===================== Product Identification =====================
MSDS NAME:SANDIMMUNE SOFT GELATIN CAPSULES 25, 50, 100 MG
NIIN:01-322-6843
Status Code:A
MSDS Number: CKQTJ
=== Responsible Party ===
Company:NOVARTIS PHARMACEUTICALS CORP
Address:59 ROUTE 10
City:EAST HANOVER
State:NJ
ZIP:07936-1080
Country:US
Info Phone Num:800-742-2422/973-781-5476
Emergency Phone Num:973-781-7000
CAGE:04520
=== Contractor Identification ===
Company:NOVARTIS PHARMACEUTICALS CORP
Address:59 ROUTE 10
Box:City:EAST HANOVER
State:NJ
ZIP:07936-1080
Country:US
Phone:800-742-2422/973-781-5476
CAGE:04520
============= Composition/Information on Ingredients =============
Name:CYCLOSPORINE, USP
CAS:59865-13-3
Minumum % Wt:25.
Maxumum % Wt:100.
Name:ETHYL ALCOHOL
CAS:64-17-5
RTECS #:KQ6300000
= Wt:12.7
OSHA PEL:1900 MG/M3;1000 PPM
ACGIH TLV:1880 MG/M3;1000 PPM
===================== Hazards Identification =====================
LD50 LC50 Mixture:LD50(RAT)=1480 MG/KG
Routes of Entry: Inhalation:UNKNOWN Skin:UNKNOWN Ingestion:YES
Reports of Carcinogenicity:NTP:YES IARC:YES
Health Hazards Acute and Chronic:TARGET ORGANS: PROLONGED OR REPEATED
EXPOSURE MAY AFFECT THE IMMUNE SYSTEM, KIDNEYS, LIVER, CENTRAL
NERVOUS SYSTEM, PANCREAS, AND CARDIOVASCULAR SYSTEM. FINISHED
PHARMACEUTICAL PRODUCT. POTENTIAL FOR EXPOSURE IS REDUCED IN THIS
FORM. SKIN/EYES/INHALATION/INGESTION: NO HAZARD IS EXPECTED FROM
NORMAL CLINICAL USE.
Explanation of Carcinogenicity:AN INCREASED INCIDENCE OF MALIGNANCY IS
A RECOGNIZED COMPLICATION OF IMMUNOSUPPRESSION IN RECIPIENTS OF
ORGAN TRANSPLANTS. THE MOST COMMON FORMS OF NEOPLASMS ARE
NON-HODGKIN'S LYMPHOMA AND CARCINOMA'S OF THE SKIN. THE RISK OF
MALIGNANCIES IN CYCLOSPORINE RECIPIENTS IS HIGHER THAN IN NORMAL,
HEALTH POPULATION.
Effects of Overexposure:THERAPEUTIC SIDE EFFECTS: RENAL DYSFUNCTION,
TREMOR, HIRSUTISM, HYPERTENSION, GUM HYPERPLASIA, AND ANAPHYLACTIC
REACTION. REPRODUCTIVE HAZARDS: EXPERIMENTAL REPRODUCTIVE EFFECTS.
THERE ARE NO ADEQUATE & WELL-CONTROLLED STUDIES IN PREGANANT
WOMEN. NURSING SHOULD BE AVOIDED DURING THERAPEUTIC USE.
MUTAGENICITY: CYCLOSPORINE WAS NOT MUTAGENIC IN SIX TEST SYSTEMS. A
MORE RECENT STUDY INDICATED A POSIT IVE EFFECT AT HIGH
CONCENTRATIONS.
Medical Cond Aggravated by Exposure:HYPERSENSITIVITY TO CYCLOSPORINE.
