Mayoly Spindler: New Study Shows Test & Treat Strategy Using Urea Breath Tests Is Cost-effective in Managing Symptoms and Consequences From Infection Caused by the Helicobacter Pylori Bacteria, Contributing to Prevent Peptic Ulcer and Gastric Cancer
PARIS, Nov. 27, 2018 /CNW/ - Helicobacter pylori infection is a major public health issue affecting 60% of the world's population with 90% of Peptic Ulcers attributed to and 80% of Gastric Cancers associated with Hp infection.
(Logo: https://mma.prnewswire.com/media/787594/Mayoly_Spindler_Laboratories_Logo.jpg )
With the support of an international expert panel composed of Pr Javier Gisbert & Dr Adrian Mc Nicholl (Spain), Pr Francesco Franceschi (Italy), Pr Peter Malfertheiner (Germany) and methodologists, a new study has been carried out to assess different strategies for Helicobacter pylori infection diagnosis & eradication control.
The results have been presented by Dr Adrian McNicholl (Hospital Universitario de La Princesa, Madrid, Spain) at the XXXIst International Workshop on Helicobacter & Microbiota in Inflammation and Cancer in Kaunas (Lithuania) on 14th September 2018 during a "State of the Art" session.
The study shows that a "Test & Treat strategy" including the use of Urea Breath Tests as recommended in Spain is as effective as carrying out an endoscopy alone and has shown to be cheaper and more cost-effective than the symptomatic treatment strategy to manage dyspeptic patients. This strategy also seems to be the most cost-effective to prevent gastric cancer.
Pr Javier Gisbert, (Hospital Universitario de La Princesa, Madrid, Spain) stated: "Although this Test & Treat" strategy is incorporated in guidelines in multiple countries, the analysis of the European Hp registry covering more than 20,000 patients shows that it is not always implemented. We need to teach our colleagues to align clinical practice with guidelines and the results from this cost-effectiveness study is an excellent opportunity for this."
Jean-Nicolas Vernin, President of Mayoly Spindler declared: "As a key player in the field of Helicobacter pylori infection management, Mayoly Spindler is very proud to support this project with the aim to improve the diagnostic and the management of patients with Hp infection and help prevent Peptic Ulcer and Gastric Cancer across the world."
By increasing awareness from Health Authorities, insurers, physicians, pharmacists and patients on the need for early diagnosis and eradication of Hp infection, this study will contribute to develop efficient prevention programs against Peptic Ulcer and Gastric Cancer.
SOURCE Mayoly Spindler Laboratories
Chronic Pain: How to Reduce Discomfort during a Workout
You may have been told that exercising is good for you no matter your health condition. This is because your body is designed to stay active in order to promote good health. Here are some of the techniques that you can use to reduce your discomfort during a workout if you suffer from chronic pain.
Engage in Stretching
Stretching is extremely beneficial when it comes to preparing your body for a workout. Even some of the lowest forms of activity can cause you pain if you have tight muscles. Getting your muscles to relax and help you to move more freely can reduce some of the discomfort that you experience following a workout. Another benefit is the stretching can help to increase your range of motion and help with chronic pain coping mechanisms.
Strengthen Core Muscle Groups
Building up other areas of your body could make completing daily tasks a little bit easier. This is because when you’re in chronic pain, you may avoid certain activities that cause you pain. Strengthening these core muscle groups can help to alleviate some of the pain that you experience. It will also decrease the amount of effort that’s required on your part just to get through the day.
Use Pain Relieving Strategies
You may have pain medication that’s prescribed to help you to be more active. Using pain medicine from a compounding pharmacy is one method to help you control your level of discomfort during a workout. Ensure that your medication is at peak efficacy levels so that you can engage in your exercise routine. This will allow you to develop your muscles so that you could end up requiring less pain managementand pain medication over time.
