Note: Ingredients listed on restricted chemical lists
EC/CAS
232-674-9/9004-34-6
Name of the chemical
cellulose
Concentration
25-35%
EC/CAS
232-679-6/9005-25-8
Name of the chemical
Starch
Concentration
4-6%
EC/CAS
209-150-3
Name of the chemical
Aluminium, zinc, magnesium and calcium stearates
Concentration
1-2%
General Information
Revision date
2014-10-28
Product name
Truvada
Chemical name
Nucleoside and nucleotide analog mixture
1.2.1 Relevant identified uses
Bulk formulated pharmaceutical product/mixture packaged in final form for patient use. Used in combination with other antiretroviral agents for the treatment and uses advised against of HIV- 1 infection in adults
Emergency telephone
1 (650) 522-6140
Icons in SDS
Company Information
company name
Gilead Sciences, Inc
e-mail address of the competent person responsible for the Safety Data Sheet
msdscoordinator@gilead.com
GHS Information
Signal word
US Hazard overview
Hazard Codes
Hazard statements (CLP)
H318
Hazard statements
Code
Statements
H318
Causes serious eye damage
Section 2
SECTION 2: Hazards identification
GHS Classification Classification of the substance or mixture Drugs in the finished state and intended for the final user are not subject to labeling in the US, EU or Canada. Please consult the prescribing/packaging information. The classification and labelling listed below is for bulk Truvada®
2.2 Label elements
SECTION 2 - HAZARDS IDENTIFICATION …continued CLP/GHS hazard
Signal word
Danger CLP/GHS hazard H318 - Causes serious eye damage US Hazard overview Warning Causes eye irritation. Used as an antiretroviral agent for the treatment of HIV-1 infection. Note This product/mixture is classified as dangerous/hazardous according to Directive
Hazard statements
CLP/GHS precautionary P280 - Wear eye/face protection. P305 + P351 + P338 - IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310 - Immediately call a Poison Center or doctor/ physician. EU symbol/indication of danger Xi - Irritant Risk (R) Phrase(s) R41 - Risk of serious damage to eyes.
Precautionary statements
S2 - Keep out of reach of children. S25 - Avoid contact with eyes. S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S39 - Wear eye/face protection.
2.3 Other hazards
Adverse effects seen with therapeutic use of Truvada® include diarrhea, nausea, abdominal pain, flatulence, pancreatitis, weakness, headache, dizziness, insomnia, abnormal dreams, allergic reactions, skin discoloration, rash, muscular weakness, bone problems, including bone pain, softening or thinning (which may lead to fractures), changes in immune system (Immune Reconstitution Syndrome). Serious effects including lactic acidosis, renal impairment, including cases of acute renal failure, and effects on the liver, including hepatomegaly and developing fat in liver. The recommended dose of Truvada® is one tablet per day (containing 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate).
2.1 Classification of the substance or mixture
Drugs in the finished state and intended for the final user are not subject to substance or mixture
