not surprised because when DS was in the hospital they gave him pancreacarb MT8s and they had more units of the last two ingredients than his normal pancrease MT10s. Probably just a consistency issue between brands.
I believe the FDA had some standardization requirements for all the enzymes. Not surprised because when DS was in the hospital they gave him pancreacarb MT8s and they had more units of the last two ingredients than his normal pancrease MT10s. Probably just a consistency issue between brands.
I believe the FDA had some standardization requirements for all the enzymes. Not surprised because when DS was in the hospital they gave him pancreacarb MT8s and they had more units of the last two ingredients than his normal pancrease MT10s. Probably just a consistency issue between brands.
I believe the FDA had some standardization requirements for all the enzymes. Not surprised because when DS was in the hospital they gave him pancreacarb MT8s and they had more units of the last two ingredients than his normal pancrease MT10s. Probably just a consistency issue between brands.
<div class="FTQUOTE"><begin quote>Probably just a consistency issue</end quote></div>Yes, they did want to fix this. The enzymes were around prior to the time rx meds needed fda approval to be on the market, so they were allowed to continue to be prescribed even after the time other meds needed to pass a more rigorous period of testing to gain approval. Now, over the last few years, the enzymes have been required to undergo the same process in order to stay on the market. They want to ensure consistency of product, etc. According to Creon's website they are the first enzyme to achieve fda approval status. I am sure the others are close behind. Here are excerpts from a <a target=_blank class=ftalternatingbarlinklarge href="http://healthcare.utah.edu/pharmacy/alerts/scan07-02-2009.pdf">letter</a> written by someone in drug information at Solvay Pharm (manufacturers of Creon):
<div class="FTQUOTE"><begin quote><u>Differences in Active Ingredients</u>
<u>Zero-overfill Formulation</u>
The new CREON® Delayed-Release Capsules formulation conforms to zero overfill
manufacturing guidelines established by the FDA; thus, the labeled lipase content of the new product reflects its actual lipase activity. In contrast,the enzyme activities of CREON® MINIMICROSPHERES® that were evaluated in six clinical studies showed that the average lipase content was approximately 120% of the labeled lipase content. CREON® Delayed-Release Capsules are available in three strengths and are dosed by lipase units. New prescriptions reflecting these new strengths must be written for CREON® Delayed-Release Capsules. Please see Section 2 of the Prescribing Information for the full dosage schedule.
(dosage chart...)
<u>Enzyme Supplier</u>
The pancrelipase in CREON® Delayed-Release Capsules is produced from pig pancreas glands supplied by Solvay Pharmaceuticals, GmbH. The pancrelipase in the CREON® MINIMICROSPHERES® formulation in the United States was produced from the pig pancreas glands supplied from Scientific Protein Laboratories, Ltd. The pancrelipase from both manufacturers are considered to be pharmaceutically comparable."
<u>Differences in Inactive Ingredients</u>
<u>Light Mineral Oil</u>
CREON® Delayed-Release Capsules do not contain light mineral oil, which was used as a lubricant in CREON®MINIMICROSPHERES®. Light mineral oil may impair the absorption of fat-soluble vitamins. As recommended by the Cystic Fibrosis Foundation 2004 Consensus Conference, vitamin levels should be monitored regularly in CF patients and vitamin doses adjusted as appropriate.</end quote></div>
<div class="FTQUOTE"><begin quote><u>Differences in Active Ingredients</u>
<u>Zero-overfill Formulation</u>
The new CREON® Delayed-Release Capsules formulation conforms to zero overfill
manufacturing guidelines established by the FDA; thus, the labeled lipase content of the new product reflects its actual lipase activity. In contrast,the enzyme activities of CREON® MINIMICROSPHERES® that were evaluated in six clinical studies showed that the average lipase content was approximately 120% of the labeled lipase content. CREON® Delayed-Release Capsules are available in three strengths and are dosed by lipase units. New prescriptions reflecting these new strengths must be written for CREON® Delayed-Release Capsules. Please see Section 2 of the Prescribing Information for the full dosage schedule.
(dosage chart...)
<u>Enzyme Supplier</u>
The pancrelipase in CREON® Delayed-Release Capsules is produced from pig pancreas glands supplied by Solvay Pharmaceuticals, GmbH. The pancrelipase in the CREON® MINIMICROSPHERES® formulation in the United States was produced from the pig pancreas glands supplied from Scientific Protein Laboratories, Ltd. The pancrelipase from both manufacturers are considered to be pharmaceutically comparable."
