Canigen L4

Country: European Union

Language: Latvian

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
08-07-2021
Summary of Product characteristics Summary of Product characteristics (SPC)
08-07-2021
Public Assessment Report Public Assessment Report (PAR)
30-07-2015

Active ingredient:

Inaktivēta Leptospira celmiem: L. interrogans serogrupas Canicola serovārs Portland-vere (celms Ca-12-000); L. interrogans serogrupas Icterohaemorrhagiae serovārs Copenhageni (celms Ic-02-001); L. interrogans serogrupas Australis serovārs Bratislava (celms Kā-05-073); L. kirschneri serogrupas Grippotyphosa serovārs Dadas (celms Gr-01-005)

Available from:

Intervet International B.V.

ATC code:

QI07AB01

INN (International Name):

Canine leptospirosis vaccine (inactivated)

Therapeutic group:

Suņi

Therapeutic area:

Immunologicals par canidae, Inaktivēta baktēriju vakcīnas (ieskaitot mycoplasma, toxoid un chlamydia)

Therapeutic indications:

Suņu aktīvai imunizācijai pret: L. interrogans serogrupas Canicola serovārs Canicola, lai samazinātu infekcijas un urīna izdalīšanos;L. interrogans serogrupas Icterohaemorrhagiae serovārs Copenhageni, lai samazinātu infekcijas un urīna izdalīšanos;L. interrogans serogrupas Australis serovārs Bratislava, lai samazinātu infekcijas;L. kirschneri serogroup Grippotyphosa serovar Bananal / Lianguang, lai samazinātu infekciju un urīna izdalīšanos.

Product summary:

Revision: 6

Authorization status:

Autorizēts

Authorization date:

2015-07-03

Patient Information leaflet

                                13
B.
LIETOŠANAS INSTRUKCIJA
14
LIETOŠANAS INSTRUKCIJA
CANIGEN L4 SUSPENSIJA INJEKCIJĀM SUŅIEM
1.
REĢISTRĀCIJAS APLIECĪBAS ĪPAŠNIEKA UN RAŽOŠANAS LICENCES
TURĒTĀJA, KURŠ ATBILD PAR SĒRIJAS IZLAIDI, NOSAUKUMS UN ADRESE, JA
DAŽĀDI
Reģistrācijas apliecības īpašnieks un par sērijas izlaidi
atbildīgais ražotājs:
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
Nīderlande
2.
VETERINĀRO ZĀĻU NOSAUKUMS
Canigen L4 suspensija injekcijām suņiem
3.
AKTĪVO VIELU UN CITU VIELU NOSAUKUMS
Viena deva (1 ml) satur:
AKTĪVĀS VIELAS:
Inaktivēti
_Leptospira _
celmi:
-
_L. interrogans _
serogrupa Canicola serovariants Portland-vere
(celms Ca-12-000)
3550-7100 U
1
-
_L. interrogans _
serogrupa Icterohaemorrhagiae serovariants
Copenhageni (celms Ic-02-001)
290-1000 U
1
-
_L. interrogans _
serogrupa Australis serovariants Bratislava
(celms As-05-073)
500-1700 U
1
-
_L. kirschneri _
serogrupa Grippotyphosa serovariants Dadas
(celms Gr-01-005)
650-1300 U
1
1
Antigēnu masas ELISA vienības.
Bezkrāsaina suspensija.
4.
INDIKĀCIJA(-S)
Suņu aktīvai imunizācijai pret:
-
_L. interrogans_
serogrupas Canicola serovariantu Canicola, lai samazinātu infekciju
un izdalīšanos ar
urīnu,
-
_L. interrogans_
serogrupas Icterohaemorrhagiae serovariantu Copenhageni, lai
samazinātu infekciju
un izdalīšanos ar urīnu,
-
_L._
_interrogans _
serogrupas Australis serovariantu Bratislava, lai samazinātu
infekciju,
-
_L._
_kirschneri _
serogrupas Grippotyphosa serovariantu Bananal/Lianguang, lai
samazinātu infekciju un
izdalīšanos ar urīnu.
Imunitātes iestāšanās: 3 nedēļas.
Imunitātes ilgums: 1 gads.
5.
KONTRINDIKĀCIJAS
15
Nav.
6.
IESPĒJAMĀS BLAKUSPARĀDĪBAS
Ļoti bieži, klīniskajos pētījumos, pāris dienas pēc
vakcinācijas novērota neliela un pārejoša ķermeņa
temperatūras paaugstināšanās (
≤
1°C), dažiem kucēniem samazinās aktivitāte un/vai samazinās
ēstgriba. Ļoti bieži, klīniskajos pētījumos, novērots neliels,
pārejošs pietūkums (
≤
4 cm) injekcij
                                
