SDS Number 129068 Approved/Revised 10-Nov-2004 Version 01
MALARONE PAEDIATRIC TABLETS
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material MALARONE PAEDIATRIC TABLETS
MALARONE PAEDIATRIC TABLETS 62.5/125 MG * MALARONE
Synonyms
PAEDIATRIC TABLETS 62.5/125 MG (US) * MALARONE JUNIOR TABLETS
62.5/125 MG * NDC NO 0173-0676-01 * NDC NO 0173-0676-02 *
ATOVAQUONE AND PROGUANIL 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
2200 Renaissance Blvd, Suite 105
King of Prussia, PA 19406 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
ATOVAQUONE 50.8
95233-18-4
PROGUANIL HYDROCHLORIDE 20.3
637-32-1
NON-HAZARDOUS INGREDIENTS 28.9
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.
Environment Dangerous for the environment. Very toxic to aquatic organisms. May cause
long-term adverse effects in the aquatic environment.
4. FIRST-AID MEASURES
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SDS Number 129068 Approved/Revised 10-Nov-2004 Version 01
MALARONE PAEDIATRIC TABLETS
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,
Procedures
corrosive or 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 Detergent solutions can be used for clean-up and decontamination
operations.
Procedures
7. HANDLING AND STORAGE
HANDLING
General Requirements Avoid breaking or crushing tablets.
STORAGE No storage requirements necessary for occupational hazards. Follow
product information storage instructions to maintain efficacy.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
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SDS Number 129068 Approved/Revised 10-Nov-2004 Version 01
MALARONE PAEDIATRIC TABLETS
Material
ATOVAQUONE
INGREDIENT
2
GSK Occupational
Hazard Category
GSK Occupational 200 mcg/m3 (8 HR TWA)
Exposure Limit
PROGUANIL HYDROCHLORIDE
INGREDIENT
2
GSK Occupational
Hazard Category
GSK Occupational 500 mcg/m3 (15 MIN STEL)
Exposure Limit
Other Equipment or None required for normal handling. Wash hands and arms thoroughly after
handling.
Procedures
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance
Pink.
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 Adverse effects might occur following ingestion.
Skin Effects Irritation is not expected following direct contact.
Eye Effects Irritation is not expected following direct contact with eyes.
Target Organ Effects Adverse effects might occur in the following organ(s) following
overexposure: kidney; lymph nodes; thymus; gastro-intestinal tract; bone
marrow and formation of blood cells.
Sensitisation Sensitisation (allergic skin reaction) is not expected.
Genetic Toxicity Not expected to be genotoxic under occupational exposure conditions.
Carcinogenicity Atovaquone, the active substance in this product, produced carcinogenic
effects in a lifetime study in mice. Not expected to produce cancer in
humans under occupational exposure conditions. No components are listed
as carcinogens by GSK, IARC, NTP or US OSHA.
Reproductive Effects Not expected to produce adverse effects on fertility or development under
occupational exposure conditions.
Pharmacological Effects This product contains active ingredient(s) with the following activity: an
inhibitor of electron transport; an inhibitor of folic acid metabolism. It is an
agent intended for the treatment of malaria. Adverse effects of
overexposure might include: headache; gastrointestinal distress; weakness;
dizziness; nosebleed; blocked nose; sore throat; sensation of bitter taste.
Other Adverse Effects None known for occupational exposure.
12. ECOLOGICAL INFORMATION
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SDS Number 129068 Approved/Revised 10-Nov-2004 Version 01
MALARONE PAEDIATRIC TABLETS
Material
Summary This material contains two or more active pharmaceutical ingredients that
have been tested, one of which may be harmful if released directly to the
environment. Specific information on that active pharmaceutical ingredient
is provided below. Appropriate precautions should be taken to limit release
of this material to the environment. Local regulations and procedures should
be consulted prior to environmental release.
ECOTOXICITY
Aquatic
Microbial Growth No toxicity to these microorganisms was observed for the active
pharmaceutical ingredient of this mixture, but the upper range of the test
Inhibition
was limited by the low water solubility of the compound.
Minimum Inhibition > 11 mcg/l, , Aspergillus flavus
Concentration: > 11 mcg/l, , Azotobacter chroococcum
> 11 mcg/l, , Chaetomium globosum
> 11 mcg/l, , Nostoc sp.
> 11 mcg/l, , Pseudomonas acidovorans
Daphnid This material contains an active pharmaceutical ingredient that is very toxic
to daphids.
EC50: 0.0035 mg/l, 48 Hours, Daphnia magna, Static
test
NOEL: 0.0018 mg/l, 48 Hours, Daphnia magna, Static
test
Terrestrial
Earthworm This mixture contains an active pharmaceutical ingredient that is not toxic
to earthworms.
Eisenia foetida, manure worm
EC50: > 1000 mg/kg, 14 Days, Nominal
Eisenia foetida, manure worm
NOEL: 1000 mg/kg, 14 Days, Nominal
MOBILITY
Solubility This material contains an active pharmaceutical ingredient that for
environmental fate predictions has very low solubility in water.
Adsorption This material contains an active pharmaceutical ingredient that is likely to
adsorb to soil or sediment. This material contains an active pharmaceutical
ingredient that is likely to adsorb to sludges and other biomass.
Soil Sediment Sorption 4.18 to 4.58, Measured
(log Koc):
Sludge Biomass 3.91 to 4.31 Calculated
Distribution Coefficient
(log Kd):
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 may have the
tendency to distribute into fats.
PERSISTENCE/DEGRADATION
Photolysis This material contains an active pharmaceutical ingredient that has been
shown to be chemically unstable in water when exposed to light. Aqueous
photolysis may be a significant depletion mechanism.
Half-Life, Aqueous: 2.63 Hours, Measured
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SDS Number 129068 Approved/Revised 10-Nov-2004 Version 01
MALARONE PAEDIATRIC TABLETS
Material
Biodegradation
Aerobic - Soil
Percent Degradation: 75 %, 1 Day, , Soil
BIOACCUMULATION This material contains an active pharmaceutical ingredient will have a
tendency to bioaccumulate in the food chain.
13. DISPOSAL CONSIDERATIONS
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 10-Nov-2004 SDS Version Number 1
SDS Sections Updated
Sections Subsections
COMPOSITION / INFORMATION ON INGREDIENTS
IDENTIFICATION OF SUBSTANCE / PREPARATION AND
OF COMPANY
REGULATORY INFORMATION
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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