LARIAM Tablets 250 mg

Transcription

1 Safety Data Sheet LARIAM Tablets 250 mg SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product name Product code LARIAM Tablets 250 mg SAP Relevant identified uses of the substance or mixture and uses advised against Use pharmaceutical active substance for malaria prevention and treatment * Details of the supplier of the safety data sheet Company information Enquiries: Roche Products Pty Limited Level 8, 3034 Hickson Road Millers Point NSW 2000 Australia Local representation: Phone Fax Emergency telephone number Emergency telephone number Phone Page: 1/9

2 SECTION 2: Hazards identification 2.1. / 2.2. Classification of the substance or mixture / Label elements GHS Classification Health Hazards: 3.1 Acute toxicity (Category 4) H332 Harmful if inhaled. 3.1 Acute toxicity (Category 4) H302 Harmful if swallowed. 3.3 Serious eye damage/eye irritation (Category 2A) H319 Causes serious eye irritation. Signalword: Warning Label: Precautionary statements: P280 Wear protective gloves/ protective clothing / eye protection / 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. P304 + P340 IF INHALED: Remove person to fresh air and keep comfortable for breathing. P312 Call a POISON CENTER/doctor/&/if you feel unwell. P273 Avoid release to the environment. Australian Remark HAZARDOUS SUBSTANCE. DANGEROUS GOODS. Poisons Schedule Schedule 4 Listed on the Australian Inventory of Chemical Substances (AICS) *2 Listed on the Australian Inventory of Chemical Substances (AICS) *3 Listed on the Australian Inventory of Chemical Substances (AICS) *4 Listed on the Australian Inventory of Chemical Substances (AICS) *5 Listed on the Australian Inventory of Chemical Substances (AICS) * Other hazards *2 *3 *4 *5 *6 Cellulose Corn starch Crospovidone Talc Magnesium stearate SECTION 3: Composition/information on ingredients Characterization contains 250 mg Mefloquine (base) in form of 274 mg Mefloquine hydrochloride UN number 3077 Page: 2/9

3 Ingredient Concentration GHSClassification (pure ingredient) Microcrystalline cellulose Lactose monohydrate % Acute toxicity (Category 4), H332 Acute toxicity (Category 4), H302 Serious eye damage/eye irritation (Category 2A), H % 10.3 % Corn starch Crospovidone Talc Magnesium stearate For the full text of the Hazard statements mentioned in this Section, see Section 16. SECTION 4: First aid measures 4.1. Description of first aid measures Eye contact Skin contact Inhalation rinse immediately with tap water for at least 20 minutes open eyelids forcibly consult a physician remove immediately contaminated clothes, wash affected skin with water and soap do not use any solvents remove the casualty to fresh air and keep him/her calm in the event of symptoms get medical treatment 4.2. Most important symptoms and effects, both acute and delayed 4.3. Indication of any immediate medical attention and special treatment needed to physician treat symptomatically Page: 3/9

4 SECTION 5: Firefighting measures 5.1. Extinguishing media Suitable extinguishing media water spray jet, dry powder, foam, carbon dioxide adapt extinguishing media to surrounding fire conditions 5.2. Special hazards arising from the substance or mixture Specific hazards substance is hazardous for water: contain firefighting wastewater formation of toxic and corrosive combustion gases (hydrogen chloride, hydrogen fluoride, nitrogen oxides) possible consider dust explosion hazard 5.3. Advice for firefighters Protection of firefighters precipitate gases/vapours/mists with water spray SECTION 6: Accidental release measures 6.1. Personal precautions, protective equipment and emergency procedures Personal precautions no special precautions required 6.2. Environmental precautions Environmental protection do not allow to enter drains or waterways if the substance reaches waters or the sewer system, inform the competent authority 6.3. Methods and material for containment and cleaning up Methods for cleaning up collect solids (avoid dust formation) and hand over to waste removal SECTION 7: Handling and storage 7.1. Precautions for safe handling Suitable materials stainless steel, enamel, glass, polyethylene 7.2. Conditions for safe storage, including any incompatibilities Storage conditions below 25 C protected from humidity Validity 36 months, 25 C Packaging materials tightly closing; material: stainless steel (lined with polyethylene bag) Page: 4/9

5 polyethylene bag in metal drum blister packages SECTION 8: Exposure controls/personal protection 8.1. Control parameters Threshold value (Roche) air IOEL (Internal Occupational Exposure Limit): 0.15 mg/m3 *1 PNEC 0.06 µg/l, based on chronic data, surface waters *1 0.6 µg/l, based on chronic data, provisional antibiotic resistance PNEC * Exposure controls Respiratory protection Hand protection Eye protection respiratory protection not necessary during normal operations Respiratory protection is recommended for dusty operations. protective gloves (eg made of neoprene, nitrile or butyl rubber) safety glasses SECTION 9: Physical and chemical properties 9.1. Information on basic physical and chemical properties Colour Form white to offwhite tablets Solubility mg/l, water (20 C) * mg/l, ethanol (20 C) * mg/l, noctanol (20 C) * mg/l, ether (20 C) *1 Partition coefficient log P ow 2.36 (noctanol/water) ph 7 *1 Melting temperature ~ 256 C (with decomposition) * Other information Page: 5/9

