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:

Expired

Authorization date:

2010-06-25

Summary of Product characteristics

Revised: September 2015
AN. 01213/2014
Page 1 of 7
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
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_
(adult) _Chabertia ovina_ (adult and L4) _Nematodirus filicollis
_(adult and L4), _Trichuris_
_ovis_ (adult).
[L4 = fourth stage larvae]
Revised: September 2015
AN. 01213/2014
Page 2 of 7
Lungworms
_Dictyocaulus filaria_ (adult and 4
th
stage larvae)
_Protostrongylus rufescens_ (adult)
Liver Fluke (trematodes)
_Fasciola gigantica, Fasciola hepatica_
Treatment of fluke at 12 weeks (mature) >95% efficacy.
Treatment of fluke at 7 weeks (late immature) 100% efficacy.
Nasal Bots
_Oestrus ovis_
Mange Mites
_Psoroptes ovis (Treatment requires a second injection of an
ivermectin-only _
_containing product 7 days later. See section 4.4 and 4.9)._
Benzimidazole
–
resistant
strains
of
_Haemonchus _
_contortus_
and
_Teladorsagia _
_circumcincta _are also controlled.
4.3
CONTRAINDICATIONS
Do not use intravenously or intramuscularly.
Do not use in cases of