Reduce Load Bearing Exercises
Another common method of exercise for those that suffer from chronic pain is to change the types of exercises that are performed. Weight bearing exercises tend to be harder on your joints and could be causing you to experience more pain. Working out in a pool is one way to alleviate the stress on your joints. Biking can be another method that reduces the strain on certain parts of your body. Trying new ways of working out can help you to develop the necessary core strength to better cope with your chronic pain.
You don’t need to suffer through pain while trying to improve your physical health. Use these strategies to reduce the amount of discomfort that you experience during and after your workout efforts.
How to Exercise When Plagued with a Herniated Disc
Regular exercise is vital for human beings. It can help people stay trim and fit. It can make them less susceptible to medical conditions such as heart disease as well. If you have a herniated disc, intense pain, weakness and numbness may be issues for you. That doesn’t mean that you have to avoid working out entirely, though. If you’re cautious, you can make getting exercise with a herniated disc work for you.
Try Pilates and Yoga
Pilates and yoga are two exercise approaches that involve a lot of stretching. If you want to take charge of your herniated disc, you should try both pilates and yoga. These forms of exercise can boost flexibility and strength alike. They can often minimize severe pain that’s located in the lower back and legs, too.
Go for Aerobics
If you’re interested in getting a workout and in managing your herniated disc discomfort at the same exact time, you should think about going for certain aerobic workouts. A few examples are swimming, cycling and even basic walking. These exercise approaches can keep you fit. They can simultaneously decrease feelings of pain as well. Ask the doctor who is providing you with herniated disc treatmentabout exercises that may be appropriate for your specific circumstances.
Find out about Dynamic Lumbar Stabilization Exercises
Speak to your aforementioned physician about dynamic lumbar stabilization exercises. These exercises zero in on the muscles that are situated in the back and the abdomen. They prioritize things such as power, flexibility, and even posture. Talk to your doctor in detail about these moves and how they may benefit your condition.
Steer Clear of All Potentially Problematic Exercises
There are some exercises techniques out there that may potentially exacerbate the pain and discomfort that’s commonly part of a herniated disc. It’s critical to steer clear of all of these exercises. Some exercises that may intensify herniated disc discomfort are twisting moves, sit-ups, squats, and vigorous running. Ask your doctor about any and all exercise options that may not be appropriate for your individual condition. He or she may be able to counsel you on exercise alternatives, too. If you’re unable to run, jogging may be preferable.
A herniated disc doesn’t necessarily mean that you have to stop working out. Exercise can in many cases minimize all kinds of herniated disc woes. It’s crucial to get your doctor’s opinion before coming up with any exercise routine, though.
CELEBRATE WINTER SOLSTICE AT THE SPA AT FOUR SEASONS HOTEL LAS VEGAS
lululemon offers complimentary meditative yoga class, followed by “solstice specials” in the Spa.
Las Vegas, NV – Nov. 26, 2018 – Welcome winter solstice and commemorate the longest night of the year with a complimentary meditative yoga class.
The Spa will offer a series of winter solstice mini rituals, featured from Dec. 17 to 23. The 25-minute “Intention Massage” utilizes warm oil combined with purifying sage, juniper and cedarwood to cleanse the body and spirit. The 25-minute “Shortest Day Facial” offers an express service inclusive of a nutrient-dense Manuka honey balm cleans, pumpkin puree mask and facial massage. The “New Beginnings Manicure” offers a gingerbread-scented service inclusive of an aromatic soak, nail maintenance and moisturizing massage.
The perfect complement to the dynamic Las Vegas Strip, the Forbes Five-Star Spa is located inside the non-gaming, non-smoking Four Seasons Hotel Las Vegas on the Hotel’s lobby level. Designed to offer a tranquil, fully customizable spa experience, The Spa features 12 treatment rooms, including two oversized couples’ suites and an expanded co-ed Zen Lounge. Guests can indulge in an array of personalized treatments and services, featuring the industry’s leading eco-friendly product lines such as Naturopathica, Phytomer, Pure Fiji and Ajne.
