PFIZER MORPHINE HYDROCHLORIDE ORAL SOLUTION. Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION

Transcription

1 Page 1 of 9 Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION PRODUCT NAME PFIZER MORPHINE HYDROCHLORIDE ORAL SOLUTION SYNONYMS "Morphine Mixture; RA-MORPH." PRODUCT NUMBERS , PRODUCT USE Pharmaceutical active used as opioid analgesic. SUPPLIER Company: Pfizer Pty Ltd Address: Wharf Road West Ryde NSW, 2116 Australia Telephone: Fax: info.australia@pfizer.com Section 2 - HAZARDS IDENTIFICATION STATEMENT OF HAZARDOUS NATURE HAZARDOUS SUBSTANCE. NON-DANGEROUS GOODS. According to the Criteria of NOHSC, and the ADG Code. CHEMWATCH HAZARD RATINGS Flammability Toxicity Body Contact Reactivity Chronic SCALE: Min/Nil=0 Low=1 Moderate=2 High=3 Extreme=4 RISK May cause harm to the unborn child. May cause harm to breastfed babies. Possible risk of irreversible effects. SAFETY Keep locked up. Do not breathe gas/fumes/vapour/spray. Avoid contact with skin. Wear suitable protective clothing. In case of insufficient ventilation, wear suitable respiratory equipment. Wear suitable gloves. Wear eye/face protection. Avoid exposure - obtain special instructions before use.

2 Page 2 of 9 Section 2 - HAZARDS IDENTIFICATION To clean the floor and all objects contaminated by this material, use water and detergent. This material and its container must be disposed of in a safe way. Keep away from food, drink and animal feeding stuffs. Section 3 - COMPOSITION / INFORMATION ON INGREDIENTS NAME CAS RN % morphine hydrochloride glycerol proprietary citric acid proprietary sodium citrate proprietary methyl paraben, sodium salt proprietary water proprietary Section 4 - FIRST AID MEASURES SWALLOWED Immediately give a glass of water. First aid is not generally required. If in doubt, contact a Poisons Information Centre or a doctor. EYE If this product comes in contact with eyes: Wash out immediately with water. If irritation continues, seek medical attention. Removal of contact lenses after an eye injury should only be undertaken by skilled personnel. SKIN If skin or hair contact occurs: Flush skin and hair with running water (and soap if available). Seek medical attention in event of irritation. INHALED If fumes, aerosols or combustion products are inhaled remove from contaminated area. Other measures are usually unnecessary. NOTES TO PHYSICIAN Treat symptomatically for a narcotic analgesic. A vigorous program of symptomatic and supportive therapy has saved many victims of poisoning. GOSSELIN et al: Clinical Toxicology of Commercial Products. Section 5 - FIRE FIGHTING MEASURES EXTINGUISHING MEDIA There is no restriction on the type of extinguisher which may be used. Use extinguishing media suitable for surrounding area. FIRE FIGHTING Alert Fire Brigade and tell them location and nature of hazard. Wear breathing apparatus plus protective gloves in the event of a fire. Prevent, by any means available, spillage from entering drains or water courses. Use fire fighting procedures suitable for surrounding area. FIRE/EXPLOSION HAZARD Non combustible. Not considered a significant fire risk, however containers may burn.

3 Page 3 of 9 Section 5 - FIRE FIGHTING MEASURES FIRE INCOMPATIBILITY Avoid contamination with oxidising agents i.e. nitrates, oxidising acids, chlorine bleaches, pool chlorine etc. as ignition may result. HAZCHEM None Section 6 - ACCIDENTAL RELEASE MEASURES MINOR SPILLS Clean up all spills immediately. Avoid breathing vapours and contact with skin and eyes. Control personal contact with the substance, by using protective equipment. Contain and absorb spill with sand, earth, inert material or vermiculite. MAJOR SPILLS Moderate hazard. Clear area of personnel and move upwind. Alert Fire Brigade and tell them location and nature of hazard. Wear breathing apparatus plus protective gloves. Prevent, by any means available, spillage from entering drains or water course. Personal Protective Equipment advice is contained in Section 8 of the MSDS. Section 7 - HANDLING AND STORAGE PROCEDURE FOR HANDLING Avoid all personal contact, including inhalation. Wear protective clothing when risk of exposure occurs. Use in a well-ventilated area. Prevent concentration in hollows and sumps. SUITABLE CONTAINER Packaging as recommended by manufacturer. Check that containers are clearly labelled. Tamper-proof containers. Polyethylene or polypropylene containers. STORAGE INCOMPATIBILITY Avoid reaction with oxidising agents. STORAGE REQUIREMENTS NOTE: Special security requirements may be mandated under Federal/State Regulation(s). Store in original containers. Store in vault fitted with warning devices or detectors recommended by various Federal/State authorities. Store in vault used only for the purpose of storage of drugs of addiction. Vault must be locked at all times except when the materials stored therein are required. Section 8 - EXPOSURE CONTROLS / PERSONAL PROTECTION EXPOSURE CONTROLS Source Material TWA TWA STEL STEL Peak Peak TWA Notes ppm mg/m³ ppm mg/m³ ppm mg/m³ F/CC Australia glycerol 10 (see Chapter 14) Exposure (Glycerin mist Standards (a)) The following materials had no OELs on our records

