VETMULIN- tiamulin fumarate concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

tiamulin fumarate (UNII: ION1Q02ZCX) (TIAMULIN - UNII:E38WZ4U54R)

Available from:

Huvepharma, Inc

Administration route:

ORAL

Prescription type:

OTC

Therapeutic indications:

Vetmulin (tiamulin hydrogen fumarate), when administered in the drinking water for five consecutive days, is an effective antibiotic for the treatment of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema ) hyodysenteriae susceptible to tiamulin at a dose level of 3.5 mg tiamulin hydrogen fumarate per pound of body weight daily and for treatment of swine pneumonia due to Actinobacillus pleuropneumoniae susceptible to tiamulin when given at 10.5 mg tiamulin hydrogen fumarate per pound of body weight daily. Swine being treated with Vetmulin (tiamulin hydrogen fumarate) should not have access to feeds containing polyether ionophores (e.g., monensin, lasalocid, narasin, salinomycin and semduramicin) as adverse reactions may occur.

Product summary:

Observe expiration date. To report suspected adverse drug events, for technical assistance or to obtain a copy of the  Safety Data Sheet, contact Huvepharma Inc. at 1-877-994-4883 or www.huvepharma.us. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov.reportanimalae

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

VETMULIN- TIAMULIN FUMARATE CONCENTRATE
HUVEPHARMA, INC
----------
VETMULIN® 12.5%
(TIAMULIN HYDROGEN FUMARATE)
Liquid Concentrate
DESCRIPTION:
Vetmulin (tiamulin hydrogen fumarate) Liquid Concentrate is a solution
containing 12.5
% tiamulin hydrogen fumarate (w/v) in an aqueous solution.
The active ingredient, tiamulin hydrogen fumarate, chemically is
14-desoxy-14-[(2-
diethylaminoethyl) mercaptoacetoxy] mutilin hydrogen fumarate, a
semi-synthetic
diterpene antibiotic. Vetmulin Liquid Concentrate is for use only in
preparing medicated
drinking water for swine.
ACTIONS:
Tiamulin is active against _Brachyspira_ (formerly _Serpulina_ or
_Treponema_) _hyodysenteriae_
and _Actinobacillus pleuropneumoniae_. It is readily absorbed from the
gut and can be
found in the blood within 30 minutes after dosing.
INDICATIONS:
Vetmulin (tiamulin hydrogen fumarate), when administered in the
drinking water for five
consecutive days, is an effective antibiotic for the treatment of
swine dysentery
associated with _Brachyspira_ (formerly _Serpulina_ or _Treponema_)
_hyodysenteriae_
susceptible to tiamulin at a dose level of 3.5 mg tiamulin hydrogen
fumarate per pound
of body weight daily and for treatment of swine pneumonia due to
_Actinobacillus_
_pleuropneumoniae_ susceptible to tiamulin when given at 10.5 mg
tiamulin hydrogen
fumarate per pound of body weight daily.
CONTRAINDICATIONS:
Swine being treated with Vetmulin (tiamulin hydrogen fumarate) should
not have access
to feeds containing polyether ionophores (e.g., monensin, lasalocid,
narasin, salinomycin
and semduramicin) as adverse reactions may occur.
WARNING:
Keep out of reach of children. Avoid contact with skin. Direct contact
with skin or
mucous membranes may cause irritation.
RESIDUE WARNINGS:
Withdraw medicated water 3 days before slaughter after treatment at
3.5 mg per pound
body weight and 7 days before slaughter after treatment at 10.5 mg per
pound body
weight.
CAUTION: FOR USE IN DRINKING WATER OF SWINE ONLY. - NOT FOR USED IN
HUMANS.
Prepare fresh medicated water