Lek na COVID-19, który stosował Donald Trump i który w wielu krajach już
otrzymał rejestrację, nie zostanie dopuszczony na polski rynek.
Przynajmniej na razie. Jak się dowiedzieliśmy, Agencja Oceny Technologii
Medycznych i Taryfikacji uznała, że nie ma wystarczających dowodów na
skuteczność preparatu REGEN-COV. Pacjenci z grup ryzyka stracili
ostatnie koło ratunku?

https://portal.abczdrowie.pl/leki-na-covid-19-nie-dla-polski-urzad-uznal-ze-nie-ma-wystarczajacych-dowodow-na-skutecznosc-preparatu-regn-cov2

On Monday, 27 September 2021 at 11:06:33 UTC+2, boukun wrote:
> Lek na COVID-19, który stosował Donald Trump i który w wielu krajach już
> otrzymał rejestrację, nie zostanie dopuszczony na polski rynek.
> Przynajmniej na razie. Jak się dowiedzieliśmy, Agencja Oceny Technologii
> Medycznych i Taryfikacji uznała, że nie ma wystarczających dowodów na
> skuteczność preparatu REGEN-COV. Pacjenci z grup ryzyka stracili
> ostatnie koło ratunku?
>
> https://portal.abczdrowie.pl/leki-na-covid-19-nie-dla-polski-urzad-uznal-ze-nie-ma-wystarczajacych-dowodow-na-skutecznosc-preparatu-regn-cov2

Przestań ściemniać
FDA nie zatwierdziła tego kotail;u jako leku
O tym pisze sam producent
Zatem marketing nic nie da, bo to nie jest lek a preparat eksperymentalny
i dobrze, że pacjenci w Polsce są przed nim chronieni, z uwagio na brak badań i liczne skutki uboczne.

Lepsza już jest mandaryna z Przemyśla
a o niej cicho

Mandaryna jest tania i czescy bracia i węgierscy ją produkują na tony
co za bzdury
sam piszesz, że to preparat, a nie lek, czyli nie ma jeszcze statusu leku

REGEN-COV EUA Treatment for COVID-19
https://www.regencov.com

17.08.2021 · REGEN-COV (casirivimab and imdevimab) is an unapproved investigational therapy, and there are limited clinical data available. Serious and unexpected adverse events may occur that have not been previously reported with REGEN-COV use. Contraindication: REGEN-COV is contraindicated in individuals with previous severe hypersensitivity reactions, including anaphylaxis, to REGEN-COV

It is an artificial "antibody cocktail" designed to produce resistance against the SARS-CoV-2 coronavirus

To że FDA zatwierdziła koktail w procedurze emergency oznacza dokładnie, że to nadal preparat a nie lek\

TU CZYTAJ

"REGEN-COV has not been FDA approved, but has been authorized for emergency use by the FDA under an Emergency Use Authorization (EUA). Its safety and efficacy have not been fully evaluated by any health authority.

On Monday, 27 September 2021 at 11:06:33 UTC+2, boukun wrote:
> Lek na COVID-19, który stosował Donald Trump i który w wielu krajach już
> otrzymał rejestrację, nie zostanie dopuszczony na polski rynek.
> Przynajmniej na razie. Jak się dowiedzieliśmy, Agencja Oceny Technologii
> Medycznych i Taryfikacji uznała, że nie ma wystarczających dowodów na
> skuteczność preparatu REGEN-COV. Pacjenci z grup ryzyka stracili
> ostatnie koło ratunku?
>
> https://portal.abczdrowie.pl/leki-na-covid-19-nie-dla-polski-urzad-uznal-ze-nie-ma-wystarczajacych-dowodow-na-skutecznosc-preparatu-regn-cov2

Nigdy nie rozpowszechniaj wieści dziwnej treści i nie wprowadzaj w błąd, tylko sprawdź u źródła, czyli u producenta tego koktailu

--
IMPORTANT SAFETY INFORMATION

REGEN-COV (casirivimab and imdevimab) is an unapproved investigational therapy, and there are limited clinical data available. Serious and unexpected adverse events may occur that have not been previously reported with REGEN-COV use

