SAFETY DATA SHEET MEGLUMINE DIATRIZOATE, SODIUM AMIDOTRIZOATE

Transcription

1 SAFETY DATA SHEET 1. Identification Product identifier Other means of identification SDS number Synonyms Recommended use Recommended restrictions MD-76 R MD76R Diatrizoate meglumine and diatrizoate MD-76R is indicated in excretion urography, aortography, pediatric angiocardiography, peripheral arteriography, selective renal arteriography, selective visceral arteriography, selective coronary arteriography with or without left ventriculography, contrast enhancement of computed tomographic brain imaging and for intravenous digital subtraction angiography. MD-76R is also indicated for the contrast enhancement in body computed tomography. ne known. Manufacturer/Importer/Supplier/Distributor information Manufacturer Company name Address Telephone Mallinckrodt 675 McDonnell Blvd. Hazelwood, MO Emergency phone number Customer Service Hour Emergency Chemtrec Hazard(s) identification Physical hazards Health hazards Environmental hazards OSHA defined hazards t classified. Sensitization, respiratory Sensitization, skin t classified. t classified. Category 1 Category 1 Labeling Contains Label elements MEGLUMINE DIATRIZOATE, SODIUM AMIDOTRIZOATE Signal word Hazard statement Precautionary statement Prevention Response Storage Danger May cause allergy or asthma symptoms or breathing difficulties if inhaled. May cause an allergic skin reaction. Avoid breathing mist or vapor. In case of inadequate ventilation wear respiratory protection. Contaminated work clothing must not be allowed out of the workplace. If on skin: Wash with plenty of water. If skin irritation or rash occurs: Get medical advice/attention. If inhaled: If breathing is difficult, remove person to fresh air and keep comfortable for breathing. If experiencing respiratory symptoms: Call a poison center/doctor. Specific treatment (see this label). Wash contaminated clothing before reuse. Store away from incompatible materials. 1 / 8

2 Disposal Hazard(s) not otherwise classified (HNOC) Supplemental information Dispose of contents/container in accordance with local/regional/national/international regulations. ne known. Read Package Insert prior to use. Ensure prompt removal from skin, eyes and clothing. As part of good laboratory and personal hygiene and safety procedure, avoid all unnecessary exposure to the chemical substance. 3. Composition/information on ingredients Mixtures Chemical name As with all contrast media, containers should be inspected prior to use to ensure that breakage or other damage has not occurred during shipping and handling. All containers should be inspected for closure integrity. Damaged containers should not Common name and synonyms CAS number % MEGLUMINE DIATRIZOATE SODIUM AMIDOTRIZOATE Composition comments 4. First-aid measures Inhalation Skin contact Eye contact Ingestion Most important symptoms/effects, acute and delayed Indication of immediate medical attention and special treatment needed General information All concentrations are in percent by weight unless ingredient is a gas. Gas concentrations are in percent by volume. If breathing is difficult, remove to fresh air and keep at rest in a position comfortable for breathing. Oxygen or artificial respiration if needed. Do not use mouth-to-mouth method if victim inhaled the substance. Induce artificial respiration with the aid of a pocket mask equipped with a one-way valve or other proper respiratory medical device. If experiencing respiratory symptoms: Call a POISON CENTER or doctor/physician. Remove contaminated clothing immediately and wash skin with soap and water. In case of eczema or other skin disorders: Seek medical attention and take along these instructions. Rinse with water. Get medical attention if irritation develops and persists. Rinse mouth. Get medical attention if symptoms occur. Dehydration: Administration of hypertonic MD-76R solutions may lead to hypovolemia and hypotension due to fluid loss from the intestine. In young or debilitated children and in elderly cachectic persons, the loss of plasma fluid may be sufficient to cause a shock-like state. In debilitated patients and in patients with electrolyte imbalances, postprocedural monitoring of hydration, serum osmolarity, electrolytes and clinical status is essential. In pediatric or severely debilitated patients, the maintenance of an open intravenous fluid line for rehydration may be advisable should hypotension or shock supervene. Electrolyte disturbances must be corrected prior to the administration of any hypertonic MD-76R solutions. Aspiration: Aspiration of MD-76R into the trachea and airways may result in serious pulmonary complications including, pulmonary edema, pneumonitis or death. Bronchial entry of any orally administered contrast medium causes a copious osmotic effusion. Therefore, avoid use of MD-76R in patients with esophagotracheal fistula and minimize risks for pulmonary aspiration in all patients. If MD-76R is given by nasogastric tube, the position of the tube in the stomach must be verified before administration. Anaphylactic Reactions: Anaphylactic reactions, including fatalities, have been reported with the use of MD-76R. Patients at increased risk include those with a history of a previous reaction to a contrast medium, patients with a known sensitivity to iodine, and patients with a known clinical hypersensitivity (bronchial asthma, hay fever, and food allergies). Medical personnel trained in the treatment of anaphylactic reactions and the necessary drugs and medical equipment should always be readily available when MD-76R is used. May cause an allergic skin reaction. May cause allergic respiratory reaction. Provide general supportive measures and treat symptomatically. Keep victim under observation. Symptoms may be delayed. Ensure that medical personnel are aware of the material(s) involved, and take precautions to protect themselves. Wash contaminated clothing before reuse. 2 / 8

