Resochin® (klorokin fosfat) plus Sumamed® (Azithromycin)

Najbolja vijest ovih mjeseci.

Resochin® ( klorokin fosfat )

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Sumamed® ( Azithromycin )

Vaše liječenje bolesti COVID -19 trenutno dostupnim lijekovima u Republici Hrvatskoj, ISKLJUČIVO uz suglasnost nadležnog bolničkog povjerenstva za lijekove i Vaš pristanak.

Liječenje se za sada temelji na liječenju simptoma i potpornom liječenju, te mjerama intenzivnog liječenja za teško oboljele. Istraživanja o pokušajima antivirusnog liječenja COVID-19 su malobrojna te za sada ne postoje dokazi o učinkovitom antivirusnom liječenju utemeljeni na kliničkim istraživanjima.

Unatoč tome, prema prvim do sada objavljenim iskustvima pokazalo se u pojedinim skupinama bolesnika da neki antivirusni lijekovi pokazuju određeno pozitivno djelovanje, iako za sada nisu odobreni za primjenu u liječenju COVID-19 te se radi o primjeni lijekova koji nisu registrirani za liječenje COVID-19.

Za liječenje bolesti COVID -19 nužno su u obzir uzete moguće kontraindikacije u primjeni, nuspojave navedenih lijekova (Resochin®) i interakcije koje može imati s drugim primijenjenim lijekovima, kao i eventualna korekcija doze lijekova ovisno o mogućem zatajenju pojedinih organa i organskih sustava.

U slučaju kliničke sumnje ili dokazane pridružene infekcije (influenca (gripa), bakterijska infekcija), ovom obliku liječenja dodaju se i drugi antivirusni/antibakterijski (Sumamed®) lijekovi. Primjena oseltamivira (Tamiflu®) indicirana je samo u slučaju istovremeno dokazane infekcije virusom influence (gripe). Za sada nema dokaza niti indikacije za istovremenu primjenu više lijekova (kombinacije) za liječenje COVID-19.

Resochin®

proizvod koji je Bayer otkrio 1934. predviđen za prevenciju i liječenje malarije, također ima i antivirusna svojstva širokog spektra te dobar učinak na imunološki sustav tijela. Novi podaci iz početnih pretkliničkih i evoluirajućih kliničkih istraživanja provedenih u Kini, iako su ograničeni, pokazuju potencijal za uporabu Resochina u liječenju pacijenata s infekcijom COVID-19.

Resochin® , a product discovered by Bayer in 1934 and indicated for prevention and treatment of malaria, also appears to have broad spectrum antiviral properties and effects on the body’s immune response. New data from initial preclinical and evolving clinical research conducted in China, while limited, shows potential for the use of Resochin®  in treating patients with COVID-19 infection.

Sumamed®

Skupina istraživača-znanstvenika iz PLIVE stvorila je 1981. godine novi antibiotik pod nazivom azitromicin, po svemu različit od ostalih do tada primjenjivanih antibiotika. U rujnu 1988. godine registriran je PLIVIN originalni antibiotik, azitromicin, poznatiji pod zaštićenim imenom

Sumamed®. Osobine azitromicina od samih početaka upućivale su na to da se radi po svemu jedinstvenom antibiotiku koji ima izvrsnu učinkovitost na najčešće uzročnike infekcija, ciljano djelovanje na mjestu infekcije, vrlo se jednostavno i kratko primjenjuje i ima odličnu podnošljivost. Iz farmakoloških osobina i kliničkih istraživanja proizišle su i originalne marketinške kampanje koje su mijenjale paradigmu razumijevanja antimikrobnog

učinka i djelovanja na mjestu infekcije, kao i način uzimanja antimikrobnih lijekova. Marketinške kampanje odnosile su se na jednostavnost i kratkoću primjene lijeka te izvrsnu učinkovitost i podnošljivost Sumameda®. U radu su prikazani počeci promocije Sumameda®.

In 1981 a group of researchers at PLIVA created azithromycin, a new antibiotic completely different from the antibiotics in use at the time. In September 1988 PLIVA registered azithromycin as its original antibiotic under the brand name Sumamed®. From the very beginning

the properties of azithromycin indicated that this was a unique antibiotic with excellent efficacy against the most common infectious agents, targeted action at the site of infection, simple dosing, short-term use and excellent tolerability. Pharmacological characteristics and results of clinical trials were used in the original advertising campaigns which resulted in a paradigm shift in the understanding of antimicrobial activity and

action at the site of infection, as well as of administration of antimicrobial drugs. Advertising campaigns referred to the simple and short-term use as well as excellent efficacy and tolerability of Sumamed®. The paper focuses on the beginnings of promotion of Sumamed®.

