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					Safety Data Sheet

Tocilizumab

according to Regulation (EC) No 1907/2006

1. Identification of the substance/preparation and of the company/undertaking
Product name Product code Use Company information Tocilizumab Ro4877533-000 - pharmaceutical active substance (antirheumatic) Enquiries: F. Hoffmann-La Roche AG Postfach CH-4070 Basel Switzerland Phone Fax E-Mail +41-61/688 54 80 +41-61/681 72 76 info.sds@roche.com Local representation:

2. Hazards identification
Most important hazards - No particular hazards known.

3. Composition/Information on ingredients
Characterization monoclonal antibody recombinant humanised immunoglobulin of isotype IgG1 - MRA - Actemra - Atlizumab 375823-41-9 Ro4877533-000 C6428H9976O2018S42 144985 g/mol

Synonyms

CAS number Roche number Empirical formula Molecular mass

Date: 29.2.08/CSE (SEISMO)

Replacing edition of:

26.3.07

Page: 1/5

Tocilizumab

4. First-aid measures
Eye contact Skin contact Inhalation Note to physician - rinse immediately with tap water for 10 minutes - open eyelids forcibly - remove immediately contaminated clothes, wash affected skin with water and soap - do not use any solvents - remove the casualty to fresh air and keep him/her calm - in the event of symptoms get medical treatment - treat symptomatically

5. Fire-fighting measures
Suitable extinguishing media Specific hazards Protection of fire-fighters - water spray jet, dry powder, foam, carbon dioxide, adapt extinguishing media to surrounding fire conditions - formation of toxic and corrosive combustion gases (nitrogen oxides, sulfur oxides) possible - precipitate gases/vapours/mists with water spray

6. Accidental release measures
Methods for cleaning up - collect spilled solutions with inert adsorbent and hand over to waste removal

7. Handling and storage

Handling Technical measures - processing in closed systems, if possible superposed by inert gas (e.g. nitrogen) - take precautionary measures against electrostatic charging

Storage Storage conditions - below -50°C - keep container tightly closed - 2 - 8 °C Tocilizumab 10% aqueous bulk solution with excipients Actemra vials (all dosage strengths)
*1 *1 *2

*1 *2

referring to: referring to:

Date: 29.2.08/CSE (SEISMO)

Replacing edition of:

26.3.07

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Tocilizumab

8. Exposure controls/Personal protection

Engineering Measures Monitoring Threshold value (Roche) air

- see 7.

- Category 1 (Roche Group Directive K1, Annex 3): IOEL >=100 µg/m3

Personal protective equipment Respiratory protection Hand protection - respiratory protection not necessary during normal operations - protective gloves (eg made of neoprene, nitrile or butyl rubber)

9. Physical and chemical properties
Colour Form Odour pH value *1 referring to: colourless, clear liquid odourless 6.0 to 7.0 Tocilizumab 10% aqueous bulk solution with excipients
*1 *1 *1 *1

10. Stability and reactivity
Stability - stable under the conditions mentioned in chapter 7 - does not contain any antimicrobial preservative; therefore, care must be taken to ensure the sterility of the prepared solution - heat Actemra, sterile injection solution containing excipients

*3

Conditions to avoid *3 referring to:

11. Toxicological information
Acute toxicity - NOEL ≥ 150 mg/kg (i.v., rat) - NOEL ≥ 100 mg/kg (i.v., monkey) - not bioavailable by oral administration - NOAEL 10 mg/kg/d (i.v., rat, 28 d)

Subacute toxicity Sensitization

- anaphylactic reactions may occur following the intravenous application of proteins; rare cases of hypersensitivity have been described - NOAEL > 100 mg/kg/w (i.v., monkey; 6 months) - not mutagenic (various in vitro test systems)

Chronic toxicity Mutagenicity

Date: 29.2.08/CSE (SEISMO)

Replacing edition of:

26.3.07

Page: 3/5

Tocilizumab

Note

-

immunosuppressive agent therapeutic dose: 4 to 8 mg/kg/month elimination half-life: 6 to 9 d side effect(s) during therapy: liver damages, infectious episodes

12. Ecological information
Ready biodegradability - readily biodegradable 89 % BOD/ThOD, 28 d ≥ 76 % active substance, 28 d (Manometric Respirometry Test, OECD No. 301 F) - barely toxic for algae (nominal concentration = 100 mg/l) (Scenedesmus (=Desmodesmus) subspicatus) EC50 (72 h) > 100 mg active substance/l NOEC (72 h) 100 mg active substance/l (OECD No. 201) - barely toxic for planktonic crustaceans (nominal concentration = 100 mg/l) (Daphnia magna) EC50 (48 h) > 100 mg active substance/l NOEC (48 h) 100 mg active substance/l (OECD No. 202) - barely toxic for fish (nominal concentration = 100 mg/l) (zebrafish) LC50 (96 h) > 100 mg active substance/l NOEC (96 h) 100 mg active substance/l (OECD No. 203) - no adverse influence on substrate biodegradation (activated sludge) concentration (14 d) 100 mg active substance/l (Manometric Respirometry Test, OECD No. 301 F) Actemra, sterile injection solution containing excipients

*3

Ecotoxicity

*3

*3

*3

*3

*3

referring to:

13. Disposal considerations
Waste from residues - observe local/national regulations regarding waste disposal - incinerate in qualified installation with flue gas scrubbing

14. Transport information
Note - not classified by transport regulations

15. Regulatory information
Note Water hazard class (Germany) - no classification and labelling according to EU directives not hazardous for water (own classification according to directive VwVwS of 17.05.1999) Actemra, sterile injection solution containing excipients

*3

*3

referring to:

Date: 29.2.08/CSE (SEISMO)

Replacing edition of:

26.3.07

Page: 4/5

Tocilizumab

16. Other information
Edition documentation - changes from previous version in sections 1, 2, 3, 8, 10, 15

The information in this safety data sheet is based on current scientific knowledge. It should not be taken as expressing or implying any warranty concerning product characteristics.
Date: 29.2.08/CSE (SEISMO) Replacing edition of: 26.3.07 Page: 5/5


				
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