General Information
Version
1.74
Revision date
2018-04-17
Product name
SPORANOX
Substance name
SPORANOX oral solution, 10 mg/ml Itraconazole
1.2.1 Relevant identified uses
Finished Pharmaceutical Product, Pharmacotherapeutic group: Antimycotics for systemic use, This SDS is only in- tended for occupational use and not for consumer use (see patient packaging insert for consumer use). This SDS is writ- ten to provide environmental, health and safety information for personnel that will be handling this finished pharmaceutical
Emergency telephone
+(32)-28083237, +1 703-527-3887
Icons in SDS
Company Information
company name
Janssen Pharmaceutica NV
e-mail address of the competent person responsible for the Safety Data Sheet
SDSJanssen@its.jnj.com
Section 2
SECTION 2: Hazards identification
Regulation (EC) No. 1272/2008 Classification of the substance or mixture
Supplemental label elements
Not a hazardous substance or mixture ac-
Additional information
The following percentage of the mixture consists of ingredient(s) with unknown hazards to the aquatic environment: EUH210 Safety data sheet available on request.
Ingredient(s) with unknown acute toxicity
40 %
2.3 Other hazards
This Finished Pharmaceutical Product is non-hazardous based on chemical classification rules. Refer to the pharmacotherapeutic group (section 1.2) and the patient packaging insert to evaluate the possible workplace hazards when this Finished Pharmaceutical Product is accidently leaking, broken or crushed.
2.1 Classification of the substance or mixture
Classification (REGULATION (EC) No 1272/2008) Not a hazardous substance or mixture according to Regulation (EC) No. 1272/2008.
