Denagard 80 Coated Type A Medicated Article description, usages, side effects, indications, overdosage, supplying and lots more!

Denagard 80 Coated Type A Medicated Article

Novartis Animal Health US, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Denagard 80 Coated Type A Medicated Article



FULL PRESCRIBING INFORMATION

Denagard®  80%

Coated ( tiamulin hydrogen fumarate )

Type A Medicated Article

For the manufacture of Denagard ® 10 Type B M edicated Swine Feed only.

Not to be used for the manufacture of Type C medicated feeds.

tiamulin hydrogen fumarate:

80% w/w (363.2g/lb.)

porcine gelatin

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.

►Denagard® 10 Type B Medicated Swine Feed label contains residue information for use in swine. ◄

Keep out of reach of children.

Irritating 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.

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.

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 Denagard® 80% Coated (tiamulin hydrogen fumarate) to mixture while mixer is running. Mix until homogeneous.

*Includes 2% overage.

Use only as directed.

For more information or to report adverse effects, call Novartis Animal Health US, Inc. at 1-800-637-0281. For a complete listing of adverse reactions for DENAGARD reported to CVM see: http://www.fda.gov/AnimalVeterinary/SafetyHealth.

Marketed by:
Novartis Animal Health US, Inc.
Greensboro, NC 27408 U.S.A.

Manufactured by:
Sandoz GmbH
A-6250 Kundl -Austria

Lot Number:

Date of Manufacture:

Date of Expiration:

Denagard® is a registered trademark of Novartis AG.
NADA 139-472, Approved by FDA.
Product # 609413
NAH/DEN80-MA/TYPE A/BGL/1
12/11





Denagard 80%
Coated (tiamulin hydrogen fumarate)

Type A Medicated Article

Net Weight:

55 lb (25 kg)

Denagard® is a registered

trademark of Novartis AG.

NADA 139-472, Approved by FDA.

Product # 609413

NAH/DEN80-MA/TYPE A/BGL/1

12/11

Denagard 80 Coated Type A Medicated Article

Tiamulin Hydrogen Fumarate POWDER

Product Information

Product Type Otc animal drug label Item Code (Source) NDC:58198-9413
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
TIAMULIN FUMARATE TIAMULIN 22 g

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:58198-9413-1 25 in 1 BAG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA139472 2011-08-01


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