Eurican L

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Inactivated leptospira canicola; Inactivated leptospira icterohaemorrhagiae

Διαθέσιμο από:

Boehringer Ingelheim Vetmedica GmbH

Φαρμακολογική κατηγορία (ATC):

QI07AB01

INN (Διεθνής Όνομα):

Inactivated leptospira canicola; Inactivated leptospira icterohaemorrhagiae

Δοσολογία:

.

Φαρμακοτεχνική μορφή:

Suspension for injection

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική περιοχή:

leptospira

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2004-11-05

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
29 May 2020
CRN009PHD
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Eurican L
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Inactivated_ Leptospira canicola................................. _} >
80% protection*
Inactivated_ Leptospira icterohaemorrhagiae............. _}
Excipient.....................................................................
qs 1 dose of 1 ml
*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 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Health Products Regulatory Authority
29 May 2020
CRN009PHD
Page 2 of 4
4.5 SPECIAL PRECAUTIONS FOR USE
(I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS:
Vaccinate only healthy animals
(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.
4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTH