Animec 10 mg/ml Solution for Injection for Cattle and Pigs

Țară: Regatul Unit

Limbă: engleză

Sursă: VMD (Veterinary Medicines Directorate)

Ingredient activ:

Ivermectin

Disponibil de la:

Chanelle Animal Health Ltd

Codul ATC:

QP54AA01

INN (nume internaţional):

Ivermectin

Forma farmaceutică:

Solution for injection

Tip de prescriptie medicala:

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

Grupul Terapeutică:

Cattle, Pigs

Zonă Terapeutică:

Endectocide

Statutul autorizaţiei:

Authorized

Data de autorizare:

2000-09-21

Caracteristicilor produsului

Revised: June 2018
AN: 01263/2017
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF VETERINARY MEDICINAL PRODUCT
Animec 10 mg/ml solution for injection for Cattle and Pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Ivermectin 10 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear colourless to slight yellow-coloured solution with no visible
particulates.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (beef and non-lactating dairy cattle) and Pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of infections with the following parasites in beef and
non-lactating dairy cattle or
pigs:
CATTLE:
GASTRO-INTESTINAL ROUNDWORMS (adult and fourth stage larvae):
_Ostertagia spp. _(including inhibited _O.ostertagi)_
_Haemonchus placei_
_Trichostrongylus axei_
_Trichostrongylus colubriformis_
_Cooperia spp._
_Oesophagostomum radiatum_
_Nematodirus helvetianus (_adult_)_
_N. spathiger _(adult)
LUNGWORMS (adult and fourth stage larvae):
_Dictyocaulus viviparus._
WARBLES:
_Hypoderma bovis_
_H. lineatum._
MANGE MITES:
_Psoroptes bovis_
Revised: June 2018
AN: 01263/2017
Page 2 of 7
_Sarcoptes scabiei _var_. bovis._
SUCKING LICE:
_Linognathus vituli_
_Haematopinus eurysternus_
PIGS:
GASTROINTESTINAL ROUNDWORMS: (adult and fourth stage larvae):
_Ascaris suum_
_Hyostrongylus rubidus_
_Oesophagostomum _spp.
_Strongyloides ransomi _(adult only)
LUNGWORMS:
_Metastrongylus _spp_. _(adult)
LICE:
_Haematopinus suis_
MANGE MITES:
_Sarcoptes scabiei _var_. suis_
The use of the product in cattle should take into account geographical
differences in the
occurrence patterns of parasites.
4.3
CONTRAINDICATIONS
Do not administer by the intravenous or intramuscular route.
Do not use in animals with known hypersensitivity to the active
ingredient.
Do not use in dogs or cats as severe adverse reactions may occur (see
also section 4.5).
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Care should be taken to avoid the followi