DENAGARD 80 COATED TYPE A MEDICATED ARTICLE- tiamulin fumarate powder

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Tiamulin Fumarate (UNII: ION1Q02ZCX) (Tiamulin - UNII:E38WZ4U54R)

Available from:

Elanco US Inc.

INN (International Name):

Tiamulin Fumarate

Composition:

Tiamulin Fumarate 22 g in 1 kg

Administration route:

ORAL

Prescription type:

OTC

Therapeutic indications:

For treatment of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema ) hyodysenteriae susceptible to Tiamulin; For control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis ; For control of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema ) hyodysenteriae susceptible to Tiamulin.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

DENAGARD 80 COATED TYPE A MEDICATED ARTICLE- TIAMULIN
FUMARATE POWDER
ELANCO US INC.
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NET WEIGHT:
55 LB (25 KG)
DENAGARD™ 80%
COATED (TIAMULIN HYDROGEN FUMARATE)
TYPE A MEDICATED ARTICLE
FOR THE MANUFACTURE OF DENAGARD 10
TYPE B MEDICATED SWINE FEED ONLY.
NOT TO BE USED FOR THE MANUFACTURE OF
TYPE C MEDICATED FEEDS.
ACTIVE INGREDIENT:
tiamulin hydrogen fumarate:
80% w/w (363.2 g/lb.)
INACTIVE INGREDIENTS:
porcine gelatin
INDICATIONS:
For treatment of swine dysentery associated with _Brachyspira_
(formerly _Serpulina_ or
_Treponema_) _hyodysenteriae_ susceptible to Tiamulin; For control of
porcine proliferative
enteropathies (ileitis) associated with _Lawsonia intracellularis_;
For control of swine
dysentery associated with _Brachyspira_ (formerly _Serpulina_ or
_Treponema_)
_hyodysenteriae_ susceptible to Tiamulin.
WARNINGS:
Denagard 10 Type B Medicated Swine Feed label contains residue
information for use in
swine.
Keep out of reach of children.
lrritating to eyes and respiratory system.
May cause sensitization by inhalation and skin contact. Do not breathe
dust.
Avoid contact with skin and eyes.
Wear suitable protective clothing and gloves.
CAUTION:
Do not feed undiluted. Do not use in feeds for animals other than
swine. The effects of
tiamulin on swine reproductive performance, pregnancy and lactation
have not been
determined. Swine being treated with Denagard (tiamulin) should not
have access to
feeds containing polyether ionophores (e.g., lasalocid, monensin,
narasin, salinomycin
and semduramicin) as adverse reactions may occur. If signs of toxicity
occur,
discontinue use.
STORAGE:
PROTECT FROM LIGHT AND MOISTURE. STORE AT OR BELOW 25°C (77°F).
TEMPORARY
EXCURSIONS TO 40°C (104°F) PERMITTED.
DIRECTIONS FOR PREPARATION OF DENAGARD 10 TYPE B MEDICATED SWINE FEED.
INGREDIENT:
Denagard 80%
Coated (tiamulin
hydrogen
fumarate)
Rice Hulls
Mineral Oil
QUANTITY PER 2000 LBS.:
56.2 lbs.*
1863.8 lbs.
80 lbs.
With mixer on, dispense mineral oil into rice hulls. Mix until
sufficiently blended. Add
Denagar