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3(2H)-Pyridazinone,4,5-dihydro-6-[2-(4-methoxyphenyl)-1H-benzimidazol-6-yl]-5-methyl-

Vetmedin? Tablets 2007-April-11
NADA (141-273)

MATERIAL SAFETY DATA SHEET

1 PRODUCT AND COMPANY IDENTIFICATION

Product Name: Vetmedin? Tablets (NADA 141-273)
Product No.: Not applicable
GHS Product Identifier: Not applicable

Synonyms: UD-CG 115 BS <=2%; Pimobendan
Molecular Formula: Mixture, not applicable
Molecular Weight: Not applicable
CAS Number: Mixture, not applicable
Chemical Family: Benzimidazol derivative cardiac indicators

Supplier: Emergency Telephone:
Boehringer Ingelheim Vetmedica, Inc. Transportation Emergency: (800) 424-9300
2621 North Belt Hwy
St. Joseph, MO 64506-2002 Medical Emergency (24HR): (866) 638-2226

Manufacturer: Non-emergency Telephone: (800) 821-7467
MEDA Manufacturing GmbH
Neurather Ring 1 Technical Assistance: (866) 638-2226
51063 Koeln
Germany

Intended Use: Vetmedin? (pimobendan) is
indicated for the is indicated for management
of the signs of mild, moderate, or severe
(modified NYHA Class IIa, IIb, IVc) congestive
heart failure in dogs due to atrioventricular
valvular insufficiency (AVVI) or dilated
cardiomyopathy (DCM). Vetmedin? is
indicated for use with concurrent therapy
for congestive heart failure (i.e. furosemide,
etc.) on a case-by-case basis.

2 HAZARDS IDENTIFICATION

Emergency Overview

Physical State: Tablets (chewable, oblong half-scored): 1.25 mg, 2.5 and 5 mg
Color: Orange to brown
Odor: No data available

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Not classified as hazardous.
Handle in accordance with good industrial hygiene and safety practice.
For dogs - oral use only - CARDIAC DRUG
Not for human use.
Precautionary Statements:
Keep out of reach of children.
If swallowed, seek medical advice and show this container or label.
Do not eat, drink, or smoke when using this product.
Wash thoroughly with soap and water after handling.
Keep only in original container.
Keep away from food, drink, and animal feedstuffs.
Keep in a dry place.
Keep at a temperature between 15 - 30??C (59 - 86??F).
Fire-fighting: Use foam, carbon dioxide, dry powder and water fog or material appropriate for
surrounding fire.
Spills: Sweep spilled substance into appropriate waste containers.

Acute effect: Vetmedin? improves systolic efficiency without the negative
pathway of increasing intracellular calcium.

Vetmedin? has a dual mode of action, acting directly on the heart as a calcium
sensitizer to increase myocardial contractility and on the peripheral circulation
through selective phosphodiesterase III inhibition to produce both peripheral and
coronary vasodilation. As a consequence, Vetmedin? increases cardiac output by
increasing the efficiency within the myofilaments, with no increase in myocardial
energy requirement.

Precautions/Contraindications: Vetmedin? tablets should not be used in cases of hypertrophic
cardiomyopathy, aortic stenosis, or any other clinical condition where an augmentation of cardiac
output is inappropriate for functional or anatomical reasons. The product should only be used in
dogs with cardiac insufficiency. A moderate positive chronotropic effect and vomiting may occur
in rare cases. However, these cases are dose-dependent and may be avoided by reducing the dose.
The safety of Vetmedin? has not been established in dogs with symptomatic heart disease or in
heart failure caused by etiologies other than AVVI (atrioventricular valvular insufficiency) or
DCM (dilated cardiomyopathy). The safe use of Vetmedin? has not been evaluated in dogs
younger than 6 months of age, dogs with congenital heart defects, dogs with diabetes mellitus or
other serious metabolic diseases, dogs used for breeding, pregnant or lactating bitches.

