Ventipulmin® Syrup 2006-July-05
(NADA 140-973)
MATERIAL SAFETY DATA SHEET
1 PRODUCT AND COMPANY IDENTIFICATION
Product Name: Ventipulmin® Syrup
Product No.: NADA 140-973
GHS Product Identifier: Not applicable
Synonyms: Not available
Molecular Formula: Mixture, not applicable
Molecular Weight: Not applicable
CAS Number: Mixture, not applicable
Chemical Family: beta-2-adrenergic agonist
Manufacturer: Emergency Telephone:
Boehringer Ingelheim Vetmedica, Inc. Transportation Emergency: (800) 424-9300
2621 North Belt Hwy
St. Joseph, MO 64506-2002 Medical Emergency (24HR): (800)530-5432
Intended Use: Oral bronchodilator for the Non-emergency Telephone: (800) 821-7467
management of horses affected with airway
obstruction, such a chronic obstructive
pulmonary disease (COPD).
2 HAZARDS IDENTIFICATION
Emergency Overview
Physical State: Liquid, syrup
Color: Clear to light yellow
Odor: Alcohol-like
WARNING!
Harmful if swallowed
Equine use only.
Not for human use.
Precautionary Statements:
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Keep away from heat, sparks and flame.
Do not use or store near heat or open flame.
Keep at a temperature not exceeding 30° C.
Keep only in original container.
Keep container closed.
Fire-fighting: Use water spray, dry chemical, carbon dioxide, foam
Fire fighters should wear complete protective clothing including self-contained breathing
apparatus.
Avoid contact with eyes, skin and clothing.
Wash thoroughly with soap and water after handling.
Wear suitable gloves and eye/face protection.
Spills: Use non-sparking equipment when picking up flammable spill. Remove ignition sources.
In case of accident or if you feel unwell, seek medical advice immediately (show the label where
possible).
Have the product container or label with you when calling a poison control center or doctor, or
going for treatment.
If swallowed, seek medical advice immediately and show this container or label.
In case of contact with eyes, directly, flush with gently flowing fresh water thoroughly.
This material and its container must be disposed of in a safe way.
Keep out of reach of children.
Keep away from food, drink, and animal feedstuffs.
Acute effect:
Ventipulmin® Syrup was shown to be safe and effective for management of COPD
in horses when used according to the recommended regimen of incremental dose
titration to effect. Ventipulmin® Syrup relieves reversible bronchospasm arising
from a variety of respiratory conditions. Ventipulmin® Syrup increases mucous
secretions for improved airway resistance and improves mucociliary transport by
decreasing thickness of mucous.
Precautions/Contraindications:
The reproduction effect in breeding stallions and brood mares has not been determined.
Ventipulmin® Syrup antagonizes the effects of prostaglandin F2 alpha and oxytocin and 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 problems.
Overdosage:
Overdose can cause increased heart rate, nausea, tachycardia, sweating and other significant
cardiovascular effects.
ADVERSE REACTIONS TO PRODUCT: Clenbuterol, like other beta adrenergic agonists, can
product significant cardiovascular effects as evidenced by elevated pulse rate, blood pressure
changes and/ or ECG changes. 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.
Potential Health Effects
Inhalation: Not expected to be an inhalation hazard with prescribed use.
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Eye Contact: Not expected to be a hazard to the eye with prescribed use. Contact
with eye may cause transient irritation.
Skin Contact: Can cause hypersensitive reactions.
Ingestion: Harmful. Ingestion may cause cardiovascular effects such as elevated pulse rate, blood
pressure changes and/or ECG changes and other systemic effects.
Chronic Health Effects: Possible hypersensitization (development of abnormal sensitivity).
Target Organ(s): Respiratory System, Cardiovascular System
Potential Physical Effects: Mild sweating, muscle tremor, restlessness, urticaria and tachycardia.
OSHA Regulatory Status: Exempt, FDA Regulated.
Environment: No data available.
