Navigation Links
CREON(R) (pancrelipase) Delayed-Release Capsules Improves Digestive Outcomes In Adults With Chronic Pancreatitis
Date:10/26/2009

have been allowed to be marketed as prescription drugs without formal NDA approval. In 2004, the FDA required manufacturers to submit New Drug Applications (NDAs) for all pancreatic enzyme replacement therapies in order to remain on the market. By April 2010, all pancreatic enzyme replacement therapies are required to have approved NDAs and must be manufactured under the new guidelines.

Important Safety Information

Warnings and precautions include fibrosing colonopathy, a rare, serious adverse reaction that has been described in association with high-dose use of pancreatic enzyme replacement therapy in the treatment of cystic fibrosis patients. Caution should be exercised when doses of CREON®( )exceed 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day). Care should be taken to ensure that CREON®( )is not chewed or retained in the mouth to avoid irritation of oral mucosa. Caution should be exercised when prescribing CREON®( )to patients with gout, renal impairment, or hyperuricemia. There is theoretical risk of viral transmission with all pancreatic enzyme products, including CREON®. Caution should be exercised when administering pancrelipase to a patient with a known allergy to proteins of porcine origin.

In the clinical study used to demonstrate the efficacy and safety of FDA-approved CREON®, the incidence of adverse events (regardless of causality) was higher during placebo treatment (71%) than during CREON®( )treatment (50%). Treatment-emergent adverse events occurring in at least two patients (greater than or equal to 6%) receiving CREON®( )or placebo were abdominal pain, abdominal pain upper, abnormal feces, cough, dizziness, flatulence, headache, and weight decreased.

CREON®( )has been approved with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh its risks
'/>"/>