Warnings: Only for use in dogs with clinical evidence of heart failure.

Overdosage: Treatment should be symptomatic.

ADVERSE REACTIONS TO PRODUCT: Adverse reactions/new clinical findings related to
CHF (congestive heart failure), the therapy of CHF, or both are sudden death, chlordane
tendineae rupture, left atrial tear, arrhythmias overall, tachycardia, syncope, weak pulses,
irregular pulses, increased pulmonary edema, dypsnea, increased respiratory rate, coughing,
gagging, pleural effusion, ascites, hepatic congestion, decreased appetite, vomiting, diarrhea,
melena, weight loss, lethargy, depression, weakness, collapse, shaking, trembling, ataxia,
seizures, restlessness, agitation, pruritus, increased water consumption, increased urination,
urinary accidents, azotemia, dehydration, abnormal serum electrolyte, protein and glucose values,

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NADA (141-273)

mild increases in serum hepatic enzyme levels, and mildly decreased platelet counts. In humans,
side effects include, weight gain, dizziness, headache, skin rash, ventricular arrhythmias and
sudden death.

If the animal??s condition worsens or does not improve, stop product immediately and consult
your veterinarian.

Potential Health Effects

Inhalation: Not expected to be an inhalation hazard in final pharmaceutical form.

Eye Contact: Not expected to be a hazard to the eye in final pharmaceutical form. Contact with
ingredients may cause transient irritation.

Skin Contact: Not expected to be a skin hazard in final pharmaceutical form. Can cause
hypersensitive reactions for patients allergic to any of the components.

Ingestion: NOT FOR USE IN HUMANS. May be harmful if ingested. Ingestion may cause
nausea, vomiting and other systemic effects.

Chronic Health Effects: Possible hypersensitization.

Target Organ(s): Heart, liver

Potential Physical Effects: Vetmedin? improves cardiac output, quality of life
and extends life expectancy in treated dogs.

OSHA Regulatory Status: Nonhazardous, exempt

Environment: No data available

3 COMPOSITION / INFORMATION ON INGREDIENTS

Chemical Name EC No. CAS- No. Concentration Classification Notes
4,5-Dihydro-6-(2-(4- ---- 74150-27-9 1.25 mg, 2.5 Xn; R22; S46 ----
methoxyphenyl-1H- and 5 mg
benzimidazol-5-yl)-5-
methyl-3(2H)-
pyridazinone
(Pimobendan)

* Formulation is proprietary
The full texts for all R-Phrases are displayed in Section 16.

4 FIRST AID MEASURES
General: Animals or persons developing anaphylactic (life-threatening) reactions, such as
difficulty in breathing or unconsciousness, must receive immediate medical attention.

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Inhalation: Move to fresh air. Treat symptomatically. Get medical attention if symptoms persist.

Eye Contact: Any material that contacts the eye should be washed out immediately with water.
If easy to do, remove contact lenses. Get medical attention if symptoms persist.

Skin Contact: Wash with soap and water. Get medical attention if symptoms occur.

Ingestion: Seek medical advice. Call a physician or poison control center immediately. Only
induce vomiting at the instruction of medical personnel. Never give anything by mouth to an
unconscious person.

Note to Physician: Vetmedin? is a cardiac medication for oral use in dogs only. Not for human
use. Treatment should be symptomatic.

5 FIRE-FIGHTING MEASURES

Extinguishing Media: Extinguish with foam, carbon dioxide, dry powder and water fog or
material appropriate for surrounding fire.

Unsuitable Extinguishing Media: None known

Special Fire Fighting Procedures: Wear self-contained breathing apparatus and protective
clothing.

Unusual Fire & Explosion Hazards: None known

Hazardous Combustion Products: Carbon monoxide, carbon dioxide, nitrogen oxides

Flammability Class: 0

6 ACCIDENTAL RELEASE MEASURES

Personal Precautions: Wear appropriate personal protective equipment for industrial use. (See
Section 8).

