Dectomax Pour-on for cattle
Country: France
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
14-09-2013
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Active ingredient:
doramectin 0.5 %
Available from:
Pfizer Limited
ATC code:
QP54AA03
Pharmaceutical form:
Pour-on solution
Therapeutic group:
doramectin
Therapeutic area:
Cattle Females, Cattle Male
Authorization date:
2011-01-12
Summary of Product characteristics
Revised: December 2011
AN: 01227/2011
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Dectomax 10 mg/ml Solution for Injection for Pigs (UK)
Zearl 10 mg/ml Solution for Injection for Pigs (IE)
Dectomax® S 10 mg / ml Solution for Injection for Pigs (AT)
Dectomax Vet., 10 mg/ml, Solution for Injection (Pigs) (DK)
Zearl pigs (FR)
Dectomax 10 mg/ml Solution for Injection for Pigs (BE, LU)
Dectomax
®
S Solution for Injection 10 mg / ml for Pigs (DE)
Dectomax 10 mg/ml Solution for Injection for Pigs (ES)
Dectomax for Pigs Vet. (SE)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml Dectomax Injection Solution 10 mg/ml contains the following:
ACTIVE SUBSTANCE:
Doramectin
10 mg
(1)
EXCIPIENT(S):
Butylhydroxyanisole (E320)
0.1 mg
(1)
Contains no overage and assumes a potency of 100 percent. The actual
amount of doramectin added will depend on the potency of the ingoing
drug substance.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Colourless to pale yellow sterile oily solution.
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For treatment of mange mites, gastrointestinal roundworms, lungworms,
kidney worms and sucking lice in pigs.
Gastrointestinal nematodes (adults and fourth stage larvae)
_Hyostrongylus rubidus _
_ _
_Ascaris suum _
Revised: December 2011
AN: 01227/2011
Page 2 of 6
_Strongyloides ransomi
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