DILATREND Tablets 6.25 mg

Transcription

1 Safety Data Sheet 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 SAP Relevant identified uses of the substance or mixture and uses advised against Use pharmaceutical active substance (βadrenoceptor antagonist) * 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/ 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 Environmental Hazards: 4.1 Hazardous to the aquatic environment (Category 3) H412 Harmful to aquatic life with long lasting effects. Precautionary statements: P273 Avoid release to the environment Other hazards Page: 1/7

2 SECTION 3: Composition/information on ingredients Characterization Synonyms mixture of 6.25% with excipients for longterm therapy of different cardiovascular disorders substituted carbazolyl compound *1 Eucardic Ingredient Concentration GHSClassification (pure ingredient) Lactose monohydrate Sucrose % Hazardous to the aquatic environment (Category 2), H % % Povidone 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 remove immediately contaminated clothes, wash affected skin with water and soap do not use any solvents remove the casualty to fresh air 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: 2/7

3 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 no particular hazards known 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 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 aluminium, glass, tested plastics 7.2. Conditions for safe storage, including any incompatibilities Storage conditions below 30 C protected from light and humidity Validity Packaging materials 36 months, < 30 C, see "best use before" date stated on the label polyethylene bag in metal drum blister packages tightly closing; material: stainless steel (lined with polyethylene bag) Page: 3/7

4 SECTION 8: Exposure controls/personal protection 8.1. Control parameters Threshold value (Roche) air IOEL (Internal Occupational Exposure Limit): mg/m3 * 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 yellow round, biplanar tablet Solubility 14.7 mg/l, water (~ 22 C, HPLC, 24 h) *1 430 mg/l, phosphate buffer (37 C, ph 4.0) * mg/l, methanol *1 > 200 g/l, DMSO (dimethyl sulfoxide) *1 Partition coefficient log P ow 4.19 (octanol/water) *1 Melting temperature 117 to 120 C * Other information SECTION 10: Stability and reactivity Reactivity Chemical stability Page: 4/7

5 10.3. Possibility of hazardous reactions Conditions to avoid Conditions to avoid warming light humidity Incompatible materials Hazardous decomposition products SECTION 11: Toxicological information Information on toxicological effects Acute toxicity LD 50 > mg/kg (oral, rat) *1 LD 50 > mg/kg (oral, mouse) *1 Chronic toxicity NOAEL 100 mg/kg/d (oral, rat; 3 months) *1 Local effects Sensitization Mutagenicity not mutagenic (various in vivo and in vitro test systems) *1 Carcinogenicity not carcinogenic (rat) *1 not carcinogenic (mouse) *1 Reproductive toxicity not teratogenic *1 does not lower parental fertility *1 STOTsingle exposure STOTrepeated exposure Aspiration hazard therapeutic dose: 12.5 to 100 mg/d *1 elimination halflife: 6 to 7 h *1 overdosing results in increase of therapeutical effects: hypotension, bradycardia *1 possible side effects: dizziness, headache, tiredness *1 Page: 5/7

6 may cause dyspnoea attacks in asthmatics *1 SECTION 12: Ecological information Toxicity Ecotoxicity strongly toxic for algae (Scenedesmus (=Desmodesmus) subspicatus) ErC 50 (72 h) 1.48 mg/l (nominal concentration) NOEC (72 h) 0.5 mg/l (nominal concentration) (OECD No. 201) *1 acute fish toxicity in a limit test is lower than daphnid or algal toxicity, hence not relevant for classification (guppy) LC 50 (96 h) > 1.34 mg/l (nominal concentration) LC 0 (96 h) 0.81 mg/l (average measured concentration) (OECD No. 203) *1 strongly toxic for planktonic crustaceans (Daphnia magna) EC 50 (48 h) 7.38 mg/l (average measured concentration) NOEC (48 h) 0.89 mg/l (average measured concentration) (OECD No. 202) *1 no adverse influence on substrate biodegradation (activated sludge) concentration (28 d) 100 mg/l (nominal concentration) (Manometric Respirometry Test, OECD No. 301 F) * Persistence and degradability Ready biodegradability not readily biodegradable 0 %, 28 d (Manometric Respirometry Test, OECD No. 301 F) * Bioaccumulative potential Mobility in soil Mobility strong adsorption (Adsorption to activated sludge in biodegradability test) * Results of PBT and vpvb assessment Other adverse effects Page: 6/7

7 SECTION 13: Disposal considerations Waste treatment methods Waste from residues return to supplier or hand over to authorised disposal company observe local/national regulations regarding waste disposal incinerate in qualified installation with flue gas scrubbing medicines should not be disposed of via wastewater 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) 2: clearly hazardous to water (according to directive AwSV of ) SECTION 16: Other information Full text of HStatements referred to under section 3 H411 Toxic to aquatic life with long lasting effects. Edition documentation changes from previous version in sections 12 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