Closiver 5 mg/ml + 125 mg/ml Solution for Injection for Sheep

Țară: Regatul Unit

Limbă: engleză

Sursă: VMD (Veterinary Medicines Directorate)

Ingredient activ:

Closantel, Ivermectin

Disponibil de la:

Norbrook Laboratories Limited

Codul ATC:

QP54AA51

INN (nume internaţional):

Closantel, Ivermectin

Forma farmaceutică:

Solution for injection

Tip de prescriptie medicala:

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

Grupul Terapeutică:

Sheep

Zonă Terapeutică:

Endectocide

Statutul autorizaţiei:

Authorized

Data de autorizare:

2010-10-01

Caracteristicilor produsului

Revised: September 2015
AN. 01215/2014
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Closiver 5 mg/ml + 125 mg/ml Solution for Injection for Sheep (UK &
IE)
Closamectin 5 mg/ml + 125 mg/ml Solution for Injection for Sheep (AT,
BE, CZ, IT,
ES & SK)
Oestrocur 5 mg/ml + 125 mg/ml Solution for Injection for Sheep (FR)
Closamectin FF 5 mg/ml + 125 mg/ml Solution for Injection for Sheep
(PT)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Ivermectin
5 mg
Closantel
125 mg
(Equivalent to Closantel sodium dihydrate)
135.9
EXCIPIENTS:
Sodium formaldehyde sulphoxylate
5 mg
For the full list of excipients, see Section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection.
A clear amber solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES:
Sheep.
4.2
INDICATIONS FOR USE (SPECIFYING THE TARGET SPECIES):
For the treatment of mixed trematode (fluke) and nematode or arthropod
infestations due to gastrointestinal roundworms, trematodes,
lungworms, nasal bots
and mites of sheep.
Gastrointestinal roundworms
_Teladorsagia circumcincta _(including inhibited L4), _Ostertagia
trifurcata _(adult and
L4), _Haemonchus contortus_ (including inhibited L4),
_Trichostrongylus axei _(adult),
_Trichostrongylus colubriformis _(adult and L4), _T. vitrinus_ (adult)
_Cooperia curticei _
(adult and L4), _Oesophagostomum columbianum _(adult and L4), _O.
venulosum_
Revised: September 2015
AN. 01215/2014
Page 2 of 7
(adult) _Chabertia ovina_ (adult and L4) _Nematodirus filicollis
_(adult and L4), _Trichuris_
_ovis_ (adult).
[L4 = fourth stage larvae]
Lungworms
_Dictyocaulus filaria_ (adult and 4
th
stage larvae)
_Protostrongylus rufescens_ (adult)
Liver Fluke (Adults and 7 weeks immature)
_Fasciola gigantica, Fasciola hepatica_
Nasal Bots
_Oestrus ovis_
Mange Mites
_Psoroptes ovis (Treatment require a second injection of an
ivermectin-only product _
_7 days later. See sections 4.4 and 4.9) _
Benzimidazole – resistant strains of _Haemonchus contortus_ and
_Teladorsagia _
_circumci