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VERSION ISSUED ON: 29 MAR 2012 Supersedes Version Dated 04 JAN 2012
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1. Identification
Brand Name: OFIRMEV®^ (acetaminophen) Injection
OFIRMEV is a sterile, non-pyrogenic, isotonic formulation of acetaminophen intended for intravenous infusion for the treatment of pain and fever. It is filled in single use clear glass USP Type II vials.
OFIRMEV is distributed by:
Cadence Pharmaceuticals, Inc. 12481 High Bluff Drive, Suite 200, San Diego, CA 92130 Phone: (858) 436- Fax: (858) 436-
24-Hour Emergency Contact: 1-877-647-
2. Hazard Identification
Overdosage can cause hepatotoxicity.
3. Composition/Information on Ingredients
None of the OFIRMEV components are considered hazardous. The composition is provided below.
Component Amount (%w/v) CAS # Acetaminophen 1.00 % 103-90- Mannitol 3.85 % 69-65- Cysteine hydrochloride, monohydrate Less than 0.01 % 52-90-
Dibasic sodium phosphate, anhydrous or Dibasic sodium phosphate, dihydrate
Less than 0.01 % 7558-79-
Less than 0.01 % 10028-24-
Water Approx. 95 % 7732-18-
Other names used to identify acetaminophen are: paracetamol (INN), N-(4-Hydroxyphenyl)acetamide, 4-hydroxyacetanilide, p-hydroxyacetanilide, p-acetaminophenol, p-acetamidophenol, N-acetyl-p-aminophenol
4. First-Aid Measures
Eye Exposure: No eye exposure is expected with this formulation under normal conditions of use. If eye exposure occurs, flush eyes with large volumes of water for 15 min. Get medical attention.
Skin Exposure: Wash contaminated area with soap and water for 15 min. Get medical attention if irritation is noted.
Ingestion: No ingestion exposure is expected with this formulation under normal conditions of use. If ingested, do not induce vomiting unless directed to do so by medical personnel. In cases where large amounts have been ingested, contact a Physician or Poison Control Center immediately. Acetylcysteine
VERSION ISSUED ON: 29 MAR 2012 Supersedes Version Dated 04 JAN 2012
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is known to significantly reduce the risk of serious hepatotoxicity, especially if taken less than eight hours after ingestion of the overdose.
Inhalation: No inhalation exposure is expected with this formulation under normal conditions of use. If inhaled, remove to fresh air. If breathing is difficult, give oxygen. If not breathing, give artificial respiration. Contact a physician immediately.
Additional Notes to Physicians: For additional guidance, refer to the Prescribing Information.
5. Fire-Fighting Measures
OFIRMEV is nonflammable.
Suitable Extinguishing Media: Not applicable
Unsuitable Extinguishing Media: Not applicable
Specific Hazards in Case of Fire: Not applicable
Special Protective Equipment and Precaution for Fire Fighters: Not applicable
6. Accidental Release Measures
Release to Land: Absorb the solution with absorbent materials and dispose according to local, state and federal guidelines.
Release to Air: If aerosolized, reduce exposures by ventilating area.
Release to Water: Refer to local water authority. Drain disposal is not recommended; refer to local, state and federal disposal guidelines.
7. Handling and Storage
Precautions for safe handling : Containers are made of glass. Handle with care to avoid breakage.
Conditions for safe storage: Store at controlled room temperature 59 °F to 86° F (15 °C to 30° C). Follow instructions provided in packaging. Do not refrigerate. Do not freeze.
8. Exposure Controls/Personal Protection
None of the components of OFIRMEV have established OSHA PEL, ACGIH TLV, or NIOSH REL values.
Respiratory Protection: Not required during normal clinical use.
Ventilation: Handle in a well-ventilated area.
Protective Gloves: Not required during normal clinical use. Wash thoroughly with warm water and soap after handling.
Eye Protection: Not required during normal clinical use.
Other Protective Clothing or Equipment: No special recommendations during normal clinical use.