4 Page 4 of 9 Section 8 - EXPOSURE CONTROLS / PERSONAL PROTECTION morphine hydrochloride: CAS: CAS: citric acid: CAS: sodium citrate: CAS: CAS: CAS: methyl paraben, sodium salt: CAS: water: CAS: MATERIAL DATA CITRIC ACID: GLYCEROL: METHYL PARABEN, SODIUM SALT: MORPHINE HYDROCHLORIDE: PFIZER MORPHINE HYDROCHLORIDE ORAL SOLUTION: Sensory irritants are chemicals that produce temporary and undesirable side-effects on the eyes, nose or throat. Historically occupational exposure standards for these irritants have been based on observation of workers' responses to various airborne concentrations. CITRIC ACID: METHYL PARABEN, SODIUM SALT: MORPHINE HYDROCHLORIDE: SODIUM CITRATE: It is the goal of the ACGIH (and other Agencies) to recommend TLVs (or their equivalent) for all substances for which there is evidence of health effects at airborne concentrations encountered in the workplace. At this time no TLV has been established, even though this material may produce adverse health effects (as evidenced in animal experiments or clinical experience). NOTE: The ACGIH occupational exposure standard for Particles Not Otherwise Specified (P.N.O.S) does NOT apply. MORPHINE HYDROCHLORIDE: Airborne particulate or vapour must be kept to levels as low as is practicably achievable given access to modern engineering controls and monitoring hardware. Biologically active compounds may produce idiosyncratic effects which are entirely unpredictable on the basis of literature searches and prior clinical experience (both recent and past). CEL TWA 0.17 mg/m3 ; STEL 0.51 mg/m3 as free base [Tas Alkaloids] GLYCEROL: The mist is considered to be a nuisance particulate which appears to have little adverse effect on the lung and does not produce significant organic disease or toxic effects. OSHA concluded that the nuisance particulate limit would protect the worker form kidney damage and perhaps, testicular effects. WATER: No exposure limits set by NOHSC or ACGIH. PERSONAL PROTECTION RESPIRATOR Type A-P Filter of sufficient capacity. (AS/NZS 1716 & 1715, EN 143:2000 & 149:2001, ANSI Z88 or national equivalent) EYE Safety glasses with side shields Chemical goggles. Contact lenses may pose a special hazard; soft contact lenses may absorb and concentrate irritants. A written policy document, describing the wearing of lens or restrictions on use, should be created for each workplace or task. This should include a review of lens absorption and adsorption for the class of chemicals in use and an account of injury experience. Medical and first-aid personnel should be trained in their removal and suitable equipment should be readily available. In the event of chemical exposure, begin eye irrigation immediately and remove contact lens as soon as practicable. Lens should be removed at the first signs of eye redness or irritation - lens should be removed in a clean environment only after workers have washed hands thoroughly. [CDC NIOSH Current Intelligence Bulletin 59], [AS/NZS 1336 or national equivalent]. HANDS/FEET The selection of the suitable gloves does not only depend on the material, but also on further marks of quality which vary from manufacturer to manufacturer. Where the chemical is a preparation of several substances, the resistance of the glove material can

