Tiamvet Solution 12.5% w/v Oral Solution for use in Drinking Water

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Tiamulin Hydrogen Fumarate

Available from:

Ceva Animal Health Ltd

ATC code:

QJ01XQ01

INN (International Name):

Tiamulin Hydrogen Fumarate

Pharmaceutical form:

Oral solution

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Pigs

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2007-09-14

Summary of Product characteristics

Revised: October 2022
AN: 01604/2022
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Tiamvet Solution 12.5% w/v Oral Solution for use in Drinking Water
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition for 1 ml:
Active substance:
Tiamulin hydrogen fumarate .......................................
125.0 mg
Equivalent to
Tiamulin
.....................................................................
101.2 mg
Excipient:
Benzyl
alcohol.............................................................
15.0 mg
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution for use in drinking water.
Clear, colourless to pale yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
PIG_S:_ For the treatment, prevention and control of swine dysentery
caused by
_Brachyspira hyodysenteriae _and complicated by Fusobacterium and
Bacteroides
spp.
4.3
CONTRA-INDICATIONS
Do not administer products containing monensin, salinomycin or narasin
during or
for at least 7 days before or after treatment. Severe growth
depression or death
may result.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
In order to avoid interactions between tiamulin and the incompatible
ionophores
monensin, narasin and salinomycin, the feed mill supplying the feed
should be
Revised: October 2022
AN: 01604/2022
Page 2 of 5
notified that tiamulin will be used and that these products should not
be included in
the feed or contaminate the feed.
The feed should be tested for the ionophores prior to use if there is
any suspicion
that contamination of the feed might occur. If an interaction does
occur, stop
tiamulin water medication immediately and replace with fresh water.
Remove
contaminated feed as soon as possible and replace with feed not
containing the
tiamulin-incompatible ionophores.
4.5
SPECIAL PRECAUTIONS FOR USE, INCLUDING SPECIAL PRECAUTIONS TO BE TAKEN
BY THE
PERSON ADMINISTERING THE MEDICINAL PRODUCT TO THE ANIMALS
i. Special precau