======================= First Aid Measures =======================
First Aid:SKIN: WASH CONTAMINATED AREA WITH SOAP AND WATER. EYE: FLUSH
WITH RUNNING WATER FOR 15 MINUTES HOLDING EYELIDS OPEN. INHALATION:
NO SPECIFIC TREATMENT IS NECESSARY SINCE THIS PRODUCT IS NOT LIKELY
TO BE HAZARDOUS BY INHALATION. INGESTION: GET MEDICAL ATTENTION
IMMEDIATELY.
===================== Fire Fighting Measures =====================
Flash Point Method:CC
Flash Point:=26.7C, 80.F
Extinguishing Media:USE MEDIA SUITABLE FOR FIRE IN SURROUNDING AREA.
Fire Fighting Procedures:EVACUATE AREA AND FIGHT FIRE FROM SAFE
DISTANCE.
Unusual Fire/Explosion Hazard:NOT AVAILABLE.
================== Accidental Release Measures ==================
Spill Release Procedures:USING APPROPRIATE PROTECTIVE EQUIPENT, SWEEP
UP AND CONTAINERIZE SPILLED MATERIAL. AVOID CONTAMINATION OF SEWERS
AND WATERWAYS.
====================== Handling and Storage ======================
Handling and Storage Precautions:STORE BELOW 86F (30C) AWAY FROM LIGHT.
PROTECT FROM LIGHT AND FREEZING. DO NOT USE IF SOLUTION IS
DISCOLORED. AVOID DIRECT SUNLIGHT, SPARKS AND OPEN FLAME.
Other Precautions:EMERGENCY OVERVIEW: FINISHED PHARMACEUTICAL PRODUCT.
REFER TO PHYSICIANS DESK REFERENCE. AFFECTS THE IMMUNE SYSTEM. CAN
CAUSE CANCER IN HUMANS.
============= Exposure Controls/Personal Protection =============
Respiratory Protection:NOT REQUIRED UNDER NORMAL CONDITIONS OF
THERAPEUTIC ADMINISTRATION AND USE.
Ventilation:NOT REQUIRED UNDER NORMAL CONDITIONS OF THERAPEUTIC
ADMINISTRATION AND USE.
Protective Gloves:USE PROTECTIVE GLOVES IF THERE IS POTENTIAL FOR SKIN
CONTACT.
Eye Protection:USE SAFETY GLASSES IF THERE IS A POTENTIAL FOR
SPLASHING.
Other Protective Equipment:NONE
Work Hygienic Practices:NONE
Supplemental Safety and Health
PRODUCT CODE: NDC 0078-0240-15, 0078-0242-15, 0078-0241-15; ANTIBIOTIC
S 7481F1, RAMIHYPHIN A.
================== Physical/Chemical Properties ==================
HCC:V1
Solubility in Water:WATER
Appearance and Odor:PINK, CORN-YELLOW, DUSTY ROSE GELATINE CAPSULE,
OBLONG; MILD ODOR.
================= Stability and Reactivity Data =================
Stability Indicator/Materials to Avoid:YES
NONE KNOWN.
Stability Condition to Avoid:PROTECT FROM LIGHT AND TEMPERATURES
EXCEEDING 86F (30C). PROTECT FROM FREEZING.
Hazardous Decomposition Products:CARBON MONOXIDE, CARBON DIOXIDE AND
NITROGEN OXIDES.
=================== Toxicological Information ===================
Toxicological Information:EYE IRRITATION-NO DATA AVAILABLE FOR
CYCLOPORINE. THE ETHANOL COMPONENT, HOWEVER, HAS BEEN FOUND
IRRITATING TO THE EYES OF ALBINO RABBITS. SKIN
IRRITATION/SENSITIZATION-NO DATA AVAILABLE FOR CYCLOPORI NE. THE
ETHANOL COMPONENT, HOWEVER, HAS BEEN FOUND IRRITATING TO THE SKIN
OF ALBINO RABBITS. ORAL TOXICITY (CYCLOPORINE): LD50 (MOUSE)=2329
MG/KG. LD50 (RAT)=1480 MG/KG. LD50 (RABBIT)>1000 MG/KG. DERM AL
TOXICITY: NO DATA AVAILABLE. PARENTERAL TOXICITY (CYCLOPORINE):
LD50 (IV-MOUSE)=148 MG/KG. LD50 (IV-RAT)=104 MG/KG. LD50
(IV-RABBIT)=46 MG/KG.
