General Information
Revision date
2014-09-30
Product name
Dantrium
Product Synonyms
Dantrolene Sodium
Chemical name
Mixture containing hydrated 1-{{{5-(4-nitrophenyl)-2-furanyl}methylene}amino}- 2-4-imidazolidinedione sodium salt
CAS No.
24868-20-0
1.2.1 Relevant identified uses
Bulk formulated pharmaceutical product/ Formulated pharmaceutical product of the substance or packaged in final form for patient use; indicated for the treatment of manifestation mixture and uses of chronic muscle stiffness/tightness
Icons in SDS
Company Information
company name
Par Sterile Products
e-mail address of the competent person responsible for the Safety Data Sheet
drugsafety@parpharm.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 Dantrium® Intravenous. SECTION 2 - HAZARDS IDENTIFICATION …continued Regulation (EC) 1272/ Not classified 2008 [GHS] Directive 67/548/EEC Not classified or 1999/45/EC
CLP CLASSIFICATION
None required None required
Signal word
None required None required US Hazard overview Not classified. 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 GHS classifications are based on Regulation (EC) 1272/2008. The EU symbol/indicator of danger, R Phrases and Safety Advice are based on Directive 1999/45/EC.
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
Dantrolene is a muscle relaxant with a direct action on skeletal muscle. Commonly reported adverse effects include drowsiness, dizziness, fatigue, weakness and general tiredness. Gastrointestinal effects (diarrhea, abdominal cramps) have also been reported. Dantrolene has also been reported to cause an increase in liver enzymes and other liver effects.
