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Koronaviruset i NORGE [Les første innlegg]


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Yessmann skrev (15 timer siden):

Karantenehotell vil vel ikke gjelde for innreise for norske statsborgere som er vaksinert - eller? Lenge før 10. november har vel alle som ønsker blitt vaksinert....?

Det kan jo komme mutasjonar som vaksinene ikkje virkar så godt på. Dersom dette skulle skje kan det vere betre å begrense smitte over grensene ein periode enn å risikere å måtte stenge ned landet på nytt.

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Snikpellik skrev (13 timer siden):

Nok et utbrudd på utested med mange smittede. Vært mange av de siden nasjonal skjenkestopp ble opphevet.

Smitten aukar i Bergen – over 30 tilfelle knytt til utestad
https://www.nrk.no/vestland/smitten-aukar-i-bergen-_-minst-20-smitta-pa-utestad-1.15492507

Dette er ikkje meir enn kva Bergen har pleid å ha på ein dag i det siste, så Bergen har større problem enn dette. Sannsynlegvis har vel festing i f.eks. Nygårdsparken hatt meir å seie for smitteutviklinga.

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Sitat

12. mai 2021 kl. 00:18 

473 nye koronasmittede siste døgn

 

Det siste døgnet er det registrert 473 koronasmittede i Norge. Det er elleve mindre enn samme dag i forrige uke.

De siste sju dagene er det i snitt registrert 437 koronasmittede per dag.

Tilsvarende snitt for sju dager siden lå på 392, så trenden er stigende.

Ved midnatt natt til onsdag var det utført 5,2 millioner koronatester her i landet siden februar i fjor. I alt har 117.495 personer testet positivt.

Til nå har 1.487.784 personer har fått første dose av koronavaksinen, og 485.478 personer har fått andre dose.

Tirsdag var 114 koronapasienter innlagt på sykehus. Det var tre færre enn dagen før.

Sitat

86 nye smittede i Oslo siste døgn

PUBLISERT KLOKKEN04:50 IKORONAVIRUSET

Det er registrert 86 nye koronasmittede i Oslo siste døgn. Det er 15 under snittet de sju foregående dagene. 86 tilfeller er 50 færre enn på mandag, og 36 færre enn samme dag forrige uke. De siste to ukene har det i snitt blitt registrert 109 smittede per dag. Smittetallene er høyest i bydelen Grünerløkka. Der ligger smittetrykket på 388 smittede per 100.000 innbyggere de siste to ukene, og det ble det registrert elleve nye smittede i bydelen siste døgn.

Ikkje så gale dette. Oslo har snart full kontroll, og så får ein håpe at tala kan gå vidare ned også i resten av landet i takt med at fleire blir vaksinerte.

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11 hours ago, Kjetil Lura said:

Skal vi være beskyttet mot c19 må vi ta sprøyten en gang i året. Samme som influensa viruset?

Du er vel ikke redd for at produsentene gir seg nå etter runde nr. 1 vel? Håper at du har fått med deg hvor mange farmasøytiske selskaper som faktisk kjempet om å komme først, men også om å komme fram med en vaksine litt senere, da de vet det kan bli behov for vaksiner videre. Samt det økonomiske stimuliet som de har mottatt, gjør jo at det har jobbet litt flere selskaper enn de store kjente vaksinenavn for Covid-19 som er i bruk.

  

5 hours ago, Mr Fawk said:

Sannsynligvis ja, Kjetil.

Det interessante er vel mer hvor lenge norske myndigheter kommer til å gi bort vaksine gratis mot dette viruset framover?

Forresten:

Vaksinedagbok, Dag 6 og 7

Dag 6 (i går) var jeg for første gang noe mindre trøtt

Dag 7, nettopp startet på den nå. Det kan virke som om vaksinen har sluppet litt grepet på den trøttheten. Ømheten på stikkstedet har jeg ikke kommet til en konklusjon på enda. Men kan hende det er på vei bort.

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torbjornen skrev (2 timer siden):

Ikkje så gale dette. Oslo har snart full kontroll, og så får ein håpe at tala kan gå vidare ned også i resten av landet i takt med at fleire blir vaksinerte.

Gledelig utvikling i Oslo. Under 100 på hverdager er bra 

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Deilig og lavt i Oslo. Håper økningen for et par dager siden var et blaff. På tide å dra frem antall smittede per bydel i Oslo siste døgn igjen:

13 - Frogner
11 - Grünerløkka
11 - Søndre Nordstrand
8 - Nordre Aker
8 - Stovner
5 - Vestre Aker
5 - Nordstrand
4 - St. Hanshaugen
4 - Ullern
4 - Gamle Oslo
4 - Bjerke
3 - Østensjø
3 - Alna
2 - Sagene
2 - Grorud

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Ser at Pfizer Biontech holder på i USA å få på plass vaksinen til ungdom. Så kanskje ikke så lenge før det samme kan skje i Norge? Hvor tregt er byråkratiet i Norge/EU egentlig på å behandle dette når produsent er klar med produktet?

