General Information
Revision date
2015-07-10
Product name
Generic brand
Chemical name
Mixture - contains an oripavine derivative
CAS No.
53152-21-9
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 pain mixture and uses
Emergency telephone
(24-hour availability
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 drug product, packaged in vials. Globally Harmonized Not classified System [GHS] SECTION 2 - HAZARDS IDENTIFICATION …continued
Hazard statements
None required None required
Signal word
None required
Precautionary statements
None required
2.3 Other hazards
Buprenorphine hydrochloride ("Buprenorphine") is an opioid analgesic compound. Common adverse effects reported with clinical use include gastrointestinal (GI) (nausea, vomiting, constipation, dry mouth) and CNS (e.g. drowsiness, lightheadedness, headaches, confusion, euphoria, hallucinations, blurred vision) effects. Skin rash and irritation were reported following transdermal patch use. Severe effects on the cardiovascular (heart attack) and respiratory (respiratory depression) systems have also occurred, usually with overdose. Hypersensitivity (allergic) reactions were also reported. Buprenorphine is a narcotic. Although it has a lower potential for dependence than morphine, its use can lead to some psychological dependence and abuse, and minor withdrawal symptoms may occur upon abrupt cessation of a prolonged exposure. Neonatal withdrawal symptoms were reported in infants born to mothers treated with buprenorphine during pregnancy. Note This mixture does not meet criteria for classification under GHS as implemented by Regulation EC No 1272/2008 (EU CLP) and Hazard Communication Standard No. 1910.1200 (US OSHA). Nevertheless, it should be handled with caution as it is pharmacologically active.
