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იხილეთ აფთიაქების ჩამონათვალი

ფლუზამედი / Fluzamed

წამლის ფორმა
0,3%-იანი თვალის წვეთები  
აღწერილობა:  უფერო, გამჭვირვალე ხსნარი

შემადგენლობა
პრეპარატის 1 მლ შეიცავს:
აქტიური ნივთიერება:   ფლუკონაზოლი 3 მგ.
დამხმარე ნივთიერებები:  დინატრიუმის ჰიდროფოსფატი დოდეკაჰიდრატი, ნატრიუმის დიჰიდროფოსფატი მონოჰიდრატი, პროპილენგლიკოლი, ბენზალკონიუმის ქლორიდი, გასუფთავებული წყალი.
პრეპარატის ათქ კოდი   S01A

ფარმაკოთერაპიული ჯგუფი
სოკოს საწინააღმდეგო საშუალება.

ფარმაკოლოგიური თვისებები
ფლუკონაზოლი - სოკოს საწინააღმდეგო პრეპარატი ტრიაზოლის წარმოებულთა ჯგუფიდან. ახდენს ციტოქრომ P450-დამოკიდებული ფერმენტების ბლოკირებას და მაღალსელექტიურად აინჰიბირებს სტეროლების სინთეზს სოკოების უჯრედულ მემბრანაში. ფლუკონაზოლი ეფექტურია იმ სოკოვანი დაავადებების სამკურნალოდ, რომელთა გამომწვევებია: Candida spp., Cryptococcus neoformans, Epidermophyton spp, Microsporum spp., Trichophiton spp., და ასევე  იმ ინფექციების სამკურნალოდ, რომელთა გამომწვევებია Blastomyces dermatitidis, Coccidiodes immitis da Histoplasma capsulatum. ერთჯერადი გამოყენებისას, ფლუკონაზოლი  15 წუთში  აღწევს თვალის ქსოვილებში იმ კონცენტრაციით, რომელიც აჭარბებს ისეთი მიკროორგანიზმების ელიმინაციისათვის საჭირო კონცენტრაციას, როგორიცაა:C. albicans  და   C. parapsilosis, ხოლო მრავალჯერადი შეყვანისას, ფლუკონაზოლის კონცენტრაცია აჭარბებს C.tropicalis  ელიმინაციისათვის საჭირო კონცენტრაციას, რის გამოც ფლუკონაზოლი წარმოადგენს ამფოტერიცინ B-ს კარგ ალტერნატივას Candida-ს ჯგუფის სოკოებით გამოწვეული კერატიტების სამკურნალოდ.

ფარმაკოკინეტიკა
კარგად აღწევს ყველა ბიოლოგიურ სითხეში.
გამოიყოფა ძირითადად თირკმელების საშუალებით, ფლუკონაზოლის 80% ექსკრეტირდება უცვლელი სახით, დაახლოებით 11%-მდე – მეტაბოლიტების სახით. ნახევარგამოყოფის პერიოდი შეადგენს 30 სთ-ს (20-50 სთ-ის დიაპაზონში).

გამოყენების ჩვენებები
თვალის სოკოვანი დაზიანებები:
- სკლერიტები;
- ენდოფთალმიტები;
- კერატიტები (კერატომიკოზები);
- კანალიკულიტები და სხვა

უკუჩვენებები
მომატებული მგრძნობელობა ფლუკონაზოლის მიმართ (მათ შორის სხვა აზალური ნაერთების მიმართ). 

გვერდითი მოქმედება
იშვიათად ვლინდება თვალების გაღიზიანება და შეწითლება.

გამოყენების წესი და დოზირება
პრეპარატი განკუთვნილია მხოლოდ ადგილობრივი გამოყენებისათვის.
ინიშნება 1-2 წვეთი დაავადებული თვალის კონიუნქტივალურ პარკში 4-ჯერ დღეში.
მკურნალობის ხანგრძლივობა  შეადგენს არა უმეტეს 3 კვირას.

ჭარბი დოზირება
ჭარბი დოზირების შემთხვევები გამოვლენილი არ არის. 

გაფრთხილება
სხვა ოფთალმოლოგიური პრეპარატების მსგავსად, შესაძლოა პრეპარატის შეწოვა სისხლში. სიფრთხილით ინიშნება თირკმლის ფუნქციის დარღვევების  მქონე პაციენტებში, დაქვეითებული იმუნიტეტის დროს (ახალშობილობის პერიოდი, შიდსი და სხვა). პრეპარატის მიღება უნდა შეწყდეს ალერგიული რეაქციების ნებისმიერი ნიშნის გამოვლინების შემთხვევაში. 

განსაკუთრებული მითითებები
პაციენტი უნდა მოერიდოს საწვეთურის თავის მოხვედრას რაიმე ზედაპირზე, რათა თავიდან იქნას აცილებული ფლაკონის შიგთავსის მიკრობული დაინფიცირება. 
პრეპარატით მკურნალობის პერიოდში არ არის რეკომენდებული კონტაქტური ლინზების ტარება. 
ფლაკონის გახსნის შემდეგ პრეპარატის გამოყენება შეიძლება ერთი თვის განმავლობაში. 
თუ პრეპარატით მკურნალობის დროს 7-10 დღის განმავლობაში გაუმჯობესება არ აღინიშნა, უნდა ვივარაუდოთ, რომ დაავადება გამოწვეულია პრეპარატის მიმართ არამგრძნობიარე მიკროორგანიზმით. 

გამოყენება ორსულობის და ლაქტაციის დროს
პრეპარატის გამოყენება ორსულობისა და ლაქტაციის პერიოდში შესაძლებელია მხოლოდ იმ შემთხვევაში, როდესაც მკურნალობის მოსალოდნელი სასარგებლო შედეგი დედისათვის აღემატება ნაყოფზე პოტენციურ რისკს. მკურნალობის განმავლობაში ძუძუთი კვება უნდა შეწყდეს. 

გამოყენება პედიატრიაში
ბავშვებში გამოყენების უსაფრთხოება დადგენილი არ არის.

ზემოქმედება ავტომობილების და სხვა მექანიზმების მართვის უნარზე 
ფლუზამედის ინსტილაციის შემდეგ პაციენტებში შეიძლება აღინიშნოს მხედველობის სიმახვილის დროებითი დაქვეითება, ამიტომ არ არის რეკომენდებული  ავტომობილის მართვა, ასევე ტექნიკასთან, დაზგებთან ან სხვა რთულ დანადგარებთან მუშაობა, რაც მოითხოვს მხედველობის სიმახვილეს.

გამოშვების ფორმა
ფლუზამედი თვალის წვეთები 5მლ პლასტმასის ფლაკონში საწვეთურით და ხრახნიანი დამცავი რგოლით. ფლაკონი მოთავსებულია მუყაოს კოლოფში გამოყენების ინსტრუქციასთან ერთად.

შენახვის პირობები
ინახება არა უმეტეს  25ºC ტემპერატურაზე, ბავშვებისათვის მიუწვდომელ ადგილას.

ვარგისიანობის ვადა
3 წელი წარმოების თარიღიდან.
არ გამოიყენოთ ვარგისიანობის ვადის გასვლის შემდეგ.

აფთიაქიდან გაცემის წესი 
ფარმაცევტული პროდუქტის ჯგუფი III – გამოიყენება ექიმის დანიშნულების გარეშე.

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