Since its publication over 15 years ago, 500 Low-Carb Recipes has become a classic in the low-carb community, earning author Dana Carpender the affectionate moniker “low-carb queen” from her fans. The book is now a bestseller, with over half a million copies sold.
Low-carb cooking has evolved. A decade ago, low-carb menus relied on ingredients like artificial sweeteners, unhealthy vegetable oils, protein additives, and processed foods from grocery store shelves, like low-carb branded snack bars and packaged meals. Today’s low-carb cooking is influenced by larger food movements, such as clean eating; farm-to-table ingredients; higher fat ratios, thanks to the popularity of ketogenic diets; and less stigmatization of foods that have substantial inclusion in a low-carb diet, namely animal foods and saturated fat due to the growth of the Paleo and traditional foods movements. The New 500 Low-Carb Recipes is the beloved cookbook updated for today's low-carb movement.
If you’ve been getting bored with your low-carb diet, this is the book for you. No longer are you confined to plain chicken breasts with a side of broccoli. You’ll find dozens of exciting ways to vary a hamburger, a steak, pork chops chicken, and fish. You’ll find a wide variety of side dishes and salads and even breads, not to mention muffins, waffles, pancakes, and granola. In short, this book has recipes for all sorts of things you never dreamed of, including:
- Artichoke Frittata
- Country Scramble
- Gingerbread Waffles
- Asian Ginger Slaw
- Cajun Chicken Salad
- Pork Piccata
- Feta-Spinach Salmon Roast
- Grasshopper Cheesecake
- And many more!
Dana Carpender (Bloomington, Indiana) is a pioneer of the low-carb movement and best-selling author of over 14 cookbooks, including The New 500 Low-Carb Recipes, 1001 Low-Carb Recipes, 500 Paleo Recipes, 15-Minute Low-Carb Recipes, The Low-Carb Diabetes Solution Cookbook, 200 Low-Carb, High-Fat Recipes, The Low-Carb Diabetes Solution, The Insulin Resistance Solution, 500 Ketogenic Recipes, and many more. To date, her books have sold over a million copies worldwide. She writes about low-carb cooking and nutrition on her Facebook page, Dana Carpender's Hold the Toast Press.
THE NEW 500 LOW-CARB RECIPES
By Dana Carpender
Publishing: January 8, 2019
$22.99 US · $29.99 CAN · 336 pages · Trade Paperback
ISBN: 9781592338634
Fair Winds Press, an imprint of The Quarto Group
Medically Supported, Scientifically Tested & Technology Based Weight Loss Solution Expands Nationally
Mobile Friendly LeanMD, Inc. Provides Users Proven and Simple to Use System to
Lose Weight Four Times Faster than Typical Weight Management Program
San Ramon, CA – November 26, 2018 – LeanMD, a technology-based solution and medically supported weight loss program that features a cutting-edge mobile app, and offers patients a way to lose weight safely and effectively, is expanding nationally. After four years of research development and nearly ten years of hands-on learning in medical practices, the proven weight loss and management solution has grown beyond its early-adopter practices and opened in physician’s offices in California, Texas, Indiana, and Colorado.
Started by Board Certified Internal Medicine and Primary Care physician Dr. Mike Temkin in his San Ramon, California practice, along with his co-founder and fellow Primary Care physician Dr. Mark Musco, who services as Chief Medical Officer, a Registered Dietician, and team of software engineers and technologists, LeanMD successfully brings together scientific and medical research, real world experiences, physician support, and cutting-edge technology. Patients sign up for the program through a local medical practice (often times, their personal doctor’s) and conveniently receive support, guidance and information through both the doctor and their personalized mobile app.
“The LeanMD program is simple and convenient to use for both the patient and the doctor,” Dr. Musco said. “It calls for real food (not packaged), uses a mobile friendly and convenient communication platform, and involves many scientifically backed results as well as education nutritional counseling for the patient. Furthermore, LeanMD is managed and overseen by your doctor, so patients immediately feel comfortable with the program from the outset.”
