Selames 360 mg spot-on solution for dogs 40.1–60.0 kg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Selamectin

Available from:

Krka, d.d., Novo mesto

ATC code:

QP54AA05

INN (International Name):

Selamectin

Dosage:

360 mg/pipette

Pharmaceutical form:

Spot-on solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

selamectin

Authorization status:

Authorised

Authorization date:

2018-12-21

Summary of Product characteristics

Health Products Regulatory Authority
19 April 2021
CRN00C756
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Selames 360 mg spot-on solution for dogs 40.1–60.0 kg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Each 3 ml pipette contains:
​
​
​
ACTIVE SUBSTANCE:
​
​
​
Selamectin
​360
​mg
​
EXCIPIENTS:
​
​
​
Butylhydroxytoluene (E321)
​2.4
​mg
​
For the full list of excipients, see section 6.1.
​
​
3 PHARMACEUTICAL FORM
Spot-on solution.
Clear, colourless to yellow to brown solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs (40.1-60.0 kg)
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.

TREATMENT OF EAR MITES (_Otodectes cynotis_).

TREATMENT OF BITING LICE INFESTATIONS (_Trichodectes canis_)

TREATMENT OF SARCOPTIC MANGE (caused by _Sarcoptes scabiei_)

TREATMENT OF ADULT INTESTINAL ROUNDWORMS (_Toxocara canis_)

PREVENTION OF HEARTWORM DISEASE caused by _Dirofilaria immitis _with
monthly administration.
4.3 CONTRAINDICATIONS
Do not use in animals under 6 weeks of age.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Do not apply when the animal's hair coat is wet. Avoid frequent
swimming or shampooing the animal because the
ma