ProMeris

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
13-07-2015
Summary of Product characteristics Summary of Product characteristics (SPC)
13-07-2015
Public Assessment Report Public Assessment Report (PAR)
14-07-2015

Active ingredient:

метафлумизон

Available from:

Pfizer Limited 

ATC code:

QP53AX25

INN (International Name):

metaflumizone

Therapeutic group:

Котки

Therapeutic area:

Ectoparasiticides за външно приложение, включително. инсектициди

Therapeutic indications:

Лечение и предотвратяване на нападения от бълхи (Ctenocephalides canis и C. felis) при котки. Ветеринарният лекарствен продукт може да бъде използван като част от терапевтичната стратегия за алергичен дерматит при бълхи (FAD).

Product summary:

Revision: 8

Authorization status:

Отменено

Authorization date:

2006-12-19

Patient Information leaflet

                                Medicinal product no longer authorised
B. ЛИСТОВКА ЗА УПОТРЕБА
19
Medicinal product no longer authorised
ЛИСТОВКА ЗА УПОТРЕБА
PROMERIS SPOT-ON ЗА КОТКИ
1.
ИМЕ И ПОСТОЯННИЯ АДРЕС НА УПРАВЛЕНИЕ
НА ПРИТЕЖАТЕЛЯ НА
ЛИЦЕНЗА ЗА УПОТРЕБА И НА
ПРОИЗВОДИТЕЛЯ, АКО ТЕ СА РАЗЛИЧНИ
ЛИЦА
Притежател на лиценза за употреба
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
Производител, отговорен за
освобождаване на партидата
Wyeth Lederle Italia S.p.A.
18, Via Franco Gorgone
95121 Catania
Italy
2.
НАИМЕНОВАНИЕ НА
ВЕТЕРИНАРНОМЕДИЦИНСКИЯ ПРОДУКТ
ProMeris 160 мг Spot-on за малки котки
ProMeris 320 мг Spot-on за големи котки
3.
СЪДЪРЖАНИЕ НА АКТИВНИТЕ СУБСТАНЦИИ И
ПОМОЩНИТЕ ВЕЩЕСТВА
АКТИВНА СУБСТАНЦИЯ
Всяки мл съдържа 200 мг метафлумизон
Всяка единична доза (пипета) от ProMeris
съдържа:
ОБЕМ ДОЗА В (МЛ)
МЕТАФЛУМИЗОН (МГ)
ProMeris за малки котки
(< 4 кг)
*
0,80 мл
160
ProMeris за големи котки
(> 4 кг)*
1,60 мл
320
*Поради ограниченото порстранство на
опаковката върху фолиото и на
пипетите, ще се
използват следните съкращения "S" и "L" ",
еквивалентни съответно на "малки" “и
“големи”
4.
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
За лечение и профилактика на
опаразитявания с бълхи (
_Ctenocephalides canis_
and
_C. felis_
) при
котки. Ветеринарномедицинският
продукт може да бъде ползван като част
от лечебна
                                
                                Read the complete document

Summary of Product characteristics

                                Medicinal product no longer authorised
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
1
Medicinal product no longer authorised
1.
НАИМЕНОВАНИЕ НА
ВЕТЕРИНАРНОМЕДИЦИНСКИЯ ПРОДУКТ
ProMeris 160 мг Spot On
за малки котки
ProMeris 320 мг Spot On за големи котки
2.
КОЛИЧЕСТВЕН И КАЧЕСТВЕН СЪСТАВ
АКТИВНА СУБСТАНЦИЯ:
Всеки мл. съдържа 200 мг метафлумизон.
Всяка единична доза (пипета) от ProMeris
съдържа:
ОБЕМ ДОЗА В (МЛ)
МЕТАФЛУМИЗОН (МГ)
ProMeris за малки котки
(< 4 кг)
0,80 мл
160 мг
ProMeris за големи котки
(> 4 кг)
1,60 мл
320 мг
ПОМОЩНИ ВЕЩЕСТВА:
За пълен списък на помощните вещества
виж точка 6.1.
3.
ФАРМАЦЕВТИЧНА ФОРМА
Spot-on разтвор
С бистър жълт до кехлибарен цвят.
4.
КЛИНИЧНИ ДАННИ
4.1
ВИДОВЕ ЖИВОТНИ, ЗА КОИТО Е
ПРЕДНАЗНАЧЕН ВМП
Котки над 8 седмична възраст.
4.2.
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ, СПЕЦИФИЧНИ ЗА
ОТДЕЛНИТЕ ВИДОВЕ ЖИВОТНИ
За лечение и профилактика на
опаразитявания с бълхи (
_Ctenocephalides_
_canis _
и
_ C._
_felis_
.) при
котки. Ветеринарномедицинският
продукт може да бъде ползван като част
от лечебната
стратегия на алергични дерматити,
причинени от бълхи (FAD).
4.3
ПРОТИВОПОКАЗАНИЯ
Да не се използва при малки котенца
под 8 седмична възраст.
4.4
СПЕЦИАЛНИ ПРЕДПАЗНИ МЕРКИ ЗА ВСЕКИ
ВИД ЖИВОТНИ, ЗА КОИТО Е ПРЕДНАЗНАЧЕН
ВМП
                                