SOURCE Solvay Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. Results Published In Journal of Cystic Fibrosis Confirm CREON(R) (pancrelipase) Delayed-Release Capsules Improves Fat Absorption in Patients With Cystic Fibrosis
2. CREON(R) (pancrelipase) Delayed-Release Capsules Improves Absorption of Fat in Young Children With Cystic Fibrosis
3. Procter & Gamble Pharmaceuticals Launches Asacol(R) HD (mesalamine) Delayed-Release Tablets
4. Aptivus(R) (tipranavir) Capsules Granted Full Approval by the U.S. FDA
5. GSK Receives Approval for HYCAMTIN(R) (topotecan) Capsules for the Treatment of Relapsed Small Cell Lung Cancer
6. Alpharma Announces Positive Results From Pivotal Phase III Efficacy Trial on ALO-01 (EMBEDA(TM)) (morphine sulfate extended-release with sequestered naltrexone hydrochloride) Capsules at the American Academy of Pain Management Annual Clinical Meeting
7. Roxane Laboratories, Inc. Updated Launch of Calcium Acetate Capsules, 667mg
8. Mylan Receives FDA Approval for Generic Version of Anticonvulsant Topamax(R) Sprinkle Capsules
9. Experimental Drug Ketasyn(TM) Improves Memory in Age-Associated Memory Impairment Study
10. First Osteoporosis Study in Hip Fracture Patients Finds Once-Yearly Reclast(R) Prevents Additional Fractures and Improves Survival
11. New England Journal of Medicine Study Shows ERBITUX(R) Improves Survival in Advanced Colorectal Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/11/2014)... 2014 On Thursday, July ... the Dow Jones Industrial Average finished the day 0.42% lower ... 0.41%. The losses were broad based as eight out of ... Health Care Sector Index ended the day at 711.88, down ... one month. Investor-Edge has initiated coverage on the following equities: ...
(Date:7/11/2014)... 11, 2014  Veran Medical Technologies, a ... the positive, cost-effective final results for the ... The SPiNPerc endobronchial percutaneous biopsy study results ... to biopsy when a traditional bronchoscopic method ... experience positive financial outcomes when more can ...
(Date:7/10/2014)... , July 11, 2014  Major advances ... of cancer are being highlighted in a three-day ... from 10-12 July, 2014.  Renowned national and ... share best practices and exchange knowledge on modern ... accurate and efficient. The Summit ...
Breaking Medicine Technology:Health Care Equipment Equities Movers and Shakers -- Research on Covidien, Baxter, DexCom, and Boston Scientific 2Health Care Equipment Equities Movers and Shakers -- Research on Covidien, Baxter, DexCom, and Boston Scientific 3Health Care Equipment Equities Movers and Shakers -- Research on Covidien, Baxter, DexCom, and Boston Scientific 4Veran Medical Publishes Lung Cancer Patient Management Study 2Improving quality and access to advanced cancer care in India and South Asia 2Improving quality and access to advanced cancer care in India and South Asia 3Improving quality and access to advanced cancer care in India and South Asia 4Improving quality and access to advanced cancer care in India and South Asia 5
... China, May 3, 2012 /PRNewswire-Asia/ -- Winner Medical Group ... the "Company"), a leading China-based exporter and retailer of ... cotton, announced today that it will release financial results ... Winner Medical,s senior management will host a conference call ...
... 2012  Omeros Corporation (NASDAQ: OMER ) today ... with each of four additional orphan G protein-coupled receptors ... developing drugs targeting those receptors is extremely difficult. Omeros ... percent of the Class A orphan GPCRs. There are ...
Cached Medicine Technology:Winner Medical Group Inc. to Host Second Quarter 2012 Earning Conference Call on Thursday, May 10, 2012 at 9:00 p.m. EDT 2Omeros Adds Four More Unlocked Orphan GPCRs to its Portfolio 2Omeros Adds Four More Unlocked Orphan GPCRs to its Portfolio 3Omeros Adds Four More Unlocked Orphan GPCRs to its Portfolio 4
(Date:7/12/2014)... July 12, 2014 Demand Response Management ... considerable benefits in reducing the imbalance between energy supply ... appliances have been rolled out (due to increasing pressure ... (AMI). This helps in controlling residential appliances and thermostats ... in the North American region, and with government mandates ...
(Date:7/12/2014)... York, New York (PRWEB) July 12, 2014 ... liver damage allegations continue to move forward in ... Court, Eastern District of Pennsylvania, Bernstein Liebhard LLP ... 2014, U.S. District Judge Lawrence F. Stengel has ... Among other things, Judge Stengel found that the ...
(Date:7/12/2014)... 2014 (HealthDay News) -- Burn injuries increase in the summer ... say burn experts. Among those most vulnerable to these seasonal ... vulnerable and often get burned by putting their hands on ... of the burn unit at Loyola University Medical Center in ... old adage of ,When you play with fire, you get ...
(Date:7/12/2014)... “After my mom’s stroke, she loss the use of her ... use of his left side. Eating became a difficult task for ... like them enjoy eating again,” said an inventor, from Fayetteville, N.C. ... HALL PLATE (P C H PLATE). , The PATRICIA CAROL HALL ... eat for individuals who suffer from stroke, experience tremors or loss ...
(Date:7/12/2014)... July 12, 2014 With prom shopping ... manufacturer and retailer, is ready to showcase its new ... new collection of evening dresses in its online shop. ... 67% off) for these elegant gowns. According to the ... end on July 26, 2014. , He says, ...
Breaking Medicine News(10 mins):Health News:North America Demand Response Management System Worth $12,522.4 Million by 2019 - New Report by MicroMarket Monitor 2Health News:North America Demand Response Management System Worth $12,522.4 Million by 2019 - New Report by MicroMarket Monitor 3Health News:North America Demand Response Management System Worth $12,522.4 Million by 2019 - New Report by MicroMarket Monitor 4Health News:Tylenol Lawsuit News: U.S. District Judge Overseeing Federal Tylenol Liver Damage Litigation Orders Deposition of Former McNeil President, Bernstein Liebhard LLP Reports 2Health News:Tylenol Lawsuit News: U.S. District Judge Overseeing Federal Tylenol Liver Damage Litigation Orders Deposition of Former McNeil President, Bernstein Liebhard LLP Reports 3Health News:Tylenol Lawsuit News: U.S. District Judge Overseeing Federal Tylenol Liver Damage Litigation Orders Deposition of Former McNeil President, Bernstein Liebhard LLP Reports 4Health News:Burn Injuries More Common in Summer 2Health News:VogueQueen.com Updates Its Summer Collection With New And Trendy Evening Dresses 2
... in India, Brazil, China and South Africa, scientists say nanotechnology ... could give developing nations new ways to diagnose and treat ... manipulate and manufacture things on a scale of 1 to ... a sheet of paper is about 100,000 nanometers thick. ...
... say researchers. Take heart, not many, at least in Australia, have ... 2 percent of the population has a lesion on their brain ... . Out of these very few will actually trigger off ... D'Souza, a neurologist at St. Vincent's Hospital Melbourne and team, who ...
... Joseph Pilates invented this popular form of exercise, Pilates ... is widely recommended for losing weight, reducing or eliminating ... question whether Pilates is any good, at least for ... ,Participants of Pilates are taught to strengthen a ...
... its pound// of flesh. ,According to Scottish experts from ... the country. Diabetes Type 2, known as maturity ... 20s, 30s,and even in teens, something that was never heard of ... lifestyle and oneself. Fast food cheaper and more ...
... with colorectal cancer who require the surgical removal ... experimental procedure may decrease the time they spend// ... both the benefits of laparoscopic surgery and open ... affiliates are currently recruiting patients for a clinical ...
... U.S. Marine Corps, 50-year-old Joseph Wollschlager Jr. felt invincible. Until ... led to the diagnosis of a life-threatening brain tumor. Survival ... a year. ,But Wollschlager is fighting all the ... the University of Michigan Comprehensive Cancer Center, Wollschlager is back ...
Cached Medicine News:Health News:India, China Trying to Fight Disease With Nanotechnology 2Health News:India, China Trying to Fight Disease With Nanotechnology 3Health News:Simple Act of Brushing Your Teeth can Trigger an Epileptic Fit, Say Experts 2Health News:Pilates-new Age Gimmick or More? 2Health News:Pilates-new Age Gimmick or More? 3Health News:Ticking Time Bomb of Scotland-diabetes 2Health News:New Surgical Technique Decreases Colorectal OR Time 2Health News:New Protocol Targets Aggressive Brain Cancer 2
Comes complete with its own case. A unique integrated design with no need for two separate bars., ,Optical surfaces are recessed for optimum protection. Extensive prism power 1,2,3,4,6,8,10,15,20...
Well established test for children but suitable for disabled people, those with learning difficulties or patients who do not share a common language with the examiner....
... System is designed to provide easy and accurate ... and are at high risk for conventional surgery. ... Carotid Stent System is 6F sheath/8F guide catheter ... ACCULINK utilizes rapid exchange (RX) technology so that ...
The New Vantage Plus. The PLUS gives you: ,P Premium intelligent optics ,L Lighter weight and brighter images ,U Unique wireless patented technology ,S Smaller and more compact size ...
Medicine Products: