Vetmulin 45% Water Soluble Granules
Country: Greece
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
06-07-2013
Summary of Product characteristics
(SPC)
06-07-2013
Active ingredient:
tiamulin fumarate 450 mg
Available from:
Huvepharma N.V.
ATC code:
QJ01XX92
Pharmaceutical form:
Granules for oral solution
Therapeutic group:
tiamulin
Therapeutic area:
Chicken, Pigs, Turkeys
Authorization date:
2010-10-11
Patient Information leaflet
SKP, Etikettering en Bijsluiter
– EN Versie
VETMULIN 450 MG/G
Page 1 of 15
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
VETMULIN 450
MG/G granules for use in drinking water for pigs. (All MS except FR)
Vetmulin 364 mg/g granules pour solution orale pour les porcs (FR)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains 364.2 mg tiamulin (as 450.0 mg Tiamulin hydrogen fumarate)
For a full list of excipients: see section 6.1
3.
PHARMACEUTICAL FORM
granules for use in drinking water .
White to pale yellow granules
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs
4.2
INDICATIONS FOR USE (SPECIFYING THE TARGET SPECIES)
Pigs
For the treatment of swine dysentery caused by tiamulin-susceptible _Brachyspira _
_hyodysenteriae_.
For the treatment of enzootic pneumonia caused by tiamulin-susceptible _Mycoplasma _
_hyopneumoniae._
The presence of the disease in the herd should be established before use.
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to
the active ingredient or to any excipient.
Do not administer products containing ionophores such as monensin, salinomycin or narasin
during or for at least 7
days before or after treatment with Vetmulin 45
SKP, Etikettering en Bijsluiter
– EN Versie
VETMULIN 450 MG/G
Page 2 of 15
See also section 4.8.
4.4
SPECIAL WARNINGS (FOR EACH TARGET SPECIES)
None
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Avoid interactions between tiamulin and the ionophore products monensin,
Read the complete document
Summary of Product characteristics
SKP, Etikettering en Bijsluiter
– EN Versie
VETMULIN 450 MG/G
Page 1 of 15
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
VETMULIN 450
MG/G granules for use in drinking water for pigs. (All MS except FR)
Vetmulin 364 mg/g granules pour solution orale pour les porcs (FR)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains 364.2 mg tiamulin (as 450.0 mg Tiamulin hydrogen fumarate)
For a full list of excipients: see section 6.1
3.
PHARMACEUTICAL FORM
granules for use in drinking water .
White to pale yellow granules
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs
4.2
INDICATIONS FOR USE (SPECIFYING THE TARGET SPECIES)
Pigs
For the treatment of swine dysentery caused by tiamulin-susceptible _Brachyspira _
_hyodysenteriae_.
For the treatment of enzootic pneumonia caused by tiamulin-susceptible _Mycoplasma _
_hyopneumoniae._
The presence of the disease in the herd should be established before use.
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to
the active ingredient or to any excipient.
Do not administer products containing ionophores such as monensin, salinomycin or narasin
during or for at least 7
days before or after treatment with Vetmulin 45
SKP, Etikettering en Bijsluiter
– EN Versie
VETMULIN 450 MG/G
Page 2 of 15
See also section 4.8.
4.4
SPECIAL WARNINGS (FOR EACH TARGET SPECIES)
None
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Avoid interactions between tiamulin and the ionophore products monensin,
Read the complete document
