Novaquin

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
28-01-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
28-01-2022
Public Assessment Report Public Assessment Report (PAR)
08-10-2015

Active ingredient:

мелоксикам

Available from:

Le Vet Beheer B.V. 

ATC code:

QM01AC06

INN (International Name):

meloxicam

Therapeutic group:

Коне

Therapeutic area:

Oxicams

Therapeutic indications:

Облекчаване на възпалението и облекчаване на болката при остри и хронични мускулно-скелетни нарушения при коне.

Product summary:

Revision: 4

Authorization status:

упълномощен

Authorization date:

2015-09-08

Patient Information leaflet

                                15
B. ЛИСТОВКА
16
ЛИСТОВКА:
NOVAQUIN 15 MG/ML ПЕРОРАЛНА СУСПЕНЗИЯ ЗА КОНЕ
1.
ИМЕ И ПОСТОЯНЕН АДРЕС НА ПРИТЕЖАТЕЛЯ
НА ЛИЦЕНЗА ЗА УПОТРЕБА
И НА ПРОИЗВОДИТЕЛЯ, АКО ТЕ СА РАЗЛИЧНИ
Притежател на лиценза за употреба
Le Vet Beheer B.V.
Wilgenweg 7
3421 TV Oudewater
The Netherlands
Производител, отговорен за
освобождаване на партидата:
Produlab Pharma B.V.
Forellenweg 16
4941 SJ Raamsdonksveer
The Netherlands
2.
НАИМЕНОВАНИЕ НА
ВЕТЕРИНАРНОМЕДИЦИНСКИЯ ПРОДУКТ
Novaquin 15 mg/ml перорална суспензия за коне
Meloxicam
3.
СЪДЪРЖАНИЕ НА АКТИВНАТА СУБСТАНЦИЯ И
ЕКСЦИПИЕНТИТЕ
Един ml съдържа:
Активна субстанция:
Meloxicam
15 mg
Ексципиенти:
Sodium benzoate
1,75 mg
Жълтеникаво-зелена вискозна
перорална суспензия
4.
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
Облекчаване на възпалението и
намаляване на болката както при остри,
така и при хронични
мускулно-скелетни нарушения при коне.
5.
ПРОТИВОПОКАЗАНИЯ
Да не се използва при бременни и
лактиращи кобили.
Да не се използва при коне, страдащи от
гастроинтестинални смущения като
възпаление и
хеморагия, нарушена чернодробна,
сърдечна или бъбречна функция и
хеморагични нарушения.
Да не се използва при
свръхчувствителност към активната
субстанция или към някой от
ексципиентите.
Да не се използва при к
                                
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Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
НАИМЕНОВАНИЕ НА
ВЕТЕРИНАРНОМЕДИЦИНСКИЯ ПРОДУКТ
Novaquin 15 mg/ml перорална суспензия за коне
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Един ml съдържа:
АКТИВНА СУБСТАНЦИЯ:
Meloxicam
15 mg
ЕКСЦИПИЕНТИ:
Sodium benzoate
1,75 mg
За пълния списък на ексципиентите, виж
т. 6.1.
3.
ФАРМАЦЕВТИЧНА ФОРМА
Перорална суспензия.
Жълтеникавo- зеленa вискозна перорална
суспензия.
4.
КЛИНИЧНИ ДАННИ
4.1
ВИДОВЕ ЖИВОТНИ, ЗА КОИТО Е
ПРЕДНАЗНАЧЕН ВМП
Коне.
4.2
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ, ОПРЕДЕЛЕНИ ЗА
ОТДЕЛНИТЕ ВИДОВЕ ЖИВОТНИ
Облекчаване на възпалението и
намаляване на болката както при остри,
така и при хронични
мускулно-скелетни нарушения при коне.
4.3
ПРОТИВОПОКАЗАНИЯ
Да не се използва при бременни и
лактиращи кобили.
Да не се използва при коне, страдащи от
гастроинтестинални смущения като
възпаление и
хеморагия, нарушена чернодробна,
сърдечна или бъбречна функция и
хеморагични нарушения.
Да не се използва при
свръхчувствителност към активната
субстанция или към някой от
ексципиентите.
Да не се използва при коне под 6
седмична възраст.
4.4
СПЕЦИАЛНИ ПРЕДПАЗНИ МЕРКИ
Няма.
4.5
СПЕЦИАЛНИ ПРЕДПАЗНИ МЕРКИ ПРИ
УПОТРЕБА
Специ
                                
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Active ingredient мелоксикам

мелоксикам

ATC code QM01AC06

QM01AC06

Marketed by Le Vet Beheer B.V. 

Le Vet Beheer B.V. 

