MSDS: Granisetron Hydrochloride Injection 0.1%
Manufacturer: Akorn Incorporated
Address: 150 S. Wyckles Road, Decatur, IL 62522
Telephone: 1-800-932-5676
Email: customer.service@akorn.com
Section 1 - IDENTIFICATION
TRADE NAME: Granisetron Hydrochloride Injection
Description: Granisetron hydrochloride injection is an antinauseant and antiemetic
agent. It is indicated for the prevention and treatment of postoperative
nausea and vomiting or that associated with emetogenic cancer therapy.
Composition CAS# TLV (mg/m? PEL (mg/m? %Content
Granisetron Hydrochloride, USP 107007-99-8 Not Established Not Established 0.112
Sodium Chloride, USP 7647-14-5 0.9
Not Established Not Established
Citric Acid, USP 77-92-9 0.2
Not Established Not Established
Sodium Citrate, Dihydrate, USP 6132-04-3 0.57
Not Established Not Established
Benzyl Alcohol, NF 100-51-6 1.0
Not Established Not Established
Water for Injection, USP 7732-18-5 QS
Not Established Not Established
Hydrochloric Acid and / or Sodium Hydroxide may be used to adjust pH
Common name of active ingredient: Granisetron Hydrochloride
Chemical Formula (s): C18H24N4O ?HCl
Legal Category: Prescription Only
Section 2 - HAZARDOUS INGREDIENTS
Symptoms of Overexposure by Route of Exposure
Inhalation: Inhalation of significant amounts of the product is not anticipated to occur.
Contact with Skin or Eyes: Contact may cause irritation. Effects may include stinging,
watering, redness and swelling of the eyes and redness and a burning sensation on the skin.
Ingestion: Ingestion is not an anticipated route of occupational exposure. However, the
active ingredient, Granisetron Hydrochloride is toxic if ingested.
Injection: Local redness and pain are the primary symptoms of accidental injection in an
occupational setting. Medical personnel are not anticipated to experience over-exposures to the
therapeutic doses of this product. However, therapeutic effects including headache, sleepiness,
agitation, anxiety, central nervous system stimulation, insomnia, extrapyramidal syndrome,
diarrhea, constipation, hypertension, hypotension, arrhythmias (e.g., sinus bradycardia, atrial
fibrillation, ventricular ectopy including non-sustained tachycardia, ECG abnormalities),
1
MSDS: Granisetron Hydrochloride Injection 0.1%
hypersensitivity reactions (anaphylaxis), sometimes severe, with skin rashes, weakness and fever
may occur.
Health Effects or Risks From Exposure
Acute: The primary health effects anticipated in an occupational setting include mild irritation
of eyes and skin as well as redness and local swelling after accidental injection.
Cancer: Granisetron Hydrochloride has demonstrated carcinogenic effects in laboratory animals.
Chronic: Based on animal data, Granisetron Hydrochloride, the active ingredient, is not
considered a potential reproductive or developmental toxicant.
Pre-Existing Medical Conditions: Pre-existing central nervous system disorders may be
aggravated by exposure to this material.
Section 3 - PHYSICAL AND CHEMICAL CHARACTERISTICS
Appearance Clear, colorless liquid
Odor Odorless
Boiling Point 100篊 (212篎)
Melting Point N/A
Vapor Pressure (mmHg at 20癈) Not Established
Vapor Density (g/m? Not Established
Viscosity Not Established
Specific Gravity 1.011 @ 25癈
pH 4.0 to 6.0
Solubility in Water soluble
Section 4 - FIRST AID MEASURES
Eyes: Hold eyelids open and flush with a steady, gentle stream of water for 15 minutes. See an
ophthalmologist (eye doctor) or other physician immediately.
Skin: Remove contaminated clothing and clean before reuse. Wash all exposed areas of skin
with plenty of soap and water. Get medical attention if irritation develops.
Inhalation: Move individual to fresh air. Get medical attention if breathing difficulty occurs. If
not breathing, provide artificial respiration assistance (mouth-to-mouth) and call a physician
immediately.
Ingestion: If swallowed, seek emergency medical attention. If victim is drowsy or unconscious
and vomiting, place on the side with head down and DO NOT give anything by mouth. DO
NOT induce vomiting. Do not leave victim unattended. Observe closely for adequacy of
breathing.