===================== Ecological Information =====================
Ecological:NO DATA VAILABLE.
==================== Disposal Considerations ====================
Waste Disposal Methods:ALL WASTES MUST BE DISPOSED OF IN ACCORDANCE
WITH LOCAL, STATE, AND FEDERAL LAWS AND REGULATIONS. (CONTACT LOCAL
OR STATE ENVIRONMENTAL AGENCY FOR SPECIFIC RULES). EPA WASTE NO.
D001.
=================== MSDS Transport Information ===================
Transport Information:GROUND/RAIL/VESSEL REGULATIONS: PROPER SHIPPING
NAME: CONSUMER COMMODITY. DOT PROPER SHIPPING NAME: CONSUMER
COMMODITY. DOT HAZARD CLASS: ORM-D. EXECPTIONS: CFR 49 SECTION
173.144, 172.101, 172.220, 1 73.156. AIR REGULATIONS: PROPER
SHIPPING NAME: CONSUMER COMMODITY. IATA PROPER SHIPPING NAME:
CONSUMER COMMODITY. IATA HAZARD CLASS: 9. IATA IDENTIFICATION
NUMBER: ID 8000. PACKAGING GROUP: III. HAZA RD LABEL: MISCELLANEOUS
DANGEROUS GOODS.. SPECIAL REQUIREMENTS: NONE. MAX. WG/PKG - PASSGR
- AIRCRAFT: 25 KG (55 LBS). MAX. WGT/PKG - CARGO ONLT AIR: 25 KG
(55 LBS).
===================== Regulatory Information =====================
SARA Title III Information:SECTION 302 EXTREMELY HAZARDOUS SUBSTANCES:
NOT LISTED. SECTION 311/312 HAZARD CATEGORIES: ACUTE HEALTH
EFFECTS, CHRONIC HEALTH EFFECTS. SECTION 3131 REPORTABLE
INGREDIENTS: NOT LISTED.
Federal Regulatory Information:OSHA: THIS MATERIAL SAFETY DATA SHEET
CONTAINS THE INFORMATION REQUIRED BY THE FEDERAL OSHA HAZARD
COMMUNICATION STANDARD (29 CFR 1910.1200)> OSHA PSM: NOT LISTED.
TSCA: NOT APPLICABLE. CERCLA: NOT LI STED. RCRA: NOT LISTED.
State Regulatory Information:NJ TCPA: THIS PRODUCT CONTAINS NONE OF THE
SUBSTANCES SUBJECT TO THE REPORTING REQUIREMENTS OF SECTION
N.J.A.C. 7:31 OF THIS ACT. NEW JERSEY: NJ RTK THRESHOLD PLANNING
QUANTITY=10,000 LBS. CALIFORNIA PROPOSITION 65: THE FOLLOWING
STATEMENT IS MADE IN ORDER TO COMPLY WITH THE CALIFORNIA SAFE
DRINKING WATER AND TOXIC ENFORCEMENT ACT OF 1986. THIS PRODUCT
CONTAINS CYCLOSPORINE, AN INGREDIENT KNOWN TO THE STATE OF
CALIFORNIA TO CAUSE CANCER.
======================= Other Information =======================
Disclaimer (provided with this information by the compiling agencies):
This information is formulated for use by elements of the Department
of Defense. The United States of America in no manner whatsoever,
expressly or implied, warrants this information to be accurate and
disclaims all liability for its use. Any person utilizing this
document should seek competent professional advice to verify and
assume responsibility for the suitability of this information to their
particular situation.
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