6 SECTION 10: Stability and reactivity Reactivity Chemical stability Possibility of hazardous reactions Conditions to avoid Conditions to avoid temperatures above 25 C humidity Incompatible materials Hazardous decomposition products SECTION 11: Toxicological information Information on toxicological effects Acute toxicity LD to 4.3 mg/l (inhal., rat, 4 h) *1 LD mg/kg (oral, rat) *1 LD mg/kg (oral, mouse) *1 Local effects skin: nonirritant (rabbit) *1 eye: irritant (rabbit) *1 Sensitization Mutagenicity not mutagenic (various test systems) *1 Carcinogenicity not carcinogenic (several species) *1 Reproductive toxicity teratogenic in animal experiments (rat, mouse); the NOEL was between 80 and 125 mg/kg per day, depending on the species *1 human experience has shown that up a full therapeutic dose mefloquine hydrochloride will produce no teratogenic effects *1 damaging to testicles (rat, 13 weeks, 46 mg/kg); no testicular damage (rhesus monkey, 13 weeks, 68 mg/kg); there is no evidence that mefloquine hydrochloride administered in therapeutic doses will impair fertility in humans *1 Page: 6/9

7 STOTsingle exposure STOTrepeated exposure Aspiration hazard dosage: treatment of malaria up to 1500 mg (orally) within 68 hours; malaria prophylaxis: 250 mg once a week, orally *1 halflife of elimination: 3 weeks (!) *1 elimination via liver and feces *1 single oral doses of 250 mg produce serum levels of about 250 ng/ml, doses of 1000 mg produce levels of about 1000 ng/ml; continuous weekly intake of 250 mg will lead to a steady state of ng/ml after 7 to 10 weeks *1 higher doses will produce nausea, dizziness, gastrointestinal irritations and in rare cases central nervous convulsions or psychotic reactions *1 SECTION 12: Ecological information Toxicity Ecotoxicity highly toxic for algae (Scenedesmus (=Desmodesmus) subspicatus) ErC 50 (72 h) mg/l (average measured concentration) EyC 50 (72 h) mg/l (average measured concentration) NOEC (72 h) mg/l (average measured concentration) (OECD No. 201) *1 highly toxic for bluegreen algae (Synechococcus leopoliensis, Cyanobacteria) ErC 50 (72 h) mg/l (average measured concentration) EyC 50 (72 h) mg/l (average measured concentration) NOEC (72 h) mg/l (average measured concentration) (OECD No. 201) *1 strongly toxic for planktonic crustaceans (Daphnia magna) EC 50 (48 h) 1.8 mg/l NOEC (48 h) 1.0 mg/l (OECD No. 202) *1 daphnid reproduction test (Daphnia magna) NOEC (21 d) 0.32 mg/l (average measured concentration) (OECD No. 211 (semistatic)) *1 strongly toxic for fish (rainbow trout) LC 50 (96 h) 2.1 mg/l NOEC (96 h) 1.5 mg/l (OECD No. 203) *1 strongly toxic for fish (Leuciscus idus) LC 50 (96 h) < 2.2 mg/l *1 strongly toxic for microorganisms (activated sludge) EC 50 (3 h) 13.7 mg/l EC 20 (3 h) 5.0 mg/l (Activated Sludge Respir. Inhib. Test, OECD No. 209) *1 Page: 7/9

8 12.2. Persistence and degradability Ready biodegradability Inherent biodegradability not readily biodegradable 0 %, 5 d (BOD5/ThOD ratio) *1 well inherently biodegradable 39 %, 1 days 88 %, 5 days 91 %, 8 days 91 %, 13 days (ZahnWellens test, OECD No. 302 B) * Bioaccumulative potential Mobility in soil Results of PBT and vpvb assessment Other adverse effects SECTION 13: Disposal considerations Waste treatment methods Waste from residues observe local/national regulations regarding waste disposal return to supplier or hand over to authorised disposal company incinerate in qualified installation with flue gas scrubbing medicines should not be disposed of via wastewater SECTION 14: Transport information IATA Class UN/ID PG PI Label III 956/956 9 Mark EHS Page: 8/9

9 IMDG Class UN PG EmS PI Label Mark III FA SF P002/IBC08 9 marine pollutant RID/ADR Class UN PG Haz.no PI Label Mark Classif. code III 90 P002/IBC08 9 EHS M7 Proper shipping name ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S. Technical name, mixture SECTION 15: Regulatory information Safety, health and environmental regulations/legislation specific for the substance or mixture Remarks regarding classification The General Administrative Regulation under the Federal Water Act on the Classification of Substances Hazardous to Water in Water Hazard Classes of 17 May 1999 has been nullified. SECTION 16: Other information Safetylab number BS1127 *1 Full text of HStatements referred to under section 3 H302 Harmful if swallowed. H319 Causes serious eye irritation. H332 Harmful if inhaled. Please note this Safety Data Sheet for the bulk product does not apply for the finished, packaged medicinal product intended for the final user. Edition documentation changes from previous version in sections 8, 12, 15 The information in this safety data sheet is based on current scientific knowledge. It should not be taken as expressing or implying any warranty concerning product characteristics. Page: 9/9