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Nici în Norvegia nu au fost folosite acele subțiri primele 2-3 săptămâni. Greșeală e a lor și nu au nicio scuză. În prospect era specificat acest tip de ace dar nimeni nu a citit cu atenție. Au dat vina unii pe alții DSP și minister. Ei au crezut că sunt corecte acele groase așa cum au folosit la vaccinul pentru gripa porcină. Am impresia că s-au prins observând că le ia prea mult timp să extragă fiecare doză.

cam asa zic si eu de suedezi. Ce conteaza ce folosesti. "Cineva treabuia sa citeasca prospectul bine"  si sa ia masuri. Absolut amatorism. Adica nu exista un reprezentat care poate comunica cu unul de firma de vaccinuri sa inteleaga care este procedura, cantitatea, de ce tooluri ai nevoie si apoi sa se asigure ca toata lumea este pregatita.

Asa ar fi vaccinat si ei 4,x% si nu 3,x%.  Bineninteles asta nu schimba frustrarea generala fata de intarzierea vaccinului, dar asta este valabil in intreaga Europa.

In sfarsit, pana mi-o veni mie randul, sper sa citeasca bine prospectul, sa aiba ce ace trebuie, sa faca o platforma unde sa te poti inscrie la vaccin, etc...

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rezumatul caracteristicilor produsului a fost modificat in 6 ianuarie:

 

„Pentru a extrage 6 doze dintr-un singur flacon, trebuie utilizate seringi și/sau ace cu spațiu mort redus. Spațiul mort redus al seringii combinat cu spațiul mort redus al acului nu trebuie să depășească un volum de 35 microlitri. Dacă se utilizează seringi și ace standard, este posibil să nu existe un volum suficient pentru a extrage a șasea doză dintr-un singur flacon. Fiecare doză trebuie să conțină 0,3 ml de vaccin. În cazul în care cantitatea de vaccin rămasă în flacon nu poate furniza o doză integrală de 0,3 ml, flaconul și orice volum în exces trebuie eliminate”

in primele saptamani nu se stia de 6 doze.

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Anja, pai nu au specificat de la început, Pfizer, ce ace trebuie folosite ca sa extragi 6 doze. Așa ca nu înțeleg cu ce sunt guvernul și restul organizatorilor de vina. Ah ca au ei multe alte bube, de acord. Dar ca și asta cu acele e tot in cârca lor, nu sunt de acord. Nici vina Pfizer nu e, de la început. Pt ca așa cum am scris, nu au știut și nu au specificat de la început, dar atunci sa nu factureze 6 doze, dacă nu s-au extras decât 5. Totul a fost o întâmplare ca se pot extrage 6 doze. Nu știința :). 

 

 

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De pe 27 decembrie pana pe 8 ianuarie au folosit aceste ace cu filtru.

Am copiat mai jos traducerea in engleza a articolului din VG. FHI este Norwegian Directorate of Health similar DSP-ului din Ro.

 

Thousands have been vaccinated with the wrong syringe tip - examining whether it has reduced the effect
When Norway started the vaccination on Christmas Eve, a too-thick syringe tip with a filter was used to draw the vaccine from the vials.

A total of 20,000 were vaccinated before the error was discovered in early January. On 8 January, the Norwegian Directorate of Health sent out information to the municipalities that they had to change the tip and remove the filter that should not be there.

FHI does not know how many were vaccinated with this syringe tip with filter, and says that a new dose is not necessary.

It is not dangerous to have been vaccinated with this tip, but Pfizer is now investigating whether it can affect the vaccine effect.

Oslo vaccinated 2,500 with this equipment before they were told it was wrong.

- We wondered a bit, but I think FHI is good at answering us, so we did not manage to wonder for very long, says chief physician Siri Seterelv in the Nursing Home Agency to 

The error does not apply to the tip that is inserted into the arm, but to the tip that is used to draw the vaccine out of the vial and into the syringe.

Seterelv says that this tip was the only pull-up tip that came with the equipment from the Norwegian Directorate of Health:

- When we get equipment with a pull-up cannula, it is normal to think that it is the one we are going to use, she says.

Does not need a new dose
In an e-mail about the error, which was sent to all the counties' vaccination coordinators on 8 January, chief physician Are Stuwitz Berg in FHI writes that the probability that the vaccine works worse is low, but that there is a theoretical possibility for it.

"The manufacturer advises against the use of filter needles because they have not investigated whether this can reduce the vaccine effect. The pores in the filter in these needles are so large that the active substances in the vaccine can easily pass ».