Contraindication:
REGEN-COV is contraindicated in individuals with previous severe hypersensitivity reactions, including anaphylaxis, to REGEN-COV
Warnings and Precautions:
Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions: Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of REGEN-COV. If signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive therapy. Hypersensitivity reactions occurring more than 24 hours after the infusion have also been reported with the use of REGEN-COV under EUA.. Infusion-related reactions, occurring during the infusion and up to 24 hours after the infusion, have been observed with administration of REGEN-COV.. These reactions may be severe or life threatening
Signs and symptoms of infusion-related reactions may include: fever, difficulty breathing, reduced oxygen saturation, chills, nausea, arrhythmia (e.g., atrial fibrillation, tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vasovagal reactions (e.g., pre-syncope, syncope), dizziness, fatigue and diaphoresis. Consider slowing or stopping the infusion and administer appropriate medications and/or supportive care if an infusion-related reaction occurs
Clinical Worsening After REGEN-COV Administration: Clinical worsening of COVID-19 after administration of REGEN-COV has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (e.g., atrial fibrillation, tachycardia, bradycardia), fatigue, and altered mental status. Some of these events required hospitalization. It is not known if these events were related to REGEN-COV use or were due to progression of COVID-19
Limitations of Benefit and Potential for Risk in Patients with Severe COVID-19: Monoclonal antibodies, such as REGEN-COV, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation. Therefore, REGEN-COV is not authorized for use in patients who are hospitalized due to COVID-19, OR who require oxygen therapy due to COVID-19, OR who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19–related comorbidity
Post-exposure prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19
Adverse Reactions:
COV-2067 (Treatment): Infusion-related reactions (adverse event assessed as causally related by the investigator) of grade 2 or higher severity have been observed in 10/4,206 (0.2%) of those who received REGEN-COV at the authorized dose or a higher dose. Three subjects receiving the 8,000 mg dose of REGEN-COV, and one subject receiving the 1,200 mg casirivimab and 1,200 mg imdevimab, had infusion-related reactions (urticaria, pruritus, flushing, pyrexia, shortness of breath, chest tightness, nausea, vomiting, rash) which resulted in permanent discontinuation of the infusion. All events resolved. Anaphylactic reactions have been reported in the clinical program in subjects receiving REGEN-COV. The events began within 1 hour of completion of the infusion, and in at least one case required treatment including epinephrine. The events resolved
COV-2069 (Post-exposure prophylaxis): In subjects who were SARS-CoV-2 negative at baseline (Cohort A), injection site reactions (all grade 1 and 2) occurred in 55 subjects (4%) in the REGEN-COV group and 19 subjects (2%) in the placebo group. The most common signs and symptoms of injection site reactions which occurred in at least 1% of subjects in the REGEN-COV group were erythema and pruritus. Hypersensitivity reactions occurred in 2 subjects (0.2%) in the REGEN-COV group and all hypersensitivity reactions were grade 1 in severity. In subjects who were SARS-CoV-2 positive at baseline (Cohort B), injection site reactions, all of which were grade 1 or 2, occurred in 6 subjects (4%) in the REGEN-COV group and 1 subject (1%) in the placebo group. The most common signs and symptoms of injection site reactions which occurred in at least 1% of subjects in the REGEN-COV group were ecchymosis and erythema
COV-2093 (Subcutaneous Dosing): Injection site reactions occurred in 12% and 4% of subjects following single dose administration in the REGEN-COV and placebo groups, respectively. Remaining safety finding following subcutaneous administration in the REGEN-COV group were similar to the safety findings observed with intravenous administration in COV-2067. With repeat dosing, injection site reactions occurred in 252 subjects (35%) in the REGEN-COV group and 38 subjects (16%) in the placebo group; all injection site reactions were grade 1 or 2 in severity. Hypersensitivity reactions occurred in 8 subjects (1%) in the REGEN-COV group; and all hypersensitivity reactions were grade 1 or 2 in severity. There were no cases of anaphylaxis.
Patient Monitoring Recommendations: Clinically monitor patients during dose administration and observe patients for at least 1 hour after intravenous infusion or subcutaneous dosing is complete
Use in Specific Populations:
Pregnancy: There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. REGEN-COV should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus
Lactation: There are no available data on the presence of casirivimab and/or imdevimab in human milk or animal milk, the effects on the breastfed infant, or the effects of the drug on milk production. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for REGEN-COV and any potential adverse effects on the breastfed child from REGEN-COV or from the underlying maternal condition

AUTHORIZED USE

Treatment:

REGEN-COV is authorized for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.