LeanMD is currently available in over 20 medical practices in cities including: Berkeley, CA; Brentwood, CA; Brookings, OR; Capitola, CA; Dallas, TX; Fresno, CA; Louisville, CO; Manteca, CA; Modesto, CA; Monroe, LA; Rocklin, CA; San Diego, CA; San Francisco, CA; San Leandro, CA; San Ramon, CA; Stockton, CA; Terre Haute, IN; and Walnut Creek, CA.
“We are thrilled to grow and expand the LeanMD program to cities and communities across the country,” Dr. Temkin added. “Physicians love our program because it is scientifically backed, numbers based, requires real food, features a technology platform which provides education, and most importantly brings their patients back to health. And the patients love LeanMD because it’s flexible, affordable, simple and works!”
Dr. Temkin’s and Dr. Musco’s shared goal: “We’d love to see every doctor in America engage and treat their patients with the LeanMD program and mobile app. We truly believe it is possible because not only does the program work, but it’s easy to use and conveniently fits into each individual’s lifestyle. We believe the best way to attract people to a healthier lifestyle is to develop products that make that lifestyle more enjoyable. That’s what LeanMD does!”
How it works?
The LeanMD program’s success to date is attributed to its scientifically backed program that works in conjunction with personal coaching, mindfulness training, education, everyday living, and mobile technology. By collaborating with the patient’s personal physician, LeanMD is able to tailor a weight loss program that fits specific needs, and both addresses and treats many chronic conditions & medical issues. Further, through the cutting-edge LeanMD app, patients have a communications platform customized to them based on information only their doctor would know. As a result, doctors can accurately monitor the patient’s progress and provide expert advice and analysis to keep them on track.
For more than five years, LeanMD has successfully aided thousands in their weight loss journey by creating a program built specifically for the patient. According to the founders, LeanMD teaches the patient what works best for his or her unique physiology, and how to eat without incessant counting.
LeanMD also provides the following:
- Real, Fresh Food: Patients eat delicious and healthy, not-prepackaged or processed foods, which means following the LeanMD is not only convenient and flexible, but manageable for the long term.
- Easy to Follow Program: The LeanMD program is simple, safe and effective.
- Personalized Support: One-to-one coaching and tools designed to help the patient mindfully manage their weight long terms ensures success through the program and after.
- Evidence-Based: Through its scientifically-based nutrition principles, LeanMD is not only safe and effective, but it also may improve conditions such as HTN, CAD, diabetes I & II, GERD and more. Losing weight may also help reduce join, back and arthritis pain; improve mobility; and reduce the need for certain medications.
- Mobile Flexibility: The LeanMD mobile app shows the patient an overview of their personal information (weight, goals, total lost); the ability to track their individual process; access to nutritional information and tips (including sources of protein, vegetables and fruits); tips and strategies for success; menu planning and shopping; exercises tracking; and mindfulness tips. Simultaneously, doctors can accurately monitor progress and provide expert advice and analysis to keep the patient on track.
During the weight loss phase of the program, LeanMD creates a calorie deficit to induce rapid weight loss. In a study of 90 patients, the average pounds lost in three-months by patients was 27.8, in six-months was 39.67. These results made LeanMD four times more effective than other programs/diets, Following the weight loss phase, LeanMD patients are moved to the Sustainable Loss Program, to help them maintain the weight loss through the use of built-in monitoring and support.
Learn more about LeanMD at www.leanMD.com.
About Dr. Michael Temkin, DO
Michael Temkin, DO, is a Board Certified Internal Medicine and Primary Care physician and co-founder of LeanMD, Inc. Michael Temkin, DO grew up in a family of physicians and is carrying on that legacy at his primary care practice in San Ramon, California. Serving patients in the Tri-Valley and throughout the Bay Area, Dr. Temkin provides compassionate care that treats the whole person, not just symptoms. Dr. Temkin is a highly-regarded internal medicine physician with more than 20 years of experience. After graduating from the Western University of Health Sciences College of Osteopathic Medicine in Pomona, California, he completed his residency in internal medicine at Alameda Medical Center in Oakland, California, through a University of California San Francisco Medical Center Program.
