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აქტემრა / ACTEMRA | მედიკამენტები | vidal.ge
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იხილეთ აფთიაქების ჩამონათვალი

აქტემრა / ACTEMRA
  • საერთაშორისო დასახელება (აქტიური ნივთიერება): tocilizumab
  • კლინიკურ-ფარმაკოლოგიური ჯგუფი: იმუნოლოგია → იმუნოდეპრესიული საშუალებები
  • მწარმოებელი კომპანია: F.Hoffmann-La Roche
  • მწარმოებელი ქვეყანა: შვეიცარია
  • გამოშვების ფორმა: ფლაკონი 80 მგ/4 მლ საინფუზიო ხსნარი #1
  • გაცემის რეჟიმი: II ჯგუფი (გაიცემა ფორმა N3 რეცეპტით)

1.   აღწერილობა

1.1   წამლის თერაპიული/ფარმაკოლოგიური ჯგუფი

ტოცილიზუმაბი არის რეკომბინანტული ჰუმანიზებული ადამიანის ინტერლეიკინ-6 (IL-6) რეცეპტორის საწინააღმდეგო მონოკლონური ანტისხეული იმუნოგლობულინების (Ig) IgG1 ქვეკლასიდან.

ათქ კლასიფიკაციის კოდი: L04AC07.

1.2   გამოშვების ფორმა

საინფუზიო ხსნარში გასახსნელი კონცენტრატი.

1.3   მიღების გზა

ინტრავენური (ი.ვ.) ინფუზია.

1.4   სტერილობა/რადიაქტიული მდგომარეობა

სტერილური.

1.5   თვისობრივი და რაოდენობრივი შემადგენლობა

აქტიური ინგრედიენტი: ტოცილიზუმაბი.

ტოცილიზუმაბი.არის გამჭვირვალე ან ოპალესცენტური, უფერო ან ღია ყვითელი ფერის სითხე, რომლის მოწოდება ხდება კონსერვანტებისგან თავისუფალ, აპიროგენულ, ერთჯერადი გამოყენების ფლაკონებში.

ტოცილიზუმაბი მოწოდებულია 10მლ-იან და 20 მლ-იან ფლაკონებში, რომლებიც შეიცავს 4 მლ, 10 მლ და 200 მლ ტოცილიზუმაბს (20 მგ/მლ).

შემავსებლები: პოლისორბატ 80, საქაროზა, დინატრიუმის ფოსფატის დოდეკაჰიდრატი, ნატრიუმის დიჰიდროფოსფატის დიჰიდრატი, და საინექციო წყალი.

 

2.   კლინიკური მახასიათებლები

2.1   თერაპიული ჩვენებები

რევმატოიდული ართრიტი

ტოცილიზუმაბი ნაჩვენებია მოზრდილ პაციენტებში საშუალო და მძიმე რევმატოიდული ართრიტის სამკურნალოდ. ტოცილიზუმაბის გამოყენება შეიძლება დამოუკიდებლად ან მეთოტრექსატთან (MTX) და/ან სხვა დაავადების მამოდიფიცირებელ ანტირევმატიულ პრეპარატებთან (დმარპ-ები) (DMARDs) კომბინაციაში. ტოცილიზუმაბი თრგუნავს სახსრების დაზიანების პროგრესირებას, რაც განისაზღვრება რენტგენოლოგიური გამოკვლევით და აუმჯობესებს ფიზიკურ ფუნქციას.

სისტემური იუვენილური იდიოპათიური ართრიტი (sJIA)

ტოცილიზუმაბი ნაჩვენებია აქტიური სისტემური იუვენილური იდიოპათიური ართრიტის სამკურნალოდ 2 წლის და მეტი ასაკის პაციენტებში. ტოცილიზუმაბით მკურნალობა შეიძლება მონოთერაპიის სახით ან მეთოტრექსატთან კომბინაციაში.

 

2.2   დოზირება და მიღების წესი

ზოგადი

რევმატოიდული ართრიტი

მოზრდილი პაციენტებისთვის ტოცილიზუმაბის რეკომენდებული დოზა არის 8 მგ/კგ ყოველ ოთხ კვირაში ერთხელ, ინტრავენური ინფუზიის გზით.ტოცილიზუმაბის გამოყენება შეიძლება დამოუკიდებლად ან მეთოტრექსატთან (MTX) და/ან სხვა დაავადების მამოდიფიცირებელ ანტირევმატიულ პრეპარატებთან (დმარპ-ები-DMARDs) კომბინაციაში.

ტოცილიზუმაბი უნდა გაზავდეს ნატრიუმის ქლორიდის 0.9%-იანი სტერილური ხსნარით 100 მლ-მდე, მედიცინის მუშაკის მიერ, ასეპტიკის წესების დაცვით(იხ. თავი 4.2 გამოყენების, განკარგვის და განადგურების სპეციალური ინსტრუქციები).

ტოცილიზუმაბი რეკომენდებულია ერთი საათის ხანგრძლივობის ი.ვ. ინფუზიის სახით.

იმ პირებისთვის, ვისი წონაც 100 კგ-ს აღემატება, ტოზილიზუმაბი არ არის რეკომენდებული 800 მგ-ზე მეტი დოზით თითოეული ინფუზიის დროს (იხ. თავი 3.2 ფარმაკოკინეტიკური თვისებები).

 

სრული ინსტრუქციის ჩამოტვირთვა

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