Note: Ingredients listed on restricted chemical lists
EC/CAS
200-018-0/79-33-4
Name of the chemical
L-(+)-Lactic acid
Concentration
0-1%
EC/CAS
215-185-5/1310-73-2
Name of the chemical
sodium hydroxide
Concentration
N/A
EC/CAS
231-791-2/7732-18-5
Name of the chemical
Water, distilled, conductivity or of similar purity H2O
Concentration
>95
EC/CAS
200-061-5
Name of the chemical
D-glucitol C6H14O6
Concentration
1-5
General Information
Revision date
2010-09-07
Product name
Irinotecan Hydrochloride Injection
Chemical name
(S)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxolHpyrano[3’,4’:6,7]- indolizino[1,2-b]quniolin-9-yl-[1,4’bipiperidine]-1’-carboxylate, monohydrochloride, trihydrate; (+)-7-Ethyl-10-hydroxycamptothecine 10-[1,4’-
1.2.1 Relevant identified uses
Antineoplastic enzyme inhibitor primarily used in the treatment of colorectal cancer
Emergency telephone
(Infotrac
Icons in SDS
Company Information
company name
Actavis hf
e-mail address of the competent person responsible for the Safety Data Sheet
safetydatasheets@actavis.com
GHS Information
Signal word
Warning
Hazard Codes
Hazard statements (CLP)
H302, H341, H361
Hazard statements
Code
Statements
H302
Harmful if swallowed
Section 2
2.1 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 labeling listed below is for bulk Irinotecan Hydrochloride.
Hazard statements
H302 - Harmful if swallowed Active ingredient is cytotoxic and will produce severe toxic effects to rapidly dividing tissues upon over-exposure. Suspected of damaging the unborn child. Possible mutagen. Gastrointestinal effects. Blood effects. May cause allergic reactions. Specific hazards: Possible foetal development hazard that may adversely affect the developing foetus. EU Hazard Symbols: H341 Suspected of causing genetic defects. H361 Suspected of damaging fertility or the unborn child.
Signal word
Warning
Precautionary statements
P201 Obtain special instructions before use. P202 Do not handle until all safety precautions have been read and understood. P281 Use personal protective equipment as required. P308 + P313 If exposed or concerned: Get medical advice/attention. P405 Store locked up. P501 Dispose of contents/container in accordance with national regulations. EU Risk Phrases: R61 – May cause harm to the unborn child. R68 – Possible risk of irreversible effects. EU Indication of Danger: Toxic to reproduction, Category 2. Mutagenic, Category 3. Principle Routes of Entry: Eye/skin contact or ingestion. Inhalation: Inhalation is not considered likely under normal usage conditions. Ingestion: May be harmful if swallowed (based upon animal data). Gastrointestinal effects (may include nausea/vomiting, abdominal pain, diarrhoea, dry mouth, colic). Blood effects (may include anaemia, neutropenia, thrombocytopenia, bone marrow depression). Dermatologic effects (may include exfoliative dermatitis, photosensitivity, rash, itching). Nervous system effects (headache, dizziness, light headedness). Cardiovascular effects (may include fluctuations in heart rate, changes in blood pressure, chest pain). Anaemia. Skin Contact: May cause irritation and/or allergic reactions, particularly to cut or abraded skin. Eye Contact: Potential for eye irritation. May cause allergic reaction.