Zapamtite datum ove objave, da ne bude rečeno da nitko nije znao.

Remember the date of this announcement.

Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open label non-randomized clinical trial

Zeljko Serdar, CCRES

PS.
Zamolio bih još jednom naše čitatelje/sugrađane da se drže svih propisanih mjera, jer će samo one pomoći u suzbijanju koronavirusa. Hvala.

Once again, I would ask our readers / fellow citizens to adhere to all the prescribed measures to combat coronavirus. Thank you.

Help Us, Help You with COVID-19

With so many stylish kettles in market these days you can put one right on your desk anywhere you are working.



The seasonal cycle of respiratory viral diseases has been widely recognized for thousands of years, as annual epidemics of the common cold and influenza disease hit the human population like clockwork in the winter season in temperate regions. Moreover, epidemics caused by viruses such as severe acute respiratory syndrome coronavirus (SARS-CoV) and the newly emerging SARS-CoV-2 occur during the winter months. The mechanisms underlying the seasonal nature of respiratory viral infections have been examined and debated for many years. The two major contributing factors are the changes in environmental parameters and human behavior. Studies have revealed the effect of temperature and humidity on respiratory virus stability and transmission rates. More recent research highlights the importance of the environmental factors, especially temperature and humidity, in modulating host intrinsic, innate, and adaptive immune responses to viral infections in the respiratory tract.



Sa toliko modernih čajnika na tržištu ovih dana, jedan možete staviti na svoj stol bilo gdje kad nešto radite.



Sezonski ciklus respiratornih virusnih bolesti široko je prepoznat već tisućama godina, budući da su godišnje epidemije obične prehlade i gripe pogodile ljudsku populaciju poput sata u zimskoj sezoni u umjerenim regijama. Nadalje, epidemije uzrokovane virusima poput teškog korovirusnog akutnog respiratornog sindroma (SARS-CoV) i novonastalog SARS-CoV-2 javljaju se tijekom zimskih mjeseci. Mehanizmi na kojima se temelji sezonska priroda respiratornih virusnih infekcija ispitivani su i raspravljani dugi niz godina. Dva glavna faktora su promjene u okolišnim parametrima i ljudskom ponašanju. Studije su otkrile utjecaj temperature i vlažnosti na stabilnost respiratornih virusa i brzinu prijenosa. Novija istraživanja ukazuju na važnost okolišnih čimbenika, posebno temperature i vlažnosti, u moduliranju domaćih, urođenih i adaptivnih imunoloških odgovora na virusne infekcije dišnih putova.


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Raise Your Vibration

Have you heard people talking about attaining a higher vibration? Are you unsure what that means or why it's important to you? In this post I am going to address both questions so that you will have a clearer understanding and hopefully want to attain it for yourself and your life.

Becoming aware of your vibration—and the levels of what surrounds you—allows you to seek opportunities to raise your vibration level. Meaning that you can help manifest your own positivity, light, and love. Even if you have no conceptual understanding of what vibrations are, you have certainly felt them. A vibration is a state of being, the atmosphere, or the energetic quality of a person, place, thought, or thing. Everything in the universe is made up of molecules vibrating at different speeds. This includes trees, bodies, rocks, animals, thoughts, and emotions. Human vibrations are composed of everything from physical matter to the way you communicate the thoughts you think. In simple terms, some molecules vibrate faster and some vibrate slower; there are higher vibrations and lower vibrations. When you are vibrating at a higher level, you feel lighter, happier, and more at ease, whereas lower vibrations feel heavy, dark, and confused.

We all vibrate energetically at a particular frequency. The lower the frequency, the denser your energy, and the heavier your problems seem. Here you may experience pain and discomfort in your physical body and experience heavy emotions and mental confusion. Psychically, your energy is darker. You need to exert a great deal of effort to accomplish your goals. Overall, your life takes on a negative quality.

The higher the frequency of your energy or vibration, the lighter you feel in your physical, emotional, and mental bodies. You experience greater personal power, clarity, peace, love, and joy. You have little, if any, discomfort or pain in your physical body, and your emotions are easily dealt with. Your energy is literally full of light! Your life flows with synchronicity, and you manifest what you desire with ease. Overall, your life takes on a positive quality.

