Note: Ingredients listed on restricted chemical lists
EC/CAS
13463-67-7
Name of the chemical
Reaction mass of titanium dioxide and silver chloride
Concentration
>=1-<5
EC/CAS
14807-96-6
Name of the chemical
Talc
Concentration
>=1-<5
General Information
Version
5.0
Revision date
2023-10-05
Product name
Giotrif Tablets
Product Synonyms
Giotrif®, film-coated tablets 20mg, 30mg, 40mg + 50 mg Active ingredient: Afatinib
1.2.1 Relevant identified uses
Pharmaceutical
1.2.2. Uses advised against
Safety Data Sheet only for the professional user
supplier name
Boehringer Ingelheim Pharmaceuticals Inc
Emergency telephone
+1 703-527-3887, +1 703-741-5970
Icons in SDS
Company Information
company name
Boehringer Ingelheim Pharmaceuticals Inc
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)
H319, H361, H362, H372
Hazard statements
Code
Statements
H319
Causes serious eye irritation
Section 2
SECTION 2: Hazards identification
Signal word
Danger
Hazard statements
H319 Causes serious eye irritation. H361 Suspected of damaging fertility or the unborn child. H362 May cause harm to breast-fed children. H372 Causes damage to organs (Skin, Gastro-intestinal sys- tem) through prolonged or repeated exposure if swallowed.
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/ while nursing. P264 Wash skin thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P280 Wear protective gloves/ protective clothing/ eye protection/ face protection.
Response
P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P308 + P313 IF exposed or concerned: Get medical advice/ attention. P337 + P313 If eye irritation persists: Get medical advice/ atten- tion.
Storage
P405 Store locked up.
Disposal
P501 Dispose of contents/ container to an approved waste dis- posal plant.
Other hazards
The pharmacological effect of the medicament has to be considered (see package leaflet) This drug is not subject to the labelling requirements under the Globally Harmonized System (GHS) This product does not contain titanium dioxide in its respirable form and would not be considered carcinogenic; however, upon crushing, grinding or other processing that could result in the gener- ation of respirable particulates, the Category 2 carcinogenic classification would apply.
2.1 Classification of the substance or mixture
1910.1200) Eye irritation : Category 2A Reproductive toxicity : Category 2 Effects on or via lactation Specific target organ toxicity : Category 1 (Skin, Gastro-intestinal system) - repeated exposure (Oral)