5 Page 5 of 9 Section 8 - EXPOSURE CONTROLS / PERSONAL PROTECTION not be calculated in advance and has therefore to be checked prior to the application. The exact break through time for substances has to be obtained from the manufacturer of the protective gloves and has to be observed when making a final choice. Suitability and durability of glove type is dependent on usage. Important factors in the selection of gloves include:. Wear chemical protective gloves, eg. PVC. Wear safety footwear or safety gumboots, eg. Rubber. OTHER Overalls. P.V.C. apron. Barrier cream. Skin cleansing cream. ENGINEERING CONTROLS Engineering controls are used to remove a hazard or place a barrier between the worker and the hazard. Well-designed engineering controls can be highly effective in protecting workers and will typically be independent of worker interactions to provide this high level of protection. The basic types of engineering controls are: Process controls which involve changing the way a job activity or process is done to reduce the risk. Enclosure and/or isolation of emission source which keeps a selected hazard "physically" away from the worker and ventilation that strategically "adds" and "removes" air in the work environment. Section 9 - PHYSICAL AND CHEMICAL PROPERTIES APPEARANCE Clear, colourless or pale yellow liquid. PHYSICAL PROPERTIES Liquid. State Liquid Molecular Weight Not Applicable Melting Range ( C) Not Viscosity Not Boiling Range ( C) Not Solubility in water (g/l) Not Flash Point ( C) Not ph (1% solution) Not Decomposition Temp ( C) Not ph (as supplied) Not Autoignition Temp ( C) Not Vapour Pressure (kpa) Not Upper Explosive Limit (%) Not Specific Gravity (water=1) Not Lower Explosive Limit (%) Not Relative Vapour Density Not (air=1) Volatile Component (%vol) Not Evaporation Rate Not Section 10 - STABILITY AND REACTIVITY CONDITIONS CONTRIBUTING TO INSTABILITY Presence of incompatible materials. Product is considered stable. Hazardous polymerisation will not occur. For incompatible materials - refer to Section 7 - Handling and Storage. Section 11 - TOXICOLOGICAL INFORMATION POTENTIAL HEALTH EFFECTS ACUTE HEALTH EFFECTS SWALLOWED Morphine and other analgesics cause nausea, vomiting, constipation, drowsiness and confusion. Urination can be difficult, and the bowel and bile ducts can spasm. They also cause dry mouth, pin point pupils, sweating, flushing, vertigo, slow and shallow breathing, weak pulse, blue-grey skin (cyanosis), palpitations, low blood pressure, low temperature, restlessness, and mood

6 Page 6 of 9 Section 11 - TOXICOLOGICAL INFORMATION changes. Acute toxic effects include lung swelling, spasticity, muscle twitching and unconsciousness. Increased pressure in the head may occur. Larger doses can cause depression of breathing and low blood pressure, with failure of circulation and deepening coma. Failure of breathing can cause death. As the analgesia (loss of sensation) wears off, sensitivity to pain is increased. Higher doses produce stiffening of the muscles and depression of the central nervous system; this can progress to stupor, sedation, unconsciousness and coma. The blood vessels may dilate, causing flushing of the face, neck and upper chest, and lowering of the blood pressure, resulting in fainting. Serious effects due to toxicity to the heart include high blood pressure, irregular heart rhythms, shock, acute heart failure and stoppage. Hypersensitive reactions can occur, producing rashes, itch, bleeding, and blistering. Digestive effects include constipation, impaction of the bowel with faeces and cramps. Urine movements may become less frequent. There may be liver abnormalities, and the liver may be enlarged and tender to touch. The material has NOT been classified by EC Directives or other classification systems as "harmful by ingestion". This is because of the lack of corroborating animal or human evidence. The material may still be damaging to the health of the individual, following ingestion, especially where pre-existing organ (eg. liver, kidney) damage is evident. Present definitions of harmful or toxic substances are generally based on doses producing mortality rather than those producing morbidity (disease, ill-health). Gastrointestinal tract discomfort may produce nausea and vomiting. In an occupational setting however, ingestion of insignificant quantities is not thought to be cause for concern. EYE Although the liquid is not thought to be an irritant (as classified by EC Directives), direct contact with the eye may produce transient discomfort characterised by tearing or conjunctival redness (as with windburn). SKIN The material is not thought to produce adverse health effects or skin irritation following contact (as classified by EC Directives using animal models). Nevertheless, good hygiene practice requires that exposure be kept to a minimum and that suitable gloves be used in an occupational setting. Contact dermatitis has been reported with morphine and other narcoticanalgesics. Open cuts, abraded or irritated skin should not be exposed to this material. Entry into the blood-stream, through, for example, cuts, abrasions or lesions, may produce systemic injury with harmful effects. Examine the skin prior to the use of the material and ensure that any external damage is suitably protected. INHALED The material is not thought to produce adverse health effects or irritation of the respiratory tract (as classified by EC Directives using animal models). Nevertheless, good hygiene practice requires that exposure be kept to a minimum and that suitable control measures be used in an occupational setting. CHRONIC HEALTH EFFECTS Strong evidence exists that this substance may cause irreversible mutations (though not lethal) even following a single exposure. Ample evidence exists, from results in experimentation, that developmental disorders are directly caused by human exposure to the material. Laboratory (in vitro) and animal studies show, exposure to the material may result in a possible risk of irreversible effects, with the possibility of producing mutation. Chronic morphine poisoning or addiction causes pin-point pupils, rapid mood changes and poor social adaptation. As dependence and tolerance occurs, there is an overwhelming need to continue taking the drug or similar drugs and to increase the dose. Prolonged therapy or abuse may cause abnormal lung function, increased body temperature, and kidney failure. Withdrawal symptoms can last for months. Abrupt withdrawal of the opiates may produce yawning, dilated pupils, tears, runny nose, sneezing, muscle tremor, headache, weakness, sweating, anxiety, irritability, disturbed sleep or insomnia, restlessness, orgasm, loss of appetite, nausea, vomiting, loss of weight, diarrhoea, dehydration, increase in the number of white blood cells, bone pain, abdominal and muscle cramps, increase in heart rate, breathing rate and blood pressure, rise in temperature and gooseflesh and blood vessel dilation or constriction. TOXICITY AND IRRITATION No significant acute toxicological data identified in literature search. Section 12 - ECOLOGICAL INFORMATION No data Ecotoxicity Ingredient Persistence: Persistence: Air Bioaccumulation Mobility Water/Soil morphine hydrochloride No Data No Data

