Closamectin 5 mg/ml/125 mg/ml Solution for Injection for Sheep

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Closantel, Ivermectin

Available from:

Norbrook Laboratories Limited

ATC code:

QP54AA51

INN (International Name):

Closantel, Ivermectin

Pharmaceutical form:

Solution for injection

Prescription type:

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

Therapeutic group:

Sheep

Therapeutic area:

Endectocide

Authorization status:

Authorized

Authorization date:

2007-02-06

Summary of Product characteristics

Revised: February 2023
AN: 01189/2022, 01191/2022, 01193/2022 & 01935/2022
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Closamectin 5 mg/ml/125 mg/ml Solution for Injection for Sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of the product contains:
ACTIVE SUBSTANCES:
Ivermectin
5 mg
Closantel (as closantel sodium dihydrate)
125 mg
(equivalent to 135,9 mg of closantel sodium dihydrate)
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), _ Teladorsagia
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_ (adult) _Chabertia ovina_ (adult and L4) _Nematodirus
filicollis _(adult and
L4), _Trichuris_ _ovis_ (adult).
[L4 = fourth stage larave]
Revised: February 2023
AN: 01189/2022, 01191/2022, 01193/2022 & 01935/2022
Page 2 of 8
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 _
_circumcincta_ are also controlled.
4.3
CONTRAINDICATIONS
Do not use by intramuscular or intravenous route.