General Information
Version
4.4
Revision date
2025-06-05
Product name
Metalyse , Lyophilisate with aqueous solution for infusion
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
Warning
Hazard Codes
Hazard statements (CLP)
H361d
Hazard statements
Code
Statements
H361d
Suspected of damaging the unborn child
Section 2
SECTION 2: Hazards identification
Regulation (EC) No. 1272/2008 Classification of the substance or mixture
Signal word
Warning
Hazard statements
H361d Suspected of damaging the unborn child.
Prevention
P201 Obtain special instructions before use. P202 Do not handle until all safety precautions have been read and understood. P280 Wear protective gloves/ protective clothing/ eye protection/ face protection/ hearing protection.
Response
P308 + P313 IF exposed or concerned: Get medical advice/ attention.
Storage
P405 Store locked up.
Disposal
P501 Dispose of contents/ container to an approved waste disposal plant.
Hazardous Ingredients
Tenecteplase
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) Reproductive toxicity, Category 2 H361d: Suspected of damaging the unborn child.
