Note: Ingredients listed on restricted chemical lists
EC/CAS
7647-01-0
Name of the chemical
Hydrochloric acid
Concentration
N/A
EC/CAS
9005-25-8
Name of the chemical
Starch
Concentration
N/A
EC/CAS
77-92-9
Name of the chemical
Citric acid
Concentration
N/A
EC/CAS
69-65-8
Name of the chemical
D-mannitol C6H14O6
Concentration
N/A
EC/CAS
7732-18-5
Name of the chemical
Water, distilled, conductivity or of similar purity H2O
Concentration
N/A
EC/CAS
50-99-7
Name of the chemical
Glucose C6H12O6
Concentration
N/A
General Information
Revision date
2014-09-02
Product name
Temgesic / Buprenex / Buprex 0.3 mg/ml, 1 ml Injection
Product Synonyms
Buprenorphine Injection
1.2.1 Relevant identified uses
Relief of moderate to severe pain Appearance Injection - Colourless liquid in glass ampoules Sublingual Tablets - White, to creamy white, tablets in blister pack
Manufacturer Name
RB Healthcare UK Limited
Emergency telephone
CONTACT A MEDICAL PRACTITIONER OR
Icons in SDS
Company Information
company name
RB Pharmaceuticals Ltd
e-mail address of the competent person responsible for the Safety Data Sheet
pharmacovigilanceUS@rb.com, rbp-pv-infomed@rbp.com
Section 2
SECTION 2: Hazards identification
OSHA Caution This is a clear, colourless, sterile injection or a white, to creamy white, sublingual tablet, that has potential adverse health effects if abused by routes other than the intended medical application. Emergency Overview Buprenorphine Hydrochloride is a potent opiate type of analgesic. Precautions must be taken and procedures adopted to prevent excessive exposure. The side effects of buprenorphine exposure include: respiratory depression, nausea/vomiting, dizziness, pinpoint pupils, euphoria, headache, sweating and drowsiness. OSHA Regulatory Status: While this material is not considered hazardous by the OSHA Hazard Communication Standard (29 CFR 1910.1200), this MSDS contains valuable information critical to the safe handling and proper use of the product. This MSDS should be retained and available for employees and other users of this product.
Potential health effects
Eyes: May cause redness, irritation, pupillary constriction, and/or allergic reaction. Skin: Prolonged exposure may cause sedation, respiratory depression, nausea, vomiting, and/or allergic reaction. Inhalation: May cause sedation, respiratory depression, nausea, vomiting, and/or allergic reaction. Ingestion: May cause sedation, respiratory depression, nausea, vomiting, and/or allergic reaction.
Medical Conditions Generally Aggravated by Exposure
Compromised respiratory function (such as chronic obstructive pulmonary disease, cor pulmonale, decreased respiratory reserve or pre-existing respiratory depression), increased intracranial pressure, impairment of hepatic function, impairment of renal function, hypothyroidism, adrenal cortical insufficiency, CNS depression, toxic psychosis, prostatic hypertrophy or urethral stricture, acute alcoholism, delirium tremens and kyphoscoliosis. Carcinogenicity: this product does not contain any carcinogens or potential carcinogens as listed by OSHA, IARC, or NTP.
Environmental effects
An accidental spill of product does not pose a significant environmental hazard (See Section 6).
