Eurican L

Summary of Product characteristics

                                Revised: November 2018
AN: 00955/2018
Page 1 of 4
SUMMARY OF PRODUCT CHARACTISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
EURICAN L
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Inactivated_ Leptospira canicola..........................._} > 80%
protection*
Inactivated_ Leptospira icterohaemorrhagiae......._}
Excipient……………………………………………………………q.s.
1 dose of
1ml
*According to Ph. Eur. hamster potency test
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Suspension for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs from 8 weeks of age.
4.2
INDICATIONS FOR USE SPECIFYING THE TARGET SPECIES
In dogs:
Active immunisation against _Leptospira canicola_ and _Leptospira _
_icterohaemorrhagiae_ to prevent mortality and to reduce_ _clinical
symptoms of
Leptospira infections caused by these agents.
Onset of immunity: 14 days after primary vaccination.
The duration of immunity is one year.
4.3
CONTRA-INDICATIONS
None
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE, INCLUDING SPECIAL PRECAUTIONS TO BE TAKEN
BY THE PERSON ADMINISTERING THE MEDICINAL PRODUCT TO ANIMALS
i.
Special precautions for use in animals
Vaccinate only healthy animals.
Revised: November 2018
AN: 00955/2018
Page 2 of 4
ii. Special precautions to be taken by the person administering the
medicinal product to the animals
In the case of accidental self-injection, wash the area immediately
with
water.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
In rare_ _cases, immediately after injection, transient pain may occur
at the
injection site. A temperature increase of approximately_ _1°C lasting
no more
than a day may occur in rare cases.
In rare circumstances a hypersensitivity reaction may occur, which may
require appropriate symptomatic treatment.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
In the absence of data from studies in seronegative bitches, the
vaccine
should only be used in pregnant bitches which have been vaccinated
before
pregnancy.
4
                                
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