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

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Ivermectin; Closantel sodium dihydrate

Tillgänglig från:

Norbrook Laboratories (Ireland) Limited

ATC-kod:

QP54AA51

INN (International namn):

Ivermectin; Closantel sodium dihydrate

Dos:

5, 125 milligram(s)/millilitre

Läkemedelsform:

Solution for injection

Receptbelagda typ:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapiområde:

ivermectin, combinations

Bemyndigande status:

Authorised

Tillstånd datum:

2008-04-25

Produktens egenskaper

Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Closamectin 5 mg/ml/125 mg/ml Solution for Injection for Sheep (IE,
BE, BG, CZ, EL, ES, FR,
HR, HU, RO, SK, UK)
Closamectin FF 5 mg/ml/125 mg/ml Solution for Injection for Sheep (PT)
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]
Lungworms
_Dictyocaulus filaria_
(adult and 4
th
stage larvae)
_Protostrongylus rufescens_
(adult)
Liver Fluke (Adults and 7 weeks immature)
_Fasciola gigantica, Fasciola hepatica_
Page 2 of 16
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.
Do not use in animals with known hyp