DORMICUM Ampoules 5 mg/5 ml

Transcription

1 Safety Data Sheet DORMICUM Ampoules 5 mg/5 ml according to Regulation (EU) nr. 1907/2006 SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product name Product code DORMICUM Ampoules 5 mg/5 ml SAP Relevant identified uses of the substance or mixture and uses advised against Use pharmaceutical active substance (shortacting hypnotic) * Details of the supplier of the safety data sheet Company information Enquiries: F. HoffmannLa Roche AG Postfach CH4070 Basel Switzerland Local representation: Phone +4161/ Fax +4161/ info.sds@roche.com 1.4. Emergency telephone number Emergency telephone number Phone +4161/ SECTION 2: Hazards identification 2.1. / 2.2. Classification of the substance or mixture / Label elements GHS Classification no classification and labelling according to CLP (EC Regulation 1272/2008) 2.3. Other hazards Benzodiazepines induce central nervous system depression and drowsiness. In addition, longer use may be habit forming. Hence, these compounds are also misused by addicts. *1 Page: 1/7

2 SECTION 3: Composition/information on ingredients Characterization pharmaceutical active substance in the class of benzodiazepines *1 Synonyms Dobralam *1 (INN) *1 Ingredient Concentration GHSClassification (pure ingredient) (base) Sodium chloride Hydrochloric acid 37% Sodium hydroxide mg/ml Acute toxicity (Category 4), H302 Hazardous to the aquatic environment (Category 1), H400 Hazardous to the aquatic environment (Category 1), H410 9 mg/ml 0.56 mg/ml Corrosive to metals (Category 1), H290 Skin corrosion/irritation (Category 1B), H314 Specific target organ toxicity Single exposure (Category 3), H335 < 0.1 % Corrosive to metals (Category 1), H290 Skin corrosion/irritation (Category 1A), H314 water solution suitable for injection 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 get medical treatment 4.2. Most important symptoms and effects, both acute and delayed Page: 2/7

3 4.3. Indication of any immediate medical attention and special treatment needed to physician treat symptomatically in severe cases of poisoning: Anexate i.v. SECTION 5: Firefighting measures 5.1. Extinguishing media Suitable extinguishing media adapt extinguishing media to surrounding fire conditions 5.2. Special hazards arising from the substance or mixture Specific hazards no particular hazards known 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 no special environmental precautions required 6.3. Methods and material for containment and cleaning up Methods for cleaning up collect liquids by means of sand, earth or another suitable material SECTION 7: Handling and storage 7.1. Precautions for safe handling Technical measures Suitable materials processing in closed systems, if possible superposed by inert gas (e.g. nitrogen) avoid formation of aerosols glass 7.2. Conditions for safe storage, including any incompatibilities Storage conditions Validity Packaging materials protected from light see "best use before" date stated on the label, after opening the content should be used within a short period ampoules Page: 3/7

4 SECTION 8: Exposure controls/personal protection 8.1. Control parameters Threshold value (Roche) air IOEL (Internal Occupational Exposure Limit): 100 µg/m3 (defined as 8hour timeweighted average) *1 STEL: 400 µg/m3 (defined as 15minutes timeweighted average) * Exposure controls General protective and hygiene measures Respiratory protection Hand protection Eye protection Analytics instruction of employees recommended respiratory protection not necessary during normal operations protective gloves (eg made of neoprene, nitrile or butyl rubber) safety glasses sampling on glass fibre filter and gravimetric or chemical determination *1 SECTION 9: Physical and chemical properties 9.1. Information on basic physical and chemical properties Colour Form Density colourless clear solution g/cm3 (20 C) Partition coefficient log P ow 2.73 (noctanol/water) *1 (HPLC Method, OECD No. 117) ph value 3.0 to Other information SECTION 10: Stability and reactivity Reactivity Page: 4/7

5 10.2. Chemical stability Stability does not contain any antimicrobial preservative; therefore, care must be taken to ensure the sterility of the prepared solution Possibility of hazardous reactions Conditions to avoid Conditions to avoid light Incompatible materials Hazardous decomposition products for stability reasons, the unused contents of open ampoules cannot be used and should be discarded SECTION 11: Toxicological information Information on toxicological effects Acute toxicity LD mg/kg (oral, rat) *1 LD mg/kg (i.v., rat) *1 Local effects Sensitization Mutagenicity not mutagenic (Ames test) *1 Carcinogenicity not carcinogenic *1 Reproductive toxicity not teratogenic *1 not embryotoxic *1 STOTsingle exposure STOTrepeated exposure Aspiration hazard after intake of substance within a short time (5 30 minutes, depending on the dose): tiredness and somnolence *1 dosage: 7.5 to 15 mg/d (adults) *1 elimination halflife: 1.5 to 2.5 hours *1 Page: 5/7

6 caution: alcohol potentiates the effect! *1 SECTION 12: Ecological information Toxicity Ecotoxicity moderately toxic for algae (Scenedesmus (=Desmodesmus) subspicatus) EbC 50 (72 h) 11.4 mg/l NOEbC (72 h) 3.7 mg/l (OECD No. 201) *1 strongly toxic for planktonic crustaceans (Daphnia magna) EC 50 (48 h) 7.1 mg/l EC 0 (48 h) 1.8 mg/l (OECD No. 202) *1 strongly toxic for fish (rainbow trout) LC 50 (96 h) 4.3 mg/l LC 0 (96 h) 3.2 mg/l (OECD No. 203) *1 barely inhibitory on aerobic bacterial respiration (activated sludge) EC 50 (3 h) > 100 mg/l (OECD No. 209) * Persistence and degradability Ready biodegradability not readily biodegradable 6 %, 28 days (CO 2 Evolution Test, Modified Sturm Test, OECD No. 301B) * Bioaccumulative potential Mobility in soil Results of PBT and vpvb assessment Other adverse effects Page: 6/7

7 SECTION 13: Disposal considerations Waste treatment methods Waste from residues observe local/national regulations regarding waste disposal SECTION 14: Transport information not classified as Dangerous Good according to the Dangerous Goods Regulations SECTION 15: Regulatory information Safety, health and environmental regulations/legislation specific for the substance or mixture Water hazard class (Germany) 1: weakly hazardous for water (according to annex 4 of directive VwVwS of ) SECTION 16: Other information Full text of HStatements referred to under section 3 H290 May be corrosive to metals. H302 Harmful if swallowed. H314 Causes severe skin burns and eye damage. H335 May cause respiratory irritation. H400 Very toxic to aquatic life. H410 Very toxic to aquatic life with long lasting effects. the antidote for an overdose of midazolam (or any other benzodiazepine) is flumazenil (Anexate ) *1 Edition documentation changes from previous version in sections 8 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: 7/7