<u>Differences in Inactive Ingredients</u>
<u>Light Mineral Oil</u>
CREON® Delayed-Release Capsules do not contain light mineral oil, which was used as a lubricant in CREON®MINIMICROSPHERES®. Light mineral oil may impair the absorption of fat-soluble vitamins. As recommended by the Cystic Fibrosis Foundation 2004 Consensus Conference, vitamin levels should be monitored regularly in CF patients and vitamin doses adjusted as appropriate.</end quote></div>
<div class="FTQUOTE"><begin quote>Probably just a consistency issue</end quote></div>Yes, they did want to fix this. The enzymes were around prior to the time rx meds needed fda approval to be on the market, so they were allowed to continue to be prescribed even after the time other meds needed to pass a more rigorous period of testing to gain approval. Now, over the last few years, the enzymes have been required to undergo the same process in order to stay on the market. They want to ensure consistency of product, etc. According to Creon's website they are the first enzyme to achieve fda approval status. I am sure the others are close behind. Here are excerpts from a <a target=_blank class=ftalternatingbarlinklarge href="http://healthcare.utah.edu/pharmacy/alerts/scan07-02-2009.pdf">letter</a> written by someone in drug information at Solvay Pharm (manufacturers of Creon):
<div class="FTQUOTE"><begin quote><u>Differences in Active Ingredients</u>
<u>Zero-overfill Formulation</u>
The new CREON® Delayed-Release Capsules formulation conforms to zero overfill
manufacturing guidelines established by the FDA; thus, the labeled lipase content of the new product reflects its actual lipase activity. In contrast,the enzyme activities of CREON® MINIMICROSPHERES® that were evaluated in six clinical studies showed that the average lipase content was approximately 120% of the labeled lipase content. CREON® Delayed-Release Capsules are available in three strengths and are dosed by lipase units. New prescriptions reflecting these new strengths must be written for CREON® Delayed-Release Capsules. Please see Section 2 of the Prescribing Information for the full dosage schedule.
(dosage chart...)
<u>Enzyme Supplier</u>
The pancrelipase in CREON® Delayed-Release Capsules is produced from pig pancreas glands supplied by Solvay Pharmaceuticals, GmbH. The pancrelipase in the CREON® MINIMICROSPHERES® formulation in the United States was produced from the pig pancreas glands supplied from Scientific Protein Laboratories, Ltd. The pancrelipase from both manufacturers are considered to be pharmaceutically comparable."
<u>Differences in Inactive Ingredients</u>
<u>Light Mineral Oil</u>
CREON® Delayed-Release Capsules do not contain light mineral oil, which was used as a lubricant in CREON®MINIMICROSPHERES®. Light mineral oil may impair the absorption of fat-soluble vitamins. As recommended by the Cystic Fibrosis Foundation 2004 Consensus Conference, vitamin levels should be monitored regularly in CF patients and vitamin doses adjusted as appropriate.</end quote></div>
<div class="FTQUOTE"><begin quote><u>Differences in Active Ingredients</u>
<u>Zero-overfill Formulation</u>
The new CREON® Delayed-Release Capsules formulation conforms to zero overfill
manufacturing guidelines established by the FDA; thus, the labeled lipase content of the new product reflects its actual lipase activity. In contrast,the enzyme activities of CREON® MINIMICROSPHERES® that were evaluated in six clinical studies showed that the average lipase content was approximately 120% of the labeled lipase content. CREON® Delayed-Release Capsules are available in three strengths and are dosed by lipase units. New prescriptions reflecting these new strengths must be written for CREON® Delayed-Release Capsules. Please see Section 2 of the Prescribing Information for the full dosage schedule.
(dosage chart...)
<u>Enzyme Supplier</u>
The pancrelipase in CREON® Delayed-Release Capsules is produced from pig pancreas glands supplied by Solvay Pharmaceuticals, GmbH. The pancrelipase in the CREON® MINIMICROSPHERES® formulation in the United States was produced from the pig pancreas glands supplied from Scientific Protein Laboratories, Ltd. The pancrelipase from both manufacturers are considered to be pharmaceutically comparable."
