Note: Ingredients listed on restricted chemical lists
EC/CAS
57-15-8
Name of the chemical
Chlorobutanol
Concentration
N/A
EC/CAS
200-317-6
Name of the chemical
Chlorobutanol
Concentration
N/A
General Information
Revision date
2014-10-02
Product name
VasostrictTM
Chemical name
Mixture - contains a synthetic peptide
1.2.1 Relevant identified uses
Bulk formulated pharmaceutical mixture/Formulated pharmaceutical product of the substance or packaged in final form for patient use; indicated to treat residual hypotension in mixture and uses adults with vasodilatory shock
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 labeling listed below is for bulk Vasopressin Injection. 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 None required US Hazard overview None required Note This mixture does not meet criteria for classification according to directive 1999/ 45/EC and Regulation EC No 1272/2008 (EU CLP). Nevertheless, it should be regarded as dangerous/hazardous because it contains a pharmacologically active substance and should be handled with care. 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
Vasopressin is a potent antidiuretic and vasoconstricting agent. The most common adverse effects reported with use (up to ~100 µg/day) include marked pallor, pounding headache, vertigo, sweating, tremor, and gastrointestinal disturbances (nausea, vomiting, diarrhea, burping, cramps, and a desire to defecate). Women reported uterine cramps/contractions. A syndrome similar to water intoxication (characterized by listlessness, drowsiness, headache, and confusion, with subsequent seizures, coma, and death) has also been reported. Consistent with its activity, the drug may increase blood pressure, slow heart rate, and instigate other cardiovascular effects (e.g., heart block, minor arrhythmias, coronary insufficiency, and heart attack). Hypersensitivity reactions have also occurred. Based on its ability to cause uterine contractions and non-clinical study results described below, vasopressin may adversely affect pregnancy and/or a developing fetus.