VERSION ISSUED ON: 29 MAR 2012 Supersedes Version Dated 04 JAN 2012
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Acetaminophen was not mutagenic in the bacterial reverse mutation assay. In contrast, acetaminophen tested positive in the in vitro mouse lymphoma assay and the in vitro chromosomal aberration assay using human lymphocytes.
In studies conducted by the National Toxicology Program, fertility assessments have been completed in Swiss mice via a continuous breeding study. There were no effects on fertility parameters in mice consuming up to 1.7 times the MHDD of acetaminophen, based on a body surface area comparison. Although there was no effect on sperm motility or sperm density in the epididymis, there was a significant increase in the percentage of abnormal sperm in mice consuming 1.7 times the MHDD (based on a body surface area comparison) and there was a reduction in the number of mating pairs producing a fifth litter at this dose, suggesting the potential for cumulative toxicity with chronic administration of acetaminophen near the upper limit of daily dosing.
Reproductive Toxicity
Pregnancy Category C. There are no studies of OFIRMEV in pregnant women; however, epidemiological data on oral acetaminophen use in pregnant women show no increased risk of major congenital malformations. The results from a large population-based prospective cohort, including data from 26,424 women with live born singletons who were exposed to oral acetaminophen during the first trimester, indicate no increased risk for congenital malformations, compared to a control group of unexposed children. The rate of congenital malformations (4.3%) was similar to the rate in the general population. A population-based, case-control study from the National Birth Defects Prevention Study showed that 11,610 children with prenatal exposure to acetaminophen during the first trimester had no increased risk of major birth defects compared to 4,500 children in the control group.
12. Ecological Information
Information is currently not available on the environmental impact of OFIRMEV (IV acetaminophen). Handle in a manner to prevent spills or releases to the environment. Tests run according to the OECD Guide–line 302 B "Inherent biodegradability: Modified Zahn–Wellens Test" showed a 99% aerobic and anaerobic degradation of acetaminophen inoculated with industrial activated sludge after 5 days.
13. Disposal Considerations
Incineration in an approved incinerator is recommended. Refer to local, state and federal disposal guidelines.
14. Transport Information
None of the components of OFIRMEV is a DOT hazardous material.
Not Regulated by DOT, IATA/ICAO, or IMDG.
15. Regulatory Information
There are no unreasonable risks (health, safety, or property), that this product would pose when transported in commerce. Hazard class definitions (49 CFR Part 173) are not applicable.
VERSION ISSUED ON: 29 MAR 2012 Supersedes Version Dated 04 JAN 2012
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OSHA Hazard Communication Standard (29 CFR 1910.1200): This product is exempt from the Occupational Safety & Health Administration (OSHA) Hazard Communication Standards.
California Proposition 65: This product contains no listed substances known to the State of California to cause cancer, birth defects, or other reproductive harm, at levels that would require a warning under the statue.
16. Other Information
Use of this product should be through or under the direction of a physician. This SDS does not address the therapeutic use of this material.
The version of the MSDS dated 04 JAN 2012 was updated to bring the format in line with the recommendations of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). The document has been renamed to “SDS” and content has been moved and added throughout.
DISCLAIMER
This document is generated to provide health, safety and environmental data. It is NOT a specification sheet and none of the displayed data should be construed as a specification. Information on this SDS was obtained from various sources which are believed to be reliable, complete and accurate. However, the information is provided without any warranty, express or implied, regarding correctness. Some of the information presented and conclusions drawn are from sources other than direct test data of the substance. The conditions or methods of handling, storage, use and disposal of the product are beyond our control and may also be beyond our knowledge. It is the user’s responsibility to determine the suitability of any material for a specific purpose and to adopt such safety precautions as deemed necessary. If the product is used as a component of another product, this SDS information may not be applicable. For these reasons, we do not assume any responsibility and expressly disclaim liability for any loss, damage or expense arising out of or in any way connected with the handling, storage, use or disposal of this product.