7 Page 7 of 9 Section 12 - ECOLOGICAL INFORMATION glycerol LOW No Data LOW HIGH citric acid LOW No Data LOW HIGH sodium citrate No Data No Data methyl paraben, sodium salt No Data No Data Section 13 - DISPOSAL CONSIDERATIONS Containers may still present a chemical hazard/ danger when empty. Return to supplier for reuse/ recycling if possible. Otherwise: If container can not be cleaned sufficiently well to ensure that residuals do not remain or if the container cannot be used to store the same product, then puncture containers, to prevent re-use, and bury at an authorised landfill. Where possible retain label warnings and MSDS and observe all notices pertaining to the product. Legislation addressing waste disposal requirements may differ by country, state and/ or territory. Each user must refer to laws operating in their area. A Hierarchy of Controls seems to be common - the user should investigate: Reduction. DO NOT allow wash water from cleaning or process equipment to enter drains. It may be necessary to collect all wash water for treatment before disposal. In all cases disposal to sewer may be subject to local laws and regulations and these should be considered first. Where in doubt contact the responsible authority. Valuable substance, hold all residues for recovery. Disposal of the material must be carried out in accordance with the requirements of the relevant Federal/State Act(s) or Code(s) regulating the disposal of Drugs of Addiction. Consult manufacturer/supplier for recycling options. Decontaminate empty containers with water; incinerate plastic bags. Recycle wherever possible. Consult manufacturer for recycling options or consult local or regional waste management authority for disposal if no suitable treatment or disposal facility can be identified. Dispose of by: burial in a land-fill specifically licenced to accept chemical and / or pharmaceutical wastes or incineration in a licenced apparatus (after admixture with suitable combustible material). Decontaminate empty containers. Observe all label safeguards until containers are cleaned and destroyed. Section 14 - TRANSPORTATION INFORMATION HAZCHEM: None (ADG7) NOT REGULATED FOR TRANSPORT OF DANGEROUS GOODS: UN, IATA, IMDG Section 15 - REGULATORY INFORMATION POISONS SCHEDULE None REGULATIONS Regulations for ingredients morphine hydrochloride (CAS: , ) is found on the following regulatory lists; "Australia - Australian Capital Territory - Environment Protection Regulation: Ambient environmental standards (Domestic water supply - inorganic chemicals)", "Australia - Australian Capital Territory - Environment Protection Regulation: Ambient environmental standards (STOCK - inorganic chemicals)", "Australia - Australian Capital Territory - Environment Protection Regulation: Pollutants entering waterways taken to cause environmental harm (Domestic water supply quality)", "Australia -

