Moxidectin (EU Pharmaceuticals) 1 mg/ml Oral Solution for Sheep

Država: Velika Britanija

Jezik: angleščina

Source: VMD (Veterinary Medicines Directorate)

Aktivna sestavina:

Moxidectin

Dostopno od:

EU Pharmaceuticals Ltd

Koda artikla:

QP54AB02

INN (mednarodno ime):

Moxidectin

Farmacevtska oblika:

Oral solution

Tip zastaranja:

POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person

Terapevtska skupina:

Sheep

Terapevtsko območje:

Anthelmintic

Status dovoljenje:

Authorized

Datum dovoljenje:

2019-10-03

Lastnosti izdelka

Unlimited Renewal: May 2024
AN: 03640/2023
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Moxidectin (EU Pharmaceuticals) 1 mg/ml oral solution for sheep.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE SUBSTANCE:
Moxidectin
1.00 mg
EXCIPIENT:
Benzyl Alcohol
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 infections caused by the following
worm
species, susceptible to moxidectin:
Adult and immature gastro-intestinal nematodes:
- _Haemonchus contortus _(including inhibited larvae)
- _Teladorsagia circumcincta _(including inhibited larvae)
- _Ostertagia trifurcata_
- _Trichostrongylus axei _(including inhibited larvae)
- _Trichostrongylus colubriformis_
- _Trichostrongylus vitrinus_
- _Nematodirus battus_
Unlimited Renewal: May 2024
AN: 03640/2023
Page 2 of 8
- _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 _Teladorsagia circumcincta _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_
_Teladorsagia circumcincta_
_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 be taken to avo