DENAGARD tiamulin solution concentrate

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

TIAMULIN FUMARATE (UNII: ION1Q02ZCX) (TIAMULIN - UNII:E38WZ4U54R)

Commercializzato da:

Novartis Animal Health US, Inc.

INN (Nome Internazionale):

TIAMULIN FUMARATE

Composizione:

TIAMULIN FUMARATE 0.125 g in 1 mL

Tipo di ricetta:

OTC

Stato dell'autorizzazione:

New Animal Drug Application

Scheda tecnica

DENAGARD- TIAMULIN SOLUTION, CONCENTRATE
NOVARTIS ANIMAL HEALTH US, INC.
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DENAGARD-LIQUID CONCENTRATE
Denagard
12.5%
(tiamulin hydrogen fumarate)
5L Liquid Concentrate
12.5% Tiamulin hydrogen fumarate
NADA 140-916, Approved by FDA
FIVE LITER (5.285 QUARTS)
(169 FL OZ; 5000 ML)
WARNING:
KEEP OUT OF REACH OF CHILDREN. Avoid direct contact with the skin.
Direct contact with skin or mucous
membranes may cause irritation.
RESIDUE WARNINGS: Withdraw medicated water 3 days before slaughter
after use at 3.5 mg per
pound and 7 days before slaughter after use at 10.5 mg per pound.
ACTIVE INGREDIENT:
This bottle contains 21.65 OZ (625.0 G) tiamulin hydrogen fumarate in
solution.
CAUTION:
FOR USE IN ANIMALS ONLY – NOT FOR HUMAN USE.
Prepare fresh medicated water daily. Use as the only source of
drinking water for 5 days. The effects
of tiamulin on swine reproductive performance, pregnancy and lactation
have not been determined.
CONTRAINDICATION:
Swine being treated with Denagard (tiamulin) should not have access to
feeds containing polyether
ionophores (e.g., monensin, lasalocid, narasin, salinomycin and
semduramicin) as adverse reactions may
occur.
INDICATIONS :
Denagard (tiamulin), 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 3.5mg 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 10.5mg tiamulin hydrogen
fumarate per pound of body weight daily.
USE DIRECTIONS:
Do not use undiluted. This bottle contains 625,000 mg tiamulin
hydrogen fumarate for use in preparing
medicated drinking water for swine. See package insert for complete
directions; read completely.
®
PROTECT FROM DIRECT SUNLIGHT. Store at controlled room temperature,
59°-77°F (15°-25°C).
RESTRICTED DRUG (CALIFORNIA):