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 (Ireland) 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
29 May 2019
CRN008W44
Page 1 of 6
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 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 aga