                                Read the complete document

Summary of Product characteristics

                                1
I PIELIKUMS
VETERINĀRO ZĀĻU APRAKSTS
2
1.
VETERINĀRO ZĀĻU NOSAUKUMS
Canigen L4 suspensija injekcijām suņiem
2.
KVALITATĪVAIS UN KVANTITATĪVAIS SASTĀVS
Viena deva (1 ml) satur:
AKTĪVĀS VIELAS:
Inaktivēti
_Leptospira _
celmi:
-
_L. interrogans _
serogrupa Canicola serovariants Portland-vere
(celms Ca-12-000)
3550-7100 U
1
-
_L. interrogans _
serogrupa Icterohaemorrhagiae serovariants
Copenhageni (celms Ic-02-001)
290-1000 U
1
-
_L. interrogans _
serogrupa Australis serovariants Bratislava
(celms As-05-073)
500-1700 U
1
-
_L. kirschneri _
serogrupa Grippotyphosa serovariants Dadas
(celms Gr-01-005)
650-1300 U
1
1
Antigēnu masas ELISA vienības.
Pilnu palīgvielu sarakstu skatīt 6.1 apakšpunktā.
3.
ZĀĻU FORMA
Suspensija injekcijām.
Bezkrāsaina suspensija.
4.
KLĪNISKĀ INFORMĀCIJA
4.1
MĒRĶA SUGAS
Suņi.
4.2
LIETOŠANAS INDIKĀCIJAS, NORĀDOT MĒRĶA SUGAS
Suņu aktīvai imunizācijai pret:
-
_L. interrogans_
serogrupas Canicola serovariantu Canicola, lai samazinātu infekciju
un izdalīšanos ar
urīnu,
-
_L. interrogans_
serogrupas Icterohaemorrhagiae serovariantu Copenhageni, lai
samazinātu infekciju
un izdalīšanos ar urīnu,
-
_L._
_interrogans _
serogrupas Australis serovariantu Bratislava, lai samazinātu
infekciju,
-
_L._
_kirschneri _
serogrupas Grippotyphosa serovariantu Bananal/Lianguang, lai
samazinātu infekciju un
izdalīšanos ar urīnu.
Imunitātes iestāšanās: 3 nedēļas.
Imunitātes ilgums: 1 gads.
4.3
KONTRINDIKĀCIJAS
Nav.
4.4
ĪPAŠI BRĪDINĀJUMI KATRAI MĒRĶA SUGAI
3
Vakcinēt tikai klīniski veselus dzīvniekus.
4.5
ĪPAŠI PIESARDZĪBAS PASĀKUMI LIETOŠANĀ
Īpaši piesardzības pasākumi, lietojot dzīvniekiem
Nav piemērojami.
Īpaši piesardzības pasākumi, kas jāievēro personai, kura lieto
veterinārās zāles dzīvnieku ārstēšanai
Izvairieties no nejaušas pašinjicēšanas vai saskares ar acīm.
Pēc saskares ar acīm skalot aci(-s) ar
ūdeni. Pašinjicēšanas vai acu kairinājuma gadījumā
nekavējoties meklēt medicīnisko palīdzību un
uzrād
                                
                                Read the complete document

Similar products

Active ingredient Inaktivēta Leptospira celmiem: L. interrogans serogrupas Canicola serovārs Portland-vere (celms Ca-12-000); L. interrogans serogrupas Icterohaemorrhagiae serovārs Copenhageni (celms Ic-02-001); L. interrogans serogrupas Australis serovārs Bratislava (celms Kā-05-073); L. kirschneri serogrupas Grippotyphosa serovārs Dadas (celms Gr-01-005)

Inaktivēta Leptospira celmiem: L. interrogans serogrupas Canicola serovārs Portland-vere (celms Ca-12-000); L. interrogans serogrupas Icterohaemorrhagiae serovārs Copenhageni (celms Ic-02-001); L. interrogans serogrupas Australis serovārs Bratislava (celms Kā-05-073); L. kirschneri serogrupas Grippotyphosa serovārs Dadas (celms Gr-01-005)

ATC code QI07AB01

QI07AB01

Marketed by Intervet International B.V.

Intervet International B.V.