3 COMPOSITION / INFORMATION ON INGREDIENTS
Chemical Name EC No. CAS- No. Concentration Classification Notes
Ethyl Alcohol 2005786 64-17-5 5.0 F, R11 ----
Glycerin 2002895 56-81-5 4.5 ---- ----
Clenbuterol HCl 2533660 37148-27-9 .0723 R43 Denmark
Carbomer 934P, NF ---- 57916-92-4 proprietary ---- ----
Methylparaben 2027857 99-76-3 proprietary ---- ----
Propylparaben 2023077 94-13-3 proprietary ---- ----
Polyethylene glycol 76960 25322-68-3 proprietary ---- ----
Sucrose 2003349 57-50-1 proprietary ---- ----
Trolamine, N.F. 2030498 102-71-6 proprietary R43 Denmark
Water 2317912 7732-18-5 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.
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.
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Ingestion: 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: For animal use only. Not for human use. Treatment for Clenbuterol HCl
overdose should be symptomatic and supportive.
5 FIRE-FIGHTING MEASURES
Extinguishing Media: Extinguish with water spray, dry chemical, carbon dioxide, foam
Unsuitable Extinguishing Media: None known
Special Fire Fighting Procedures: Wear self-contained breathing apparatus and protective
clothing. Use water spray to keep fire-exposed containers cool.
Unusual Fire & Explosion Hazards: Combustible liquid and vapor
Hazardous Combustion Products: Carbon monoxide, carbon dioxide, hydrochloric acid gas
Flammability Class: 2
6 ACCIDENTAL RELEASE MEASURES
Personal Precautions: Wear appropriate personal protective equipment. (See Section 8).
Spill Cleanup Methods: STEPS TO BE TAKEN IF SIGNIFICANT QUANTITIES OF LIQUID
IS SPILLED: Eliminate all ignition sources. Wear an approved respirator, eye protection,
personal protective coverings and gloves. Use HEPA filtered vacuum or wet sweeping to clean
up spillage. 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.
7 HANDLING AND STORAGE
Handling: HANDLING SIGNIFICANT QUANTITIES OF LIQUID: Avoid contact with eyes,
skin or clothing. Absorb spilled liquid and collect for disposal. Wash hand thoroughly after
handling.
Storage: Keep only in the original container. Safety cap should be placed on the bottle when not
in use. Store at a controlled room temperature 15°-30° C (59°-86° F). Keep from heat and flame.
Keep from freezing. Store away from foodstuffs.
8 EXPOSURE CONTROLS / PERSONAL PROTECTION
Exposure Limits:
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Chemical Name Source Type Exposure Limits Notes
Carbomer 934P, ---- ---- N/A ----
N.F.
0.14 ug/m3
Clenbuterol HCl Harmonized TWA ----
Exposure
Limit
Ethyl alcohol ACGIH 8-HR TWA 1000 ppm Irritation
Ethyl alcohol OSHA Z-1 PEL 1000 ppm ----
Ethanol (Ethyl Alberta 8-HR TWA 1000 ppm Irritation
Alcohol)
Ethanol British 8-HR TWA 1000 ppm ----
Columbia
Ethanol Ontario 8-HR TWA 1000 ppm ----
Ethyl Alcohol Quebec 8-HR TWA 1000 ppm ----
1000 ml/m3
Ethanol Austria TWA ----
MAK List
Ethyl alcohol Belgium 8-HR TWA 1000 ppm ----
Ethanol Denmark TWA 1000 ppm ----
Ethanol Finland 8-HR TWA 1000 ppm ----
Ethanol France TWA 5000 ppm ----
500 ml/m3
Ethanol Germany Limit Value Short term
exposure
classification
category : II
Ethanol Greece 8-HR TWA 1000 ppm ----
Ethanol Iceland 8-HR TWA 1000 ppm ----
Ethanol Italy 8-HR TWA 1000 ppm ----
Ethanol Netherlands MAC TWA 500 ppm ----
Ethanol Portugal 8-hr Exposure 1000 ppm ----
Limit
