SDS Number 110584 Approved/Revised 14-Jul-2008 Version 11
VALTREX CAPLETS
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
space
Material VALTREX CAPLETS
space
VALTREX CAPLETS 500 MG * VALTREX CAPLETS 1 G * VALTREX TABLETS 500 MG *
Synonym(s)
VALTREX S TABLETS 500 MG * RAPIVIR TABLETS * ZELITREX TABLETS * NDC NO
0173-0565-04 * NDC NO 0173-0565-10 * NDC NO 0173-0933-08 * NDC NO 0173-0933-10 *
NDC NO 0173-0933-56 * VALACYCLOVIR HYDROCHLORIDE, FORMULATED PRODUCT
space
GlaxoSmithKline, Corporate Environment, Health & Safety
Company Name
980 Great West Road
Brentford, Middlesex TW8 9GS UK
space
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
space
GlaxoSmithKline, Corporate Environment, Health & Safety
One Franklin Plaza, 200 N 16th Street
Philadelphia, PA 19102-1225 US
space
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
space
Ingredients CAS # Percent EC-No.
NON-HAZARDOUS INGREDIENTS Unassigned 27 to 29
VALACYCLOVIR HYDROCHLORIDE 124832-27-5 71 to 73
3. HAZARDS IDENTIFICATION
space
Expected to be non-combustible.
Fire and Explosion
space
Handling this product in its final form presents minimal risk from occupational exposure.
Health
Health effects information is based on hazards of components. Caution - Pharmaceutical
agent. Possible effects of overexposure in the workplace include: headache; nausea.
space
No environmental hazards have been identified for this material.
Environment
4. FIRST-AID MEASURES
space
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.
space
Physical form suggests that risk of inhalation exposure is negligible.
Inhalation
Page 1 / 5
SDS Number 110584 Approved/Revised 14-Jul-2008 Version 11
VALTREX CAPLETS
Material
space
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.
space
Wash immediately with clean and gently flowing water. Continue for at least 15 minutes.
Eye Contact
Obtain medical attention.
space
NOTES TO HEALTH PROFESSIONALS
Treat according to locally accepted protocols. For additional guidance, refer to the current
Medical Treatment
prescribing information or to the local poison control information centre.
space
Refer to prescribing information for detailed description of medical conditions caused by or
Medical Conditions
aggravated by overexposure to this product.
Caused or Aggravated by
Exposure
space
No specific antidotes are recommended.
Antidotes
.
5. FIRE-FIGHTING MEASURES
space
Not expected for the product, although the packaging is combustible.
Fire and Explosion Hazards
space
Water or foam extinguishers are recommended.
Extinguishing Media
Carbon dioxide or dry powder extinguishers may be ineffective.
space
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.
space
Toxic, corrosive or flammable thermal decomposition products are expected when the
Hazardous Combustion
product is exposed to fire.
Products
6. ACCIDENTAL RELEASE MEASURES
space
Wear protective clothing and equipment consistent with the degree of hazard.
Personal Precautions
space
For large spills, take precautions to prevent entry into waterways, sewers, or surface drainage
Environmental Precautions
systems.
space
Collect and place it in a suitable, properly labelled container for recovery or disposal.
Clean-up Methods
space
No specific decontamination or detoxification procedures have been identified for this
Decontamination Procedures
product.
7. HANDLING AND STORAGE
space
HANDLING
No special control measures required for the normal handling of this product. Normal room
General Requirements
ventilation is expected to be adequate for routine handling of this product.
space
No storage requirements necessary for occupational hazards. Follow product information
STORAGE
storage instructions to maintain efficacy.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
space
VALACYCLOVIR HYDROCHLORIDE
INGREDIENT
1
GSK Occupational Hazard
Category
GSK Occupational 5000 mcg/m3 (8 HR TWA)
Exposure Limit
space
None required for normal handling. Wash hands and arms thoroughly after handling.
Other Equipment or
Procedures
Page 2 / 5
SDS Number 110584 Approved/Revised 14-Jul-2008 Version 11
VALTREX CAPLETS
Material
9. PHYSICAL AND CHEMICAL PROPERTIES
space
Appearance
Blue.
Colour
space
Tablet.
Physical Form
10. STABILITY AND REACTIVITY
space
This product is expected to be stable.
Stability
space
None for normal handling of this product.
Conditions to Avoid
11. TOXICOLOGY INFORMATION
space
This preparation contains ingredient(s) with the following activity: a nucleoside analogue. This
Pharmacological Effects
product is intended for the treatment of viral infection. Adverse effects of overexposure might
include: headache; nausea.
space
Adverse effects might occur in the following organ(s) following overexposure: kidney.