<u>Differences in Inactive Ingredients</u>
<u>Light Mineral Oil</u>
CREON® Delayed-Release Capsules do not contain light mineral oil, which was used as a lubricant in CREON®MINIMICROSPHERES®. Light mineral oil may impair the absorption of fat-soluble vitamins. As recommended by the Cystic Fibrosis Foundation 2004 Consensus Conference, vitamin levels should be monitored regularly in CF patients and vitamin doses adjusted as appropriate.</end quote></div>
<div class="FTQUOTE"><begin quote>Probably just a consistency issue</end quote></div>Yes, they did want to fix this. The enzymes were around prior to the time rx meds needed fda approval to be on the market, so they were allowed to continue to be prescribed even after the time other meds needed to pass a more rigorous period of testing to gain approval. Now, over the last few years, the enzymes have been required to undergo the same process in order to stay on the market. They want to ensure consistency of product, etc. According to Creon's website they are the first enzyme to achieve fda approval status. I am sure the others are close behind. Here are excerpts from a <a target=_blank class=ftalternatingbarlinklarge href="http://healthcare.utah.edu/pharmacy/alerts/scan07-02-2009.pdf">letter</a> written by someone in drug information at Solvay Pharm (manufacturers of Creon):
<div class="FTQUOTE"><begin quote><u>Differences in Active Ingredients</u>
<u>Zero-overfill Formulation</u>
The new CREON® Delayed-Release Capsules formulation conforms to zero overfill
manufacturing guidelines established by the FDA; thus, the labeled lipase content of the new product reflects its actual lipase activity. In contrast,the enzyme activities of CREON® MINIMICROSPHERES® that were evaluated in six clinical studies showed that the average lipase content was approximately 120% of the labeled lipase content. CREON® Delayed-Release Capsules are available in three strengths and are dosed by lipase units. New prescriptions reflecting these new strengths must be written for CREON® Delayed-Release Capsules. Please see Section 2 of the Prescribing Information for the full dosage schedule.
(dosage chart...)
<u>Enzyme Supplier</u>
The pancrelipase in CREON® Delayed-Release Capsules is produced from pig pancreas glands supplied by Solvay Pharmaceuticals, GmbH. The pancrelipase in the CREON® MINIMICROSPHERES® formulation in the United States was produced from the pig pancreas glands supplied from Scientific Protein Laboratories, Ltd. The pancrelipase from both manufacturers are considered to be pharmaceutically comparable."
<u>Differences in Inactive Ingredients</u>
<u>Light Mineral Oil</u>
CREON® Delayed-Release Capsules do not contain light mineral oil, which was used as a lubricant in CREON®MINIMICROSPHERES®. Light mineral oil may impair the absorption of fat-soluble vitamins. As recommended by the Cystic Fibrosis Foundation 2004 Consensus Conference, vitamin levels should be monitored regularly in CF patients and vitamin doses adjusted as appropriate.</end quote></div>
<div class="FTQUOTE"><begin quote><u>Differences in Active Ingredients</u>
<u>Zero-overfill Formulation</u>
The new CREON® Delayed-Release Capsules formulation conforms to zero overfill
manufacturing guidelines established by the FDA; thus, the labeled lipase content of the new product reflects its actual lipase activity. In contrast,the enzyme activities of CREON® MINIMICROSPHERES® that were evaluated in six clinical studies showed that the average lipase content was approximately 120% of the labeled lipase content. CREON® Delayed-Release Capsules are available in three strengths and are dosed by lipase units. New prescriptions reflecting these new strengths must be written for CREON® Delayed-Release Capsules. Please see Section 2 of the Prescribing Information for the full dosage schedule.
(dosage chart...)
<u>Enzyme Supplier</u>
The pancrelipase in CREON® Delayed-Release Capsules is produced from pig pancreas glands supplied by Solvay Pharmaceuticals, GmbH. The pancrelipase in the CREON® MINIMICROSPHERES® formulation in the United States was produced from the pig pancreas glands supplied from Scientific Protein Laboratories, Ltd. The pancrelipase from both manufacturers are considered to be pharmaceutically comparable."
