Tulissin 100: Product Information (Page 3 of 3)

ANIMAL SAFETY

Cattle
Safety studies were conducted in feeder calves receiving a single subcutaneous dose of 25 mg/kg BW, or 3 weekly subcutaneous doses of 2.5, 7.5, or 12.5 mg/kg BW. In all groups, transient indications of pain after injection were seen, including head shaking and pawing at the ground. Injection site swelling, discoloration of the subcutaneous tissues at the injection site and corresponding histopathologic changes were seen in animals in all dosage groups. These lesions showed signs of resolving over time. No other drug-related lesions were observed macroscopically or microscopically.
An exploratory study was conducted in feeder calves receiving a single subcutaneous dose of 10, 12.5, or 15 mg/kg BW. Macroscopically, no lesions were observed. Microscopically, minimal to mild myocardial degeneration was seen in one of six calves administered 12.5 mg/kg BW and two of six calves administered 15 mg/kg BW.
A safety study was conducted in preruminant calves 13 to 27 days of age receiving 2.5 mg/kg BW or 7.5 mg/kg BW once subcutaneously. With the exception of minimal to mild injection site reactions, no drug-related clinical signs or other lesions were observed macroscopically or microscopically.
Swine
Safety studies were conducted in pigs receiving a single intramuscular dose of 25 mg/kg BW, or 3 weekly intramuscular doses of 2.5, 7.5, or 12.5 mg/kg BW. In all groups, transient indications of pain after injection were seen, including restlessness and excessive vocalization. Tremors occurred briefly in one animal receiving 7.5 mg/kg BW. Discoloration and edema of injection site tissues and corresponding histopathologic changes were seen in animals at all dosages and resolved over time. No other drug-related lesions were observed macroscopically or microscopically.

STORAGE CONDITIONS:

Store at or below 30°C (86°F). Use within 45 days of first puncture and puncture a maximum of 20 times. Consider using automatic injection equipment or a repeater syringe. When using a needle or draw-off spike larger than 16 gauge, discard any remaining product immediately after use.

HOW SUPPLIED

HOW SUPPLIED: TULISSIN 100 Injectable Solution is available in the following package sizes:50 mL vial ; 100 mL vial ; 250 mL vial ; 500 mL vial

Manufactured for: Virbac AH, Inc. — P.O. Box 162059, Fort Worth, TX 76161 — Made in France

Approved by FDA under ANADA # 200-669

To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Virbac AH, Inc. at 1-800-338-3659 or us.virbac.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

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©2021 Virbac Corporation. All Rights Reserved. TULISSIN is a registered trademark of Virbac S.A.

Rev. 10/21

8838620

label
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TULISSIN 100 tulathromycin injection, solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:51311-006
Route of Administration SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TULATHROMYCIN (TULATHROMYCIN) TULATHROMYCIN 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
MONOTHIOGLYCEROL
CITRIC ACID ACETATE
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51311-006-50 50 mL in 1 VIAL, MULTI-DOSE None
2 NDC:51311-006-10 100 mL in 1 VIAL, MULTI-DOSE None
3 NDC:51311-006-25 250 mL in 1 VIAL, MULTI-DOSE None
4 NDC:51311-006-51 500 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200669 12/15/2021
Labeler — Virbac AH, Inc. (131568396)
Registrant — Virbac AH, Inc. (131568396)

Revised: 09/2022 Virbac AH, Inc.

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