Ethanol Spain 8-hr VLA-ED 1000 ppm ----
(Daily Exposure
Limit )
Ethanol Sweden NGV (Level Limit 500 ppm ----
Value)
Ethanol Switzerland TWA 500 ppm ----
Ethanol United TWA 1000 ppm ----
Kingdom
10 mg/m3
Glycerin Mist ACGIH 8-HR TWA ----
5 mg/m3
Glycerin Mist, OSHA Z-1 PEL ----
Respirable
Fraction
15 mg/m3
Glycerin Mist, OSHA Z-1 PEL ----
Total Dust
10 mg/m3
Glycerin mist Alberta 8-HR TWA ----
10 mg/m3
Glycerin � mist British 8-HR TWA ----
Columbia
10 mg/m3
Glycerin mist Ontario 8-HR TWA ----
10 mg/m3
Glycerin (mist) Quebec 8-HR TWA ----
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10 mg/m3
Glycerina, niebla Mexico TWA ----
10 mg/m3
Glycerin Belgium 8-HR TWA ----
20 mg/m3
Glycerin Finland 8-HR Limit ----
10 mg/m3
Glycerin France TWA ----
10 mg/m3
Glycerin Greece 8-HR TWA ----
(anhydrous)
10 mg/m3
Glycerol, Mist Ireland 8-hour TWA ----
10 mg/m3
Glycerin Mist Italy 8-hour TWA ----
10 mg/m3
Glycerol Netherlands MAC TWA ----
10 mg/m3
Glycerin Portugal 8-hr Exposure ----
Limit
10 mg/m3
Glycerin Spain 8-hr VLA-ED ----
(Daily Exposure
Limit )
10 mg/m3
Glycerol, Mist United TWA ----
Kingdom
Methylparaben ---- ---- N/A ----
Propylparaben ---- ---- N/A ----
1000 mg/m3
Polyethylenglykole Austria 8-HR TWA ----
(mittlere
molmassee 200-
400), einatembare
fraction
1000 mg/m3
Polyethyleneglycol 8-HR ----
(PEG) med Denmark
middelmolvaeGT
pĂĄ
1000 mg/m3
Polyethylenglydol Germany Limit Value ----
600 (PEG 600)
1000 mg/m3
Polyethyleenglycol Netherlands MAC TWA (TGG) ----
(Mol.Gew.200-
600)
10 mg/m3
Sucrose ACGIH 8-HR TWA Lung
5 mg/m3
Sucrose, respirable OSHA Z-1 PEL ----
fraction
15 mg/m3
Sucrose, total dust OSHA Z-1 PEL ----
10 mg/m3
Sucrose Alberta 8-HR TWA ----
3 mg/m3
Sucrose (respirable British 8-HR TWA ----
fraction) Columbia
10 mg/m3
Sucrose (total dust) British 8-HR TWA ----
Columbia
10 mg/m3
Sucrose (total dust) Ontario 8-HR TWA ----
10 mg/m3
Sucrose Quebec 8-HR TWA ----
10 mg/m3
Sucrose Belgium 8-HR TWA ----
10 mg/m3
Saacharose France VME ----
10 mg/m3
Sucrose Ireland 8-HR OEL ----
10 mg/m3
Saccarosio Italy 8-HR TWA ----
10 mg/m3
Saccharose Netherland MAC TWA ----
10 mg/m3
Sacarose Portugal 8-HR TWA ----
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10 mg/m3
Sacrosa Spain 8-hr VLA-ED ----
(Daily Exposure
Limit )
10 mg/m3
Sucrose United TWA ----
Kingdom
5 mg/m3
Triethanolamine ACGIH 8-HR TWA Irritation; liver;
kidney
5 mg/m3
Triethanolamine Alberta 8-HR TWA Irritation effect
5 mg/m3
Triethanolamine British 8-HR TWA ----
Columbia
3.1 mg/m3
Triethanolamine Ontario 8-HR TWA ----
5 mg/m3
Triethanolamine Quebec 8-HR TWA ----
5 mg/m3
Triethanolamin, Austria TWA Sensitizer
einatembare
fraction
5 mg/m3
Tri-ethanolamine Belgium 8-HR TWA ----
3.1 mg/m3
Triethanolamin Denmark TWA ----
5 mg/m3
Triethanolamine Iceland 8-HR TWA Allergenic
substance
5 mg/m3
Triethanolamine Ireland 8-HR TWA ----
5 mg/m3
Triethanolamine Italy 8-HR TWA ----
5 mg/m3
Triethanolamine Netherlands MAC TWA (TGG) ----
5 mg/m3
Triethanolamina Portugal 8-HR TWA ----
5 mg/m3
Triethanolamina Spain 8-hr VLA-ED ----
(Daily Exposure
Limit )
5 mg/m3
Triethanolamin Sweden NGV (Level Limit ----
Value)
Engineering Controls: Not generally required when handling containers or liquid. (See exposure
limits). Good general ventilation (typically 10 air changes per hour) should be used. Ventilation
rates should be matched to conditions.