Spill Cleanup Methods: STEPS TO BE TAKEN IF SIGNIFICANT QUANTITIES OF
TABLETS ARE BROKEN: Wear an approved respirator, eye protection, personal protective
coverings and gloves. Use HEPA filtered vacuum or wet sweeping to clean up spillage. Avoid
dust. Place spillage in appropriate container for waste disposal. Wash contaminated clothing
before use.

Environmental Precautions: Prevent runoff from entering drains, sewers or streams. Dike
for later disposal.

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7 HANDLING AND STORAGE

Handling: HANDLING SIGNIFICANT QUANTITIES OF BROKEN TABLETS: Avoid contact
with eyes, skin or clothing. Do not taste or swallow. Avoid generating dust. Wash hand
thoroughly after handling.

Storage: Keep container tightly closed. Do not store above 15 - 30?? C (59 - 86?? F) to maintain
product integrity during shelf life. Protect from heat and direct sunlight. Store in a dry place.
Keep out of reach of children.

8 EXPOSURE CONTROLS / PERSONAL PROTECTION

Exposure Limits:
Chemical Name Source Type Exposure Notes
Limits
0.025 mg/m3
4,5-Dihydro-6-(2-(4- BIEL TWA BIEL-Group 3
methoxyphenyl-1H-
benzimidazol-5-yl)-
5-methyl-3(2H)-
pyridazinone
.25 mg/m3
4,5-Dihydro-6-(2-(4- BIEL TWA BIEL, 15 min, 2x
methoxyphenyl-1H-
benzimidazol-5-yl)-
5-methyl-3(2H)-
pyridazinone
0.125 mg/m3
4,5-Dihydro-6-(2-(4- BIEL TWA BIEL, 60 min, 1x
methoxyphenyl-1H-
benzimidazol-5-yl)-
5-methyl-3(2H)-
pyridazinone

BIEL=Boehringer Ingelheim Exposure Level
BI-STEL= Boehringer Ingelheim Short-Term Exposure Limit
Factor=Exceeding factor for Short-Term Exposure

Engineering Controls: Not generally required when handling containers or tablets. Good general
ventilation (typically 10 air changes per hour) should be used. Ventilation rates should be
matched to conditions. If operations involve crushing or other processes that may release powder,
use process enclosures, local exhaust ventilation, or other engineering controls to maintain
airborne levels below recommended exposure limits.

Respiratory Protection: Not generally required when handling containers or tablets. If
containers or tablets are broken and if engineering controls do not maintain airborne
concentrations below recommended exposure limits (where applicable) or to an acceptable level
(in countries where exposure limits have not been established), an approved respirator must be
worn. In the United States of America, if respirators are used, a program should be instituted to
assure compliance with OSHA standard 63 FR 1152, January 8, 1998. Respirator type: Dust

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PERSONAL PROTECTIVE EQUIPMENT: Not generally required when handling containers
or tablets. If containers or tablets are compromised or exposure to the active ingredient or mixture
is likely wear:

Eye Protection: Wear safety glasses with side shields (or goggles).

Hand Protection: Wear suitable gloves.

Skin Protection: Wear disposable coveralls, lab coat, or protective clothing appropriate for the
risk of exposure.

Hygiene Measures: Eye bath, washing facilities

9 PHYSICAL AND CHEMICAL PROPERTIES

Color: Orange to brown
Odor: No data available
Odor Threshold: Not applicable
Physical State: Tablets (chewable, oblong half-scored): 1.25 mg, 2.5 and 5 mg
pH: No data available
Melting Point: No data available
Freezing Point: No data available
Boiling Point: No data available
Flash Point: No data available
Ignition Temperature: No data available
Flammability Limit ?? Upper (%): No data available
Flammability Limit ?? Lower (%): No data available
Evaporation rate: No data available
Vapor Pressure: No data available
Vapor Density (Air=1): No data available
Specific Gravity: No data available
Solubility: No data available
Partition Coefficient (n-Octanol/water): No data available
Autoignition Temperature: Not applicable
Decomposition Temperature: No data available

10 STABILITY AND REACTIVITY

Stability: Stable

Conditions to Avoid: None known

Incompatible Materials: Strong oxidizing agents

Hazardous Decomposition Products: Carbon oxides, nitrogen oxide

Possibility of Hazardous Reactions: Hazardous polymerization will not occur.