<u>Differences in Inactive Ingredients</u>
<u>Light Mineral Oil</u>
CREON® Delayed-Release Capsules do not contain light mineral oil, which was used as a lubricant in CREON®MINIMICROSPHERES®. Light mineral oil may impair the absorption of fat-soluble vitamins. As recommended by the Cystic Fibrosis Foundation 2004 Consensus Conference, vitamin levels should be monitored regularly in CF patients and vitamin doses adjusted as appropriate.</end quote></div>
<div class="FTQUOTE"><begin quote>Probably just a consistency issue</end quote>Yes, they did want to fix this. The enzymes were around prior to the time rx meds needed fda approval to be on the market, so they were allowed to continue to be prescribed even after the time other meds needed to pass a more rigorous period of testing to gain approval. Now, over the last few years, the enzymes have been required to undergo the same process in order to stay on the market. They want to ensure consistency of product, etc. According to Creon's website they are the first enzyme to achieve fda approval status. I am sure the others are close behind. Here are excerpts from a <a target=_blank class=ftalternatingbarlinklarge href="http://healthcare.utah.edu/pharmacy/alerts/scan07-02-2009.pdf">letter</a> written by someone in drug information at Solvay Pharm (manufacturers of Creon):
<div class="FTQUOTE"><begin quote><u>Differences in Active Ingredients</u>
<u>Zero-overfill Formulation</u>
The new CREON® Delayed-Release Capsules formulation conforms to zero overfill
manufacturing guidelines established by the FDA; thus, the labeled lipase content of the new product reflects its actual lipase activity. In contrast,the enzyme activities of CREON® MINIMICROSPHERES® that were evaluated in six clinical studies showed that the average lipase content was approximately 120% of the labeled lipase content. CREON® Delayed-Release Capsules are available in three strengths and are dosed by lipase units. New prescriptions reflecting these new strengths must be written for CREON® Delayed-Release Capsules. Please see Section 2 of the Prescribing Information for the full dosage schedule.
(dosage chart...)
<u>Enzyme Supplier</u>
The pancrelipase in CREON® Delayed-Release Capsules is produced from pig pancreas glands supplied by Solvay Pharmaceuticals, GmbH. The pancrelipase in the CREON® MINIMICROSPHERES® formulation in the United States was produced from the pig pancreas glands supplied from Scientific Protein Laboratories, Ltd. The pancrelipase from both manufacturers are considered to be pharmaceutically comparable."
<u>Differences in Inactive Ingredients</u>
<u>Light Mineral Oil</u>
CREON® Delayed-Release Capsules do not contain light mineral oil, which was used as a lubricant in CREON®MINIMICROSPHERES®. Light mineral oil may impair the absorption of fat-soluble vitamins. As recommended by the Cystic Fibrosis Foundation 2004 Consensus Conference, vitamin levels should be monitored regularly in CF patients and vitamin doses adjusted as appropriate.</end quote>
<div class="FTQUOTE"><begin quote><u>Differences in Active Ingredients</u>
<u>Zero-overfill Formulation</u>
The new CREON® Delayed-Release Capsules formulation conforms to zero overfill
manufacturing guidelines established by the FDA; thus, the labeled lipase content of the new product reflects its actual lipase activity. In contrast,the enzyme activities of CREON® MINIMICROSPHERES® that were evaluated in six clinical studies showed that the average lipase content was approximately 120% of the labeled lipase content. CREON® Delayed-Release Capsules are available in three strengths and are dosed by lipase units. New prescriptions reflecting these new strengths must be written for CREON® Delayed-Release Capsules. Please see Section 2 of the Prescribing Information for the full dosage schedule.
(dosage chart...)
<u>Enzyme Supplier</u>
The pancrelipase in CREON® Delayed-Release Capsules is produced from pig pancreas glands supplied by Solvay Pharmaceuticals, GmbH. The pancrelipase in the CREON® MINIMICROSPHERES® formulation in the United States was produced from the pig pancreas glands supplied from Scientific Protein Laboratories, Ltd. The pancrelipase from both manufacturers are considered to be pharmaceutically comparable."
