Closiver Injection
Country: Portugal
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
21-08-2013
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Active ingredient:
closantel 12.5 w/v, ivermectin 0.5 w/v
Available from:
Norbrook Laboratories Limited
ATC code:
QP54AA51
Pharmaceutical form:
Solution for injection
Therapeutic group:
ivermectin, combinations
Therapeutic area:
Cattle Females, Cattle Food
Authorization date:
2011-11-25
Summary of Product characteristics
Revised: May 2013
AN: 00417/2012
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Closiver 5 mg/ml/125 mg/ml Solution for Injection for Cattle and Sheep (UK & IE)
Closamectin 5 mg/ml/125 mg/ml Solution for Injection for Cattle and Sheep (AT,
BE, CZ, ES, SK)
Closamectine 5 mg/ml/125 mg/ml Solution for Injection for Cattle and Sheep (FR)
Closamectin FF 5 mg/ml/125 mg/ml Solution for Injection for Cattle and Sheep
(PT)
Closivet 5 mg/ml/125 mg/ml Solution for Injection for Cattle and Sheep (IT)
Ivermectin/Closantel
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 a 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
Cattle and Sheep.
4.2
INDICATIONS FOR USE (SPECIFYING THE TARGET SPECIES)
CATTLE:
For the treatment of mixed trematode (fluke) and nematode or arthropod
infestations due to the following gastrointestinal roundworms, lungworms,
eyeworms, warbles, mites and lice:
Gastrointestinal roundworms
_Ostertagia ostertagi _(including inhibited larval stages), _Ostertagia lyrata _(adult),
_Haemonchus placei_ (adult and immature), _Trichostrongylus axei _(adult and
immature), _Trichostrongylus colubriformis _(adult and
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