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11 TOXICOLOGICAL INFORMATION

Animal Safety:
Vetmedin? was used safely in dogs concurrently receiving furosemide, digoxin, enalapril,
atenolol, spironolactone, nitroglycerin, hydralazine, diltizaem, antiparasitic products (including
heartworm prevention, antibiotics (metronidazole, cephalexin, amoxicillin-clavulanate,
fluoroquinolones), topical ophthalmic and otic products, famotidine, theophylline, levothyroxine
sodium, diphenhydramine, hydrocodone, metoclopramide, and butorphanol, and in dogs on
sodium restricted diets.

At 3 and 5 times the recommended dosage, administered over a 6-month period of time,
pimobendan caused an exaggerated hemodynamic response in the normal dog heart, which was
associated with cardiac myopathy.

Acute Toxicity
Chemical Name Test Results
Vetmedin? Oral LD50 (rat): 4,120 mg/kg
4,5-Dihydro-6-(2-(4-methoxyphenyl-1H-benzimidazol-5- Oral LD50 (rat): 950 mg/kg
yl)-5-methyl-3(2H)-pyridazinone Oral LD50 (mouse): > 2gm/kg
Oral LD50 (monkey): > 2gm/kg
(Pimobendan)

In studies with rats and rabbits, pimobendan had no effect on fertility and embryotoxic effects
occurred only at maternotoxic doses. In experiments with rats it has been shown that pimobendan
is excreted into milk. No information is available on the safety of Vetmedin? in pregnant and
lactating bitches.

Ames test: Negative

Carcinogenicity: Did not show carcinogenic effects in animal experiments.

Listed Carcinogens: None

12 ECOLOGICAL INFORMATION

Ecotoxicity: No data available
Persistence and degradability: No data available
Mobility in soil: No data available
Other adverse effects: No data available

Germany WGK: Product: Vetmedin?: Class 2: water-endangering.

13 DISPOSAL CONSIDERATIONS

General Information: Dispose of in accordance with local, state and federal regulations.

Disposal Methods: No specific disposal method required. Do not empty into drains; dispose of
this material and its container in a safe way. Do not contaminate water, food, or feed by storage
disposal.

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Container: Since emptied containers retain product residue, follow label warnings even after
container is emptied.

14 TRANSPORT INFORMATION

DOT: Not regulated

TDG: Not regulated

ADR/RID: Not regulated

IATA: Not regulated

IMDG: Not regulated

15 REGULATORY INFORMATION

Canadian Controlled Products Regulations: This product has been classified according to the
hazard criteria of the Canadian Controlled Products Regulations, Section 33, and the MSDS
contains all required information.

WHMIS Classification: Noncontrolled, exempt

Inventory Status

This product is not listed on the US TSCA Inventory. Therefore, it can only be used for TSCA exempt
purposes such as R&D or veterinary use.
This material is not listed on the DSL Inventory.
3(2H)-pyridazinone, 4, 5-dihydro-6-(2-(4-methoxyphenyl)-1H-benzimidazol-5-yl)-5-methyl-
(Pimobendan) is listed on the Japan and New Zealand inventories.

US Regulations

FEDERAL LAW RESTRICTS THIS DRUG TO USE BY OR ON ORDER OF A
LICENSED VETERINARIAN.

