Rexxolide

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
17-09-2021
Summary of Product characteristics Summary of Product characteristics (SPC)
17-09-2021
Public Assessment Report Public Assessment Report (PAR)
01-01-1970

Active ingredient:

тулатромицин

Available from:

Dechra Regulatory B.V.

ATC code:

QJ01FA94

INN (International Name):

tulathromycin

Therapeutic group:

Cattle; Pigs; Sheep

Therapeutic area:

Антибактериални средства за системна употреба

Therapeutic indications:

Cattle: Treatment and metaphylaxis of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis susceptible to tulathromycin. Наличието на болестта в стадото трябва да бъде установено преди метафилактичното лечение. Treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis susceptible to tulathromycin. Pigs: Treatment and metaphylaxis of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica susceptible to tulathromycin. Наличието на болестта в стадото трябва да бъде установено преди метафилактичното лечение. The product should only be used if pigs are expected to develop the disease within 2–3 days. Овца: лечение на ранните стадии на инфекцията pododermatitis (копытная гниене), свързани с вирулентным пилей dichelobacter nodosus, които изискват системно лечение.

Product summary:

Revision: 2

Authorization status:

упълномощен

Authorization date:

2020-12-03

Patient Information leaflet

                                19
B.
ЛИСТОВКА
20
ЛИСТОВКА:
REXXOLIDE 100 MG/ML ИНЖЕКЦИОНЕН РАЗТВОР ЗА
ГОВЕДА, СВИНЕ И ОВЦЕ
1.
ИМЕ И ПОСТОЯНEН АДРЕС НА ПРИТЕЖАТЕЛЯ
НА ЛИЦЕНЗА ЗА УПОТРЕБА И НА
ПРОИЗВОДИТЕЛЯ, АКО ТЕ СА РАЗЛИЧНИ
Притежател на лиценза за употреба:
Dechra Regulatory B.V.
Handelsweg 25
5531 AE Bladel
Холандия
Производител, отговорен за
освобождаване на партидата:
Eurovet Animal Health B.V.
Handelsweg 25
5531 AE Bladel
Холандия
2.
НАИМЕНОВАНИЕ НА
ВЕТЕРИНАРНОМЕДИЦИНСКИЯ ПРОДУКТ
REXXOLIDE 100 mg/ml инжекционен разтвор за
говеда, свине и овце
tulathromycin
3.
СЪДЪРЖАНИЕ НА АКТИВНАТА СУБСТАНЦИЯ И
ЕКСЦИПИЕНТИТЕ
Всеки 1 ml съдържа:
АКТИВНА СУБСТАНЦИЯ:
Tulathromycin
100 mg
ЕКСЦИПИЕНТИ:
Monothioglycerol 5 mg
Бистър, безцветен до слабо жълт
разтвор.
4.
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
Говеда:
Лечение и метафилаксия на
респираторни заболявания при говеда
(BRD), причинени от
_Mannheimia haemolytica_
,
_Pasteurella multocida, Histophilus somni _
и
_Mycoplasma bovis_
,
чувствителни към tulathromycin. Преди
употребата на продукта трябва да бъде
установено
наличие на заболяването в
групата.Лечение на инфекциозен
кератоконюнктивит по говедата
(IBK), причинен от
_Moraxella bovis_
, чувствителна към tulathromycin.
Свине:
Лечение и метафилаксия на
респираторни заболявания при свинете,
причинени от
_Actinobacillus pleuropneumoniae
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
НАИМЕНОВАНИЕ НА
ВЕТЕРИНАРНОМЕДИЦИНСКИЯ ПРОДУКТ
REXXOLIDE 100 mg/ml инжекционен разтвор за
говеда, свине и овце
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Всеки 1 ml съдържа:
АКТИВНА СУБСТАНЦИЯ:
Tulathromycin
100 mg
ЕКСЦИПИЕНТИ:
Monothioglycerol 5 mg
За пълния списък на ексципиентите, виж
т. 6.1.
3.
ФАРМАЦЕВТИЧНА ФОРМА
Инжекционен разтвор.
Бистър, безцветен до слабо жълт
разтвор.
4.
КЛИНИЧНИ ДАННИ
4.1
ВИДОВЕ ЖИВОТНИ, ЗА КОИТО Е
ПРЕДНАЗНАЧЕН ВМП
Говеда, свине и овце.
4.2
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ, ОПРЕДЕЛЕНИ ЗА
ОТДЕЛНИТЕ ВИДОВЕ ЖИВОТНИ
Говеда:
Лечение и метафилаксия на
респираторни заболявания при говеда
(BRD), причинени от
_Mannheimia haemolytica_
,
_Pasteurella multocida, Histophilus somni _
и
_Mycoplasma bovis_
,
чувствителни към tulathromycin. Преди
употребата на продукта трябва да бъде
установено
наличие на заболяването в групата.
Лечение на инфекциозен
кератоконюнктивит по говедата (IBK),
причинен от
_Moraxella bovis_
,
чувствителна към tulathromycin.
Свине:
Лечение и метафилаксия на
респираторни заболявания при свине
(SRD), причинени от
_Actinobacillus pleuropneumoniae_
,
_Pasteurella multocida, Mycoplasma hyopneumoniae_
,
_Haemophilus _
_parasuis _
и
_Bordetella bronchiseptica, _
чувствителни към tulathromycin. Преди
употребата на
пр
                                
                                Read the complete document

Similar products

Active ingredient тулатромицин

тулатромицин

ATC code QJ01FA94

QJ01FA94

Marketed by Dechra Regulatory B.V.

