General Information
Revision date
2014-11-25
Product name
None identified
1.2.1 Relevant identified uses
Bulk formulated pharmaceutical mixture/formulated pharmaceutical product of the substance or packaged in final form for veterinary use; indicated as a sedative and analgesic for mixture and uses cats and dogs
Emergency telephone
+1 (866) 683-0660 (General inquiries
Icons in SDS
Company Information
company name
Putney
e-mail address of the competent person responsible for the Safety Data Sheet
customersupport@putneyvet.com
GHS Information
Signal word
None
Section 2
2.1 Classification of the substance or mixture
Drugs in the finished state and intended for the final user are not subject to labeling in the US, EU or Canada. Please consult the prescribing/packaging information. The classification and labelling listed below is for bulk Dexmedetomidine Hydrocholoride Sterile Injectable Solution Regulation (EC) 1272/ Not classified 2008 [GHS] SECTION 2 - HAZARDS IDENTIFICATION …continued Directive 67/548/EEC Not classified or 1999/45/EC
CLP CLASSIFICATION
None required None required
Signal word
None required Attention US Hazard overview None required Note This mixture is not classified as dangerous/hazardous according to directive 1999/ 45/EC, Regulation EC No 1272/2008 (EU CLP), and applicable US regulations. See Section 16 for full text of EU and GHS classifications. The EU symbol/ indicator of danger, R Phrases and Safety Advice are based on Directive 67/548/ EEC or 1999/45/EC. The GHS classifications are based on Regulation (EC) 1272/ 2008. See Section 16 for full text of EU and GHS classifications.
Hazard statements
CLP/GHS None required
Precautionary statements
EU symbol/indication None required of danger Risk (R) Phrase(s) None required None required
2.3 Other hazards
Dexmedetomidine hydrochloride is an α2-adrenergic agonist with potent sedative properties. The most common adverse effects reported with clinical use of mixtures containing dexmedetomidine are hypotension, bradycardia, and dry mouth. Other adverse effects include transient hypertension, fever, hypoxia, and anemia, and tachycardia episodes. Symptoms of withdrawal (e.g., nausea, vomiting, and agitation) have been reported following discontinuation after 7 days of repeated administration.
