General Information
Version
2.0
Revision date
2021-12-08
Product name
Prascend tablets (pergolide mesylate) Tablets, 1 mg
Product Synonyms
with API: Pergolide mesylate <= 0.33 %
1.2.1 Relevant identified uses
Pharmaceutical
1.2.2. Uses advised against
Safety Data Sheet only for the professional user., For veteri- on use nary use only, Refer to the product insert for complete instruc- tions on usage
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
Hazard Codes
Hazard statements (CLP)
H362
Hazard statements
Code
Statements
H362
May cause harm to breast-fed children
Section 2
SECTION 2: Hazards identification
Regulation (EC) No. 1272/2008 Classification of the substance or mixture
Hazard statements
H362 May cause harm to breast-fed children.
Prevention
P201 Obtain special instructions before use. P202 Do not handle until all safety precautions have been read and understood. P260 Do not breathe dust. P263 Avoid contact during pregnancy and while nursing. P264 Wash skin thoroughly after handling.
Response
P308 + P313 IF exposed or concerned: Get medical advice/ attention.
Hazardous Ingredients
Pergolide methanesulfonate
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) Effects on or via lactation H362: May cause harm to breast-fed children.