Dechra Regulatory B.V.

INN (International Name) tulathromycin

tulathromycin

Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 17-09-2021
Summary of Product characteristics Summary of Product characteristics Spanish 17-09-2021
Public Assessment Report Public Assessment Report Spanish 01-01-1970
Patient Information leaflet Patient Information leaflet Czech 17-09-2021
Summary of Product characteristics Summary of Product characteristics Czech 17-09-2021
Public Assessment Report Public Assessment Report Czech 01-01-1970
Patient Information leaflet Patient Information leaflet Danish 17-09-2021
Summary of Product characteristics Summary of Product characteristics Danish 17-09-2021
Public Assessment Report Public Assessment Report Danish 01-01-1970
Patient Information leaflet Patient Information leaflet German 17-09-2021
Summary of Product characteristics Summary of Product characteristics German 17-09-2021
Public Assessment Report Public Assessment Report German 01-01-1970
Patient Information leaflet Patient Information leaflet Estonian 17-09-2021
Summary of Product characteristics Summary of Product characteristics Estonian 17-09-2021
Public Assessment Report Public Assessment Report Estonian 01-01-1970
Patient Information leaflet Patient Information leaflet Greek 17-09-2021
Summary of Product characteristics Summary of Product characteristics Greek 17-09-2021
Public Assessment Report Public Assessment Report Greek 01-01-1970
Patient Information leaflet Patient Information leaflet English 17-09-2021
Summary of Product characteristics Summary of Product characteristics English 17-09-2021
Public Assessment Report Public Assessment Report English 01-01-1970
Patient Information leaflet Patient Information leaflet French 17-09-2021
Summary of Product characteristics Summary of Product characteristics French 17-09-2021
Public Assessment Report Public Assessment Report French 01-01-1970
Patient Information leaflet Patient Information leaflet Italian 17-09-2021
Summary of Product characteristics Summary of Product characteristics Italian 17-09-2021
Public Assessment Report Public Assessment Report Italian 01-01-1970
Patient Information leaflet Patient Information leaflet Latvian 17-09-2021
Summary of Product characteristics Summary of Product characteristics Latvian 17-09-2021
Public Assessment Report Public Assessment Report Latvian 01-01-1970
Patient Information leaflet Patient Information leaflet Lithuanian 17-09-2021
Summary of Product characteristics Summary of Product characteristics Lithuanian 17-09-2021
Public Assessment Report Public Assessment Report Lithuanian 01-01-1970
Patient Information leaflet Patient Information leaflet Hungarian 17-09-2021
Summary of Product characteristics Summary of Product characteristics Hungarian 17-09-2021
Public Assessment Report Public Assessment Report Hungarian 01-01-1970
Patient Information leaflet Patient Information leaflet Maltese 17-09-2021
Summary of Product characteristics Summary of Product characteristics Maltese 17-09-2021
Public Assessment Report Public Assessment Report Maltese 01-01-1970
Patient Information leaflet Patient Information leaflet Dutch 17-09-2021
Summary of Product characteristics Summary of Product characteristics Dutch 17-09-2021
Public Assessment Report Public Assessment Report Dutch 01-01-1970
Patient Information leaflet Patient Information leaflet Polish 17-09-2021
Summary of Product characteristics Summary of Product characteristics Polish 17-09-2021
Public Assessment Report Public Assessment Report Polish 01-01-1970
Patient Information leaflet Patient Information leaflet Portuguese 17-09-2021
Summary of Product characteristics Summary of Product characteristics Portuguese 17-09-2021
Public Assessment Report Public Assessment Report Portuguese 01-01-1970
Patient Information leaflet Patient Information leaflet Romanian 17-09-2021
Summary of Product characteristics Summary of Product characteristics Romanian 17-09-2021
Public Assessment Report Public Assessment Report Romanian 01-01-1970
Patient Information leaflet Patient Information leaflet Slovak 17-09-2021
Summary of Product characteristics Summary of Product characteristics Slovak 17-09-2021
Public Assessment Report Public Assessment Report Slovak 01-01-1970
Patient Information leaflet Patient Information leaflet Slovenian 17-09-2021
Summary of Product characteristics Summary of Product characteristics Slovenian 17-09-2021
Public Assessment Report Public Assessment Report Slovenian 01-01-1970
Patient Information leaflet Patient Information leaflet Finnish 17-09-2021
Summary of Product characteristics Summary of Product characteristics Finnish 17-09-2021
Public Assessment Report Public Assessment Report Finnish 01-01-1970
Patient Information leaflet Patient Information leaflet Swedish 17-09-2021
Summary of Product characteristics Summary of Product characteristics Swedish 17-09-2021
Public Assessment Report Public Assessment Report Swedish 01-01-1970
Patient Information leaflet Patient Information leaflet Norwegian 17-09-2021
Summary of Product characteristics Summary of Product characteristics Norwegian 17-09-2021
Patient Information leaflet Patient Information leaflet Icelandic 17-09-2021
Summary of Product characteristics Summary of Product characteristics Icelandic 17-09-2021
Patient Information leaflet Patient Information leaflet Croatian 17-09-2021
Summary of Product characteristics Summary of Product characteristics Croatian 17-09-2021
Public Assessment Report Public Assessment Report Croatian 01-01-1970

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