Vetmulin 100 mg/g oral granules for pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tiamulin hydrogen fumarate

Available from:

Huvepharma NV

ATC code:

QJ01XQ01

INN (International Name):

Tiamulin hydrogen fumarate

Dosage:

100 milligram(s)/gram

Pharmaceutical form:

Granules

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Pigs

Therapeutic area:

tiamulin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2010-02-12

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
VETMULIN 100 mg/g oral granules for pigs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Each gram contains: Tiamulin hydrogen fumarate 100 mg (equivalent to
tiamulin 81 mg).
Excipients: For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral granules.
A yellowish granular material.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pig.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of swine dysentery caused by_ Brachyspira
hyodysenteriae._
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
ingredient or to any of the excipients.
Do not administer products containing ionophores such as monensin,
salinomycin or narasin during or for at least seven
days before or after treatment with the product.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The uptake of medication by animals can be altered as a consequence of
illness. For animals with a reduced feed intake,
treat parenterally using an appropriate injectable product.
Long term or repeated use should be avoided by improving management
practice and thorough cleansing and
disinfection.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_2_
_8_
_/_
_0_
_8_
_/_
_2_
_0_
_1_
_4_
_C_
_R_
_N_
_ _
_7_
_0_
_1_
_8_
_4_
_4_
_3_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Do not use the product in liquid f