Ridamec 1 mg/ml oral solution for sheep

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Moxidectin

Dostępny od:

Chanelle Pharmaceuticals Manufacturing Limited

Kod ATC:

QP54AB02

INN (International Nazwa):

Moxidectin

Dawkowanie:

1 milligram(s)/millilitre

Forma farmaceutyczna:

Oral solution

Typ recepty:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupa terapeutyczna:

Sheep

Dziedzina terapeutyczna:

moxidectin

Wskazania:

Endectoparasiticides

Status autoryzacji:

Authorised

Data autoryzacji:

2017-08-25

Charakterystyka produktu

Health Products Regulatory Authority
14 February 2022
CRN00CQ6Q
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Ridamec 1 mg/ml oral solution for sheep
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE SUBSTANCE:
Moxidectin 1.00 mg
EXCIPIENT:
Benzyl Alcohol (E1519) 40.0 mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral solution
Clear colourless to yellowish solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sheep.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment and prevention of mixed infections of sheep with
parasites sensitive to moxidectin
Adult and/or immature gastro-intestinal nematodes:
- _Haemonchus contortus _(including inhibited larvae)
- _Teladorsagiacircumcincta _(including inhibited larvae)
- _Teladorsagiatrifurcata_
- _Trichostrongylus axei _(including inhibited larvae)
- _Trichostrongylus colubriformis_
- _Trichostrongylus vitrinus_
- _Nematodirus battus_
- _Nematodirus spathiger_
- _Nematodirus filicolis _(adults only)
- _Strongyloides papillosus _(larval stages only)
- _Cooperia curticei _(adults only)
- _Cooperia oncophora_
- _Oesophagostomum columbianum_
- _Oesophagostomum venulosum _(adults only)
- _Chabertia ovina_
- _Trichuris ovis _(adults only)
Adult respiratory tract nematode:
- _Dictyocaulus filaria_
The product has a persistent effect in preventing reinfection:
for 5 weeks by _Teladorsagiacircumcincta _and _Haemonchus contortus_
for 4 weeks by _Oesophagostomum columbianum_
_ _
Clinical trials, after experimental and natural infection, have shown
that the product is effective against certain benzimidazole
resistant strains of:
_Haemonchus contortus_
Health Products Regulatory Authority
14 February 2022
CRN00CQ6Q
Page 2 of 5
_Teladorsagiacircumcincta_
_Trichostrongylus colubriformis_
_Cooperia curticei_
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active substance
or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Care should