Target Organ Effects
Assessment based upon information from animal studies.
space
Routes of Exposure
Not expected to be toxic following ingestion.
Oral Toxicity
space
No studies have been conducted.
Skin Effects
space
No studies have been conducted.
Eye Effects
space
Potential for inducing allergic reactions via the dermal or respiratory route is not known.
Sensitisation
space
Genetic toxicity is not expected under occupational exposure conditions based upon negative
Genetic Toxicity
results in laboratory assays. No evidence of DNA damage occurred in the following assay(s):
bacterial mutation assay (Ames).
space
Not expected to produce cancer in humans under occupational exposure conditions based
Carcinogenicity
upon negative results in laboratory assays.
space
Not expected to produce adverse effects on fertility or development under occupational
Reproductive Effects
exposure conditions.
space
None known for occupational exposure.
Other Adverse Effects
12. ECOLOGICAL INFORMATION
space
This material contains an active pharmaceutical ingredient that has been tested, and no
Summary
environmental effects have been identified. Local regulations and procedures should be
consulted prior to environmental release.
Specific information on the active pharmaceutical ingredient is provided below.
space
ECOTOXICITY
Aquatic
This material contains an active pharmaceutical ingredient that is not
Activated Sludge
toxic to activated sludge microorganisms.
Respiration
space
IC50: > 100 mg/l, 3 Hours, Activated sludge
space
This material contains an active pharmaceutical ingredient that is not
Microbial Growth
toxic to these microorganisms.
Inhibition
space
> 1000 mg/l, , Pseudomonas fluorescens
Minimum Inhibition
> 1000 mg/l, , Chaetomium globosum
Concentration:
> 1000 mg/l, , Aspergillus flavus
> 1000 mg/l, , Nostoc sp.
> 1000 mg/l, , Azotobacter chroococcum
space
This material contains an active pharmaceutical ingredient that is not
Daphnid
toxic to daphnids.
space
EC50: 340 mg/l, 48 Hours, Daphnia magna, Static test
space
NOEC: 56 mg/l, 48 Hours, Daphnia magna, Static test
Page 3 / 5
SDS Number 110584 Approved/Revised 14-Jul-2008 Version 11
VALTREX CAPLETS
Material
space
MOBILITY
This material contains an active pharmaceutical ingredient that for environmental fate
Solubility
predictions has solubility in water.
space
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.
space
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.
space
PERSISTENCE/DEGRADATION
This material contains an active pharmaceutical ingredient that has been shown to be
Hydrolysis
chemically unstable in water. Hydrolysis may be a significant depletion mechanism.
space
Half-Life, Neutral: 55.92 Hours, Measured
space
Half-Life, Acidic: 68.38 Days, Measured
space
Half-Life, Basic: 15.13 Hours, Measured
space
Hydrolysis Product(s) - By ACYCLOVIR
Products
space
This material contains an active pharmaceutical ingredient that is unlikely to undergo
Photolysis
photodegradation.
space
UV/Visible Spectrum: 264
space
This material 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.
space
Aerobic - Ready
Percent Degradation: 0.08 %, 28 days, Modified Sturm test.
space
Aerobic - Inherent
Percent Degradation: 100 %, 14 days, Modified Zahn-Wellens, Activated sludge
space
This material contains an active pharmaceutical ingredient that will not have a tendency to
Bioaccumulation
bioaccumulate in the food chain.
13. DISPOSAL CONSIDERATIONS
space
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.
space
Observe all local and national regulations when disposing of this product.
Regulatory Requirements
14. TRANSPORT INFORMATION
space
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.
space
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
space
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.
space
EU Classification and Labelling
Exempt from requirements of EU Dangerous Preparations directive - product regulated as a medicinal product,
cosmetic product or medical device.
space
US OSHA Standard (29 CFR Part 1910.1200)
This dosage form is exempt from the requirements of the OSHA Hazard Communication
Classification
Standard.
Page 4 / 5
SDS Number 110584 Approved/Revised 14-Jul-2008 Version 11
VALTREX CAPLETS
Material
space
Other US Regulations
Exempt
TSCA Status
16. OTHER INFORMATION
space
GSK Hazard Determination
References
space
11
SDS Version Number
space
SDS Sections Updated
Sections Subsections
COMPOSITION / INFORMATION ON INGREDIENTS
space
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.
Page 5 / 5
|