SDS Number 110565 Approved/Revised 18-Jul-2008 Version 12
LANOXIN TABLETS
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
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Material LANOXIN TABLETS
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LANOXIN TABLETS 0.125 MG * LANOXIN TABLETS 0.25 MG * LANACORDIN
Synonym(s)
COMPRIMIDOS * LENOXIN MITE TABLETS 125 MG * LENOXIN TABLETS 250 MG * NDC
NO 0173-0242-55 * NDC NO 0173-0242-56 * NDC NO 0173-0242-75 * NDC NO
0173-0249-55 * NDC NO 0173-0249-56 * NDC NO 0173-0249-75 * NDC NO 0173-0249-80 *
DIGOXIN, FORMULATED PRODUCT
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GlaxoSmithKline, Corporate Environment, Health & Safety
Company Name
980 Great West Road
Brentford, Middlesex TW8 9GS UK
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UK General Information: +44-20-8047-5000
Transport Emergency (EU) +44-1865-407333
Medical Emergency +1-612-221-3999, Ext 221
Information and Advice: US number, available 24 hours
Multi-language response
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GlaxoSmithKline, Corporate Environment, Health & Safety
One Franklin Plaza, 200 N 16th Street
Philadelphia, PA 19102-1225 US
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US General Information: +1-888-825-5249
Transport Emergency (non EU) +1-703-527-3887
US number, available 24 hours
Multi-language response
.
2. COMPOSITION / INFORMATION ON INGREDIENTS
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Ingredients CAS # Percent EC-No.
DIGOXIN 20830-75-5 0.13 244-068-1
Other components below reportable levels >99
3. HAZARDS IDENTIFICATION
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Expected to be non-combustible.
Fire and Explosion
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Caution - Potent pharmaceutical agent.
Health
Exposure might occur via skin; ingestion; eyes.
Possible effects of overexposure in the workplace include: cardiovascular effects.
Health effects information is based on hazards of components.
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No information is available about the potential of this product to produce adverse
Environment
environmental effects.
4. FIRST-AID MEASURES
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Never attempt to induce vomiting. Do not attempt to give any solid or liquid by mouth if the
Ingestion
exposed subject is unconscious or semi-conscious. Wash out the mouth with water. If the
exposed subject is fully conscious, give plenty of water to drink. Obtain medical attention.
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Physical form suggests that risk of inhalation exposure is negligible.
Inhalation
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SDS Number 110565 Approved/Revised 18-Jul-2008 Version 12
LANOXIN TABLETS
Material
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Using appropriate personal protective equipment, remove contaminated clothing and flush
Skin Contact
exposed area with large amounts of water. Obtain medical attention if skin reaction occurs,
which may be immediate or delayed.
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Wash immediately with clean and gently flowing water. Continue for at least 15 minutes.
Eye Contact
Obtain medical attention.
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NOTES TO HEALTH PROFESSIONALS
Medical treatment in cases of overexposure should be treated as an overdose of a cardiac
Medical Treatment
glycoside. Treat according to locally accepted protocols. For additional guidance, refer to the
local poison control information centre.
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Pre-placement and periodic health surveillance is not usually indicated. The final
Health Surveillance
determination of the need for health surveillance should be determined by local risk
Procedures
assessment.
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For medical treatment in cases of overexposure, a recommended antidote would be Digibind.
Antidotes
The decision as to whether the severity of poisoning requires administration of any antidote
and actual dose required should be made by qualified medical personnel. For the latest
information, refer to the local poison control information centres.
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5. FIRE-FIGHTING MEASURES
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Not expected for the product, although the packaging is combustible.
Fire and Explosion Hazards
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Water, dry powder or foam extinguishers are recommended. Carbon dioxide extinguishers
Extinguishing Media
may be ineffective.
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For single units (packages): No special requirements needed. For larger amounts (multiple
Special Firefighting
packages/pallets) of product: Since toxic, corrosive or flammable vapours might be evolved
Procedures
from fires involving this product and associated packaging, self contained breathing
apparatus and full protective equipment are recommended for firefighters. If possible, contain
and collect firefighting water for later disposal.
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Toxic, corrosive or flammable thermal decomposition products are expected when the
Hazardous Combustion
product is exposed to fire.
Products
6. ACCIDENTAL RELEASE MEASURES
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Use protective clothing during clean-up prior to disposal of spilled product.
Personal Precautions
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For large spills, take precautions to prevent entry into waterways, sewers, or surface drainage
Environmental Precautions
systems.
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Collect and place it in a suitable, properly labelled container for recovery or disposal.
