Macrosyn: Product Information (Page 4 of 4)

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 25°C (77°F)

50 mL – Use within 28 days of first puncture and puncture a maximum of 17 times with a needle.

100 mL – Use within 28 days of first puncture and puncture a maximum of 17 times with a needle.

250 mL – Use within 28 days of first puncture and puncture a maximum of 29 times with a needle or 5 times with a dosage delivery device. If using a needle or draw-off spike larger than 4 gauge, discard any remaining product immediately after use.

500 mL – Use within 28 days of first puncture and puncture a maximum of 29 times with a needle or 5 times with a dosage delivery device. If using a needle or draw-off spike larger than 4 gauge, discard any remaining product immediately after use.

HOW SUPPLIED

Macrosyn Injectable Solution is available in the following package sizes: 50 mL, 100 mL, 250 mL and 500 mL vial.

Macrosyn^TM is a Trademark of Bimeda, Inc.

Manufactured for: Bimeda, Inc. Le Sueur, MN 56058 www.bimeda.com

N.A. Corp. Address: Bimeda, Inc., One Tower Lane, Oakbrook Terrace, IL 60181

Approved by FDA under ANADA # 200-657

To report suspected adverse drug events, for technical assistance, or to obtain a copy of the Safety Data Sheet (SDA), contact Bimeda, Inc. at 1-888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/reportanimalae.

250 mL

MACROSYN tulathromycin injection, solution

Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:61133-4010 Route of Administration INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TULATHROMYCIN (TULATHROMYCIN) TULATHROMYCIN 100 mg in 1 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:61133-4010-2 100 mL in 1 VIAL, GLASS None 2 NDC:61133-4010-1 50 mL in 1 VIAL, GLASS None 3 NDC:61133-4010-3 250 mL in 1 VIAL, GLASS None 4 NDC:61133-4010-4 500 mL in 1 VIAL, GLASS None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200657 02/18/2021

Labeler — Bimeda, Inc. (060492923)

Establishment
Name	Address	ID/FEI	Operations
Bimeda- MTC		256232216	manufacture

Establishment
Name	Address	ID/FEI	Operations
Wisdom Parmaceutical Co., Ltd.		527609114	api manufacture

Revised: 02/2021 Bimeda, Inc.