SDS Number 110584 Approved/Revised 02-Apr-2007 Version 10
VALTREX CAPLETS
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material VALTREX CAPLETS
VALTREX CAPLETS 500 MG * VALTREX CAPLETS 1 G * VALTREX
Synonyms
TABLETS 500 MG * 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
GlaxoSmithKline, Corporate Environment, Health & Safety
Company Name
980 Great West Road
Brentford, Middlesex TW8 9GS UK
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
GlaxoSmithKline, Corporate Environment, Health & Safety
One Franklin Plaza, 200 N 16th Street
Philadelphia, PA 19102-1225 US
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
Percentage
Ingredients CAS RN
VALACYCLOVIR HYDROCHLORIDE 71 to 73
124832-27-5
NON-HAZARDOUS INGREDIENTS 27 to 29
Unassigned
3. HAZARDS IDENTIFICATION
Expected to be non-combustible.
Fire and Explosion
Health Handling this product in its final form presents minimal risk from
occupational exposure. Health effects information is based on hazards of
components. Caution - Pharmaceutical agent. Possible effects of
overexposure in the workplace include: headache; nausea.
Environment No environmental hazards have been identified for this material.
4. FIRST-AID MEASURES
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SDS Number 110584 Approved/Revised 02-Apr-2007 Version 10
VALTREX CAPLETS
Material
Ingestion Never attempt to induce vomiting. Do not attempt to give any solid or liquid
by mouth if the 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.
Inhalation Physical form suggests that risk of inhalation exposure is negligible.
Skin Contact Using appropriate personal protective equipment, remove contaminated
clothing and flush exposed area with large amounts of water. Obtain
medical attention if skin reaction occurs, which may be immediate or
delayed.
Eye Contact Wash immediately with clean and gently flowing water. Continue for at least
15 minutes. Obtain medical attention.
NOTES TO HEALTH PROFESSIONALS
Medical Treatment Treat according to locally accepted protocols. For additional guidance, refer
to the current prescribing information or to the local poison control
information centre.
Medical Conditions Refer to prescribing information for detailed description of medical
conditions caused by or aggravated by overexposure to this product.
Caused or Aggravated
by Exposure
Antidotes No specific antidotes are recommended.
5. FIRE-FIGHTING MEASURES
Fire and Explosion Not expected for the product, although the packaging is combustible.
Hazards
Extinguishing Media Water or foam extinguishers are recommended.
Carbon dioxide or dry powder extinguishers may be ineffective.
Special Firefighting For single units (packages): No special requirements needed. For larger
amounts (multiple packages/pallets) of product: Since toxic, corrosive or
Procedures
flammable vapours might be evolved 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.
Hazardous Combustion Toxic, corrosive or flammable thermal decomposition products are
expected when the product is exposed to fire.
Products
6. ACCIDENTAL RELEASE MEASURES
Personal Precautions Wear protective clothing and equipment consistent with the degree of
hazard.
Environmental Precautions For large spills, take precautions to prevent entry into waterways, sewers, or
surface drainage systems.
Clean-up Methods Collect and place it in a suitable, properly labelled container for recovery or
disposal.
Decontamination No specific decontamination or detoxification procedures have been
identified for this product.
Procedures
7. HANDLING AND STORAGE
HANDLING
General Requirements No special control measures required for the normal handling of this
product. Normal room ventilation is expected to be adequate for routine
handling of this product.
STORAGE No storage requirements necessary for occupational hazards. Follow
product information storage instructions to maintain efficacy.
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SDS Number 110584 Approved/Revised 02-Apr-2007 Version 10
VALTREX CAPLETS
Material
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
VALACYCLOVIR HYDROCHLORIDE
INGREDIENT
1
GSK Occupational
Hazard Category
GSK Occupational 5000 mcg/m3 (8 HR TWA)
Exposure Limit
Other Equipment or None required for normal handling. Wash hands and arms thoroughly after
handling.
Procedures
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance
Blue.
Colour
Tablet.
Physical Form
10. STABILITY AND REACTIVITY
Stability This product is expected to be stable.
Conditions to Avoid None for normal handling of this product.
11. TOXICOLOGICAL INFORMATION
Oral Toxicity Not expected to be toxic following ingestion.
Skin Effects No studies have been conducted.
Eye Effects No studies have been conducted.
Target Organ Effects Adverse effects might occur in the following organ(s) following
overexposure: kidney. Assessment based upon information from animal
studies.
Sensitisation Potential for inducing allergic reactions via the dermal or respiratory route is
not known.
