General Information
Version
1.0
Revision date
2015-10-09
Product name
Tresiba 100 U/ml, 200 U/ml
Product name
Tresiba 100 U/ml, 200 U/ml
Identification on the label/Trade name
Source Solution
1.2.1 Relevant identified uses
Drug Product. Tresiba® is a long-acting basal insulin called insulin degludec. It is used to treat diabetes mellitus in patients one year of age or older
Icons in SDS
Company Information
company name
Novo Nordisk
GHS Information
Signal word
Danger
Hazard Codes
Hazard statements (CLP)
H317, H370
Hazard statements
Code
Statements
H317
May cause an allergic skin reaction
Section 2
SECTION 2: Hazards identification
Classification (GHS-US) Classification of the substance or mixture Classification (GHS-US) Skin Sens. 1 H317 STOT SE 1 H370 Full text of H-phrases: see section 16
2.2 Label elements
GHS-US labeling
Hazard pictograms
GHS07 GHS08
Signal word
Danger
Hazard statements
H317 - May cause an allergic skin reaction H370 - Causes damage to organs (circulatory system, circulatory organs)
Precautionary statements
P260 - Do not breathe mist P261 - Avoid breathing mist P264 - Wash hands thoroughly after handling P270 - Do not eat, drink or smoke when using this product P272 - Contaminated work clothing must not be allowed out of the workplace P280 - Wear appropriate PPE P302 + P352 - If on skin: Wash with plenty of soap and water P307 + P311 - If exposed: Call a poison center/doctor P333+P313 - If skin irritation or rash occurs: Get medical advice/attention P362+P364 - Take off contaminated clothing and wash it before reuse P405 - Store locked up P501 - Dispose of contents/container to comply with local/regional/national/international regulations
Other hazards which do not result in classification
Inactive ingredients include: glycerol, metacresol, phenol, zinc, hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injections. Inadvertent needle sticks may pose the risk of blood borne pathogens. 09/10/2015 EN (English) Page 1
Ingredient(s) with unknown acute toxicity
No data available
2.1 Classification of the substance or mixture
Classification (GHS-US) Skin Sens. 1 H317 STOT SE 1 H370 Full text of H-phrases: see section 16
