Teflaro

Hazard statements (CLP)

H317, H334

Code

Statements

H317

May cause an allergic skin reaction

2.1 Classification of the substance or mixture

The classification and labelling listed below is for bulk Ceftaroline Fosamil for Injection (400 mg/vial and 600 mg/vial). Regulation (EC) Respiratory sensitizer - Category 1. Skin Sensitizer - Category 1. 1272/2008 [GHS] Directive 67/548/EEC Xn - R42/43 or 1999/45/EC SECTION 2 - HAZARDS IDENTIFICATION …continued

Signal word

Danger Danger SECTION 2 - HAZARDS IDENTIFICATION …continued US Hazard overview Contains ceftaroline fosamil- a cephalosporin antibiotic. May cause allergic respiratory/ skin reaction. Note This product/mixture is classified as dangerous/hazardous according to directive 1999/45/EC, Regulation EC No 1272/2008 (EU CLP) and applicable US regulations. The GHS classifications are based on Regulation (EC) 1272/2008. The EU symbol/indicator of danger, R Phrases and Safety Advice are based on Directive 1999/45/EC.

CLP CLASSIFICATION

H317 - May cause allergic skin reaction. H334 - May cause allergy or asthma

Hazard statements

symptoms or breathing difficulties if inhaled. CLP/GHS P261 - Avoid breathing dust. P272 - Contaminated work clothing should not be

Precautionary statements

allowed out of the workplace. P280 - Wear protective gloves/eye protection/face protection. P285 - In case of inadequate ventilation wear respiratory protection. P302 + P352 - If on skin: Wash with plenty of soap and water. P304 + P341 - IF INHALED: If breathing is difficult, remove victim to fresh air and keep at rest in a position comfortable for breathing. P333 + P313 - If skin irritation or rash occurs: Get medical advice/attention. P342 + P311 - If experiencing respiratory symptoms: Call a POISON CENTER or doctor/physician. P363 - Wash contaminated clothing before reuse. P501 - Dispose of contents/container to location in accordance with local/regional/national/international regulations. EU symbol/indication of danger Xn - Harmful Risk (R) Phrase(s) R42/43 - May cause sensitization by inhalation and skin contact. S22 - Do not breathe dust. S24 - Avoid contact with skin. S36/37 - Wear suitable protective clothing and gloves.

2.3 Other hazards

Ceftaroline fosamil for Injection is being used to treat certain microbial infections. It contains ceftaroline fosamil, a pro-drug of the cephalosporin antibiotic ceftaroline. In clinical trials, diarrhea, nausea, and skin rash were the most frequently reported adverse reactions. Cephalosporins, as a class, are known occupational sensitizers and can cause potentially severe sensitization/hypersensitivity reactions. Hypersensitivity reactions including anaphylaxis, bronchospasms, urticaria and pruritis have been reported in no more than 5% of patients receiving a cephalosporin. In patients with a known hypersensitivity to this class of compounds, cross-hypersensitivity can occur in up to 10% of patients.