He is a member of the American College of Physicians, the American Osteopathic Association, and the Obesity Medicine Association. Dr. Temkin stays involved in the community and has served as the team physician for the California High School football team in San Ramon for over 15 years. He’s an affiliated physician with San Ramon Regional Medical Center and John Muir Medical Center. Dr. Temkin’s philosophy centers around using preventive care to treat the whole patient. He believes in treating the root causes of symptoms to help patients heal from chronic conditions, and helping patients lose excess weight so they can feel their best. He takes the time to really listen to patients and cultivate relationships with them, so they feel comfortable talking with him and heeding his honest advice about improving their health.
About Dr. Mark Musco, MD
Mark Musco, MD, is a Primary Care Physician, founder and owner of Diablo Family Physicians, and co-founder of LeanMD, Inc. His specific medical interests include: Pediatric and Adolescent care; Diabetes, Hypertension, Lipid Disorders; Exercise & Nutrition; Preventive Health and Education; Men’s Health; and Weight Loss. He was drawn to family medicine for the relationship and connection with his patients. The passion he has for listening to and advocating for his patients is what drives his love of medicine. Dr. Musco co-founded Diablo Family Physicians with his wife Dr. Dolores Musco, with their mission being to treat patients like family and provide the best care possible for the community. Dr. Musco earned his MD from The Chicago Medical School and completed his residency in family medicine at the UCLA School of Medicine affiliated program at Ventura County Medical Center. He is certified through the American Board of Family Medicine. When not caring for patients at the practice Dr. Musco can be found hanging out with his family or on Mount Diablo on his Mountain Bike.
About LeanMD, Inc.
LeanMD is a medically supported weight loss program that features a mobile app, and offers patients a way to lose weight safely and effectively. Founded on evidence-based medicine and scientifically backed nutrition principles, LeanMD was developed by a team of dedicated professionals that included physicians, registered dieticians, technologists and software engineers. The medically supervised program gives participants access to the best and most up-to-date medical, pharmaceutical, and nutritional support available. Both high tech and high touch, LeanMD is designed to help users achieve weight loss that is both healthy and sustainable. Powered by mobile technology, physicians and patients alike benefit from the efficiency, one-stop convenience and remote access that LeanMD offers. Today, LeanMD has locations throughout California, Colorado, Indiana, Louisiana, Texas and Oregon, with new markets scheduled to launch. Learn more at www.leanmd.com.
Popular Carrot Rewards App Celebrates Million-User Milestone by Launching Carrot Plus
TORONTO, Nov. 26, 2018 /CNW/ - Carrot Rewards, Canada's most popular wellness app, marks the arrival of its one-millionth user today by launching Carrot Plus, a version that enables Canadians to earn rewards up to 10x faster when they achieve their daily walking goals.
The celebrated platform — named Best App in Canada by MobileSyrup and ranked as one of the fastest growing startup companies by Canadian Business and Maclean's magazine — has already awarded Canadians two billion points from everyday reward programs like Aeroplan®, SCENE®, Petro-Points™, More Rewards®, Drop and RBC Rewards™. Users earn their choice of loyalty points for participating in fun wellness quizzes and for staying physically active and meeting daily step goals.
By upgrading to one of three Carrot Plus tiers, Canadians will now be able to earn 2x, 5x or even 10x more rewards when they reach their personalized daily step goals, for a special introductory monthly subscription fee of $1.99, $3.99 or $5.99 respectively. Users who upgrade to Carrot Plus for a full year will also qualify for the special introductory pricing as well as additional bonuses of hundreds, or in some cases, thousands of reward points.
"We're doing it again," said Andreas Souvaliotis, Founder and CEO of Carrot Rewards. "Now that we've proven the unique power of everyday wellness incentives, now that we know the positive difference Carrot can make in the daily wellness and physical activity levels of entire populations, now is the time to raise our impact bar again by offering Canadians the option to earn even more rewards for staying active each day. We are proud of the incredible difference we've made in the lives of one million people and we're ready to create even more engagement and positive behaviour changes across the country."