8 Page 8 of 9 Section 15 - REGULATORY INFORMATION Australian Capital Territory - Environment Protection Regulation: Pollutants entering waterways taken to cause environmental harm (IRRIG)", "Australia - Australian Capital Territory - Environment Protection Regulation: Pollutants entering waterways taken to cause environmental harm (STOCK)", "Australia Drinking Water Guideline Values For Physical and Chemical Characteristics", "Australia Inventory of Chemical Substances (AICS)", "Australia Narcotic Drugs Act - Schedule I Drugs", "Australia National Pollutant Inventory", "United Nations List of Narcotic Drugs Under International Control - Section 1", "WHO Guidelines for Drinking-water Quality - Chemicals for which guideline values have not been established" glycerol (CAS: ) is found on the following regulatory lists; "Australia Exposure Standards", "Australia High Volume Industrial Chemical List (HVICL)", "Australia Inventory of Chemical Substances (AICS)", "Australia National Pollutant Inventory", "Australia Therapeutic Goods Administration (TGA) Substances that may be used as active ingredients in Listed medicines", "CODEX General Standard for Food Additives (GSFA) - Additives Permitted for Use in Food in General, Unless Otherwise Specified, in Accordance with GMP", "GESAMP/EHS Composite List - GESAMP Hazard Profiles", "IMO IBC Code Chapter 17: Summary of minimum requirements", "IMO IBC Code Chapter 18: List of products to which the Code does not apply", "IMO MARPOL 73/78 (Annex II) - List of Other Liquid Substances", "International Council of Chemical Associations (ICCA) - High Production Volume List", "International Fragrance Association (IFRA) Survey: Transparency List", "OECD List of High Production Volume (HPV) Chemicals" citric acid (CAS: ) is found on the following regulatory lists; "Australia High Volume Industrial Chemical List (HVICL)", "Australia Inventory of Chemical Substances (AICS)", "Australia National Pollutant Inventory", "Australia Therapeutic Goods Administration (TGA) Substances that may be used as active ingredients in Listed medicines", "CODEX General Standard for Food Additives (GSFA) - Additives Permitted for Use in Food in General, Unless Otherwise Specified, in Accordance with GMP", "GESAMP/EHS Composite List - GESAMP Hazard Profiles", "IMO IBC Code Chapter 17: Summary of minimum requirements", "IMO MARPOL 73/78 (Annex II) - List of Noxious Liquid Substances Carried in Bulk", "International Council of Chemical Associations (ICCA) - High Production Volume List", "International Fragrance Association (IFRA) Survey: Transparency List", "OECD List of High Production Volume (HPV) Chemicals", "OSPAR National List of Candidates for Substitution Norway", "United Nations Consolidated List of Products Whose Consumption and/or Sale Have Been Banned, Withdrawn, Severely Restricted or Not Approved by Governments" sodium citrate (CAS: , , ) is found on the following regulatory lists; "Australia Inventory of Chemical Substances (AICS)", "Australia National Pollutant Inventory", "Australia Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) - Schedule 4", "CODEX General Standard for Food Additives (GSFA) - Additives Permitted for Use in Food in General, Unless Otherwise Specified, in Accordance with GMP", "GESAMP/EHS Composite List - GESAMP Hazard Profiles", "International Council of Chemical Associations (ICCA) - High Production Volume List", "International Fragrance Association (IFRA) Survey: Transparency List", "OECD List of High Production Volume (HPV) Chemicals" methyl paraben, sodium salt (CAS: ) is found on the following regulatory lists; "Australia Inventory of Chemical Substances (AICS)", "Australia National Pollutant Inventory" water (CAS: ) is found on the following regulatory lists; "Australia Inventory of Chemical Substances (AICS)", "IMO IBC Code Chapter 18: List of products to which the Code does not apply", "International Fragrance Association (IFRA) Survey: Transparency List", "OECD List of High Production Volume (HPV) Chemicals", "OSPAR National List of Candidates for Substitution Norway" No data for Pfizer Morphine Hydrochloride Oral Solution (CW: ) Section 16 - OTHER INFORMATION Denmark Advisory list for selfclassification of dangerous substances Substance CAS Suggested codes morphine hydrochloride Carc3; R40 Mut3; R68 Rep3; R63 Xn; R22 sodium citrate Xn; R22 sodium citrate Xn; R22 methyl paraben, sodium salt Mut3; R68 INGREDIENTS WITH MULTIPLE CAS NUMBERS Ingredient Name CAS morphine hydrochloride , sodium citrate , , Classification of the preparation and its individual components has drawn on official and authoritative sources as well as

9 Page 9 of 9 Section 16 - OTHER INFORMATION independent review by the Chemwatch Classification committee using available literature references. A list of reference resources used to assist the committee may be found at: The (M)SDS is a Hazard Communication tool and should be used to assist in the Risk Assessment. Many factors determine whether the reported Hazards are Risks in the workplace or other settings. This document is copyright. Apart from any fair dealing for the purposes of private study, research, review or criticism, as permitted under the Copyright Act, no part may be reproduced by any process without written permission from CHEMWATCH. TEL (+61 3) Issue Date: 23-Jan-2012 Print Date: 6-Aug-2012 This is the end of the MSDS.