MERILYM 3, SUSPENSION FOR INJECTION FOR DOGS.

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

BORRELIA GARINII, BORRELIA AFZELII, BORRELIA BURGDORFERI SENSU STRICTO

MAH:

Merial Animal Health Limited

ATC_code:

QI07AB04

INN:

BORRELIA GARINII, BORRELIA AFZELII, BORRELIA BURGDORFERI SENSU STRICTO

dosage:

Unknown

pharmaceutical_form:

Suspension for Injection

prescription_type:

POM

therapeutic_group:

Canine

therapeutic_area:

Borrelia vaccine

therapeutic_indication:

Immunological - Inactivated vaccine

authorization_status:

Authorised

authorization_date:

2013-05-10

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Merilym 3, suspension for injection for dogs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition of one dose (1 ml):
ACTIVE SUBSTANCES:
Inactivated _Borrelia burgdorferi sensu lato_:
_Borrelia garinii_.......................................................... RP
1*
_Borrelia afzelii........................................................... _RP
1*
_Borrelia burgdorferi sensu stricto_............................. RP
1*
*RP = Relative potency (ELISA test) compared with the reference serum obtained after vaccination of mice with a
vaccine batch that has successfully passed the challenge test in the target species.
ADJUVANT:
Aluminium (as hydroxide)......................................... 2 mg
EXCIPIENTS:
Formaldehyde............................................................. max. 0.5 mg/ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection.
Pinkish up to white fluid containing white sediment that disperses easily when the content is shaken.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 13/06/2014_
_CRN 7015961_
_page number: 1_
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunization of dogs from 12 weeks of age, to induce an anti-OspA response against _Borrelia spp. _(_B._
_burgdorferi sensu stricto_, _B. garinii _and _B. afzelii_).
Reduction of _Borrelia _transmission was only investigated under laboratory conditions, following a challenge with field
ticks (collected from a region known to be affected by _Borrelia_). Under these conditions, it was shown that no _Borrelia_
could be isolated from the skin of vaccinated dogs, while _Bo