Animal NDC 0010-3017-03 Ventipulmin

Table of Contents

• Other
• Caution:
• Each Ml Contains:
• Description:
• Indications:
• Contraindications:
• Warning:
• Human Warnings:
• Dosage And Administration:
• Dosage Schedule:
• Directions For Administration:
• Dosage Calculation Chart
• Precaution:
• Adverse Reactions:
• How Supplied:
• Storage:
• Principal Display Panel – 330 Ml Container Label
• Principal Display Panel – 330 Ml Display Carton – Front And Side Panel

Other

Approved by FDA under NADA # 140-973

For oral use in horses only

VENTIPULMIN is a registered trademark of Boehringer Ingelheim Vetmedica GmbH.

Marketed by:

Boehringer Ingelheim Animal Health USA Inc.

Duluth, GA 30096

Caution:

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Federal law prohibits the extralabel use of this drug in food animals.

Each Ml Contains:

Clenbuterol HCl 72.5 mcg

Description:

Clenbuterol (4-amino-alpha-[(tert-butylamino) methyl]-3, 5-dichlorobenzyl alcohol hydrochloride) is a beta-2-adrenergic agonist which provides bronchodilating properties as well as other effects, with minimum effect on the cardiovascular system. It is provided as a colorless, palatable syrup. VENTIPULMIN Syrup (clenbuterol hydrochloride) is antagonized by beta-adrenergic blocking agents.

Indications:

VENTIPULMIN Syrup (clenbuterol hydrochloride) is indicated for the management of horses affected with airway obstruction, such as occurs in chronic obstructive pulmonary disease (COPD).

Contraindications:

VENTIPULMIN Syrup antagonizes the effects of prostaglandin F2 α and oxytocin. VENTIPULMIN Syrup should not be used in pregnant mares near term. Because tachycardia may occur, VENTIPULMIN Syrup should not be used in horses suspected of having cardiovascular impairment.

Warning:

The effect on reproduction in breeding stallions and brood mares has not been determined. Treatment starting with dosages higher than the initial dose is not recommended.

Human Warnings:

Not for use in humans. Do not use in horses intended for human consumption. Keep out of reach of children. In case of accidental ingestion, contact a physician immediately. Ingestion of VENTIPULMIN Syrup may cause undesirable reactions. Clenbuterol, like other beta adrenergic agonists, can produce significant cardiovascular effects in some people as evidenced by elevated pulse rate, blood pressure changes and/or ECG changes.

Dosage And Administration:

Administer orally twice a day (b.i.d.). Initial dose is 0.5 mL/100 lbs body weight (0.8 mcg/kg) twice daily.

Dosage Schedule:

Initial dosage: administer 0.5 mL/100 lbs (0.8 mcg/kg) for 3 days (6 treatments); If no improvement, administer 1.0 mL/100 lbs (1.6 mcg/kg) for 3 days (6 treatments); If no improvement, administer 1.5 mL/100 lbs (2.4 mcg/kg) for 3 days (6 treatments); If no improvement, administer 2.0 mL/100 lbs (3.2 mcg/kg) for 3 days (6 treatments); If no improvement, horse is non-responsive to clenbuterol and treatment should be discontinued. Recommended duration of treatment at effective dose is 30 days. At the end of this 30-day treatment period, drug should be withdrawn to determine recurrence of signs. If signs return, the 30-day treatment regimen may be repeated. If repeating treatment, the step-wise dosage schedule should be repeated.

Directions For Administration:

Remove safety cap and seal; replace with enclosed plastic dispensing cap. Remove cover from dispensing tip and connect syringe (without needle). Draw out appropriate volume of VENTIPULMIN Syrup. Administer orally to the horse. Replace cover on dispensing tip to prevent leakage.

Dosage Calculation Chart

Administer two treatments per day.

Precaution:

The safety cap should be placed on the bottle when not in use.

Adverse Reactions:

Mild sweating, muscle tremor, restlessness, urticaria and tachycardia may be observed in some horses during the first few days of treatment. May cause elevated creatine kinase (CK) serum levels. Ataxia was observed in 3 out of 239 horses (1.3%) in clinical studies. To report suspected adverse events, for technical assistance, or to obtain a copy of the Safety Data Sheet (SDS), contact Boehringer Ingelheim Animal Health USA Inc. at 1-888-637-4251. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.

How Supplied:

VENTIPULMIN Syrup is available in 100 mL and 330 mL plastic bottles containing 72.5 mcg clenbuterol HCl per mL.

NDC 0010-3017-02 – 100 mL, NDC 0010-3017-03 – 330 mL

Storage:

Store at or below 25°C (77°F). Avoid freezing.

Principal Display Panel – 330 Ml Container Label

NDC 0010-3017-03

Ventipulmin® Syrup

Clenbuterol HCl 72.5 mcg/mL

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Caution: Federal law prohibits the extralabel use of this drug in food animals.

For oral use in horses only

Approved by FDA under NADA # 140-973

Principal Display Panel – 330 Ml Display Carton – Front And Side Panel

NDC 0010-3017-03

Ventipulmin® Syrup

Clenbuterol HCl 72.5 mcg/mL

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Caution: Federal law prohibits the extralabel use of this drug in food animals.

For oral use in horses only

Approved by FDA under NADA # 140-973