                                Read the complete document

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Active ingredient метафлумизон

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ATC code QP53AX25

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Marketed by Pfizer Limited 

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INN (International Name) metaflumizone

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Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 13-07-2015
Summary of Product characteristics Summary of Product characteristics Spanish 13-07-2015
Public Assessment Report Public Assessment Report Spanish 14-07-2015
Patient Information leaflet Patient Information leaflet Czech 13-07-2015
Summary of Product characteristics Summary of Product characteristics Czech 13-07-2015
Public Assessment Report Public Assessment Report Czech 14-07-2015
Patient Information leaflet Patient Information leaflet Danish 13-07-2015
Summary of Product characteristics Summary of Product characteristics Danish 13-07-2015
Public Assessment Report Public Assessment Report Danish 14-07-2015
Patient Information leaflet Patient Information leaflet German 13-07-2015
Summary of Product characteristics Summary of Product characteristics German 13-07-2015
Public Assessment Report Public Assessment Report German 14-07-2015
Patient Information leaflet Patient Information leaflet Estonian 13-07-2015
Summary of Product characteristics Summary of Product characteristics Estonian 13-07-2015
Public Assessment Report Public Assessment Report Estonian 14-07-2015
Patient Information leaflet Patient Information leaflet Greek 13-07-2015
Summary of Product characteristics Summary of Product characteristics Greek 13-07-2015
Public Assessment Report Public Assessment Report Greek 14-07-2015
Patient Information leaflet Patient Information leaflet English 13-07-2015
Summary of Product characteristics Summary of Product characteristics English 13-07-2015
Public Assessment Report Public Assessment Report English 14-07-2015
Patient Information leaflet Patient Information leaflet French 13-07-2015
Summary of Product characteristics Summary of Product characteristics French 13-07-2015
Public Assessment Report Public Assessment Report French 14-07-2015
Patient Information leaflet Patient Information leaflet Italian 13-07-2015
Summary of Product characteristics Summary of Product characteristics Italian 13-07-2015
Public Assessment Report Public Assessment Report Italian 14-07-2015
Patient Information leaflet Patient Information leaflet Latvian 13-07-2015
Summary of Product characteristics Summary of Product characteristics Latvian 13-07-2015
Public Assessment Report Public Assessment Report Latvian 14-07-2015
Patient Information leaflet Patient Information leaflet Lithuanian 13-07-2015
Summary of Product characteristics Summary of Product characteristics Lithuanian 13-07-2015
Public Assessment Report Public Assessment Report Lithuanian 14-07-2015
Patient Information leaflet Patient Information leaflet Hungarian 13-07-2015
Summary of Product characteristics Summary of Product characteristics Hungarian 13-07-2015
Public Assessment Report Public Assessment Report Hungarian 14-07-2015
Patient Information leaflet Patient Information leaflet Maltese 13-07-2015
Summary of Product characteristics Summary of Product characteristics Maltese 13-07-2015
Public Assessment Report Public Assessment Report Maltese 14-07-2015
Patient Information leaflet Patient Information leaflet Dutch 13-07-2015
Summary of Product characteristics Summary of Product characteristics Dutch 13-07-2015
Public Assessment Report Public Assessment Report Dutch 14-07-2015
Patient Information leaflet Patient Information leaflet Polish 13-07-2015
Summary of Product characteristics Summary of Product characteristics Polish 13-07-2015
Public Assessment Report Public Assessment Report Polish 14-07-2015
Patient Information leaflet Patient Information leaflet Portuguese 13-07-2015
Summary of Product characteristics Summary of Product characteristics Portuguese 13-07-2015
Public Assessment Report Public Assessment Report Portuguese 14-07-2015
Patient Information leaflet Patient Information leaflet Romanian 13-07-2015
Summary of Product characteristics Summary of Product characteristics Romanian 13-07-2015
Public Assessment Report Public Assessment Report Romanian 14-07-2015
Patient Information leaflet Patient Information leaflet Slovak 13-07-2015
Summary of Product characteristics Summary of Product characteristics Slovak 13-07-2015
Public Assessment Report Public Assessment Report Slovak 14-07-2015
Patient Information leaflet Patient Information leaflet Slovenian 13-07-2015
Summary of Product characteristics Summary of Product characteristics Slovenian 13-07-2015
Public Assessment Report Public Assessment Report Slovenian 14-07-2015
Patient Information leaflet Patient Information leaflet Finnish 13-07-2015
Summary of Product characteristics Summary of Product characteristics Finnish 13-07-2015
Public Assessment Report Public Assessment Report Finnish 14-07-2015
Patient Information leaflet Patient Information leaflet Swedish 13-07-2015
Summary of Product characteristics Summary of Product characteristics Swedish 13-07-2015
Public Assessment Report Public Assessment Report Swedish 14-07-2015
Patient Information leaflet Patient Information leaflet Norwegian 13-07-2015
Summary of Product characteristics Summary of Product characteristics Norwegian 13-07-2015
Patient Information leaflet Patient Information leaflet Icelandic 13-07-2015
Summary of Product characteristics Summary of Product characteristics Icelandic 13-07-2015

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