Being in a higher vibration is going to become more and more important to you and the rest of the world as we experience greater awareness of the polarities between the lower and higher vibrations. We will begin to perceive greater separation between the "dark" and the "light" almost as if we live in two worlds at once. We will need to consciously choose between the dark and the light or the higher and the lower vibrations.

Despair and desperation due to challenges will consume those vibrating at a lower frequency. Know that help is available from those vibrating at the higher frequency. The lower and denser energies will naturally want to rise when around the higher and lighter energies. However, this process will feel very uncomfortable for people who carry the lower energies and people who carry the higher energies for a while. It is important for people who carry a higher vibration to maintain it and not lower it no matter how uncomfortable it feels. Those people resonating at a higher vibration will only be able to maintain it as long as they don't succumb to the pull of the lower vibration. That pull will come in the form of old programs and patterns of needing approval or of wanting to "fit in."

When you choose to be in a higher vibration, you are an example. Choosing the light of a higher vibration requires a firm commitment to it even when it feels as though you no longer fit in. You won't receive approval or fit in any longer because you WILL stand out from those with a lower vibration just as a tiny light in the midst of a dark room stands out. Understand that those with the lower vibration have the potential to raise their frequency. Remember that you will be able to find people who resonate at a higher vibration where you will have the support you need to keep your light shining bright.

So for now, I hope you benefited out of this post. Please feel free to share your experiences with low and high vibrations below. Any advice you can share on how to raise your vibration will be appreciated!



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Pathways beyond Sustainability

There are 12 design principles in permaculture. I think they can be applied to daily life, work and play which will allow us to live happier and healthier, to work more effectively and to create a more sustainable world.

Here are the 12 principles:

Observe and interact.

Catch and store energy.

Obtain a yield.

Apply self-regulation and accept feedback.

Use and value renewable resources and services.

Produce no waste.

Design from patterns to details.

Integrate rather than segregate.

Use small and slow solutions.

Use and value diversity.

Use edges and value the marginal.

Creatively use and respond to change.

How can we use these principles to guide our life or our work?

Observe and interact- Let’s slow down and observe and appreciate our surroundings and others. Let’s slow down and interact with others, in real life, not on our phones.

Catch and store energy- Take time to relax to restore balance and energy. Also, for me this means associating myself with those who bring positive energy and it means doing things that bring me joy and make me feel energized like running and learning.

Obtain a yield- In permaculture, this of course might mean planting in such a way that the most food is created. The food is the reward. In life, we can work to obtain an intrinsic or extrinsic reward. These rewards need not be strictly financial. Perhaps the reward is making a difference in your client’s life or making your coworker’s day a little bit easier.

Apply self-regulation and accept feedback- Self-regulation or self-control allows us to be accountable and it empowers us. Feedback helps us improve which will help us excel at work.

Use and value renewable resources and services and produce no waste- These two principles are simply common sense tips to living a eco-friendly lifestyle and in creating a more sustainable world.

Design from patterns to details- Permaculture calls for standing back and observing patterns in nature and in society and then filling in the details; this might make for a more efficient and logical way to work as well.

Integrate rather than segregate and use and value diversity- These principles translate perfectly in how we should all live in harmony with each other by integrating everyone into our communities and valuing diversity.

Use small and slow solutions- Permaculture uses small and slow solutions because they are easier to manage than bigger solutions and they allow for the use of local resources leading to more sustainable outcomes. While this may not always be feasible- sometimes we need big and fast solutions to solve some of society’s greatest problems- this principle can potentially be a valuable tool for problem solving.

Use edges and value the marginal- Permaculture suggests that the interface between things is where the most interesting things take place. These are often the most valuable, diverse and productive parts of the system. This might mean extending a community garden out onto an edge near an unused railway. In life and work, we can try to more effectively use our resources including the edges.

Creatively use and respond to change- This requires no explanation, but in a changing world, it remains an important principle in both life and work. To remain a viable and sustainable business and to live well, we must be resilient and creatively work with change.

Using these principles may allow us to create a better life and a better world by caring for the earth and caring for people.

