Reagent 1

SECTION 2: Hazards identification

1272/2008 Classification of the substance or mixture

Hazard pictograms

Not applicable

Signal word

Not applicable

Hazard statements

Not applicable

2.3 Other hazards

This product contains purified human coagulation factors isolated from human plasma. Each donor unit used in the preparation has tested negative (using FDA approved methods) for the presence of Hepatitis B surface antigen and antibodies against Hepatitis C, HIV 1 and 2. This product contains bovine serum albumin (BSA). All donor animals are from BSE- and TSE-free livestock. Donor animals have been subjected to veterinary examination before and after donation, determining that the animals are indeed free of infectious materials. Although this product has been thoroughly tested, biological materials should always be handled as potentially infectious as a precaution.

2.1 Classification of the substance or mixture

Upon assessment, this mixture is not classified as hazardous according to 1272/2008. 2.2. Label elements Hazard pictogram Not applicable Signal word Not applicable Hazard statement Not applicable 2.3. Other hazards This product contains purified human coagulation factors isolated from human plasma. Each donor unit used in the preparation has tested negative (using FDA approved methods) for the presence of Hepatitis B surface antigen and antibodies against Hepatitis C, HIV 1 and 2. This product contains bovine serum albumin (BSA). All donor animals are from BSE- and TSE-free livestock. Donor animals have been subjected to veterinary examination before and after donation, determining that the animals are indeed free of infectious materials. Although this product has been thoroughly tested, biological materials should always be handled as potentially infectious as a precaution. SECTION 3: Composition/information on ingredients 3.2. Mixtures Note that the table shows known hazards of the ingredients in pure form. These hazards are reduced or eliminated when mixed or diluted, see Section 16d. Constituent Classification Concentration CALCIUM CHLORIDE DIHYDRATE CAS No: 10035-04-8 Eye Irrit 2; H319 8 % EC No: 233-140-8 Index No: 017-013-00-2 REACH: 01-2119494219-28 Explanations to the classification and labelling of the ingredients are given in Section 16e. Official abbreviations are printed in normal font. Text in italics are specifications and/or complements used in the calculation of the classification of this mixture, see Section 16b. SECTION 4: First aid measures 4.1. Description of first aid measures Generally In case of concern, or if symptoms occur, call a doctor/physician. Upon breathing in Fresh air and rest. If symptoms persist seek medical advice. Upon eye contact For safety reasons, flush eyes with water; If symptoms occur, seek medical advice. Upon skin contact Normal washing of the skin is considered sufficient; If nevertheless symptoms do occur, contact a physician. Upon ingestion Rinse mouth out thoroughly first with water, then SPIT OUT the rinse water. Drink at least half a litre of water and seek medical advice. DO NOT INDUCE VOMITING. 4.2. Most important symptoms and effects, both acute and delayed Upon eye contact Splashes in eyes may cause burning pain. Irritation may occur due to mechanical abrasion. Upon skin contact Prolonged contact may cause skin irritation. 4.3. Indication of any immediate medical attention and special treatment needed Symptomatic treatment. Upon contact with a doctor, make sure to have the label or this safety data sheet with you. SECTION 5: Fire-fighting measures 5.1. Extinguishing media Extinguish with water mist, powder, carbon dioxide or alcoholresistant foam. 5.2. Special hazards arising from the substance or mixture Gases detrimental to health can be spread in case of fire. 5.3. Advice for fire-fighters Protective measures should be taken regarding other material at the site of the fire. In case of fire use a respirator mask. Wear full protective clothing. SECTION 6: Accidental release measures 6.1. Personal precautions, protective equipment and emergency procedures Avoid inhalation and exposure to skin and eyes. Keep unauthorized and unprotected people at a safe distance. Use recommended safety equipment, see section 8. Ensure good ventilation. 6.2. Environmental precautions Avoid release to drains, soil or watercourses. 6.3. Methods and material for containment and cleaning up Carefully collect dry product without dust formation and dispose as waste. Minor spills can be dried up or flushed away with water. 6.4. Reference to other sections See section 8 and 13 for personal protection equipment and disposal considerations. SECTION 7: Handling and storage