Genetic Toxicity Genetic toxicity is not expected under occupational exposure conditions
based upon negative results in laboratory assays. No evidence of DNA
damage occurred in the following assay(s): bacterial mutation assay
(Ames).
Carcinogenicity Not expected to produce cancer in humans under occupational exposure
conditions based upon negative results in laboratory assays.
Reproductive Effects Not expected to produce adverse effects on fertility or development under
occupational exposure conditions.
Pharmacological Effects This preparation contains ingredient(s) with the following activity: a
nucleoside analogue. This product is intended for the treatment of viral
infection. Adverse effects of overexposure might include: headache;
nausea.
Other Adverse Effects None known for occupational exposure.
12. ECOLOGICAL INFORMATION
Summary This material contains an active pharmaceutical ingredient that has been
tested, and no 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.
ECOTOXICITY
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SDS Number 110584 Approved/Revised 02-Apr-2007 Version 10
VALTREX CAPLETS
Material
Aquatic
Activated Sludge This material contains an active pharmaceutical ingredient that is not toxic
to activated sludge microorganisms.
Respiration
IC50: > 100 mg/l, 3 Hours, Activated sludge
Microbial Growth This material contains an active pharmaceutical ingredient that is not toxic
to these microorganisms.
Inhibition
Minimum Inhibition > 1000 mg/l, , Chaetomium globosum
Concentration: > 1000 mg/l, , Aspergillus flavus
> 1000 mg/l, , Nostoc sp.
> 1000 mg/l, , Azotobacter chroococcum
> 1000 mg/l, , Pseudomonas fluorescens
Daphnid This material contains an active pharmaceutical ingredient that is not toxic
to daphnids.
EC50: 340 mg/l, 48 Hours, Daphnia magna, Static test
NOEL: 56 mg/l, 48 Hours, Daphnia magna, Static test
MOBILITY
Solubility This material contains an active pharmaceutical ingredient that for
environmental fate predictions has solubility in water.
Volatility This material contains an active pharmaceutical ingredient that will not
readily enter into the air from hard surfaces or from a container of the pure
substance.
Partitioning This material contains an active pharmaceutical ingredient with
octanol/water partition coefficient data that suggests that for environmental
fate predictions the active pharmaceutical ingredient will not have the
tendency to distribute into fats.
PERSISTENCE/DEGRADATION
Hydrolysis This material contains an active pharmaceutical ingredient that has been
shown to be chemically unstable in water. Hydrolysis may be a significant
depletion mechanism.
Half-Life, Neutral: 55.92 Hours, Measured
Half-Life, Acidic: 68.38 Days, Measured
Half-Life, Basic: 15.13 Hours, Measured
Hydrolysis Product(s) - By ACYCLOVIR
Products
Photolysis This material contains an active pharmaceutical ingredient that is unlikely to
undergo photodegradation.
UV/Visible Spectrum: 264
Biodegradation This material contains an active pharmaceutical ingredient that is not
readily biodegradable but is inherently biodegradable (as defined by 1993
OECD Testing Guidelines) and is not expected to persist in the
environment.
Aerobic - Ready
Percent Degradation: 0.08 %, 28 days, Modified Sturm test.
Aerobic - Inherent
Percent Degradation: 100 %, 14 days, Modified Zahn-Wellens, Activated
sludge
BIOACCUMULATION This material contains an active pharmaceutical ingredient that will not have
a tendency to bioaccumulate in the food chain.
13. DISPOSAL CONSIDERATIONS
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SDS Number 110584 Approved/Revised 02-Apr-2007 Version 10
VALTREX CAPLETS
Material
Disposal Collect for recycling or recovery if possible. The disposal method for
rejected products/returned goods must ensure that they cannot be re-sold or
Recommendations
re-used.
Regulatory Requirements Observe all local and national regulations when disposing of this product.
14. TRANSPORT INFORMATION
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.
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
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.
EU Classification and Labelling
Exempt from requirements of EU Dangerous Preparations directive - product regulated as a medicinal
product, cosmetic product or medical device.
US OSHA Standard (29 CFR Part 1910.1200)
Classification This dosage form is exempt from the requirements of the OSHA Hazard
Communication Standard.
Other US Regulations
TSCA Status Exempt
16. OTHER INFORMATION
References GSK Hazard Determination
Date Approved/Revised 02-Apr-2007 SDS Version Number 10
SDS Sections Updated
Sections Subsections
IDENTIFICATION OF SUBSTANCE / PREPARATION AND
OF COMPANY
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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