General Information
Revision date
2018-09-29
Product name
Ozurdex
Product Synonyms
Dexamethasone Intravitreal Implant
1.2.1 Relevant identified uses
Indicated for the treatment of macular edema following branch retinal vein occlusion
Manufacturer Name
Allergan plc
Emergency telephone
1-800-424-9300, +1-703-741-5970
Icons in SDS
Company Information
company name
Allergan plc
e-mail address of the competent person responsible for the Safety Data Sheet
SDS@Allergan.com
GHS Information
Signal word
Warning
Hazard Codes
Hazard statements (CLP)
H361, H362
Hazard statements
Code
Statements
H361
Suspected of damaging fertility or the unborn child
Section 2
SECTION 2: Hazards identification
OSHA Hazards Classification
2.2 Label elements
Emergency Overview Warning
Hazard statements
H361 - Suspected of damaging fertility or the unborn child H362 - May cause harm to breast-fed children Appearance Intravitreal Implant Physical state Solid Odor No information available Chemical Name Symptoms Dexamethasone Adverse effects include muscle wasting, muscle pain or weakness, delayed wound healing, and atrophy of the protein matrix of the bone resulting in osteoporosis, vertebral compression fractures, aseptic necrosis of femoral or humeral heads, or pathologic fractures of long bones are manifestations of protein catabolism which may occur during prolonged therapy with glucocorticoids. Chemical Name
Medical Conditions Generally Aggravated by Exposure
Dexamethasone Oral inhalation therapy should not be used in patients with untreated systemic fungal, bacterial, viral, or parasitic infections.
Precautionary statements
P202 - Do not handle until all safety precautions have been read and understood P281 - Use personal protective equipment as required P405 - Store locked up P501 - Dispose of contents/ container to an approved waste disposal plant P280 - Wear protective gloves/protective clothing/eye protection/face protection P201 - Obtain special instructions before use P260 - Do not breathe dust/fume/gas/mist/vapors/spray P263 - Avoid contact during pregnancy/while nursing P264 - Wash face, hands and any exposed skin thoroughly after handling P270 - Do not eat, drink or smoke when using this product P308 + P313 - IF exposed or concerned: Get medical advice/attention
Further information
Unknown Acute Toxicity 56% of the mixture consists of ingredient(s) of unknown toxicity
2.1 Classification of the substance or mixture
OSHA Regulatory Status This chemical is considered hazardous by the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200) Reproductive toxicity Category 2 Effects on or via lactation Yes