INN (International Name) Canine leptospirosis vaccine (inactivated)

Canine leptospirosis vaccine (inactivated)

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 08-07-2021
Summary of Product characteristics Summary of Product characteristics Bulgarian 08-07-2021
Public Assessment Report Public Assessment Report Bulgarian 30-07-2015
Patient Information leaflet Patient Information leaflet Spanish 08-07-2021
Summary of Product characteristics Summary of Product characteristics Spanish 08-07-2021
Public Assessment Report Public Assessment Report Spanish 30-07-2015
Patient Information leaflet Patient Information leaflet Czech 08-07-2021
Summary of Product characteristics Summary of Product characteristics Czech 08-07-2021
Public Assessment Report Public Assessment Report Czech 30-07-2015
Patient Information leaflet Patient Information leaflet Danish 08-07-2021
Summary of Product characteristics Summary of Product characteristics Danish 08-07-2021
Public Assessment Report Public Assessment Report Danish 30-07-2015
Patient Information leaflet Patient Information leaflet German 08-07-2021
Summary of Product characteristics Summary of Product characteristics German 08-07-2021
Public Assessment Report Public Assessment Report German 30-07-2015
Patient Information leaflet Patient Information leaflet Estonian 08-07-2021
Summary of Product characteristics Summary of Product characteristics Estonian 08-07-2021
Public Assessment Report Public Assessment Report Estonian 30-07-2015
Patient Information leaflet Patient Information leaflet Greek 08-07-2021
Summary of Product characteristics Summary of Product characteristics Greek 08-07-2021
Public Assessment Report Public Assessment Report Greek 30-07-2015
Patient Information leaflet Patient Information leaflet English 07-05-2020
Summary of Product characteristics Summary of Product characteristics English 07-05-2020
Public Assessment Report Public Assessment Report English 30-07-2015
Patient Information leaflet Patient Information leaflet French 08-07-2021
Summary of Product characteristics Summary of Product characteristics French 08-07-2021
Public Assessment Report Public Assessment Report French 30-07-2015
Patient Information leaflet Patient Information leaflet Italian 08-07-2021
Summary of Product characteristics Summary of Product characteristics Italian 08-07-2021
Public Assessment Report Public Assessment Report Italian 30-07-2015
Patient Information leaflet Patient Information leaflet Lithuanian 08-07-2021
Summary of Product characteristics Summary of Product characteristics Lithuanian 08-07-2021
Public Assessment Report Public Assessment Report Lithuanian 30-07-2015
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Summary of Product characteristics Summary of Product characteristics Hungarian 08-07-2021
Public Assessment Report Public Assessment Report Hungarian 30-07-2015
Patient Information leaflet Patient Information leaflet Maltese 08-07-2021
Summary of Product characteristics Summary of Product characteristics Maltese 08-07-2021
Public Assessment Report Public Assessment Report Maltese 30-07-2015
Patient Information leaflet Patient Information leaflet Dutch 08-07-2021
Summary of Product characteristics Summary of Product characteristics Dutch 08-07-2021
Public Assessment Report Public Assessment Report Dutch 30-07-2015
Patient Information leaflet Patient Information leaflet Polish 08-07-2021
Summary of Product characteristics Summary of Product characteristics Polish 08-07-2021
Public Assessment Report Public Assessment Report Polish 30-07-2015
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Summary of Product characteristics Summary of Product characteristics Portuguese 08-07-2021
Public Assessment Report Public Assessment Report Portuguese 30-07-2015
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Summary of Product characteristics Summary of Product characteristics Romanian 08-07-2021
Public Assessment Report Public Assessment Report Romanian 30-07-2015
Patient Information leaflet Patient Information leaflet Slovak 08-07-2021
Summary of Product characteristics Summary of Product characteristics Slovak 08-07-2021
Public Assessment Report Public Assessment Report Slovak 30-07-2015
Patient Information leaflet Patient Information leaflet Slovenian 08-07-2021
Summary of Product characteristics Summary of Product characteristics Slovenian 08-07-2021
Public Assessment Report Public Assessment Report Slovenian 30-07-2015
Patient Information leaflet Patient Information leaflet Finnish 08-07-2021
Summary of Product characteristics Summary of Product characteristics Finnish 08-07-2021
Public Assessment Report Public Assessment Report Finnish 30-07-2015
Patient Information leaflet Patient Information leaflet Swedish 08-07-2021
Summary of Product characteristics Summary of Product characteristics Swedish 08-07-2021
Public Assessment Report Public Assessment Report Swedish 30-07-2015
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Summary of Product characteristics Summary of Product characteristics Norwegian 08-07-2021
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Summary of Product characteristics Summary of Product characteristics Icelandic 08-07-2021
Patient Information leaflet Patient Information leaflet Croatian 08-07-2021
Summary of Product characteristics Summary of Product characteristics Croatian 08-07-2021
Public Assessment Report Public Assessment Report Croatian 30-07-2015

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Canigen L4