2
MSDS: Granisetron Hydrochloride Injection 0.1%
Section 5 - FIRE AND EXPLOSION HAZARD DATA
Flash point: Non-flammable Autoignition Temperature: Not applicable
UEL: No applicable information found
LEL: No applicable information found
Extinguishing Media: Use water spray, carbon dioxide, dry chemical, foam, or halon
Unusual Fire and Explosion Hazards: No unusual fire or explosion hazards are expected.
Hazardous Combustion Products: May emit toxic fumes when exposed to heat or fire.
Section 6 - STABILITY AND REACTIVITY DATA
Stability: Stable at normal temperatures and pressures.
Incompatibility: May react with strong oxidizing agents
(e.g., peroxides, permanganates, nitric acid, etc.)
Hazardous Decomposition: May emit toxic fumes when heated to decomposition
Hazardous Polymerization: Will not occur
Section 7 - PROTECTION INFORMATION
Ventilation and Engineering Controls: Follow standard medical product handling procedures
Respiratory Protection: Not normally required for routine medical administration
Eye Protection: Approved eye protection to safeguard against potential eye contact is
recommended.
Hand Protection: Wash hands before and after using latex, nitrile, or rubber gloves.
Body Protection: No special body protection required for routine, medical administration of
this product. Wear lab coat, gown, or smock, as appropriate for procedure.
Product Preparation Instructions for Medical Personnel: Follow standard procedures for
handling pharmaceutical materials and recommendations presented on the Package Insert.
Section 8 - HANDLING AND STORAGE
Work and Hygiene Practices: Avoid getting this product ON or IN you. Do not eat, drink,
smoke or apply cosmetics while handling the product. Wash hands thoroughly after handling.
Particular care in working with this product must be practiced in pharmacies and other
preparation areas and during patient administration. Precautions should be taken during the
following activities: - Withdrawal of needles from drug vials,
- Drug transfers using syringes and needles or filter straws,
- Expulsion of air from drug-filled syringes.
3
MSDS: Granisetron Hydrochloride Injection 0.1%
Storage and Handling Practices: Employees must be trained to properly use the product.
Ensure vials are properly labeled. Store only in approved containers. Keep away from sources of
ignition and any incompatible materials or conditions. Store at room temperature 15 to 30癈 (59
to 86癋). Protect from light. Do not use discolored solutions. Do not freeze.
Protective Practices During Maintenance of Contaminated Equipment: When cleaning non-
disposable equipment, wear latex or nitrile gloves (double gloving is recommended), goggles,
and lab coat. Wash equipment with soap and water. All needles, syringes, vials and other
disposable items contaminated with this product should be disposed of properly.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN
Section 9 - ACCIDENTAL RELEASE MEASURES
Wear protective equipment, including eye protection, to avoid exposure.
Section 10 - TOXICOLOGY INFORMATION
Toxicity Data: The following information is for Granisetron Hydrochloride, the active
ingredient
IV LD50 (rat) = 14 mg/kg
Oral LD50 (rat) = 350 mg/kg
IV LD50 (mouse) = 17 mg/kg
Oral LD50 (mouse) = 350 mg/kg
Carcinogenicity: Data indicates some carcinogenic potential in rodents, although at doses
exceeding human clinical dose. There was a statistically significant increase in the incidence of
2
hepatocellular carcinomas and adenomas in males treated with 5 mg/kg/day (30 mg/m /day, 81
times the recommended human dose based on body surface area) and above, and in females
2
treated with 25 mg/kg/day (150 mg/m /day, 405 times the recommended human dose based on
body surface area). No increase in liver tumors was observed at a dose of 1 mg/kg/day (6
2
mg/m /day, 16 times the recommended human dose based on body surface area) in males and 5
2
mg/kg/day (30 mg/m /day, 81 times the recommended human dose based on body surface area)
in females. In a 12-month oral toxicity study, treatment with Granisetron Hydrochloride 100
2
mg/kg/day (600 mg/m /day, 1622 times the recommended human dose based on body surface
area) produced hepatocellular adenomas in male and female rats while no such tumors were
found in the control rats. A 24-month mouse carcinogenicity study of Granisetron Hydrochloride
did not show a statistically significant increase in tumor incidence, but the study was not
conclusive. It is not listed as carcinogenic by NTP, IARC or OSHA.