3 5. Fire-fighting measures Flammable properties Suitable extinguishing media Unsuitable extinguishing media Specific hazards arising from the chemical Special protective equipment and precautions for firefighters Fire-fighting equipment/instructions Specific methods General fire hazards unusual fire or explosion hazards noted. Use fire-extinguishing media appropriate for surrounding materials. ne known. During fire, gases hazardous to health may be formed such as: Carbon monoxide and carbon dioxide. Nitrogen Oxides (NOx). Iodine. Self-contained breathing apparatus and full protective clothing must be worn in case of fire. Move containers from fire area if you can do so without risk. In case of fire and/or explosion do not breathe fumes. Use standard firefighting procedures and consider the hazards of other involved materials. unusual fire or explosion hazards noted. 6. Accidental release measures Personal precautions, protective equipment and emergency procedures Methods and materials for containment and cleaning up Keep unnecessary personnel away. Keep people away from and upwind of spill/leak. Wear appropriate protective equipment and clothing during clean-up. Ensure adequate ventilation. Avoid inhalation of vapors or mists. Local authorities should be advised if significant spillages cannot be contained. For personal protection, see section 8 of the SDS. This product is miscible in water. Large Spills: Stop the flow of material, if this is without risk. Dike the spilled material, where this is possible. Cover with plastic sheet to prevent spreading. Absorb in vermiculite, dry sand or earth and place into containers. Following product recovery, flush area with water. Small Spills: Wipe up with absorbent material (e.g. cloth, fleece). Clean surface thoroughly to remove residual contamination. Environmental precautions 7. Handling and storage Precautions for safe handling Conditions for safe storage, including any incompatibilities Never return spills to original containers for re-use. For waste disposal, see section 13 of the SDS. Avoid discharge into drains, water courses or onto the ground. Protect from light. Keep away from heat. Avoid breathing mist or vapor. Avoid contact with skin. Avoid contact with eyes. Avoid contact with clothing. Provide adequate ventilation. Wear appropriate personal protective equipment. Observe good industrial hygiene practices. Wash thoroughly after handling. As with all contrast media, containers should be inspected prior to use to ensure that breakage or other damage has not occurred during shipping and handling. All containers should be inspected for closure integrity. Damaged Store at controlled room temperature C (68-77 F). Store away from heat and light. Store in original tightly closed container. Keep container tightly closed. Store in a well-ventilated place. Store away from incompatible materials (see Section 10 of the SDS). 8. Exposure controls/personal protection Occupational exposure limits Biological limit values Appropriate engineering controls exposure limits noted for ingredient(s). biological exposure limits noted for the ingredient(s). Ensure adequate ventilation, especially in confined areas. Individual protection measures, such as personal protective equipment Eye/face protection If contact is likely, safety glasses with side shields are recommended. Wear a full-face respirator, if needed. Chemical respirator with organic vapor cartridge and full facepiece. Skin protection Hand protection Other Respiratory protection Chemical resistant gloves. Wear appropriate chemical resistant clothing. personal respiratory protective equipment normally required. In case of insufficient ventilation, wear suitable respiratory equipment. 3 / 8

