#SÚKL

[ocemsemlci]

Stanislav Novotný se ptá Aleny Dernerové na nelegální vývozy léků do zahraničí, proč v lékárnách chybí základní léky pro dětské pacienty a nečinnost ministra Válka https://ocemsemlci.cz/o-cem-se-mlci-alena-dernerova-2/?feed_id=1102

[pepikhipik]

Upozornění na množící se výskyty případů podezření z padělání léčivého přípravku Ozempic

SÚKL obdržel od EMA i dalších zahraničních autorit informaci o množících se případech podezření z padělání léčivého přípravku Ozempic 1mg, 0,5mg a 0,25mg.

[cysnews]

Dostupnost léků: Kde hledat informace?

Dostupnost léků: Kde hledat informace?

Dodavatelé léčivých přípravků mají povinnost Státnímu ústavu pro kontrolu léčiv nahlásit zahájení uvádění léčivého přípravku na trh, případné přerušení, následné obnovení či ukončení dodávek. SÚKL je tak o aktuálním stavu léčivého přípravku informován, pokud je hlášení provedeno. (more…)

[jirsen-blog]

Tvrdá patření proti covid-19 směřují ke kolektivní imunitě

Tvrdá patření proti covid-19 směřují ke kolektivní imunitě

Aktuální opatření proti šíření nového koronaviru covid-19 SARS-CoV-2 (zkráceně též C19) nejsou po chuti velké části obyvatel napříč celým světem. Víme opravdu všechno a nebo se zde na pozadí této tzv. pandemie něco podivného? Na celkovém průběhu je znát pozitivní výsledek vakcinace novými typy vakcín. Na počtech hospitalizovaných je vidět, že v celkovém počtu vážně nemocných jsou totiž zejména…

[frostdeer]

“A tiny island of doom and gloom”

That’s p much our country right now.

If you are wondering why I might seem a bit more “well fuck everything” than usual (I know it’s been my default mindset), well, WE HAVE A SITUATION. I know the entire world has a situation, but in the words of our PM, we truly are “best in covid” these days.

Under the cut, because, boy, I wrote more than I expected to write.

CNN article here covered it kinda nicely: 

https://edition.cnn.com/2021/02/28/europe/czech-republic-coronavirus-disaster-intl/index.html

I would also like to comment on a few things from the article:

“ It has a democratically elected government. “

- Yes, we do. But the very same government is led by a PM that has been criminally investigated for the past 3 years (I think) due to some not-really-legally-gained EU funds for his private business (hello?!) and there have been demonstrations against him for the past 2+ years. He has been asked to resign many many times, not just by the public, but also by some other politicians.

“Speaking in the Parliament on Friday, Prime Minister Andrej Babiš admitted his government has made "far too many mistakes," but said it was not the time to argue about the past. “

- Yes, he has admitted. But will he resign, as he was asked multiple times before because of these bad decisions of this government? No, of course not. There’s election in autumn, and he needs all the brownie points so his party gets elected again so he can stay in power. Even if he says his actions aren’t politically motivated, but, really? Does anyone believe that? Really? #ohwell

We had 3 ministers of health in the past year. Ahem.

We also had a lot of experts who were advising the government, but at some point there were too many of them. One expert said something, second advisor said another thing, a minister of health said something a little different, then the PM said something compeltely different and then even the president said something even more completely different. And now, how the fuck are we supposed to know what should we do and whose word is the “official” one. Last summer was a mess, people thought “oh yay epidemic ended, we can go run free and go in bars!” 

End of summer was also the time when the PM said his famous line “We’re best in covid” and then it started getting downhill and continues going downhill to this moment.