About Carrot Rewards
Carrot Rewards is an AI-driven public engagement platform that leverages behavioural economics and nudge theory to motivate Canadians to make better everyday lifestyle choices. Carrot Rewards harnesses the power of the most popular consumer loyalty programs in Canada to maximize its appeal and user engagement. Carrot users earn their choice of Aeroplan® Miles, SCENE® points, Petro-Points™, More Rewards® points, Drop points or RBC Rewards each time they interact with the app. The Carrot platform was created in collaboration with public sector agencies, the three leading Canadian health NGOs and the private sector.
With over a million downloads across Canada, Carrot is the most popular and trusted public engagement platform in the country. Carrot was recognized as Canadian App of the Year by MobileSyrup, is ranked as a Top 10 Loyalty Program in Canada by the Bond Brand Loyalty Report and as one of the Top Fastest Growing Companies by Canadian Business and Maclean's.
For more information, please visit: www.carrotapp.com
Twitter & Instagram: @carrot_rewards
Facebook: /carrotrewards
Available for Interviews:
Andreas Souvaliotis, Founder and CEO, Carrot Rewards
Lorne Solway, Chief Marketing and Strategy Officer, Carrot Rewards
SOURCE Carrot Insights
Health Canada Has Now Authorized ADYNOVATE® [Antihemophilic Factor (Recombinant), PEGylated] in Pediatrics for Treatment of Children Under 12 with Hemophilia A[1]
Canadian children now have access to ADYNOVATE®, which offers a twice-weekly prophylaxis dosing schedule and on-demand control of bleeding episodes1
TORONTO, Nov. 26, 2018 /CNW/ - Shire Pharma Canada ULC (Shire Canada), the leading global biotechnology company focused on rare diseases, is pleased to announce that on November 21, 2018 Health Canada authorized the extended indication for ADYNOVATE® [Antihemophilic Factor (Recombinant), PEGylated] for children under the age of 12 living with hemophilia A.1 In Canada, hemophilia A affects fewer than 1 in 10,000 people, or about 2,500 individuals.2
With this approval, Canadians under the age of 12 living with hemophilia A will now have access to ADYNOVATE®, the first extended half-life (EHL) PEGylated (Recombinant) factor VIII treatment available for:1
- Control and prevention of bleeding episodes
- Prophylaxis to prevent or reduce the frequency of bleeding episodes
- Perioperative management
ADYNOVATE® is designed to offer twice-weekly prophylaxis dosing as well as on-demand control of bleeding episodes for children with hemophilia A and for use during surgery.1 It is built on ADVATE® [Antihemophilic Factor (Recombinant)],1 the world's most widely used FVIII treatment.
"It is an exciting time in hemophilia care, with many promising products in the pipeline and coming to market," said Paul Wilton, President, Canadian Hemophilia Society.
Health Canada's authorization of the extended indication for ADYNOVATE® was based on data from a multi-centre, open-label, prospective, uncontrolled Phase 3 clinical study of patients under 12 years of age.1
The safety and efficacy of ADYNOVATE® was evaluated in a total of 73 pediatric previously treated patients (PTPs) with severe hemophilia A, of which 66 subjects were dosed (32 subjects aged <6 years and 34 subjects aged 6 to <12 years).1 The prophylactic regimen was 40 to 60 IU/kg of ADYNOVATE twice a week, with a mean (SD) dose of 51.1 IU/kg (5.5).1 The ABR was analyzed in a negative binomial model with the presence or absence of target joints and age at screening <6 years versus 6 to <12 years as covariates, and the duration of the observation period in years as an offset.1 The point estimate for the overall mean ABR was 3.04 (95% CI 2.21 – 4.19), with a median of 2.0.1 The point estimate for the mean ABR of spontaneous bleeds was 1.16 (95% CI 0.74 – 1.83), with a median of 0, and for joint bleeds it was 1.10 (95% CI 0.64 – 1.91), with a median of 0.1
Of the 66 subjects treated prophylactically:1
- 73 per cent experienced no joint bleeding episodes
- 67 per cent experienced no spontaneous bleeding episodes
- 38 per cent experienced no bleeding episodes
ADYNOVATE® was first approved in Canada in November 2016, for use in hemophilia A patients 12 years and older for on-demand treatment, prophylaxis and perioperative management to reduce the frequency of bleeding episodes.
