APSAMIX TIAMULINA 100 mg/g
Country: Spain
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
24-01-2013
Summary of Product characteristics
(SPC)
24-01-2013
Active ingredient:
tiamulin hydrogen fumarate 100 mg/g
Available from:
ANDRÉS PINTALUBA S.A.
ATC code:
QJ01XQ01
Pharmaceutical form:
Premix for medicated feed
Therapeutic group:
Tiamulin
Therapeutic area:
Pigs Food
Authorization date:
2011-04-18
Patient Information leaflet
1/5
SUMMARY OF PRODUCT CHARACTERISTICS (SPC)
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
APSAMIX TIAMULINA 100 mg/g
Premix for medicated feedingstuff (fattening pigs)
2.- QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
ACTIVE SUBSTANCE:
Tiamulin hydrogen fumarate
100 mg
(equivalent to 80 mg of Tiamulin)
EXCIPIENTS:
Calcium carbonate (E-170)
Other excipients q.s.
1 g
“For a full list of excipients, see section 6.1.”
3.- PHARMACEUTICAL FORM
Premix for medicated feedingstuff
4.- CLINICAL PARTICULARS
4.1.- TARGET SPECIES
Porcine (Fattening pigs)
4.2.- INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment and prevention of swine dysentery caused by _Brachyspira hyodysenteriae _in
fattening pigs.
The presence of disease in the herd should be established before treatment.
4.3.- CONTRAINDICATIONS
Do not use in animals with hepatic and renal dysfunction.
Do not use in case of hypersensitivity to pleuromutilins or to any of the excipients.
Do not administer together with coccidiostats such as monovalent and divalent
carboxylic polyether ionophore antibiotics.
4.4.- SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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4.5.- SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Not applicable.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE MEDICINAL
PRODUCT TO ANIMALS
People with known hypersensitivity to Tiamulin should avoid any contact with the
product.
When handling the veterinary medicinal product or the medicated feed, direct contact
with eyes, skin and mucous membranes should be avoided as it may cause irritatio
Read the complete document
Summary of Product characteristics
1/5
SUMMARY OF PRODUCT CHARACTERISTICS (SPC)
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
APSAMIX TIAMULINA 100 mg/g
Premix for medicated feedingstuff (fattening pigs)
2.- QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
ACTIVE SUBSTANCE:
Tiamulin hydrogen fumarate
100 mg
(equivalent to 80 mg of Tiamulin)
EXCIPIENTS:
Calcium carbonate (E-170)
Other excipients q.s.
1 g
“For a full list of excipients, see section 6.1.”
3.- PHARMACEUTICAL FORM
Premix for medicated feedingstuff
4.- CLINICAL PARTICULARS
4.1.- TARGET SPECIES
Porcine (Fattening pigs)
4.2.- INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment and prevention of swine dysentery caused by _Brachyspira hyodysenteriae _in
fattening pigs.
The presence of disease in the herd should be established before treatment.
4.3.- CONTRAINDICATIONS
Do not use in animals with hepatic and renal dysfunction.
Do not use in case of hypersensitivity to pleuromutilins or to any of the excipients.
Do not administer together with coccidiostats such as monovalent and divalent
carboxylic polyether ionophore antibiotics.
4.4.- SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
2/5
4.5.- SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Not applicable.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE MEDICINAL
PRODUCT TO ANIMALS
People with known hypersensitivity to Tiamulin should avoid any contact with the
product.
When handling the veterinary medicinal product or the medicated feed, direct contact
with eyes, skin and mucous membranes should be avoided as it may cause irritatio
Read the complete document