In my personal opinion, one of the biggest reasons we’re in this mess is also the fact that police doesn’t really fine people who are caught breaking the restrictions. Not having a mask in the public transport? Well put it on, but don’t do it next time, okay? If the police was fining people everytime they caught someone not following the restrictions (like in some other countries), boy, would they have tons of extra funding and people might take the rules a bit more seriously. But no, an agreement is fine, right?   #ohwell_2

A lot of people here are also in the extreme antivax mindset, not just when concerning vaccines in general, but the whole “please wear a mask”. To them it’s a muzzle, preventing their freedom of speech and yadda yadda, I mean, just imagine the Typical American Karen(tm) and that’s p much those people. Not to mention they just go to their fave pubs through the backdoor, drinking, partying, as if nothing was happening. Not to mention politicians and publicly known people do that as well. In fact, our second minister of health had to resign because of the fact he was caught leaving a restaurant (mistake 1 - restaurants were not allowed to be open) after 10pm (mistake 2 - 10pm was a curfew at that time) and without a mask (mistake 3 - well duh). The fact that some of these very publicly known personas are also the ones who openly say that “covid is a hoax” (like our former president, who in a big turn of events actually got covid last week, eh), well, it doesn’t really help the situation either.

The vaccination system is absolutely not going according to plan, the registration system for the vaccines is a goddamn mess, prioritised groups are people over 80 years and medical personnel, and then it was supposed to be a turn for people with chronic diseases that compromise immunity and thus have a bigger chance to have a difficult case of covid if infected (a group into which I belong)... and it has been changed multiple times. Currently the people who are allowed to register are people over 70 years AND teachers. Because there is also a strong push for schools being reopened, I mean... * shrug * Oh, and for some reason people (mostly seniors) are refusing to be vaccinated by Astra Zeneca vaccine, which is just laying unused in the warehouses because of that. At least the teachers reportedly don’t mind, “as long as it is not Sputnik”.

Talking about Sputnik... Earlier, our president (a very pro-russian and pro-chinese person, FYI) said that he personally talked to Putin and that Putin promised to send some Sputnik vaccines to CZ. And that he (president) would demand them to be used. Our PM however opposes that even if we got the Sputnik vaccines, they won’t be used until approved by the EMA. President says, for him the approval of SÚKL (czech agency for medicine control) would be enough. And I just... You know what, I think I better stop now.

If you managed to read all the way down here, I applaud you, because I don’t even know if the entire fucking post makes sense.

To sum it up, I am frustrated by the situation because there is nothing I can do other than I am already doing. I have been following the goddamn restrictions since last year, and seeing half of the country being absolute selfish dicks by shitting on these rules just angers me to the point I am having frequent spikes of anxiety that I haven’t had for YEARS. 

I wish that you guys are doing much better, both on the personal plain and within your respective countries. This is the life now, I guess.

Stay strong, my friends.

Oh well.

[prazskytankista]

Hledají novou nemoc, aby drželi opatření. Prof. Beran tvrdě. A odhalil kšeft

Vládnoucí garnitury by se podle profesora Jiřího Berana neměly vůbec zabývat tím, jaké informace mají či nemají občané dostávat. Odmítá tak, že by politici měli rozhodovat například o tom, jaké webové stránky a informace blokovat. „To není věc, kterou by se měli zabývat… Neměli by vstupovat do toho, co si lidé mezi sebou říkají. To mi připadá naprosto absurdní,“ řekl pro Nadační fond Svědomí národa s tím, že cenzura do demokratické společnosti nepatří. Kritizoval též rozhodnutí ministra zdravotnictví Vlastimila Válka jít při rozhodování o očkování starších dětí proti názoru SÚKL. source https://www.parlamentnilisty.cz/zpravy/kauzy/Hledaji-novou-nemoc-aby-drzeli-opatreni-Prof-Beran-tvrde-A-odhalil-kseft-704108

[autoring]

Postup Státního ústavu pro kontrolu léčiv (SÚKL) ve věci distribuce ochranných prostředků seniorům by podle ministra vnitra Jana Hamáčka (ČSSD) mohl vést k naplnění trestného činu obecného ohrožení. Strategické zásoby ochranných prostředků státu by podle něj mohly být znehodnoceny.

[epiderma-blog]

SÚKL stahuje některé léky na vysoký krevní tlak, vyskytla se u nich závada jakosti

SÚKL stahuje některé léky na vysoký krevní tlak, vyskytla se u nich závada jakosti

Státní ústav pro kontrolu léčiv stahuje kvůli závadě jakosti některé léky obsahující látku valsartan. Ty jsou předepisovány na vysoký krevní tlak, po infarktu myokardu a při chronickém srdečním selhání. Opatření se týká všech šarží přípravků Blessin, Blessin Plus H, Kylotan Neo, Kylotan Plus H, Valzap, Valzap Combi a Vanatex HCT.

