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ბიოლევოქსი / Biolevox | მედიკამენტები | vidal.ge

**შემადგენლობა:**

**თითოეული მილილიტრი შდგება:**

ნატრიუმის ჰიალურონატი 25.0 მგ

NaCl 0,9% 8.5 მგ

Disodium hydrogenphosphate 0.563 მგ

Sodium dihydrogenphosphate 0.045 მგ

საინექციო წყალი

**წყარო** / **წარმოშობა**

ეს პროდუქტი მიღებულია ფერმენტაციის გზით და გამოიყენება სახსარშიდა ვისკოელასტიურობის გასაუმჯობესებლად. არის სტერილური და არ იწვწვს სიცხეს.

**შემადგენლობა**
1 მლ ხსნარი შეიცავს 25.0 მგ ფერმენტაციით მიღებულ, სტერილურ, იზოტონურ, უპიროგენო, დაბალი ფოსფატის ბუფერის მქონე ნატრიუმის ჰიალურონატს, ph 7,2 და საინექციო წყალს.

**თერაპიული სფერო**
დეგენერაციული ან ტრავმული მიზეზით გამოწვეული მუხლის ან სხვა სინოვიალურ სახსარის ტკივილი და სახსრის შეზრუდული მობილობა.

**უკუჩვენებები**
პროდუქტი არ უნდა იქნას გამოყენებული პაციენტებში თუ მათ აქვთ:
· იპერმგრძნობელობით ნებისმიერი ინგრედიენტის მიმართ.
· სეპტიური ართრიტი
· კანის ინფექციებით ან დერმატოლოგიური დაავადებეით ინექციის სავარაუდო ადგილას
· თუ იღებენ ისეთ კოაგულაციის ინჰიბიტორებს როგორიც არის პრეპარატი Macumar-ი

**გაფრთხილება**
რადგან სეპტიური ართრიტი არის სერიოზული გვერდითი ეფექტი, გთხოვთ გამოიჩინოთ სიფრთხილე ქირურგიული ჩარევისას.

პრეპარატი უნდა შეიყვანოთ სახსარშიდა სივრცეში.

ინტრა-სისხლძარღვთა ან ინტრა-ქსოვილური ინექცია დაუშვებელია.

ბავშვებში ან ორსულ ქალებში ჰიალურონის მჟავის მოქმედების შესახებ კლინიკური მონაცემები არ არის ხელმისაწვდომი. ამიტომ პრეპარატი არ უნდა გამოიყენოთ ამ პაციენტებში.

დაზიანებული შეფუთვის შემთხვევაში პროდუქტი არ უნდა გამოიყენოთ.

პროდუქტი უნდა იქნას გამოყენებული შეფუთვაზე მითითებულ ივადის გასვლამდე.

ბიოშეღწევადობის ტესტირებისას პროდუქტის ბიოშეღწევადობის ნიშნები არ გამოვლენილა.

ზოგიერთი ადგილობრივი უარყოფითი რეაქცია შეიძლება გამოვლინდეს სახსარშიდა ინექციის შემდეგ, როგორიცაა სიწითლე, შეშუპება, სიცხე და ტკივილი. 5-10 წუთის განმავლობაში ყინულის ადგილობრივი გამოყენებით შეიძლება ამ ეფექტების შემცირება.

ცნობილი არ არის შეუთავსებლობა სხვა დღემდე გავრცელებულ სახსარშიდა საინექციო პრეპარატებთან.
პრეპარატის ინექციის პირველ დღეებში ანალგეტიკების ან ანთების საწინააღმდეგო საშუალების პერორალური მიღება შეიძლება სასარგებლო იყოს.

პრეპარატი არ უნდა იყოს გამოყენებული ამონიუმის მეოთხეულ ნაერთებთან ერთად.

პრეპარატის გასტერილება მეორადი გამოყენების მიზნით, დაუშვებელია, რადგან ამან შეიძლება გამოიწვიოს ინფექცია ან/და პროდუქტის არაეფექტურობა.

**გამოყენება და დოზირება**

შპრიცი არის წინასწარ შევსებული. ლუერის საკეტი უნდა მოიხსნას და შესაბამისი ბასრ წვერიანი ნემსი უნდა დაეხრახნოს ლუერის საკეტზე. რეკომენდირებულია ეთჯერადი ნემსის გამოყენება. ნემსები შედის შეფუთვაში. ინექციამდე შპრიციდან გამოდევნეთ საჰაერო ბუშტები. კანის დეზინფექცია ხდება ადგილობრივი ანტისეპტიკით.

4.8 მლ პრეპარატით შევსებული შპრიცი არის მხოლოდ მუხლზე ადაპტირებული მოცულობა.

4.8 მლ ერთჯერადი ინექციის რეკომენდებული მუხლის სამკურნალო დოზა არის ერთი ინექცია, რომელიც შეიძლებანგანმეორდეს 6 თვის შემდეგ, კლინიკური ეფექტისა და და პაციენტის მიერ მიღებული ტკივილის შემსუბუქების საფუძველზე.

**თვისებები და მოქმედების მექანიზმი**

სახსარშიდა სითხე შეიცავს ფიზიოლოგიურ ჰიალურონის მჟავას, რომელიც განაპირობებს სახსრის ელასტიურობას და უმტკივნეულო მოძრაობას მისი საპოხი თვისებების წყალობით. ის აგრეთვე, მონაწილეობს სახსრის ხრტილოვანი ქსოვილის კვებაში. სახსარშიდა სითხის ინექცია გზით ჰიალურონის მჟავით შევსება აუმჯობესებს სახსარშიდა სითხის საპოხ თვისებას. 1-5 სახსარშიდა ინექციის შემდეგ სახსრის მოქნილობა უმჯობესდება და დეგენერაციული დაზიანებებთან ასოცირებული ტკივილი მცირდება.

**შეფუთვა**

1 კოლოფი, რომელიც შეიცავს 120 მგ ნატრიუმის ჰიალურონატით წინასწარ შევსებულ 4.8 მლ შპრიცს, სტერილურ შეფუთვაში და სტერილური ნემსით (მაგ., 19 ან 21 გ), რომელიც შეფუთულია ცალკე.

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