Note: Ingredients listed on restricted chemical lists
EC/CAS
201-766-0/87-69-4
Name of the chemical
L-(+)-tartaric acid
Concentration
>=30-<50
General Information
Version
3.0
Revision date
2022-12-15
Product name
Pradaxa Capsules
Product Synonyms
Pradaxa® Capsules 50 mg, 75 mg, 110 mg and 150 mg
1.2.1 Relevant identified uses
Pharmaceutical
1.2.2. Uses advised against
Safety Data Sheet only for the professional user on use
Emergency telephone
+498007790900, +1 703-527-3887, +49800 1817059
Icons in SDS
Company Information
company name
Boehringer Ing. Pharma GmbH & Co. KG
e-mail address of the competent person responsible for the Safety Data Sheet
EHS-Services@Boehringer-Ingelheim.com
GHS Information
Signal word
Danger
Hazard Codes
Hazard statements (CLP)
H318
Hazard statements
Code
Statements
H318
Causes serious eye damage
Section 2
SECTION 2: Hazards identification
Regulation (EC) No. 1272/2008 Classification of the substance or mixture
Signal word
Danger
Hazard statements
H318 Causes serious eye damage.
Prevention
P280 Wear eye protection/ face protection.
Response
P305 + P351 + P338 + P310 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if pre- sent and easy to do. Continue rinsing. Immediately call a POISON CENTER/ doctor.
Hazardous Ingredients
(+)-tartaric acid
Additional information
EUH212 Warning! Hazardous respirable dust may be formed when used. Do not breathe dust.
2.3 Other hazards
This substance/mixture contains no components considered to be either persistent, bioaccumula- tive and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher.
ECOLOGICAL INFORMATION
The substance/mixture does not contain components considered to have endocrine disrupting properties according to REACH Article 57(f) or Commission Delegated regu- lation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher.
TOXICOLOGICAL INFORMATION
The substance/mixture does not contain components considered to have endocrine disrupting properties according to REACH Article 57(f) or Commission Delegated regulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher. This drug is not subject to the labelling requirements under the Globally Harmonized System (GHS) The pharmacological effect of the medicament has to be considered (see package leaflet).
2.1 Classification of the substance or mixture
Classification (REGULATION (EC) No 1272/2008) Serious eye damage, Category 1 H318: Causes serious eye damage.