[goldacrylicnails]

Sukl operates pursuant to part.

Based on the earlier step, the letter will probably be sent to an individual by ship with the experience that are used to be able to issue typically the certificate also to activate use of the website. If you give us with these sign in information, you may resolve this task remotely or even eventually. Just during business office settings. Using the previous move, a page will be provided for you simply by mail while using credentials used to matter the qualification and to encourage access to the particular portal. Should you provide us using these login data, you can remedy this step distantly or finally. Only in the course of office options. Furthermore, súkl operates pursuant to part 81a for the register regarding medicinal goods with restrictions. In order to abide by these legal provisions, súkl is currently possessing a new erecept information program. This new program, which changes the now used alternative system concerning electronic script, must match both security and technical criteria just like compliance considering the requirements within the cyber secureness act, acquiescence with accumulated system demands that will be attentive to the high load up, availability together with requirements to be able to safety since 1 the month of january 2018, that time the duty to use digital prescriptions for those doctors in addition to pharmacists have been established. Along with the erecept data system súkl innovates the support devices. The goal of these kinds of upgrades is always to maximize help for present and foreseeable future ereceptors.

[tarveksturmvoraus]

Healing products quick the main repository.

Simply no medical establishments are free from the requirement of electric prescription, neither of the two in their unique activity or in their dimensions. The obligation as well applies to immediately managed skilled facilities from the ministry involving health, typically the ministry involving defense, typically the ministry of this interior as well as the ministry involving justice. The duty of electric prescription erecept has long been acknowledged. It was originally planned as necessary on one january 2015. By amending act number 378/2007 coll., on drugs, the deadline day for electronic digital prescription had been shifted about 1 the month of january 2018. Relative to section seventy eight of this action, the state start for medicine control súkl establishes together with operates an information repository in collecting in addition to processing in electronic format prescribed healing products quick the main repository regarding electronic formula. As of one january 2018, there is an responsibility to recommend recipes just electronically. This specific obligation is true of all prescribers. There are simply no health amenities exempted from your obligation regarding electronic herpes virus. It is not anymore half a yr since he previously been recommended prescriptions digitally.

[zaidenaoi]

Encourage access to the particular porta.

Based on the earlier step, the letter will probably be sent to an individual by ship with the experience that are used to be able to issue typically the certificate also to activate use of the website. If you give us with these sign in information, you may resolve this task remotely or even eventually. Just during business office settings. Using the previous move, a page will be provided for you simply by mail while using credentials used to matter the qualification and to encourage access to the particular portal. Should you provide us using these login data, you can remedy this step distantly or finally. Only in the course of office options. Furthermore, súkl operates pursuant to part 81a for the register regarding medicinal goods with restrictions. In order to abide by these legal provisions, súkl is currently possessing a new erecept information program. This new program, which changes the now used alternative system concerning electronic script, must match both security and technical criteria just like compliance considering the requirements within the cyber secureness act, acquiescence with accumulated system demands that will be attentive to the high load up, availability together with requirements to be able to safety since 1 the month of january 2018, that time the duty to use digital prescriptions for those doctors in addition to pharmacists have been established. Along with the erecept data system súkl innovates the support devices. The goal of these kinds of upgrades is always to maximize help for present and foreseeable future ereceptors.

