Animec 0.8mg/ml Oral Solution for Sheep

Država: Velika Britanija

Jezik: engleski

Izvor: VMD (Veterinary Medicines Directorate)

Aktivni sastojci:

Ivermectin

Dostupno od:

Chanelle Pharmaceuticals Manufacturing Ltd

ATC koda:

QP54AA01

INN (International ime):

Ivermectin

Farmaceutski oblik:

Oral solution

Tip recepta:

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

Terapijska grupa:

Sheep

Područje terapije:

Endectocide

Status autorizacije:

Authorized

Datum autorizacije:

2010-07-08

Svojstava lijeka

Revised: October 2014
AN: 00740/2014
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ANIMEC 0.8mg/ml Oral Solution for Sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each ml contains:
Ivermectin
0.8mg
Excipient(s):
Benzyl Alcohol (E1519)
28.6mg
Butylhydroxyanisole (E320)
0.10 mg
Propyl Gallate (E310)
0.10 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral Solution.
A transparent, yellow coloured solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Sheep
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of infections with the following parasites:
Nematodes
Gastrointestinal roundworms (adult and fourth larval stage)
Haemonchus contortus
Teladorsagia circumcincta
Trichostrongylus spp.
Cooperia spp.
Nematodirus spp.
Including N. battus
Strongyloides papillosus
Chabertia ovina
Lungworms(adult and fourth larval stage)
Dictyocaulus filaria
Revised: October 2014
AN: 00740/2014
Page 2 of 6
Arthropods
Nasal bot (all larval stages)
Oestrus ovis
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
ingredient or any
of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Care should be taken to avoid the following practices because they
increase the
risk of development of resistance and could ultimately result in
ineffective therapy:
•
Too frequent and repeated use of anthelmintics from the same class,
over
an extended period of time.
•
Underdosing, which may be due to underestimation of body weight or
misadministration of the product.

Resistance to ivermectin (an avermectin) has been reported in
Teladorsagia in
sheep and goats within the EU and it is common in Haemonchus in sheep
outside
the EU. Therefore the use of this product should be based on local
(regional,
farm) epidemiological information about susceptibility of nematode and
recommendations on how to limit further selection for resistance to
anthelmintics.
Suspected clinical cases of resistance to anthelm