Luveris

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
06-09-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
06-09-2022
Public Assessment Report Public Assessment Report (PAR)
03-08-2011

Active ingredient:

лутропин алфа

Available from:

Merck Europe B.V. 

ATC code:

G03GA07

INN (International Name):

lutropin alfa

Therapeutic group:

Полови хормони и слиза на половата система,

Therapeutic area:

Ovulation Induction; Infertility, Female

Therapeutic indications:

Luveris във връзка с фоликуло стимулиращ хормон (FSH) препарат се препоръчва за стимулиране на фоликуларен развитие при жени с тежки лутеинизиращия-хормон (LH) и ФСХ дефицит. В клинични проучвания, при тези пациенти са били идентифицирани ендогенен нивото на серумните нива на LH .

Product summary:

Revision: 21

Authorization status:

упълномощен

Authorization date:

2000-11-29

Patient Information leaflet

                                22
Б. ЛИСТОВКА
23
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПОТРЕБИТЕЛЯ
РАЗТВОРИТЕЛ В АМПУЛИ
LUVERIS 75 IU ПРАХ И РАЗТВОРИТЕЛ ЗА
ИНЖЕКЦИОНЕН РАЗТВОР
лутропин алфа (lutropin alfa)
ПРОЧЕТЕТЕ ВНИМАТЕЛНО ЦЯЛАТА ЛИСТОВКА,
ПРЕДИ ДА ЗАПОЧНЕТЕ ДА ИЗПОЛЗВАТЕ ТОВА
ЛЕКАРСТВО, ТЪЙ КАТО ТЯ СЪДЪРЖА ВАЖНА
ЗА ВАС ИНФОРМАЦИЯ.
-
Запазете тази листовка. Може да се
наложи да я прочетете отново.
-
Ако имате някакви допълнителни
въпроси, попитайте Вашия лекар,
фармацевт или
медицинска сестра.
-
Това лекарство е предписано лично на
Вас. Не го преотстъпвайте на други
хора. То може
да им навреди, независимо че
признаците на тяхното заболяване са
същите както Вашите.
-
Ако получите някакви нежелани
реакции, уведомете Вашия лекар,
фармацевт или
медицинска сестра. Това включва и
всички възможни нежелани реакции,
неописани в
тази листовка. Вижте точка 4.
КАКВО СЪДЪРЖА ТАЗИ ЛИСТОВКА:
1.
Какво представлява Luveris и за какво се
използва
2.
Какво трябва да знаете, преди да
използвате Luveris
3.
Как да използвате Luveris
4.
Възможни нежелани реакции
5.
Как да съхранявате Luveris
6.
Съдържание на опаковката и
допълнителна информация
1.
КАКВО ПРЕДСТАВЛЯВА LUVERIS И ЗА КАКВО СЕ
ИЗПОЛЗВА
КАКВО ПРЕДСТА
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Luveris 75 IU прах и разтворител за
инжекционен разтвор
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Един флакон съдържа 75 IU лутропин алфа
(lutropin alfa)*.
* (рекомбинантен човешки лутеинизиращ
хормон, r-hLH), произведен от генно
модифицирани
овариални клетки на китайски хамстер
(CHO) с рекомбинантна ДНК технология.
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Прах и разтворител за инжекционен
разтвор (прах за инжекция)
Външен вид на праха: бели,
лиофилизирани пелети
Външен вид на разтворителя: бистър,
безцветен разтвор
pH на реконституирания разтвор е между
7,5 до 8,5.
За самостоятелно приложение от
пациенти трябва да се имат предвид
форми, различни
от ампули.
4.
КЛИНИЧНИ ДАННИ
4.1
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
Luveris в комбинация с
фоликулостимулиращ хормон (FSH) е
показан за стимулация на
фоликулното развитие при възрастни
жени с тежък дефицит на лутеинизиращ
хормон (LH) и
FSH.
4.2
ДОЗИРОВКА И НАЧИН НА ПРИЛОЖЕНИЕ
Терапията с Luveris трябва да започне под
наблюдение на лекар, с опит в
лечението на
нарушения на фертилитета.
Дозировка
При жени, които с
                                
                                Read the complete document

Similar products

Active ingredient лутропин алфа

лутропин алфа

ATC code G03GA07

G03GA07

Marketed by Merck Europe B.V. 

Merck Europe B.V. 

INN (International Name) lutropin alfa

lutropin alfa

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Patient Information leaflet Patient Information leaflet Spanish 06-09-2022
Summary of Product characteristics Summary of Product characteristics Spanish 06-09-2022
Public Assessment Report Public Assessment Report Spanish 03-08-2011
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Luveris