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Plasma derived therapy for coronavirus (COVID-19)

Rajeev Venkayya, President of Global Vaccines Business, discusses the latest on the coronavirus and Takeda including recently announced plan to develop a new plasma-derived-therapy to help treat high-risk individuals with COVID-19. Takeda Pharmaceutical Co is developing an experimental therapy for the novel coronavirus or Covid-19 with the goal of making it available in 9 to 18 months, Japan’s largest drugmaker said.

"We will do all that we can to address the novel coronavirus threat, ” Dr Rajeev Venkayya, president of Takeda’s vaccine business unit and head of the response team, said in a statement.

Oboljelima od koronavirusa na raspolaganju je tek ograničena terapija, jer pravog lijeka zasad nema pa se liječe simptomi. No, znanstvenici diljem svijeta pokušavaju u što kraćem roku doći i do lijeka i do cjepiva pa su informacije o tome sve češće. Najnovija govori da je japanska farmaceutska tvrtka Takeda na putu da krene u masovnu proizvodnju lijeka čiji bi temelj bila plazma oporavljenih pacijenata.
Naime, Japanci su razvili lijek koristeći plazmu, odnosno dijelove imunosnog sustava ljudi koji su oboljeli od koronavirusa i uspješno se oporavili. Terapija djeluje tako da antitijela oporavljenih pacijenata smanjuju utjecaj virusa i potiču brži oporavak.

U plazmi oporavljenih pacijenta nalaze se antitijela koja onda uništavaju virus ako organizam dođe s njim u doticaj. No, onaj tko nikad nije bio izložen nekom virusu ili bakterijama, kao što je to slučaj s koronavirusom, nema antitijela i velika je vjerojatnost da će se razboljeti. Kad se oboljelom unese plazma s antitijelima nekoga tko je prebolio koronavirus, ona će pomoći da se organizam lakše i brže oporavi. Stručnjaci se slažu da vrijedi pokušati s plazmom, ali to neće biti terapija za sve, već samo za one najteže pacijente, kažu u Takedi.

Takeda is closely monitoring the novel coronavirus (COVID-19) outbreak and the global response. As a company dedicated to the health and well-being of people around the globe, we are committed to taking steps to help those impacted by the coronavirus and try to lower the risk of transmission.

To this end, we announced today that we are initiating the development of an anti-SARS-CoV-2 polyclonal hyperimmune globulin (H-IG) to treat high-risk individuals with COVID-19, which we’re calling TAK-888. SARS-CoV-2 is the virus that causes COVID-19. Hyperimmune globulin is a plasma derived-therapy that has previously been shown to be effective in the treatment of severe acute viral respiratory infections and could be a treatment option for patients with COVID-19.  We’re collaborating with several health and regulatory agencies and health care partners across the globe to move the research forward. To develop TAK-888, scientists need to have access to source plasma from people who have successfully recovered from COVID-19.

In parallel, we are also exploring whether currently marketed and pipeline products may be an effective treatment option for infected patients. This will take time, but we are moving as quickly as possible.   In addition, Takeda is partnering with public entities and other pharmaceutical companies through the Innovative Medicines Initiative in Europe to leverage our collective expertise with the hope of developing diagnostics for COVID-19as well as inhibitors to help prevent future outbreaks, and consider whether the currently approved medicines might be repurposed. We are excited about the potential to address this public health crisis in both the short and long-term, but we knew from the beginning that we needed to act immediately.  This is why we are doing what we can to support healthcare workers in China by sending medical protective clothing, including masks and protective jumpsuits to impacted regions. Our first donation arrived in Wuhan, China and was delivered to local hospitals in early February. The second donation consisting of 5000 jumpsuits arrived shortly afterwards, and our third donation, which included critical medicines, is being delivered now. In addition, Takeda has donated JPY 31 million to the Red Cross and various hospitals in China.

While we continue to monitor the worldwide impact very closely and ensure we have the appropriate contingency plans in place, we are confident that patients will continue to receive Takeda medicines, and that our supply chain has not been negatively impacted by the spread of COVID-19.

We are actively taking steps to help the broader patient and health care provider community, the health and safety of our employees is also a top priority. Where possible, we are strongly encouraging employees in impacted regions, including Japan, to split shifts, commute in off-peak hours, or work from home.  We are also providing support for working parents who are home with children due to school closures.  We are significantly limiting international travel and utilizing technology in place of face-to-face meetings, to continue to collaborate and minimize business disruption as much as possible.  We are closely monitoring the outbreak and recommendations of public health authorities and will update this guidance on a regular basis.