"As a leader in developing innovative therapies to improve care for hemophilia patients, Shire is pleased to now offer a treatment option that can help Canadians manage hemophilia A from early childhood through to adulthood," said Eric Tse, General Manager, Shire Canada. "ADYNOVATE®'s unique PEGylation technology allows patients to achieve their treatment goals by providing bleed protection and extending time between treatments, allowing patients to spend more time leading active lives, doing what they love."
About Hemophilia A
Hemophilia A, the most common type of hemophilia, is a rare bleeding disorder that causes longer-than-normal bleeding due to lack of clotting factor VIII in the blood.3 Hemophilia primarily affects males, with an incidence of one in 5,000 male births.4 The severity of hemophilia A is determined by the amount of factor in the blood, with more severity associated with lower amounts of factor.5 More than half of patients with hemophilia A have the severe form of the condition.5 Approximately 25-30% of individuals with severe hemophilia A develop inhibitors.6 Inhibitors are a rare, but a serious medical problem that can occur when a person with hemophilia has an immune response to treatment with clotting factor concentrates.7
About ADYNOVATE®
ADYNOVATE® is built on the full-length ADVATE® molecule,1 a treatment for hemophilia A that has been used by patients worldwide for more than 13 years.8 ADYNOVATE® provides proven prophylaxis with twice-weekly dosing for patients with hemophilia A, helping to further individualize options for this patient population.1 The PEGylation technology was selected because it maintains the integrity of the parent molecule (ADVATE®) and reduces the time at which the body clears ADYNOVATE®, resulting in an extended circulating half-life.1
ADYNOVATE® is contraindicated in patients who have had prior anaphylactic reaction to ADYNOVATE®, to the parent molecule (ADVATE®[Antihemophilic Factor (Recombinant)]), mouse or hamster protein, or excipients of ADYNOVATE® (e.g. Tris, calcium chloride, mannitol, sodium chloride, trehalose, glutathione, histidine, and/or polysorbate 80).1
The most common adverse reactions (≥1% of subjects) reported in the clinical studies were headache, diarrhea, nausea and rash.1
Hypersensitivity reactions have been reported with ADYNOVATE®.1 Allergic-type hypersensitivity reactions, including anaphylaxis, are rare complications of treatment with recombinant antihemophilic factor, including the parent molecule, ADVATE®.1 Immediately discontinue administration and initiate appropriate treatment if hypersensitivity reactions occur.1
PEG exposure levels resulting from ADYNOVATE® therapy are very low.1 Based upon available experimental data, there is also a lack of evidence supporting the potential for accumulation of the specific PEG (20kDA) used in the pegylation of ADYNOVATE®.1 The potential for PEG accumulation with ADYNOVATE® is therefore considered to be low.1
Formation of neutralizing antibodies (inhibitors) to factor VIII can occur following administration of factor VIII products.1 Monitor patients regularly for the development of factor VIII inhibitors by appropriate clinical observations and laboratory tests.1 Perform an assay that measures factor VIII inhibitor concentration if the plasma factor VIII level fails to increase as expected, or if bleeding is not controlled with expected dose.1 Inhibitor development has been reported in ADYNOVATE®.1
The safety and efficacy of ADYNOVATE® in routine prophylaxis and the treatment of bleeding episodes have been evaluated in 66 previously treated children aged less than 12 years.1 There were no severe bleeding episodes in the study and none of the subjects underwent surgery.1
Pharmacokinetic studies in children (<12 years) have demonstrated higher clearance, a shorter half-life and lower incremental recovery of factor VIII compared to adults.1
To report SUSPECTED ADVERSE REACTIONS, contact Shire at drugsafety@shire.com, or Health Canada at 1-866-234-2345 or https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html.
