Identification
Product identifiers, regulatory numbers, and supplier information
Product Information
- Product Name
- FX(h)-FVIII:C
- Product Code
- BIOPHEN™ FIX – R1
Regulatory Identifiers
- CAS Number
- N/A
Identified Uses
FX(h)-FVIII:C
Manufacturers & Suppliers
HYPHEN BioMed
manufacturer
155 rue d'Eragny, 95000 Neuville-sur-Oise, France
+33.1.34.40.65.10
Emergency Contacts
HYPHEN BioMed
+33.1.34.40.65.10
during normal business hours only
Poisons Information Service in France
+33.1.45.42.59.59
Emergency Poison Advice
+61 13 11 26
24 hours
Hazard Identification
GHS classification, signal word, pictograms, and hazard statements
Hazard Classifications
GHS Pictograms
GHS07
Hazard Statements
Precautionary Statements
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Composition / Information on Ingredients
Chemical components, concentration ranges, and hazardous substance identification
This product contains material of animal origin and should be considered as potentially capable of transmitting infectious diseases. The preparation contains material of human origin which has been tested and found negative for HBSAg, anti-HIV and HCV. As with all materials of human origin, this product should be regarded as potentially hazardous to health. Therefore, it should be handled in compliance with appropriate laboratory safety procedures to minimise the risk of transmitting infectious pathogens.
| Chemical Name | CAS Number | Concentration | Hazardous |
|---|---|---|---|
| Tris-(hydroxyméthyl) aminométhane | 77-86-1 | 20% | Yes |
| Calcium Chloride Dihydrate | 10035-04-8 | 10% | Yes |
| Copper Sulfate | 7758-98-7 | 1% | Yes |
Notes
Do not inject or ingest. This product contains material of animal origin and should be considered as potentially capable of transmitting infectious diseases. The preparation contains material of human origin which has been tested and found negative for HBSAg, anti-HIV and HCV. As with all materials of human origin, this product should be regarded as potentially hazardous to health. Therefore, it should be handled in compliance with appropriate laboratory safety procedures to minimise the risk of transmitting infectious pathogens.
First Aid Measures
Emergency procedures for chemical exposure incidents
IF INHALED: Remove victim to fresh air. Keep warm and at rest. If irritation occurs, get medical advice.
SKIN CONTACT: Wash off immediately with plenty of soap and water water – emergency showers should preferably be used. Take off immediately all contaminated clothing, send contaminated clothing to a specialist cleaning company before reuse. If skin reaction occurs, get medical advice.
EYE CONTACT: Rinse immediately with plenty of water for at least 15 minutes holding the eyelids open. If possible, remove contact lenses. Continue to rinse, get medical advice.
INGESTION: call immediately a POISON CENTER. Do not induce vomiting, rinse mouth. Never give anything by mouth to an unconscious person.
Firefighting Measures
Extinguishing media, specific hazards, and firefighter protection
Product itself is non-combustible; adapt fire extinguishing measures to surrounding areas
Water spray
In the event of fire, the following can be released: Carbon dioxide (CO₂); Carbon monoxide (CO)
Do not breathe fire/explosion fumes.
Firefighter Protection
Wear protective equipment. Self-contained breathing apparatus.
Accidental Release Measures
Spill cleanup procedures, containment, and environmental protection
Refer to protective measures listed in section 7 and 8. Avoid contact with skin, eyes and clothing. Avoid dust formation. Do not breathe gas/mist/vapours.
Prevent further spillage if safe. Do not allow product to enter drains or any water course. Avoid release to the environment.
Collect spilled material with absorbent material. Clean contaminated surfaces and devices in compliance with all applicable legal requirements and regulations. Transfer to suitable, closed and labelled containers for storage/disposal.
Materials: absorbent material
Related Products
Similar products with comparable safety profiles
Handling and Storage
Safe handling precautions, storage conditions, and workplace requirements
Design and operate processes, insofar as the state of technology permits, in such a way that dangerous substances may not be released / contact with the skin can be ruled out.
Keep container tightly closed in a cool, well-ventilated place. Store locked up. Containers which are opened must be carefully closed and kept upright to prevent leakage.
Do not eat, drink or smoke during work time. Keep away from food, drink and animal feeding stuffs. Wash hands and skin before breaks and after work. Do not inhale vapours. Avoid contact with eyes and skin. Remove soiled or soaked clothing immediately.
No special measures necessary.
Exposure Controls / PPE
Occupational exposure limits, engineering controls, and protective equipment
Technical measures and appropriate working operations should be given priority over the use of personal protective equipment. To handle under an extraction system.
Wear appropriate protective gloves. Prior to use, check in any case suitability of protective glove for the specific workplace conditions. Use proper glove removal technique (without touching glove's outer surface) to avoid skin contact with this product. Dispose of contaminated gloves after use in accordance with applicable laws and good laboratory practices. Protective gloves must be tested and approved under EN374 standard. Replace protective gloves immediately when they become worn and damaged.
Use equipment for eye and face protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU).
If this is not possible, provide for appropriate respiratory and face protection according to the quantity of product to handle: large scale activities / emergency use: breathing apparatus tested and certified to EN136– full-face mask and particulate filter tested and certified to EN143; small scale activities / laboratory use: breathing apparatus tested and certified to EN140 – half face particulate (air-purifying) mask / quarter mask and particulate filter tested and certified to EN 143; breathing apparatus tested and certified to EN 149 – half face particulate (air-purifying) mask. Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU).
During product handling, wear appropriate protective clothing in compliance with the applicable rules. The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specific workplace.
Prevent further spillage/release of material if safe. Do not allow product to enter drains or any water course. Avoid release to the environment.
Physical and Chemical Properties
Appearance, physical state, melting point, boiling point, and material characteristics
Stability and Reactivity
Chemical stability, hazardous reactions, and incompatible materials
The preparation is stable if handled and stored as recommended under section 7.
No dangerous reactions known if handled in compliance with applicable provisions/under normal conditions of use.
None if used for the intended purpose.
None if used for the intended purpose.
None known.
None if used for the intended purpose.
Ecological Information
Environmental toxicity, biodegradation, and bioaccumulation data
The data for this section has not been processed yet.
Disposal Considerations
Waste treatment methods, disposal recommendations, and waste codes
Dispose of waste in compliance with national rules and consultation with environmental services.
Dispose of waste in compliance with national rules and consultation with environmental services. The waste code is established in consultation with your regional waste disposer.
Transport Information
UN numbers, shipping names, transport classes, and regulatory requirements
Regulatory Information
Chemical regulations, safety assessments, and compliance status
This MSDS file is comply to the requirements described on the Regulation (EC) No 1907/2006 (REACH) and 1272/2008 (CLP).
Frequently Asked Questions
Common questions about safety, handling, and properties
What is the hazard signal word for FX(h)-FVIII:C?
The signal word is warning.
What is the physical form of FX(h)-FVIII:C?
FX(h)-FVIII:C is a lyophilised powder appearing as lyophilised powder with white / yellow color.
What is FX(h)-FVIII:C used for?
FX(h)-FVIII:C
What are the hazard statements for FX(h)-FVIII:C?
This substance has 4 hazard statements:
- H315: Causes skin irritation.
- H319: Causes serious eye irritation.
- H335: May cause respiratory irritation.
- H412: Harmful to aquatic life with long lasting effects.