- Anti-SARS-CoV-2 polyclonal hyperimmune globulin (H-IG) being developed to treat infected, high-risk individuals with COVID-19- Exploring the potential to repurpose marketed products and molecules to potentially treat COVID-19

Cambridge, Mass. and Osaka, Japan, March 4, 2020 – Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today will share with members of the United States Congress that it is initiating the development of an anti-SARS-CoV-2 polyclonal hyperimmune globulin (H-IG) to treat high-risk individuals with COVID-19, while also studying whether Takeda’s currently marketed and pipeline products may be effective treatments for infected patients. SARS-CoV-2 is the virus that causes COVID-19.

Hyperimmune globulins are plasma derived-therapies that have previously been shown to be effective in the treatment of severe acute viral respiratory infections and may be a treatment option for COVID-19. As a leader in plasma-derived therapies with more than 75 years of experience in the development of plasma-derived products, Takeda has the expertise to research, develop, and manufacture a potential anti-SARS-CoV-2 polyclonal H-IG, which Takeda is referring to as TAK-888.

“As a company dedicated to the health and well-being of people around the world, we will do all that we can to address the novel coronavirus threat,” said Dr. Rajeev Venkayya, President of Takeda’s Vaccine Business Unit and co-lead of the company’s COVID-19 response team. “We have identified relevant assets and capabilities across the company and are hopeful that we can expand the treatment options for patients with COVID-19 and the providers caring for them.”

Takeda is currently in discussions with multiple national health and regulatory agencies and health care partners in the US, Asia, and Europe to expeditiously move the research into TAK-888 forward. This requires access to source plasma from people who have successfully recovered from COVID-19 or who have been vaccinated, once a vaccine is developed. These convalescent donors have developed antibodies to the virus that could potentially mitigate severity of illness in COVID-19 patients and possibly prevent it.

H-IG works by concentrating the pathogen-specific antibodies from plasma collected from recovered patients or vaccinated donors in the future.  By transferring the antibodies to a new patient, it may help that person’s immune system respond to the infection and increase their chance of recovery. Because the plasma needed for TAK-888 is unlikely to come from current plasma donors, Takeda will initially produce the therapy in a segregated area within its manufacturing facility in Georgia, and development and production of it should not negatively impact Takeda’s ability to produce its other plasma-derived therapies.

“Plasma-derived therapies are critical, life-saving medicines that thousands of people with rare and complex diseases rely on every day around the world,” said Dr. Chris Morabito, Takeda’s Head of Research and Development, Plasma-Derived Therapies Business Unit. “Our heritage, combined with our scale, expertise and capabilities, uniquely position Takeda to realize the potential of plasma-derived therapies, such as TAK-888.”

In addition, Takeda is exploring whether select marketed therapies and molecules in its drug library could be viable candidates for the effective treatment of COVID-19. These efforts are at an early stage but being given a high priority within the company.   

An internal working group of in-house experts in public health, vaccines, plasma-derived therapies, and R&D will continue to seek opportunities to leverage our expertise and extensive network of global partners to address COVID-19. COVID-19 is the disease caused by severe acute respiratory syndrome coronavirus (SARS-CoV-2), which can cause pneumonia and has resulted in more than 3,000 deaths globally since its recent discovery. To date, there are no approved vaccines or therapies to prevent or treat COVID-19.

About Takeda Pharmaceutical Company LimitedTakeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries.

For more information, visit https://www.takeda.com.

About Plasma-Derived TherapiesPlasma-derived therapies are essential for treating patients with a variety of rare, life-threatening, complex and genetic diseases for which there are few or no other treatment options. Plasma is the clear, straw-colored liquid portion of blood that remains after red blood cells, white blood cells, and platelets are removed. Plasma has multiple components with different clinical uses. ​Plasma products have existed for ~ 80 years, and industry-wide research is underway to assess the larger potential therapeutic value of plasma in new diseases.

Media Contacts:Japanese Media                                             

Kazumi Kobayashi                                                                

Kazumi.Kobayashi@Takeda.com                   

+81 (0) 3-3278-2095                                                               

Media outside Japan

Katie Joyce

Katie.Joyce@Takeda.com 

+1 (617) 678-9370

Deborah Hibbett

Deborah.Hibbett@Takeda.com

+ 41 79 961 8464

Important NoticeFor the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

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