SELAPRO 360 mg spot-on solution for very large dogs (40.1–60.0 kg)

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Selamectin

Tilgængelig fra:

Norbrook Laboratories Limited

ATC-kode:

QP54AA05

INN (International Name):

Selamectin

Dosering:

360 mg/pipette

Lægemiddelform:

Spot-on solution

Recept type:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk område:

selamectin

Autorisation status:

Authorised

Autorisation dato:

2018-10-26

Produktets egenskaber

Health Products Regulatory Authority
26 October 2018
CRN000WFZ
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
SELAPRO 360 mg spot-on solution for very large dogs (40.1–60.0 kg)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Each 3.0ml pipette contains:
​
​
​
ACTIVE SUBSTANCE:
​
​
​
Selamectin
​360
​mg
​
EXCIPIENTS:
​
​
​
Butylhydroxytoluene
​2.4
​mg
​
For the full list of excipients, see section 6.1.
​
​
3 PHARMACEUTICAL FORM
Spot-on solution.
A clear, colourless to yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
TREATMENT AND PREVENTION OF FLEA INFESTATIONS caused by
_Ctenocephalides _spp. for
one month following a single administration. This is as a result of
the adulticidal,
larvicidal and ovicidal properties of the product. The product is
ovicidal for 3 weeks
after administration. Through a reduction in the flea population,
monthly treatment
of pregnant and lactating animals will also aid in the prevention of
flea infestations in
the litter up to seven weeks of age. The product can be used as part
of a treatment
strategy for flea allergy dermatitis and through its ovicidal and
larvicidal action may
aid in the control of existing environmental flea infestations in
areas to which the
animal has access.
PREVENTION OF HEARTWORM DISEASE caused by _Dirofilaria immitis _with
monthly
administration. Selamectin may be safely administered to animals
infected with adult
heartworms, however, it is recommended, in accordance with good
veterinary
practice, that all animals 6 months of age or more living in countries
where a vector
exists should be tested for existing adult heartworm infections before
beginning
medication with Selamectin. It is also recommended that dogs should be
tested
Health Products Regulatory Authority
26 October 2018
CRN000WFZ
Page 2 of 9
periodically for adult heartworm infections, as an integral part of a
heartworm
prevention strategy, even when Selame