Moxiclear 100 mg + 25 mg spot-on solution for medium dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Imidacloprid; Moxidectin

Available from:

Norbrook Laboratories (Ireland) Limited

ATC code:

QP54AB52

INN (International Name):

Imidacloprid; Moxidectin

Dosage:

100, 25 mg/pipette

Pharmaceutical form:

Spot-on solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

moxidectin, combinations

Authorization status:

Authorised

Authorization date:

2017-11-24

Summary of Product characteristics

Health Products Regulatory Authority
14 November 2019
CRN009G6R
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Moxiclear 100 mg + 25 mg spot-on solution for medium dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1.0 ml pipette contains:
ACTIVE SUBSTANCES:
Imidacloprid 100 mg
Moxidectin 25 mg
EXCIPIENTS:
Butylhydroxytoluene (E 321) 1.0 mg
Benzyl alcohol to 1 ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Spot-on solution.
A clear colourless to yellow solution with light opalescence.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For dogs suffering from, or at risk from, mixed parasitic infections:

​For the treatment and prevention of flea infestation
(Ctenocephalides felis),

the treatment of biting lice (Trichodectes canis),

the treatment of ear mite infestation (Otodectes cynotis), sarcoptic
mange (caused by Sarcoptes scabiei var. canis),

the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria
immitis),

the treatment of circulating microfilariae (Dirofilaria immitis),

the treatment of cutaneous dirofilariosis (adult stages of Dirofilaria
repens)

the prevention of cutaneous dirofilariosis (L3 larvae of Dirofilaria
repens),

the reduction of circulating microfilariae (Dirofilaria repens),

the prevention of angiostrongylosis (L4 larvae and immature adults of
Angiostrongylus vasorum),

the treatment of Angiostrongylus vasorum and Crenosoma vulpis,

the prevention of spirocercosis (Spirocerca lupi),

the treatment of infections with gastrointestinal nematodes (L4
larvae, immature adults and adults of Toxocara
canis, Ancylostoma caninum and Uncinaria stenocephala, adults of
Toxascaris leonina and Trichuris vulpis).
The product can be used as part of a treatment strategy for flea
allergy dermatitis (FAD).
4.3 CONTRAINDICATIONS
Do not use in puppies under 7 weeks of age.
Do not use in cases of hypersensitivity to the active substances