Irritancy of Product: This product is expected to be mildly irritating to contaminated skin, eyes
and other tissues. The active ingredient is irritating to the eyes and the skin.
Sensitization to the Product: Rare cases of hypersensitivity reactions, sometimes severe (e.g.,
anaphylaxis, shortness of breath, hypotension, uticaria) have been reported. In addition,
4
MSDS: Granisetron Hydrochloride Injection 0.1%
hypersensitivity reactions may occur in patients who have exhibited hypersensitivity to other
selective 5-HT 3 receptor antagonists.
Reproductive Toxicity Information: This material is classified as a Pregnancy Category B (No
Evidence of Risk).
Mutagenicity: Granisetron Hydrochloride is not mutagenic in the Ames gene mutation assay
and mouse lymphoma gene mutation assay, mouse micronucleus and hepatocyte DNA assay.
Mutagenic in unscheduled DNA synthesis and human lymphocyte chromosomal assay.
Embryotoxicity/Teratogenicity Toxicity: Not a developmental toxicant nor did it cause
malformations in rats at doses 405 times the human recommended clinical dose based on body
surface area.
50
Section 11 - ECOLOGICAL INFORMATION
All work practices must be aimed at eliminating environmental contamination.
Environmental Stability: The components of this product will degrade in the environment into
organic and inorganic constituents, especially upon exposure to light.
Effect of Materials on Plants or Animals: No specific information is available on the effect of
Granisetron Hydrochloride on plants or animals in the environment. Due to the small product
size and dilute concentration of the components, this product is not anticipated to cause adverse
effects.
Effect of Chemicals on Aquatic Life: No specific information is available on the effect of
Granisetron Hydrochloride on plants or animals in the aquatic environment. Due to the small
product size and dilute concentration of the components, this product is not anticipated to cause
adverse effects.
Section 12 - REGULATORY INFORMATION
U.S. REGULATIONS:
U.S. SARA Reporting Requirements: The components of this product are not subject to the
reporting requirements of Sections 302, 304 and 313 of Title II of the Superfund Amendments
and Reauthorization Act.
U.S. SARA Threshold Planning Quantity: Not applicable
U.S. TSCA Inventory Status: Granisetron Hydrochloride is a "drug" as defined by the Federal
Food, Drug and Cosmetic Act and is therefore not a chemical substance under TSCA.
California Safe Drinking Water and Toxic Enforcement Act (Proposition 65): This product
does NOT contain a chemical known to the State of California to cause developmental and
reproductive effects.
Other U.S. Federal Regulations: Based on this product's use, the requirements of the OSHA
Bloodborne pathogen Standard (29 CFR 1910.1030) are applicable.
CANADIAN REGULATIONS:
Canadian DSL/NDSL Status: Granisetron Hydrochloride is regulated by the Food and Drug
Administration of Health Canada and is therefore exempt from the requirements of CEPA.
5
MSDS: Granisetron Hydrochloride Injection 0.1%
ANSI Labeling (Based on 129.1, Provided to Summarize Occupational Exposure Hazards):
Granisetron Hydrochloride should be administered under the supervision of a qualified
physician. Avoid over-exposure. Avoid contact with eyes, skin and clothing. Do not eat, drink or
smoke when handling Granisetron Hydrochloride. Do not taste or swallow. Wash thoroughly
after handling. Clean up spills promptly.
Section 13 - DISPOSAL INFORMATION
Dispose of material according to Federal, State, and Local regulations. The method typically
used is incineration.
Section 14 - TRANSPORTATION INFORMATION
Material is not Hazardous as Defined by 49 CFR 172.101 U S Department of Transportation
Proper Shipping Name: Not applicable
Hazard Class Number and Description: Not applicable
UN Identification Number: Not applicable
Packing Group: Not applicable
DOT Label(s) required: Not applicable
North American Emergency Response Guidebook Number (1996): Not applicable.
MARINE POLLUTANT: No component of this product is listed as a Marine Pollutant
(49 CFR 172.101, Appendix B)
Transport Canada Transportation of Dangerous Goods Regulations: Not applicable
Section 15 - OTHER INFORMATION
The information given herein is in good faith and to the best of our knowledge but no warranty,
expressed or implied, is made.
6
|