Merilym 3, suspension for injection for dogs

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Borrelia garinii; Borrelia afzelii; Borrelia burgdorferi sensu stricto

Beschikbaar vanaf:

Boehringer Ingelheim Vetmedica GmbH

ATC-code:

QI07AB04

INN (Algemene Internationale Benaming):

Borrelia garinii; Borrelia afzelii; Borrelia burgdorferi sensu stricto

Dosering:

.

farmaceutische vorm:

Suspension for injection

Prescription-type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutisch gebied:

borrelia

Autorisatie-status:

Authorised

Autorisatie datum:

2013-05-10

Productkenmerken

Health Products Regulatory Authority
06 September 2019
CRN008P8D
Page 1 of 4
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.
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 _Borrelia_ were
isolated from the skin of non vaccinated dogs.
Reduction of transmission of _Borrelia_ from the tick to the host has
not been quantified, and no correlation has been
established between a specific level of antibodies and reduction of
_Borrelia_ transmission. The efficacy of