SELAPRO 120 mg spot-on solution for medium dogs (10.1–20.0 kg)

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Selamectin

Disponible depuis:

Norbrook Laboratories (Ireland) Limited

Code ATC:

QP54AA05

DCI (Dénomination commune internationale):

Selamectin

Dosage:

120 mg/pipette

forme pharmaceutique:

Spot-on solution

Type d'ordonnance:

POM: Prescription Only Medicine as defined in relevant national legislation

Domaine thérapeutique:

selamectin

Statut de autorisation:

Authorised

Date de l'autorisation:

2018-10-26

Résumé des caractéristiques du produit

Health Products Regulatory Authority
29 May 2019
CRN008W44
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
SELAPRO 120 mg spot-on solution for medium dogs (10.1–20.0 kg)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Each 1.0ml pipette contains:
​
​
​
ACTIVE SUBSTANCE:
​
​
​
Selamectin
​120
​mg
​
EXCIPIENTS:
​
​
​
Butylhydroxytoluene (E321)
​0.8
​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
periodically for adult heartworm infections, as an integral part of a
heartworm prevention strategy, even when Selamectin has
been administered monthly. This product is not effective against a