Respiratory Protection: Not generally required when handling containers or liquid. 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: NIOSH approved air-purifying respirator with an
appropriate, government approved (where applicable), air-purifying filter, cartridge, or canister.
PERSONAL PROTECTIVE EQUIPMENT: Not generally required when handling containers.
If containers are compromised or exposure to the active ingredient or mixture is likely wear:
Eye Protection: Wear safety glasses with side shields (or goggles).
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Hand Protection: Wear suitable gloves.
Skin Protection: It is a good industrial hygiene practice to minimize skin contact.
Hygiene Measures: Eye bath, washing facilities
9 PHYSICAL AND CHEMICAL PROPERTIES
Color: Clear to light yellow
Odor: Alcohol-like
Odor Threshold: 100 ppm (ethyl alcohol)
Physical State: Liquid, syrup
pH: No data available
Melting Point: 17.9° C (64.2° F) (glycerin)
Freezing Point: No data available
Boiling Point: 78.5° C (173.3° F) (ethyl alcohol)
Flash Point: 43.3° C (110° F)
Flammability Limit � Upper (%): No data available
Flammability Limit � Lower (%): No data available
Evaporation rate: No data available
Vapor Pressure: 43 mmHg (ethyl alcohol)
Vapor Density (Air=1): 3.17 (glycerin)
Specific Gravity: 1.09
Solubility: No data available
Partition Coefficient (n-Octanol/water): No data available
Autoignition Temperature: No data available
Decomposition Temperature: No data available
10 STABILITY AND REACTIVITY
Stability: Stable
Conditions to Avoid: Heat
Incompatible Materials: Strong oxidizing agents
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, hydrochloric acid gas
Possibility of Hazardous Reactions: Hazardous polymerization will not occur
11 TOXICOLOGICAL INFORMATION
Specified Substances
Acute Toxicity
Chemical Name Test Results
Clenbuterol HCl Intravenous LD50 (mouse): 27,600 µg/kg
Oral LD50 (rat): 315 mg/kg
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Oral LD50 (dog): 67 mg/kg
Ethyl Alcohol Eye Irritation (rabbit): 500 mg � severe irritation
Skin Irritation (rabbit): 20 mg/24H � moderate irritation
Inhalation (rat) LC50 : 20000 ppm/10H
Oral LD50 (guinea pig) : 5560 mg/kg
Glycerol Eye Irritation (rabbit): 126 mg � mild irritation
Skin Irritation (rabbit): 500 mg/24H � mild irritation
Oral LD50 (rat) : 12,600 mg/kg
Oral LD50 (mouse) : 4090 mg/kg
Dermal LD50 ( rabbit): > 10 gm/kg
Listed Carcinogens
Chemical IARC NTP OSHA ACGIH
Name
Ethanol I Known carcinogen Not listed Not listed
(Inadequate data - (alcoholic beverage
animals; Sufficient data � consumption)
humans)
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: Ethanol: ID No: 96; Class 1: slightly water-endangering; Glycerin: ID No: 116;
Class 1: slightly water-endangering; Triethanolamine: ID No: 201: Class 1: slightly water-
endangering; Methylparaben: ID No: 3413: Class 1: slightly water-endangering; Propylparaben:
ID No: 6054: Class 1: slightly water-endangering; Polyethylene Glykol: ID No: 279: Class 1:
slightly 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.
RCRA Information: EPA Hazardous: D001 (ethyl alcohol)
Container: Since emptied containers retain product residue, follow label warnings even after
container is emptied.