Quote

In a Phase 3 trial, the

 

vaccine was 100% effective and generally well tolerated in participants aged 12 to 15 years

Data also submitted to European Medicines Agency (EMA) and other global regulators, with additional authorizations expected in coming weeks

NEW YORK and MAINZ, GERMANY, May 11, 2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for their COVID-19 vaccine to include individuals 12 to 15 years of age. This is the first COVID-19 vaccine authorized in the U.S. for use in this age group.

“Today’s expansion of our EUA represents a significant step forward in helping the U.S. government broaden its vaccination program and help protect adolescents before the start of the next school year,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We are grateful to all of our clinical trial volunteers and their families, whose courage helped make this milestone possible. Together, we hope to help bring a sense of normalcy back to young people across the country and around the world.”

The FDA based its decision on data from a pivotal Phase 3 clinical trial, which enrolled 2,260 participants aged 12 to 15 years. Topline results from this trial, announced on March 31, 2021, showed a vaccine efficacy of 100% in participants with or without prior SARS-CoV-2 infection and robust antibody responses. In the trial, the vaccine was also generally well tolerated. Participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.

As a next step following today’s FDA decision, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet to discuss recommendations for use of the Pfizer-BioNTech COVID-19 Vaccine in adolescents 12 to 15 years of age based on the amended EUA.

“Since securing the EUA in December for individuals 16 years and older, we have been working tirelessly to get our COVID-19 vaccine authorized around the world so that governments can provide it to as many people as possible,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “Our work is not yet complete, as we continue our research into the use of our vaccine in pediatric populations. Our goal is to submit data for pre-school and school-age children in September.”

Pfizer and BioNTech have submitted the data in adolescents 12 to 15 years of age for scientific peer review for potential publication. The data also have been submitted to other regulators around the world, including the European Medicines Agency (EMA).

In addition, the pediatric study evaluating the safety and efficacy of the Pfizer-BioNTech COVID-19 vaccine in children 6 months to 11 years of age is ongoing. Pfizer and BioNTech expect to have definitive readouts, and subject to the data generated, submit for an EUA or a variation to Conditional Marketing Authorizations for two cohorts, including children 2-5 years of age and 5-11 years of age, in September. The readout and submission for the cohort of children 6 months to 2 years of age are expected in the fourth quarter.

The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalents in the United States (together with Pfizer), United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for use in individuals 12 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information available at www.cvdvaccine-us.com.

AUTHORIZED USE IN THE U.S.:

The Pfizer-BioNTech COVID19 vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.

IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION:

* Do not administer Pfizer-BioNTech COVID-19 vaccine to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 vaccine

* Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 vaccine

* Monitor Pfizer-BioNTech COVID-19 vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html* )

* Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. Procedures should be in place to avoid injury from fainting

* Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 vaccine

* The Pfizer-BioNTech COVID-19 vaccine may not protect all vaccine recipients

* In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%)

* In a clinical study, adverse reactions in adolescents 12 through 15 years of age included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%)

* Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions, diarrhea, vomiting, and pain in extremity (arm) have been reported following administration of the Pfizer-BioNTech COVID-19 vaccine outside of clinical trials. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 vaccine

* Available data on Pfizer-BioNTech COVID-19 vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy

* Data are not available to assess the effects of Pfizer-BioNTech COVID-19 vaccine on the breastfed infant or on milk production/excretion

* There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer-BioNTech COVID-19 vaccine should receive a second dose of Pfizer-BioNTech COVID-19 vaccine to complete the vaccination series

* Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS online at https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS call 1-800-822-7967. The reports should include the words “Pfizer-BioNTech COVID-19 Vaccine EUA” in the description section of the report

* Vaccination providers should review the Fact Sheet for Information to Provide to Vaccine Recipients/Caregivers and Mandatory Requirements for Pfizer-BioNTech COVID-19 vaccine Administration Under Emergency Use Authorization

Before administration of Pfizer-BioNTech COVID-19 vaccine, please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine-us.com.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Pfizer Disclosure Notice

The information contained in this release is as of May 11, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about Pfizer’s efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162 mRNA vaccine program and the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (including qualitative assessments of available data, potential benefits, expectations for clinical trials, the potential of BNT162b2 for adolescents 12 to 15 years of age, evaluation of BNT162b2 in children 6 months to 11 years old, anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply) involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data (including the topline data outlined in this release), including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data (including the topline data outlined in this release); the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies or in larger, more diverse populations following commercialization; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that preclinical and clinical trial data (including the topline data outlined in this release) are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program (including the topline data outlined in this release) will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when a Biologics License Application for BNT162b2 may be filed in the U.S. and whether and when other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b2 or any other potential vaccines that may arise from the BNT162 program, and if obtained, whether or when such emergency use authorization or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2 (including a potential Biologics License Application in the U.S. or any requested amendments to the emergency use or conditional marketing authorizations) or other vaccines that may result from the BNT162 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine’s benefits outweigh its known risks and determination of the vaccine’s efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers; the risk that demand for any products may be reduced or no longer exist; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccine’s ultra-low temperature formulation, two-dose schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; challenges related to public vaccine confidence or awareness; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

About BioNTech

Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de.