Clean-up Methods
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Water can be used for clean-up and decontamination operations. No specific
Decontamination Procedures
decontamination or detoxification procedures have been identified for this product.
7. HANDLING AND STORAGE
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HANDLING
Avoid breaking or crushing tablets.
General Requirements
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No storage requirements necessary for occupational hazards. Follow product information
STORAGE
storage instructions to maintain efficacy.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
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DIGOXIN
INGREDIENT
5
GSK Occupational Hazard
Category
GSK Occupational 1 mcg/m3 (8 HR TWA)
Exposure Limit
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SDS Number 110565 Approved/Revised 18-Jul-2008 Version 12
LANOXIN TABLETS
Material
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ENGINEERING CONTROLS
The active ingredient was formerly assigned to OHC 4 with the Highly Potent notation. An
Exposure Controls
Exposure Control Approach (ECA) is established for operations involving this material based
upon the OEL/Occupational Hazard Category and the outcome of a site- or operation-specific
risk assessment. Refer to the Exposure Control Matrix for more information about how ECA's
are assigned and how to interpret them. Special considerations apply in the planning, design,
review and implementation of controls - seek specialist assistance from local occupational
hygienist or safety department.
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Open handling may result in overexposure. It is strongly advised that dedicated areas and
Containment
containment, such as glove boxes, isolators, and enclosed material transfer systems be used
to prevent personnel exposure and spread of contamination.
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Local exhaust ventilation (LEV) is not appropriate at this level, since total containment should
Ventilation
usually be used.
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Strict control of access to the working area is essential. Only trained personnel should enter
Administrative
the area during operations. Adopt procedures to prevent contamination of working materials
and adjacent areas.
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PERSONAL PROTECTIVE EQUIPMENT
When isolation is not possible, chemical splash goggles or equivalent eye protection must be
Eye Protection
used with other applicable protective equipment.
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Care must be exercised if insufficient data are available and further guidance should be
Gloves
sought from your local EHS department. Glove selection must take into account any solvents
and other hazards present. The selection of gloves for a specific activity must be based on
the material's properties and on possible permeation and degradation that may occur under
the circumstances of use. Potential allergic reactions can occur with certain glove materials
(e.g. Latex) and therefore these should be avoided.
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When isolation is not possible, respiratory protective equipment (RPE) should be combined
Respirators
with applicable protective equipment.
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Follow all local regulations if personal protective equipment (PPE) is used in the workplace.
Other Equipment or
When isolation is not possible in production areas, applicable protective equipment must be
Procedures
used. Consider additional control procedures for maintenance, cleaning and emergencies.
9. PHYSICAL AND CHEMICAL PROPERTIES
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Appearance
Tablet.
Physical Form
10. STABILITY AND REACTIVITY
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This product is expected to be stable.
Stability
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None for normal handling of this product.
Conditions to Avoid
11. TOXICOLOGY INFORMATION
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This material is a cardiac glycoside.
Pharmacological Effects
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Adverse effects might occur in the following organ(s) following overexposure: heart.
Target Organ Effects
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Routes of Exposure
Not expected to be toxic following ingestion.
Oral Toxicity
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No studies have been conducted.
Inhalation Toxicity
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Irritation is not expected following direct contact.
Skin Effects
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Irritation is not expected following direct contact with eyes.
Eye Effects
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Sensitisation (allergic skin reaction) is not expected.
Sensitisation
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Not expected to be genotoxic under occupational exposure conditions.
Genetic Toxicity
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No components are listed as carcinogens by GSK, IARC, NTP or US OSHA.
Carcinogenicity
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Not expected to produce adverse effects on fertility or development under occupational
Reproductive Effects
exposure conditions.
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The following adverse effects have been noted with therapeutic use of this material:
Other Adverse Effects
symptoms of hypersensitivity (such as skin rash, hives, itching, and/or difficulty breathing).
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SDS Number 110565 Approved/Revised 18-Jul-2008 Version 12
LANOXIN TABLETS
Material
12. ECOLOGICAL INFORMATION
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This material contains an active pharmaceutical ingredient that has been tested and which
Summary
may be harmful if released directly to the environment. Consult the MSDS of the active
ingredient for specific information about potential environmental effects. Appropriate
precautions should be taken to limit release of this mixture to the environment. Local
regulations and procedures should be consulted prior to environmental release.
Specific information on the active pharmaceutical ingredient is provided below.
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ECOTOXICITY
Aquatic
This material contains an active pharmaceutical ingredient that is not
Activated Sludge
toxic to activated sludge microorganisms.