State Regulations
California Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65): None
Massachusetts Right-To-Know List: None
Minnesota Hazardous Substances List: None
New Jersey Right-To-Know List: None
Pennsylvania Right-To-Know List: None
Rhode Island Right-To-Know List: None

European Regulations
Switzerland Toxins List 1: None
Austria MAK List (Annex I): None
Denmark (Annex 3.6, April 2005): None
Germany (Dangerous Substances Ordinance 2004, Annex III): None

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Norway (List of Dangerous Substance): None
Sweden (Sensitizers- Annex 3): None

16 OTHER INFORMATION

Hazard Ratings

Health Hazard Fire Hazard Reactivity Hazard
2 0 0
HMIS

Health Hazard Fire Hazard Reactivity Hazard Special Hazard
1 0 0 N/A
NFPA
*- Chronic health effect; 0 ?? Minimal; 1 ?? Slight; 2 ?? Moderate; 3 ?? Serious; 4 ?? Severe

This product has been reviewed and is classified and labeled as follows in full accord with EC
Directive 67/548 and all other current applicable amending Directives, including, but not limited
to, 91/155/EC, 1999/45/EC, 2001/58/EC and 2001/59/EC.

Not classified as hazardous.
Handle in accordance with good industrial hygiene and safety practice.

For Pimobendan:
Xn: Harmful
R22: Harmful if swallowed.
S46: If swallowed, seek medical advice immediately and show this container or label.

ABBREVIATIONS:
BIV - Boehringer Ingelheim Vetmedica, Inc.
AIHA- American Industrial Hygiene Association
mppcf ?? million particles/cubic foot
N/A - Not applicable
N/E - Not established
NYHA ?? New York Heart Association

References:
1. Ariel WebInsight Regulatory Database. Regulatory Summary for North America,
Eastern Europe, Western Europe, Asia Pacific, and Global Inventories Database.
2. GHS Manual
3. Pimobendan can prolong lives of dogs with heart failure up to nine months.
Boehringer Ingelheim, Germany, January 11, 2007.
4. RTECS, 3(2H)-pyridazinone, 4, 5-dihydro-6-(2-(4-methoxyphenyl)-1H-
benzimidazol-5-yl)-5-methyl-, No. UR6373000, Review Date, 200012.
5. Vetmedin? Chewable Tablets, Product Specification Sheet.
6. Vetmedin? Package Insert.
7. Vetmedin? Product Label
Revision Information: New MSDS
Prepared by: Boehringer Ingelheim Vetmedica, Inc.
Issue Date: 04/11/07

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Disclaimer: The information provided herein is offered by Boehringer Ingelheim Vetmedica,
Inc. (??BIV??) in good faith as accurate as of the date hereof, but without guarantee. This
information includes information which has been generated by other parties and provided to BIV,
and which BIV has not independently verified. The information provided herein relates only to
the specific product designated, and may not be valid where such product is used in combination
with any other materials or in any process. The information provided herein is offered solely for
your consideration, investigation and verification, and Boehringer Ingelheim Vetmedica, Inc.
(??BIV??) expressly disclaims all liability for reliance thereon. BIV EXPRESSLY DISCLAIMS
ALL WARRANTIES OF EVERY KIND AND NATURE (INCLUDING WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE) WITH RESPECT
TO THE USE OR SUITABILITY OF THE PRODUCT. In addition, since the conditions of use
and suitability of the product for particular uses are beyond BIV??s control, ALL RISKS OF USE
OF THE PRODUCT ARE THEREFORE ASSUMED BY THE USER, AND BIV EXPRESSLY
DISCLAIMS ANY AND ALL LIABILITY AS TO ANY RESULTS OBTAINED O ARISING FROM ANY USE OF THE PRODUCT. Use or transmission of the information
contained herein in any other format than the format as presented is strictly prohibited. Nothing
herein shall be construed as permission or recommendation for the use of the product in a manner
that might infringe an existing patent. BIV neither represents nor warrants that the format, content
or product formulas contained in this document comply with the laws of any other country except
the United States of America.
? Copyright 2001 Boehringer Ingelheim Vetmedica, Inc. All rights reserved.

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