INN (International Name) meloxicam

meloxicam

Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 28-01-2022
Summary of Product characteristics Summary of Product characteristics Spanish 28-01-2022
Public Assessment Report Public Assessment Report Spanish 08-10-2015
Patient Information leaflet Patient Information leaflet Czech 28-01-2022
Summary of Product characteristics Summary of Product characteristics Czech 28-01-2022
Public Assessment Report Public Assessment Report Czech 08-10-2015
Patient Information leaflet Patient Information leaflet Danish 28-01-2022
Summary of Product characteristics Summary of Product characteristics Danish 28-01-2022
Public Assessment Report Public Assessment Report Danish 08-10-2015
Patient Information leaflet Patient Information leaflet German 28-01-2022
Summary of Product characteristics Summary of Product characteristics German 28-01-2022
Public Assessment Report Public Assessment Report German 08-10-2015
Patient Information leaflet Patient Information leaflet Estonian 28-01-2022
Summary of Product characteristics Summary of Product characteristics Estonian 28-01-2022
Public Assessment Report Public Assessment Report Estonian 08-10-2015
Patient Information leaflet Patient Information leaflet Greek 28-01-2022
Summary of Product characteristics Summary of Product characteristics Greek 28-01-2022
Public Assessment Report Public Assessment Report Greek 08-10-2015
Patient Information leaflet Patient Information leaflet English 28-01-2022
Summary of Product characteristics Summary of Product characteristics English 28-01-2022
Public Assessment Report Public Assessment Report English 08-10-2015
Patient Information leaflet Patient Information leaflet French 28-01-2022
Summary of Product characteristics Summary of Product characteristics French 28-01-2022
Public Assessment Report Public Assessment Report French 08-10-2015
Patient Information leaflet Patient Information leaflet Italian 28-01-2022
Summary of Product characteristics Summary of Product characteristics Italian 28-01-2022
Public Assessment Report Public Assessment Report Italian 08-10-2015
Patient Information leaflet Patient Information leaflet Latvian 28-01-2022
Summary of Product characteristics Summary of Product characteristics Latvian 28-01-2022
Public Assessment Report Public Assessment Report Latvian 08-10-2015
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Summary of Product characteristics Summary of Product characteristics Lithuanian 28-01-2022
Public Assessment Report Public Assessment Report Lithuanian 08-10-2015
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Summary of Product characteristics Summary of Product characteristics Hungarian 28-01-2022
Public Assessment Report Public Assessment Report Hungarian 08-10-2015
Patient Information leaflet Patient Information leaflet Maltese 28-01-2022
Summary of Product characteristics Summary of Product characteristics Maltese 28-01-2022
Public Assessment Report Public Assessment Report Maltese 08-10-2015
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Summary of Product characteristics Summary of Product characteristics Dutch 28-01-2022
Public Assessment Report Public Assessment Report Dutch 08-10-2015
Patient Information leaflet Patient Information leaflet Polish 28-01-2022
Summary of Product characteristics Summary of Product characteristics Polish 28-01-2022
Public Assessment Report Public Assessment Report Polish 08-10-2015
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Summary of Product characteristics Summary of Product characteristics Portuguese 28-01-2022
Public Assessment Report Public Assessment Report Portuguese 08-10-2015
Patient Information leaflet Patient Information leaflet Romanian 28-01-2022
Summary of Product characteristics Summary of Product characteristics Romanian 28-01-2022
Public Assessment Report Public Assessment Report Romanian 08-10-2015
Patient Information leaflet Patient Information leaflet Slovak 28-01-2022
Summary of Product characteristics Summary of Product characteristics Slovak 28-01-2022
Public Assessment Report Public Assessment Report Slovak 08-10-2015
Patient Information leaflet Patient Information leaflet Slovenian 28-01-2022
Summary of Product characteristics Summary of Product characteristics Slovenian 28-01-2022
Public Assessment Report Public Assessment Report Slovenian 08-10-2015
Patient Information leaflet Patient Information leaflet Finnish 28-01-2022
Summary of Product characteristics Summary of Product characteristics Finnish 28-01-2022
Public Assessment Report Public Assessment Report Finnish 08-10-2015
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Summary of Product characteristics Summary of Product characteristics Swedish 28-01-2022
Public Assessment Report Public Assessment Report Swedish 08-10-2015
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Summary of Product characteristics Summary of Product characteristics Norwegian 28-01-2022
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Patient Information leaflet Patient Information leaflet Croatian 28-01-2022
Summary of Product characteristics Summary of Product characteristics Croatian 28-01-2022
Public Assessment Report Public Assessment Report Croatian 08-10-2015

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