Respiration
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IC50: > 100 mg/l, 3 Hours, Activated sludge
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NOEC: 100 , 3 Hours, Activated sludge
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No toxicity to algae was observed for the active pharmaceutical
Algal
ingredient in this mixture, but the upper range of the test was limited
by the low water solubility of the compound.
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IC50: > 10 mg/l, 72 Hours, Selenastrum
capricornutum, green algae
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NOEC: 10 mg/l, 72 Hours, Selenastrum capricornutum,
green algae
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This material contains an active pharmaceutical ingredient that is
Daphnid
harmful to daphnids. This material contains an active pharmaceutical
ingredient that is not toxic to daphnids in chronic toxicity studies.
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EC50: 24.2 mg/l, 24 Hours, Daphnia magna, Static
test
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Chronic LOEC: > 10 mg/l, 7 Days, Ceriodaphnia dubia, Static
renewal test
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Chronic NOEC: 10 mg/l
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This material contains an active pharmaceutical ingredient that is toxic
Fish
to fish.
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Adult Oncorhyncus mykiss, rainbow trout
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EC50: 2.9 mg/l, 96 Hours, Static test
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Adult Oncorhyncus mykiss, rainbow trout
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NOEC: 0.56 mg/l, 96 Hours, Static test
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MOBILITY
This material contains an active pharmaceutical ingredient that for environmental fate
Solubility
predictions has limited solubility in water.
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This material contains an active pharmaceutical ingredient that will not readily enter into the
Volatility
air from hard surfaces or from a container of the pure substance.
This material contains an active pharmaceutical ingredient that will not readily enter into air
from water.
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Henrys Law Constant < 1.00E-16 atm m3/mol, Estimated
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This material contains an active pharmaceutical ingredient that is not likely to adsorb to soil
Adsorption
or sediment if released directly to the environment. This material contains an active
pharmaceutical ingredient that is not likely to adsorb to sludge or biomass if released directly
to the environment.
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Sludge Biomass 1.78 Measured at pH 7
Distribution Coefficient
(log Kd):
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This material contains an active pharmaceutical ingredient with octanol/water partition
Partitioning
coefficient data that suggests that for environmental fate predictions the active
pharmaceutical ingredient will not have the tendency to distribute into fats.
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SDS Number 110565 Approved/Revised 18-Jul-2008 Version 12
LANOXIN TABLETS
Material
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PERSISTENCE/DEGRADATION
This mixture contains an active pharmaceutical ingredient that is likely to undergo
Photolysis
photodegradation.
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UV/Visible Spectrum: 220 nm
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This mixture contains an active pharmaceutical ingredient that is not readily biodegradable
Biodegradation
but is inherently biodegradable (as defined by 1993 OECD Testing Guidelines) and is not
expected to persist in the environment.
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Aerobic - Inherent
Percent Degradation: > 99 %, 14 days, Zahn-Wellens, Activated sludge
13. DISPOSAL CONSIDERATIONS
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Collect for recycling or recovery if possible. The disposal method for rejected
Disposal Recommendations
products/returned goods must ensure that they cannot be re-sold or re-used. Wherever
possible, disposal should be in an on-site licenced chemical incinerator, if allowed by the
incinerator licence or permit. If no on-site incinerator is available, dispose of material in a
licenced commercial chemical incinerator.
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Observe all local and national regulations when disposing of this product.
Regulatory Requirements
14. TRANSPORT INFORMATION
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The SDS should accompany all shipments for reference in the event of spillage or accidental release. Only authorised persons
trained and competent in accordance with appropriate national and international regulatory requirements may prepare dangerous
goods for transport.
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UN Classification and Labelling
Transportation and shipping of this product is not restricted. It has no known,
Transport Information
significant hazards requiring special packaging or labelling for air, maritime, US or
European ground transport purposes.
15. REGULATORY INFORMATION
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The information included below is an overview of the major regulatory requirements. It should not be considered to be an
exhaustive summary. Local regulations should be consulted for additional requirements.
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EU Classification and Labelling
Exempt from requirements of EU Dangerous Preparations directive - product regulated as a medicinal product,
cosmetic product or medical device.
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US OSHA Standard (29 CFR Part 1910.1200)
This dosage form is exempt from the requirements of the OSHA Hazard Communication
Classification
Standard.
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Other US Regulations
Exempt
TSCA Status
16. OTHER INFORMATION
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GSK Hazard Determination
References
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12
SDS Version Number
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The information and recommendations in this safety data sheet are, to the best of our knowledge, accurate as of the date of
issue. Nothing herein shall be deemed to create any warranty, express or implied. It is the responsibility of the user to determine
the applicability of this information and the suitability of the material or product for any particular purpose.
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