<u>Differences in Inactive Ingredients</u>
<u>Light Mineral Oil</u>
CREON® Delayed-Release Capsules do not contain light mineral oil, which was used as a lubricant in CREON®MINIMICROSPHERES®. Light mineral oil may impair the absorption of fat-soluble vitamins. As recommended by the Cystic Fibrosis Foundation 2004 Consensus Conference, vitamin levels should be monitored regularly in CF patients and vitamin doses adjusted as appropriate.</end quote>
<div class="FTQUOTE"><begin quote>Probably just a consistency issue</end quote>Yes, they did want to fix this. The enzymes were around prior to the time rx meds needed fda approval to be on the market, so they were allowed to continue to be prescribed even after the time other meds needed to pass a more rigorous period of testing to gain approval. Now, over the last few years, the enzymes have been required to undergo the same process in order to stay on the market. They want to ensure consistency of product, etc. According to Creon's website they are the first enzyme to achieve fda approval status. I am sure the others are close behind. Here are excerpts from a <a target=_blank class=ftalternatingbarlinklarge href="http://healthcare.utah.edu/pharmacy/alerts/scan07-02-2009.pdf">letter</a> written by someone in drug information at Solvay Pharm (manufacturers of Creon):
<br />
<br /><div class="FTQUOTE"><begin quote><u>Differences in Active Ingredients</u>
<br />
<br /><u>Zero-overfill Formulation</u>
<br />The new CREON® Delayed-Release Capsules formulation conforms to zero overfill
<br />manufacturing guidelines established by the FDA; thus, the labeled lipase content of the new product reflects its actual lipase activity. In contrast,the enzyme activities of CREON® MINIMICROSPHERES® that were evaluated in six clinical studies showed that the average lipase content was approximately 120% of the labeled lipase content. CREON® Delayed-Release Capsules are available in three strengths and are dosed by lipase units. New prescriptions reflecting these new strengths must be written for CREON® Delayed-Release Capsules. Please see Section 2 of the Prescribing Information for the full dosage schedule.
<br />
<br />(dosage chart...)
<br />
<br /><u>Enzyme Supplier</u>
<br />The pancrelipase in CREON® Delayed-Release Capsules is produced from pig pancreas glands supplied by Solvay Pharmaceuticals, GmbH. The pancrelipase in the CREON® MINIMICROSPHERES® formulation in the United States was produced from the pig pancreas glands supplied from Scientific Protein Laboratories, Ltd. The pancrelipase from both manufacturers are considered to be pharmaceutically comparable."
<br />
<br /><u>Differences in Inactive Ingredients</u>
<br />
<br /><u>Light Mineral Oil</u>
<br />CREON® Delayed-Release Capsules do not contain light mineral oil, which was used as a lubricant in CREON®MINIMICROSPHERES®. Light mineral oil may impair the absorption of fat-soluble vitamins. As recommended by the Cystic Fibrosis Foundation 2004 Consensus Conference, vitamin levels should be monitored regularly in CF patients and vitamin doses adjusted as appropriate.</end quote>
<br />
<br /><div class="FTQUOTE"><begin quote><u>Differences in Active Ingredients</u>
<br />
<br /><u>Zero-overfill Formulation</u>
<br />The new CREON® Delayed-Release Capsules formulation conforms to zero overfill
<br />manufacturing guidelines established by the FDA; thus, the labeled lipase content of the new product reflects its actual lipase activity. In contrast,the enzyme activities of CREON® MINIMICROSPHERES® that were evaluated in six clinical studies showed that the average lipase content was approximately 120% of the labeled lipase content. CREON® Delayed-Release Capsules are available in three strengths and are dosed by lipase units. New prescriptions reflecting these new strengths must be written for CREON® Delayed-Release Capsules. Please see Section 2 of the Prescribing Information for the full dosage schedule.
<br />
<br />(dosage chart...)
<br />
<br /><u>Enzyme Supplier</u>
<br />The pancrelipase in CREON® Delayed-Release Capsules is produced from pig pancreas glands supplied by Solvay Pharmaceuticals, GmbH. The pancrelipase in the CREON® MINIMICROSPHERES® formulation in the United States was produced from the pig pancreas glands supplied from Scientific Protein Laboratories, Ltd. The pancrelipase from both manufacturers are considered to be pharmaceutically comparable."
<br />
<br /><u>Differences in Inactive Ingredients</u>
<br />
<br /><u>Light Mineral Oil</u>
<br />CREON® Delayed-Release Capsules do not contain light mineral oil, which was used as a lubricant in CREON®MINIMICROSPHERES®. Light mineral oil may impair the absorption of fat-soluble vitamins. As recommended by the Cystic Fibrosis Foundation 2004 Consensus Conference, vitamin levels should be monitored regularly in CF patients and vitamin doses adjusted as appropriate.</end quote>