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შემადგენლობა
სოსეფენი 2 მგ/მლ პერორალური წვეთები, ხსნარი
ხსნარის 1 მლ შეიცავს:
აქტიური ინგრედიენტი: კეტოტიფენის წყალბადის ფუმარატი 2.75 მგ (2 მგ კეტოტიფენის ფუძის ექვივალენტი)
დამხმარე ნივთიერებები: პროპილენის გლიკოლი, სორბიტოლი, ლიმონმჟავა, ნატრიუმის ციტრატი, ნატრიუმის მეტალ ჰიდროქსიბენზოატი, ნატრიუმის პროპილჰიდროქსიბენზოატი, საქარინის ნატრიუმი, მარწყვის არომატიზატორი და გასუფთავებული წყალი.
ჩვენებები
- ბრონქული ასთმის შეტევების პროფილაქტიკა
- ალერგიული რინიტი
- ალერგიული კონიუნქტივიტი
- ალერგიული დერმატოზები, ჭინჭრის ციება
მიღების წესები და დოზები
ხსნარი დოზირებულია წვეთების დოზირების სისტემით და დაყოფილია 25 ხაზად
• 7 ხაზი შეესაბამება 0.5 მგ კეტოტიფენს
• 13 ხაზი შეესაბამება 1.0 მგ კეტოტიფენს
• 25 ხაზი შეესაბამება 2.0 მგ კეტოტიფენს
მოზრდილები და ბავშვები (3 წლის ასაკიდან) – 1 მგ დღეში ორჯერ (დილით და საღამოს)
ბავშვები (6 თვიდან 3 წლამდე) – 0.05მგ/კგ დღეში ორჯერ (დილით და საღამოს)
გვერდითი მოვლენები
ძილიანობა და სედაცია (ძალიან ხშირად/ხშირად მკურნალობის დასაწყისში, რაც ჩვეულებრივ სპონტანურად გადის ისე, რომ მკურნალობის შეწყვეტა საჭირო არ არის), გულისრევა, ღებინება, დისპეფსია, ასთენია, პირის სიმშრალე, თავბრუსხვევა.
ცენტრალური ნერვული სისტემის სტიმულაციის სიმპტომები, როგორიცაა, აგზნება, გაღიზიანება, უძილობა და ნერვოზულობა აღინიშნება განსაკუთრებით ბავშვებში. გარდა ამისა, აღინიშნება კონტაქტური დერმატიტი, გამონაყარი, სტივენ-ჯონსონის სინდრომი, დისპნოე, წონაში მომატება, სინკოპე და აბსტინენციის სინდრომი.
ძალიან იშვიათად: კეტოტიფენმა შეიძლება გამოიწვიოს კრუნჩხვები, ღვიძლის ფერმენტების მომატება და ჰეპატიტი. კეტოტიფენით მკურნალობისას აღინიშნა არითმიის ცალკეული შემთხვევები.
ინსტრუქციის ფურცელში მოცემული მითითებების დაცვით მცირდება არასასურველი ეფექტების რისკი
. ისეთი გვერდითი ეფექტის გამოვლენისას, რომელიც აღწერილი არ არის მოცემულ ინსტრუქციაში, მიმართეთ ექიმს.
უკუჩვენება
მომატებული მგრძნობელობა კეტოტიფენის ან ნებისმიერი დამხმარე ნივთიერების მიმართ.
ორსულობა და ლაქტაცია
მიუხედავად იმისა, რომ არ არსებობს მონაცემები პრეპარატის ტერატოგენური მოქმედების შესახებ, სოსეფენის გამოყენება ორსულობის პერიოდში რეკომენდებული არ არის. კეტოტიფენი გამოიყოფა დედის რძეში; ამიტომ, სოსეფენის მიღებისას ძუძუთი კვება უნდა შეწყდეს.
განსაკუთრებული მითითებები
სოსეფენის წვეთები შეიცავს პარაჰიდროქსიბენზოატებს, რომლებმაც შეიძლება გამოიწვიონ დაყოვნებული სახის ალერგიული რეაქცია, როგორიცაა კონტაქტური დერმატიტი; ძალიან იშვიათად კი, მყისიერი რეაქციები ჭინჭრის გამონაყარით და ბრონქოსპაზმი.

გავლენა ავტომობილების მართვისა და მექანიზმებთან მუშაობის უნარზე:
კეტოტიფენით მკურნალობის პირველი რამდენიმე დღის განმავლობაში შეიძლება აღინიშნოს რეაქციების შეფერხება. პაციენტი უნდა მოერიდოს სატრანსპორტო საშუალებების მართვასა და მექანიზმებთან მუშაობას იმ დრომე, ვიდრე ცნობილი არ გახდება კეტოტიფენის მოქმედება ინდივიდუალურ პიროვნებაზე.
ჭარბი დოზირება
ჭარბი დოზის მიღებისას ვლინდება დაბნეულობა, ძილიანობა, ნისტაგმი, თავის ტკივილი, დეზორიენტაცია, ტაქიკარდია, ჰიპოტენზია, შექცევადი კომა; განსაკუთრებით ბავშვებში – ჰიპერაგზნება ან კრუნჩხვები. ასევე შეიძლება აღინიშნოს ბრადიკარდია და სუნთქვის დათრგუნვა.
მკურნალობა სიმპტომატურია. ჭარბი დოზის მიღებიდან ერთი საათის განმავლობაში რეკომენდებულია აქტივირებული ნახშირით მკურნალობა. აუცილებლობისას, მკურნალობა და გულ-სისხლძარღვთა სისტემის მონიტორინგი; თუ სახეზეა აგზნება, შეიძლება გამოყენებული იყოს ხანმოკლედ მოქმედი ბარბიტურატები ან ბენზოდიაზეპინები.
სხვა წამლებთან ურთიერთქმედება
სოსეფენმა შეიძლება გააძლიეროს დამამშვიდებელი, საძილე საშუალებების, ანტიჰისტამინებისა და ალკოჰოლის ეფექტები.
რამდენიმე შემთხვევაში აღინიშნა თრომბოციტების შექცევადი ხასიათის დაქვეითება იმ პაციენტებში, რომლებიც სოსეფენთან ერთად იღებდნენ პერორალურ ანტიდიაბეტურ საშუალებებს. ამიტომ, თავიდან უნდა იქნას აცილებული პრეპარატების ამგვარი კომბინაცია.
კეტოტიფენი ზრდის ბრონქების გამაფართოებელი საშუალებების მოქმედებას; ამიტომ, ეს უკანასკნელნი სოსეფენის მიღებისას ნაკლებად ხშირად უნდა იქნას გამოყენებული.
შენახვის პირობები და ვადები
ვარგისიანობის ვადა იხილეთ გარეთა შეფუთვაზე.

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