14 TRANSPORT INFORMATION
DOT: Not regulated
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Special provision 49 CFR 173.150 (e) - Aqueous solution containing greater than 50% water and
less than 24% alcohol.
TDG: Not regulated
Alcohol/water solutions exempt if the ethanol range is 0-50%.
ADR/RID: Not regulated
Aqueous solutions of ethyl alcohol and alcoholic beverages containing not more than 24%
alcohol by volume are not subject to the provisions of the ADR.
IATA: Not regulated
Special provision A58. Ethanol aqueous solutions containing 24% or less alcohol by volume.
IMDG: Not regulated
Special provision 144. Aqueous solutions containing 24% or less ethanol by volume.
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 material 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.
US Regulations
FEDERAL LAW PROHIBITS EXTRA LABEL USE OF THIS DRUG IN FOOD
ANIMALS.
FEDERAL LAW RESTRICTS THIS DRUG TO USE BY OR ON ORDER OF LICENSED
VETERINARIANS.
CERCLA Hazardous Substance List (40 CFR 302.4):
Component Reportable
Quantity
Ethyl alcohol (Generic RCRA Waste No. D001) 100
California Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65): Ethyl
alcohol in alcoholic beverages
Massachusetts Right-To-Know List: Denatured alcohol, ethanol, ethyl alcohol; Glycerin mist
Minnesota Hazardous Substances List: Ethanol; Glycerin mist
New Jersey Right-To-Know List: Ethanol
Pennsylvania Right-To-Know List: Ethanol; 1,2,3-Propanetriol
Rhode Island Right-To-Know List: Ethanol; Glycerin mist; Glycerol
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European Regulations
Denmark: The MAL-factor Ethanol - 7 m3 air/10g substance. (The MAL-factor applies to
concentrations > 0% by weight)
Netherlands: Ethanol: Fertility Risk Category: 1
Switzerland Toxins List 1: 1, 2,3-Propantriol
16 OTHER INFORMATION
Hazard Ratings
Health Hazard Fire Hazard Reactivity Hazard
2 2 0
HMIS
Health Hazard Fire Hazard Reactivity Hazard Special Hazard
2 2 0 N/A
NFPA
*- Chronic health effect; 0 � Minimal; 1 � Slight; 2 � Moderate; 3 � Serious; 4 � Severe
Mixture -
R10 � Flammable
R43- Irritant
S24 - Avoid Contact with skin.
S37 � Wear suitable gloves.
From Section 3
F- Flammable
R11-Highly Flammable
R43- Irritant
S24 - Avoid Contact with skin.
S37 - Wear suitable gloves.
ABBREVIATIONS:
BIV - Boehringer Ingelheim Vetmedica, Inc.
AIHA- American Industrial Hygiene Association
mppcf � million particles/cubic foot
N/A - Not applicable
N/E - Not established
References:
1. Freedom of Information Summary. NADA 140-973. VENTIPULMIN® Syrup
Boehringer Ingelheim Vetmedica, Inc. May 11, 1998. www.fda.gov
2. VENTIPULMIN® Syrup. Product Reference Information. Boehringer Ingelheim
Vetmedica, Inc. www.bi-vetmedica.com
3. Federal Register.Vol 63, No. 149, Tuesday, August 4, 1998/ Rules and Regulations
4. FDA Veterinarian. July/August 1998. Vol. IIII, No. IV
5. Ariel WebInsight Regulatory Database. Regulatory Summary for North America,
Western Europe, and Global Inventories Database.
6. RTECS � Benzenemethanol, 4-amino-3,5-dichloro-alpha-(((1,1-
dimethylethyl)amino)methyl)-
7. RTECS � Ethyl alcohol. RTECS No. KQ6300000.
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8. RTECS � Glycerol. RTECS No.MA8050000.
9. GHS Manual
Revision Information: Updated all sections of the MSDS for ANSI, GHS and OSHA
Compliance.
Prepared by: Boehringer Ingelheim Vetmedica, Inc.
Issue Date: 07/05/06
Supercedes Date: 5/31/05
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 OR
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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