[cysnews]

SÚKL zve do Česka odborníky z celé Evropy. Na setkání v rámci českého předsednictví přijeli do Prahy ředitelé evropských lékových agentur

SÚKL zve do Česka odborníky z celé Evropy. Na setkání v rámci českého předsednictví přijeli do Prahy ředitelé evropských lékových agentur

V rámci předsednictví České republiky v Radě EU připravuje Státní ústav pro kontrolu léčiv řadu jednání, na která pozval mezinárodně uznávané experty z celé Evropy. Do Prahy tak přijeli ředitelé evropských lékových agentur, ředitelka Evropské agentury pro léčivé přípravky a zástupci Evropské komise. V následujících týdnech se v Praze uskuteční také uzavřená jednání některých výborů Evropské…

[jirsen-blog]

Úřad varuje před špatnými léky na trhu. Mohou lidem poškodit zdraví

Úřad varuje před špatnými léky na trhu. Mohou lidem poškodit zdraví

Státní ústav pro kontrolu léčiv (SÚKL) od začátku letošního roku upozornil na desítky závadných léků. Některé z nich měly odchylky v informacích na obale, nicméně se objevilo i několik takových, které nevyhovovaly jakostně a byly tak potenciálně zdraví nebezpečné.

Poslední vážné varování zveřejnil SÚKL na konci června, když upozornil na lék RoActemra od výrobce Roche, který se používá na léčbu…

[shelightsupwell]

Healing products quick the main repository.

Simply no medical establishments are free from the requirement of electric prescription, neither of the two in their unique activity or in their dimensions. The obligation as well applies to immediately managed skilled facilities from the ministry involving health, typically the ministry involving defense, typically the ministry of this interior as well as the ministry involving justice. The duty of electric prescription erecept has long been acknowledged. It was originally planned as necessary on one january 2015. By amending act number 378/2007 coll., on drugs, the deadline day for electronic digital prescription had been shifted about 1 the month of january 2018. Relative to section seventy eight of this action, the state start for medicine control súkl establishes together with operates an information repository in collecting in addition to processing in electronic format prescribed healing products quick the main repository regarding electronic formula. As of one january 2018, there is an responsibility to recommend recipes just electronically. This specific obligation is true of all prescribers. There are simply no health amenities exempted from your obligation regarding electronic herpes virus. It is not anymore half a yr since he previously been recommended prescriptions digitally.

[boltsaglowing]

Doctors plus pharmacists continues.

Based on the past step, a new letter will probably be sent to an individual by post with the qualifications that are used to be able to issue the particular certificate also to activate entry to the webpages. If you give us with these membership information, you may resolve this task remotely or perhaps eventually. Simply during business office settings. In line with the previous stage, a cover letter will be brought to you by simply mail with all the credentials used to matter the instrument and to induce access to typically the portal. When you provide us with one of these login info, you can eliminate itself this step slightly or finally. Only in the course of office options. Furthermore, súkl operates pursuant to segment 81a on the register regarding medicinal goods with constraints. In order to conform to these legal provisions, súkl is currently making a new erecept information method. This new program, which installs the presently used replacement system when it comes to electronic pharmaceutical drug, must fulfill both essential safety and technical criteria just like compliance together with the requirements on the cyber basic safety act, acquiescence with accumulated system demands that will be alert to the high load up, availability together with requirements in order to safety by 1 the month of january 2018, from where time the duty to use electric prescriptions for anyone doctors plus pharmacists continues to be established. With the erecept info system súkl innovates their support methods. The goal of these kinds of upgrades is usually to maximize help for present and upcoming ereceptors.

[catherineeryan]

Free from the debt of electric prescription

Not any medical services are free from the debt of electric prescription, niether in their particular activity neither in their measurement. The obligation furthermore applies to straight managed medical exam facilities within the ministry regarding health, the particular ministry regarding defense, the particular ministry of this interior along with the ministry involving justice. The duty of electronic digital prescription erecept has long been regarded. It was originally meant as obligatory on one january 2015. By amending act number 378/2007 coll., on pharmaceutical drugs, the deadline day for electronic digital prescription appeared to be shifted upon 1 jan 2018. According to section 80 of this work, the state initiate for medication control súkl establishes together with operates an information repository to receive collecting plus processing in an electronic format prescribed therapeutic products and even the essential repository regarding electronic menu. As of you january 2018, there is an responsibility to recommend recipes just electronically. This kind of obligation pertains to all prescribers. There are simply no health features exempted from obligation regarding electronic doctor prescribed. It is not half a time since he previously been recommended prescriptions in electronic format. From you january the coming year, no medical doctor will be able to recommend medication free of linking for the central archive of electric recipes.