Vetmulin 125 mg/ml Concentrate for Oral Solution
Country: Ireland
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
28-09-2013
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Active ingredient:
tiamulin hydrogen fumarate 125 mg/ml
Available from:
Huvepharma N.V.
ATC code:
QJ01XQ01
Pharmaceutical form:
Oral solution
Therapeutic group:
Tiamulin
Therapeutic area:
Chicken, Pigs, Turkeys
Authorization date:
2009-11-25
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
VETMULIN 125 MG/ML SOLUTION
Huvepharma NV
Page 1 of 16
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vetmulin 125 mg/ml Oral Solution for use in drinking water for pigs (BE, BG, CZ,
EL, HU, IE, NL, PL, RO, UK, ES, IT, AT, DE, PT)
VETMULIN VET, Oral Solution for use in drinking water for pigs (DK)
Vetmulin 101.2 mg/ml Oral Solution for use in drinking water for pigs (FR)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance 125 mg Tiamulin hydrogen fumarate (equivalent to 101.2 mg
tiamulin
Excipients
Methyl parahydroxybenzoate (E218):0.90 mg
Propyl parahydroxybenzoate (E216): 0.10 mg
For a full list of excipients: see section 6.1
3.
PHARMACEUTICAL FORM
Oral solution for use in drinking water
Clear colourless to slightly yellow liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs
4.2
INDICATIONS FOR USE (SPECIFYING THE TARGET SPECIES)
For the treatment of swine dysentery caused by or further complicated by tiamulin-
SUMMARY OF PRODUCT CHARACTERISTICS
VETMULIN 125 MG/ML SOLUTION
Huvepharma NV
Page 2 of 16
susceptible _Brachyspira hyodysenteriae. _
Treatment of enzootic pneumonia and the reduction of lesions caused by tiamulin-
susceptible _Mycoplasma hyopneumoniae _
SUMMARY OF PRODUCT CHARACTERISTICS
VETMULIN 125 MG/ML SOLUTION
Huvepharma NV
Page 3 of 16
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active ingredient.
Do not administer products containing monensin, salinomycin ,narasin,
maduramycin or other ionophores during or for at least seven days before or after
treatment with the product. See also section 5.1. and 4.8.
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