SELAPRO 15 mg spot-on solution for dogs and cats (< 2.5 kg)

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Selamectin

זמין מ:

Norbrook Laboratories Limited

קוד ATC:

QP54AA05

INN (שם בינלאומי):

Selamectin

כמות:

15 mg/pipette

טופס פרצבטיות:

Spot-on solution

סוג מרשם:

POM: Prescription Only Medicine as defined in relevant national legislation

איזור תרפויטי:

selamectin

מצב אישור:

Authorised

תאריך אישור:

2018-10-26

מאפייני מוצר

Health Products Regulatory Authority
26 October 2018
CRN000WFZ
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
SELAPRO 15 mg spot-on solution for dogs and cats (< 2.5 kg)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Each 0.25 ml pipette contains:
​
​
​
ACTIVE SUBSTANCE:
​
​
​
Selamectin
15​
mg​
​
EXCIPIENTS:
​
​
​
Butylhydroxytoluene (E321)
0.2​
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 and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
CATS AND DOGS:
• 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
Health Products Regulatory Authority
26 October 2018
CRN000WFZ
Page 2 of 9
medication with Selamectin. It is also recommended that dogs should be
tested
periodically for adult heartworm infections, as an integral part of a
heartworm
preve