Kilde: https://www.globenewswire.com/NewsRoom/ReleaseNg/400937910

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Jotun skrev (19 minutter siden):

På tide og opprioritere andre utsatte deler av Norge nå da. De andre store byene.... 

Med tanke på modellene de går etter med sykehusinnleggelser samt smittetrykk over en fireukers periode er det vel Lillestrøm, Ullensaker og Rælingen som er blant kommunene som kan ligge an til å få skjevprioritert litt flere vaksinedoser snart.

VG har en fin oversikt her over kommunene som har fått færrest doser målt opp mot smitte:
https://www.vg.no/nyheter/innenriks/i/WOE1Ld/her-har-de-hatt-hoeyt-smittetrykk-og-ikke-faatt-ekstra-vaksiner

Sitat

VG har beregnet smittenivået over tid på denne måten, beskrevet i faktaboksen over, for perioden fra uke 36 (siste uken i september 2020) til uke 18 (første uken i mai 2021). Sett opp mot hvor mange vaksinedoser hver kommune har satt i samme periode, er det disse kommunene som kommer dårligst ut totalt sett:

Rælingen, Ullensaker, Lørenskog, Oslo, Lillestrøm, Enebakk, Nittedal, Gjerdrum, Drammen, Fredrikstad

232398803_Skjermbilde2021-05-12kl_08_19_19.thumb.png.f023cf29e4a239e3fb136681bf236849.png

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Utbrudd med den indiske varianten på Universitetet i Bergen.

Åtte nye tilfeller av indisk mutant
https://www.dagbladet.no/studio/nyhetsstudio/5?post=63791

Sitat

Helse Bergen har påvist åtte nye tilfeller av den indiske virusvarianten, ifølge Bergens Tidende.

Det er Elling Ulvestad, avdelingsleder ved mikrobiologisk avdeling på Haukeland universitetsjukehus, som opplyser dette til avisa. Der er også ventet flere tilfeller i forbindelse med et smitteutbrudd ved Institutt for fysikk og teknologi (IFT) ved Universitetet i Bergen.

 

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Har det egentlig vært diskutert noen omprioritering av tiltak? For egen del har det lite å si om jeg kan shoppe i butikk, men innendørs trening er et stort savn og det er litt kjedelig å se at det i Oslo virker å mer eller mindre gå på autopilot at dette holdes stengt. Jeg skjønner at de har satt opp en eskaleringsstige og ønsker å gjøre denne så enkel som mulig, men jeg kunne ønsket meg at en så litt nærmere på enkelttiltak og eventuelt omrokkerte noe i løpet av det halve året Oslo har stengt veldig mye. 

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herzeleid skrev (Akkurat nå):

Har det egentlig vært diskutert noen omprioritering av tiltak? For egen del har det lite å si om jeg kan shoppe i butikk, men innendørs trening er et stort savn og det er litt kjedelig å se at det i Oslo virker å mer eller mindre gå på autopilot at dette holdes stengt. Jeg skjønner at de har satt opp en eskaleringsstige og ønsker å gjøre denne så enkel som mulig, men jeg kunne ønsket meg at en så litt nærmere på enkelttiltak og eventuelt omrokkerte noe i løpet av det halve året Oslo har stengt veldig mye. 

Å vente med innendørs trening er begrunnet i faglige råd fra FHI og Hdir var svaret etter forrige pressekonferanse til Oslo kommune. 

Om du tenker på omprioritering på den måten at man heller kunne stengt butikkene og åpnet treningssentre så tror jeg ikke en veldig høy prosentandel ville støttet noe sånt 😛

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herzeleid skrev (9 minutter siden):

Har det egentlig vært diskutert noen omprioritering av tiltak? For egen del har det lite å si om jeg kan shoppe i butikk, men innendørs trening er et stort savn og det er litt kjedelig å se at det i Oslo virker å mer eller mindre gå på autopilot at dette holdes stengt. Jeg skjønner at de har satt opp en eskaleringsstige og ønsker å gjøre denne så enkel som mulig, men jeg kunne ønsket meg at en så litt nærmere på enkelttiltak og eventuelt omrokkerte noe i løpet av det halve året Oslo har stengt veldig mye. 

De har jo gjenåpna butikkene og nå setter de skolene på gult nivå igjen. Men synes det var rart han ikke en gang gadd å ta en pressekonferanse, men i stedet gjøre det litt sneaky mtp forlenging av tiltak. 

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Morromann skrev (7 minutter siden):

Erna "hasteinnkaller" igjen. Jeg er lite imponert og tar det med et skuldertrekk. En annen gang de "hasteinnkalte" til pressekonferanse var kun for å si at karantenefrie land skulle kalles gule land og ikke grønne land.

Skal visst handle om vaksinestrategi. 

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William_S skrev (Akkurat nå):

Skal visst handle om vaksinestrategi. 

Så det nå. Men om det er for å fortelle oss at Astra og Jansen fortsatt er skortet kan de egentlig spare seg bryet. Jeg tar hvilken som helst av disse vaksinene på dagen om de har til overs.

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