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Product Name: Ferric Carboxymaltose
Other Names: Ferric(III)-hydroxide–polymaltose complex, FCM
Recommended Uses: Intravenous iron replacement therapy for treatment of iron deficiency anemia
Manufacturer: [Company specific information]
Emergency Contact: [Local or national emergency number]
CAS Number: 9007-72-1
UN Number: Not regulated for transport
Globally Harmonized System (GHS): Classified as non-hazardous under GHS
Signal Word: None
Pictograms: No symbol required
Hazard Statements: Not expected to produce hazardous effects under normal use
Precautionary Statements: Avoid exposure to individuals with documented hypersensitivity
Routes of Exposure: Intravenous administration; avoid ingestion, inhalation, or dermal contact in raw form
Target Organs: May affect gastrointestinal tract, liver in overdose situations
Specific Hazards: Chronic overexposure may lead to iron overload, adverse hypersensitivity, or local phlebitis
Active Ingredient: Iron(III)-hydroxide complex with carboxymaltose
Iron Content: Approximately 27 mg/mL as elemental iron
Carboxymaltose Content: Proprietary polysaccharide
Excipient Ingredients: Water for injection, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment)
Impurities: No known significant impurities or decomposition products
Concentration: Typically supplied as a solution containing 50 mg/mL (iron basis)
Inhalation: Remove to fresh air, seek medical attention if symptoms develop
Skin Contact: Wash with soap and water, remove contaminated clothing, contact physician for persistent irritation
Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses, seek medical advice for irritation
Ingestion: Do not induce vomiting, seek immediate medical attention, monitor for potential toxicity
After Intravenous Exposure (Accidental): Observe for hypersensitivity reactions, manage anaphylaxis with supportive measures
Important Symptoms: Rash, bronchospasm, hypotension, gastrointestinal upset, iron toxicity in overdose
Special Instructions: Always consult medical personnel
Suitable Extinguishing Media: Water spray, dry powder, foam, carbon dioxide
Unsuitable Extinguishing Media: None identified for this product
Specific Fire Hazards: Solution does not support combustion; no hazardous thermal decomposition products expected
Protective Equipment: Standard protective gear for chemical fires; self-contained breathing apparatus if fumes are generated
Hazardous Combustion Products: Carbon monoxide, carbon dioxide, oxides of iron, potential low-level organic vapors
Firefighting Advice: Prevent contamination of watercourses with runoff
Personal Protection: Wear suitable gloves, goggles, and protective clothing when handling spills
Environmental Precautions: Do not discharge into drains, watercourses, or soil
Methods for Cleanup: Absorb with inert material (sand or earth), collect in a suitable container, dispose of as hazardous waste
Spill Area Management: Ventilate area, wash residues with water, prevent further dispersion
Medical Surveillance: Monitor exposed individuals for adverse reactions
Decontamination: Flush area with copious amounts of water, isolate contaminated tools and clothing
Handling: Use only in designated environments with proper medical supervision, avoid inhalation, ingestion, and skin contact
Storage Temperature: 15–30°C (59–86°F); protect from freezing and extreme heat
Storage Conditions: Store in original container, keep tightly closed, away from incompatible chemicals
Incompatibilities: Strong oxidizers, strong acids or bases
Safe Practices: Prevent contamination by human and animal food, restrict access to qualified users
Special Precautions: Avoid prolonged storage after first opening, adhere to product expiry dates
Occupational Exposure Limits: No established threshold for ferric carboxymaltose; observe limits for iron compounds where applicable
Engineering Controls: Use local exhaust ventilation or process enclosures for bulk handling
Personal Protective Equipment: Gloves (nitrile or latex), protective eyewear, lab coat or apron
Respiratory Protection: Not typically necessary, but use a suitable mask during accidental release or bulk transfer
Hygiene Measures: Wash hands after handling, avoid eating or drinking in work area, remove contaminated clothing immediately
Physical State: Brown, colloidal aqueous solution
Odor: Practically odorless
Melting Point: Not applicable (aqueous solution)
Boiling Point: Approx. 100°C
Solubility: Soluble in water
pH: 5.0–7.0 at 20°C
Specific Gravity: About 1.1 g/mL
Viscosity: Slightly viscous solution
Partition Coefficient: Not established
Evaporation Rate: Comparable to water
Flash Point: Not applicable
Explosion Limits: Not explosive under normal conditions
Chemical Stability: Stable under recommended storage conditions
Conditions to Avoid: Excessive heat, direct sunlight, freezing temperatures
Materials to Avoid: Strong oxidizing agents, strong acids and alkalis
Hazardous Decomposition Products: Iron oxides, carbon-based gases in case of thermal degradation
Polymerization: Product does not undergo hazardous polymerization
Reactivity: No significant reactivity with most materials
Acute Toxicity: Low toxicity in clinical doses; high doses may cause iron toxicity
Potential Health Effects: Nausea, headache, hypotension, allergic reactions in sensitive individuals
Chronic Toxicity: Prolonged or repeated exposure may result in iron overload (hemochromatosis), affecting liver and pancreas
Routes of Entry: Intravenous, accidental skin or mucosal contact
Carcinogenicity: No evidence classified by IARC, NTP, or OSHA
Mutagenicity: No significant mutagenic effects observed
Reproductive Toxicity: No conclusive effects in animal or human studies at therapeutic doses
Target Organs: Gastrointestinal tract, cardiovascular system in overdose cases
Ecotoxicity: No acute aquatic toxicity at low concentrations; iron compounds may be hazardous in large industrial spills
Persistence and Degradability: Biodegradable components; ferric iron may persist in aquatic environments
Bioaccumulation Potential: Low for mammalian exposure, potential for aquatic species in contaminated waterways
Mobility in Soil: Moderately mobile; binds to organic matter and sediments
Aquatic Impact: Can cause oxygen depletion and impact aquatic organisms if discharged in large quantities
Other Adverse Effects: None known at product use levels
Waste Disposal Methods: Dispose of in accordance with local, state, and national regulations; incinerate in specialized facility if required
Product Disposal: Do not discharge into sewer systems or waterways
Container Disposal: Empty containers should be handled as hazardous waste; triple rinse and render unusable
Special Handling: Segregate from municipal waste, label properly for collection by licensed chemical disposal entities
UN Number: Not classified as dangerous for transport
Proper Shipping Name: Not regulated
Transport Hazard Class: None
Packing Group: None
Special Precautions for Transport: Prevent exposure to extreme temperatures, maintain upright during transit, transport as per standard biomedical guidelines
Regulatory Listing: Not listed as hazardous by major transport authorities (ADR, IMDG, IATA)
Labeling (Regulatory): Not classified as hazardous under OSHA Hazard Communication Standard
TSCA Inventory: Iron components listed, product as a complex not specifically included
International Inventories: Consult region-specific chemical inventories for compliance
USA: FDA-approved drug product for intravenous use
Europe: Regulated under EMA as a medicinal product
Other Regions: Subject to health agency oversight and product registration
Risk Phrases: Not classified
Safety Phrases: Observe product labeling for warnings and precautions
Additional References: Refer to local, regional, and international regulations for detailed compliance