4 Thermal hazards General hygiene considerations Wear appropriate thermal protective clothing, when necessary. Always observe good personal hygiene measures, such as washing after handling the material and before eating, drinking, and/or smoking. Routinely wash work clothing and protective equipment to remove contaminants. Contaminated work clothing should not be allowed out of the workplace. 9. Physical and chemical properties Appearance Physical state Liquid. Form Liquid. Aqueous solution. Color Clear. Odor Odorless. Odor threshold ph Melting point/freezing point 32 F (0 C) Approx. Initial boiling point and boiling 212 F (100 C) Approx. range Flash point Evaporation rate Flammability (solid, gas) Upper/lower flammability or explosive limits Flammability limit - lower (%) Flammability limit - upper (%) Explosive limit - lower (%) Explosive limit - upper (%) Vapor pressure Vapor density Relative density Solubility(ies) Solubility (water) Soluble in water. Partition coefficient (n-octanol/water) Auto-ignition temperature Decomposition temperature Viscosity 10. Stability and reactivity Reactivity Chemical stability Possibility of hazardous reactions Conditions to avoid Incompatible materials Hazardous decomposition products The product is stable and non-reactive under normal conditions of use, storage and transport. Material is stable under normal conditions. dangerous reaction known under conditions of normal use. Contact with incompatible materials. ne known. hazardous decomposition products are known. 4 / 8

5 11. Toxicological information Information on likely routes of exposure Ingestion May cause abdominal cramping, nausea, vomiting, diarrhea, skin rashes, itching, heartburn, dizziness, or headache in some patients, but most reactions are mild and pass quickly. Inhalation Skin contact Eye contact Symptoms related to the physical, chemical and toxicological characteristics Information on toxicological effects Acute toxicity May cause allergy or asthma symptoms or breathing difficulties if inhaled. May cause an allergic skin reaction. May cause skin irritation. May cause eye irritation. Dehydration: Administration of hypertonic MD-76R solutions may lead to hypovolemia and hypotension due to fluid loss from the intestine. In young or debilitated children and in elderly cachectic persons, the loss of plasma fluid may be sufficient to cause a shock-like state. In debilitated patients and in patients with electrolyte imbalances, postprocedural monitoring of hydration, serum osmolarity, electrolytes and clinical status is essential. In pediatric or severely debilitated patients, the maintenance of an open intravenous fluid line for rehydration may be advisable should hypotension or shock supervene. Electrolyte disturbances must be corrected prior to the administration of any hypertonic MD-76R solutions. Aspiration: Aspiration of MD-76R into the trachea and airways may result in serious pulmonary complications including, pulmonary edema, pneumonitis or death. Bronchial entry of any orally administered contrast medium causes a copious osmotic effusion. Therefore, avoid use of MD-76R in patients with esophagotracheal fistula and minimize risks for pulmonary aspiration in all patients. If MD-76R is given by nasogastric tube, the position of the tube in the stomach must be verified before administration. Anaphylactic Reactions: Anaphylactic reactions, including fatalities, have been reported with the use of MD-76R. Patients at increased risk include those with a history of a previous reaction to a contrast medium, patients with a known sensitivity to iodine, and patients with a known clinical hypersensitivity (bronchial asthma, hay fever, and food allergies). Medical personnel trained in the treatment of anaphylactic reactions and the necessary drugs and medical equipment should always be readily available when MD-76R is used. May cause allergic respiratory and skin reactions. May cause an allergic skin reaction. May cause allergy or asthma symptoms or breathing difficulties if inhaled. Components Species MEGLUMINE DIATRIZOATE (CAS ) Acute Other LD50 Mouse Rat Test Results mg/kg (Intravenous) mg/kg (Intravenous) * Estimates for product may be based on additional component data not shown. Skin corrosion/irritation May cause skin irritation. Serious eye damage/eye May irritate eyes. irritation Respiratory or skin sensitization Respiratory sensitization May cause allergy or asthma symptoms or breathing difficulties if inhaled. Skin sensitization May cause an allergic skin reaction. Germ cell mutagenicity Carcinogenicity Diatrizoate Sodium is investigated as a possible mutagen. 5 / 8