Please see full Prescribing Information within the Canadian Product Monograph.
About Shire
Shire is the global biotechnology leader serving patients with rare diseases and specialized conditions. We seek to push boundaries through discovering and delivering new possibilities for patient communities who often have few or no other champions. Relentlessly on the edge of what's next, we are serial innovators with a diverse pipeline, offering fresh thinking and new hope. Serving patients and partnering with healthcare communities in over 100 countries, we strive to be part of the entire patient journey to enable earlier diagnosis, raise standards of care, accelerate access to treatment, and support patients. Our diverse portfolio of therapeutic areas includes Immunology, Hematology, Genetic Diseases, Neuroscience, Internal Medicine and Ophthalmics.
Championing patients is our call to action: it brings the opportunity and responsibility to change people's lives. www.shire.com
About Shire Pharma Canada ULC
Shire Pharma Canada ULC is a subsidiary of Shire. Our Canadian office is located in Toronto, Ontario. For more information, please visit: www.shirecanada.com.
SOURCE Shire Pharma Canada ULC
Healthy Lifestyle Habits Can Prevent Dementia
Chattanooga, TN, Nov. 23, 2018 ― Dr. Timothy R. Jennings speaks expertly on a subject that concerns over 5.5 million people across the nation: how to prevent dementia and keep our mind sharp as we age. A psychiatrist and international speaker, Jennings introduces his new book, recently rated #1 by Amazon in books on dementia, The Aging Brain: Proven Steps to Prevent Dementia and Sharpen Your Mind.
Dr. Jennings prescribes simple, everyday actions we can take to stave off disease, promote vitality, and prevent dementia and late-onset Alzheimer's. "The choices we make now can help us to keep our minds sharp and maintain our independence as we age,” says Jennings.
An easy-to-use guide to maintaining brain and body health throughout life, The Aging Brain is based on solid, up-to-date scientific research, and the interventions discussed can prevent progression toward dementia, even in those already showing signs of mild cognitive impairment. The recommendations also may help reduce disability and depression.
"This book isn't just for people hoping to slow the aging process,” says Jennings. "It's also for anyone who is a caregiver to someone at risk of or already beginning to suffer from dementia. It offers a hopeful, healthy way forward.”
Jennings, who maintains a private practice in Chattanooga, TN, has authored several books, including The God-Shaped Brain and The God-Shaped Heart. He is a Distinguished Fellow of the American Psychiatric Association and Fellow of the Southern Psychiatric Association, and is president and founder of Come and Reason Ministries.
For more information about Dr. Jennings, please visit the website: https://www.agingbrainbook.com.
To connect with Dr. Jennings, please visit: https://www.facebook.com/DrTimJennings/ and https://twitter.com/timjenningsmd.
The Aging Brain: Proven Steps to Prevent Dementia and Sharpen Your Mind
Baker Books
Released: June 2018
ISBN-10: 080107522X
ISBN-13: 978-0801075223
Reviews for The Aging Brain: Proven Steps to Prevent Dementia and Sharpen Your Mind:
Dr. Caroline Leaf, Cognitive Neuroscientist, Communication Pathologist and Author: "Great advice and excellent science on aging! It's well worth following and applying these principles so as to age the way we are supposed to.”
Rodney A. Poling, MD, DFAPA, medical director, Behavioral Healthcare Center, Columbia TN., and board-certified geriatric psychiatrist: "A well-researched and commonsense book aimed at helping one understand the complexities of dementia, while offering recommendations for maintaining healthy brain function into our later years.”
Michael Lyles, psychiatrist, author, and speaker: "Dr. Jennings clearly describes how to practically manage the medical and lifestyle variables that can positively impact brain health and the process of aging. Age is a number, but getting old is a lifestyle.”