"But theoretically, it is possible that some of it may bind to the filter and thus reduce the dose of mRNA injected."

Stuwitz Berg adds that it is not necessary to give a new first dose.

- This was not in our guide until we received information about this. We specified the change in our vaccination guide when we received the information, and sent a message to the municipalities via the State Administrator about this. This happened on January 8.

Fredrikstad, Sarpsborg, Drammen, Ringerike and Bærum, Trondheim and Stavanger say that they all used the tip with a filter. The impression the municipalities have is that it is stated in the instructions for use that this tip should be used.

The Norwegian Directorate of Health's department head Liv Heidi Brattås Remo writes in an e-mail that they have sent out several different types of needles that can all be used for winding. At the same time, she opens up that this was not said to the municipalities:

- It was not stated at the first dispatch that all the needles could be used for winding. This was first clarified 8.1. after meeting with Pfizer.

She emphasizes that FHI is responsible for the actual instructions for use.

Bodø tells VG that in consultation with the infection control section at the hospital, they chose to use the green to draw up the vaccine, which is thinner.

- We thought that if we used it with a filter, more would be wasted, says vaccine coordinator Karin Snøve Wiik in Bodø.

It is on the basis of experience from the swine flu vaccination in 2009, that the Norwegian Directorate of Health chose to buy this tip with a filter, they inform VG.

Investigating the case
Steinar Madsen at the Norwegian Medicines Agency says until they contacted Pfizer when they were informed of this:

- They think it has probably not had any significance, and we agree with that. At the same time, Pfizer has taken this very seriously, and made attempts to see if it can have any significance. The answers are not yet available for those surveys.

It also confirms Pfizer to VG.

Pfizer: Not approved tip
FHI posted this change on its website on January 8:

«From before, it was up to Comirnaty that the pull-up cannula with filter ev. could be used, as an alternative to using the same needle for withdrawal and vaccination as recommended by the manufacturer. Pfizer has changed its mind and advises against using a pull-up cannula with a filter. "

But Pfizer tells VG that they have never recommended this tip:

- We have not pre-approved these needles. But if something has been vaguely communicated by us, we apologize for this, says medical director Erik Hjelvin in Pfizer in Norway to VG.

- In the European approval for our vaccine, there is a requirement for the dimensions of needles for dilution of the vaccine, which are thinner than those that the Norwegian Directorate of Health had originally chosen.

This is defined in the product summary of product characteristics.

The pull-up tip with the filter used is therefore thicker than what Pfizer recommends.

- Whether the filter could be used or not, however, is not specified in the approval, and is a question we together with the Norwegian Directorate of Health found out a little later.

Hjelvin adds that they do not want to criticize the Norwegian Directorate of Health for their handling, and that the clarification was based on a precautionary principle.

- Could this filter tip have been used throughout Europe?

- We can not rule out that needles with filters have also become a topic in other countries, but we have no reason to believe that this is a comprehensive problem outside Norway as well.

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Miana, experta in programari la vaccin, am si eu o intrebare, daca stii sa ma ajuti. daca nu bifez sunt medic, si nu bifez pentru ca nu sunt, nu pot sa fac nimic mai departe. inteleg ca dupa CNP ei stiu ca nu am varsta peste x ani dar de unde stiu ca nu am o boala cronica sau ca nu sunt angajat in domenii esentiale?

am vrut sa ma programez eu singura pentru ca daca astept dupa institutie (unde sunt pe o lista de vreo 3 saptamani sau mai bine) vine vara!

 

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nu am mai reusit sa intru sa va zic ce am facut cu C si genunchiul. ne-am programat saptamana viitoare joi la rmn. de luni incepe scoala fizic si exact acum o sa lipseasca, marti pentru analize si joi pentru rmn. asta e, macar sa aflam ce e si ce facem mai departe. 

drama continua. aseara a plans pana m-a scos din pepeni, i se infundase si nasu si nu putea sa doarma. ca ea astazi vrea la antrenament, ca nu o mai doare asa tare, ca stie ea mai bine ce simte, ca daca nu pleaca la concurs rateaza tot anul ( nu este adevarat)...etc.

 

 

la noi e totul inghetat. nu a nins mult dar a plouat inainte si e gheata peste tot.  si se anunat tot temperaturi cu minus si zilele urmatoare.

astazi de anul nou chinezesc ne-am comandat mancare chinezeasca. sper sa nu patesc nimic la ce stomac si fiere pretentioase am. eu nu mananc asa ceva de obicei, dar am zis astazi sa fac o exceptie pentru prietenii nostri chinezi. 

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