6 Reproductive toxicity Specific target organ toxicity - single exposure Specific target organ toxicity - repeated exposure Aspiration hazard 12. Ecological information Ecotoxicity Persistence and degradability Bioaccumulative potential Mobility in soil Other adverse effects 13. Disposal considerations Disposal instructions Local disposal regulations Hazardous waste code Waste from residues / unused products Contaminated packaging When administered intravenously, diatrizoate salts cross the placenta and are evenly distributed in fetal tissues. teratogenic effects attributable to diatrizoate meglumine or diatrizoate sodium have been observed in teratology studies performed in animals. There are, however, no adequate and well-controlled studies in pregnant women. Procedures including radiation involve a certain risk related to the exposure of the fetus. Diatrizoate meglumine is excreted in breast milk following intravascular administration. Because small amounts of enteral gastrointestinal radiopaque agents may be absorbed following oral or rectal administration, caution should be exercised when they are administered to a nursing woman. The product is not classified as environmentally hazardous. However, this does not exclude the possibility that large or frequent spills can have a harmful or damaging effect on the environment. Because this product is intended for use by hospital or clinic patients, it is expected to be treated by standard wastewater treatment facilities with no adverse environmental impacts. data is available on the degradability of this product. data available. data available. ne known. Dispose of contents/container in accordance with local/regional/national/international regulations. If medical waste is involved, such as blood, blood products, or sharps, the waste must be handled as a biohazard and disposed of accordingly. If not a biohazard, consult local, state and federal regulations for proper disposal. Dispose in accordance with all applicable regulations. The waste code should be assigned in discussion between the user, the producer and the waste disposal company. Dispose of in accordance with local regulations. Empty containers or liners may retain some product residues. This material and its container must be disposed of in a safe manner (see: Disposal instructions). Empty containers should be taken to an approved waste handling site for recycling or disposal. Since emptied containers may retain product residue, follow label warnings even after container is emptied. 14. Transport information DOT t regulated as dangerous goods. IATA t regulated as dangerous goods. IMDG t regulated as dangerous goods. Transport in bulk according to This substance/mixture is not intended to be transported in bulk. Annex II of MARPOL 73/78 and the IBC Code 6 / 8

7 15. Regulatory information US federal regulations This product is a "Hazardous Chemical" as defined by the OSHA Hazard Communication Standard, 29 CFR TSCA exempt status. TSCA Section 12(b) Export tification (40 CFR 707, Subpt. D) t regulated. CERCLA Hazardous Substance List (40 CFR 302.4) t listed. SARA 304 Emergency release notification t regulated. OSHA Specifically Regulated Substances (29 CFR ) t listed. Superfund Amendments and Reauthorization Act of 1986 (SARA) Hazard categories Immediate Hazard - Yes Delayed Hazard - Fire Hazard - Pressure Hazard - Reactivity Hazard - SARA 302 Extremely hazardous substance t listed. SARA 311/312 Hazardous chemical Other federal regulations Clean Air Act (CAA) Section 112 Hazardous Air Pollutants (HAPs) List t regulated. Clean Air Act (CAA) Section 112(r) Accidental Release Prevention (40 CFR ) t regulated. Safe Drinking Water Act (SDWA) US state regulations t regulated. US. Massachusetts RTK - Substance List t regulated. US. New Jersey Worker and Community Right-to-Know Act t listed. US. Pennsylvania Worker and Community Right-to-Know Law t listed. US. Rhode Island RTK t regulated. US. California Proposition 65 California Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65): This material is not known to contain any chemicals currently listed as carcinogens or reproductive toxins. International Inventories Country(s) or region Australia Canada Canada China Europe Europe Japan Inventory name Australian Inventory of Chemical Substances (AICS) Domestic Substances List (DSL) n-domestic Substances List (NDSL) Inventory of Existing Chemical Substances in China (IECSC) European Inventory of Existing Commercial Chemical Substances (EINECS) European List of tified Chemical Substances (ELINCS) Inventory of Existing and New Chemical Substances (ENCS) On inventory (yes/no)* 7 / 8

8 Country(s) or region Korea New Zealand Philippines United States & Puerto Rico Inventory name Existing Chemicals List (ECL) New Zealand Inventory Philippine Inventory of Chemicals and Chemical Substances (PICCS) Toxic Substances Control Act (TSCA) Inventory On inventory (yes/no)* *A "Yes" indicates that all components of this product comply with the inventory requirements administered by the governing country(s) A "" indicates that one or more components of the product are not listed or exempt from listing on the inventory administered by the governing country(s). 16. Other information, including date of preparation or last revision Issue date Version # 01 Disclaimer Revision Information Mallinckrodt provides the information contained herein in good faith but makes no representation as to its comprehensiveness or accuracy. This document is intended only as a guide to the appropriate precautionary handling of the material by a properly trained person using this product. Individuals receiving the information must exercise their independent judgment in determining its appropriateness for a particular purpose. MALLINCKRODT MAKES NO REPRESENTATIONS OR WARRANTIES, EITHER EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO THE INFORMATION SET FORTH HEREIN OR THE PRODUCT TO WHICH THE INFORMATION REFERS. ACCORDINGLY, MALLINCKRODT WILL NOT BE RESPONSIBLE FOR DAMAGES RESULTING FROM USE OF OR RELIANCE UPON THIS INFORMATION. Product and Company Identification: Synonyms Physical & Chemical Properties: Multiple Properties 8 / 8