- NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165.
- OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html
- American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006; 63:1172-1193.
- Polovich, M., White, J. M. & Kelleher, L.O. (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice (2nd. ed.) Pittsburgh, PA: Oncology Nursing Society.
Epirubicin Hydrochloride Injection is available in colorless glass, single-dose vials, type I containing 2 mg epirubicin hydrochloride per mL as a sterile, preservative-free, ready-to-use solution in the following strengths:
- 50 mg/25 mL single-dose vial, NDC 45963-608-68 1 vial per carton
- 200 mg/100 mL single-dose vial, NDC 45963-608-60 1 vial per carton
Store refrigerated between 2° and 8°C (36° and 46°F).
Do not freeze.
Protect from light. Retain in carton until time of use.
For Single-Dose Only; Discard unused portion.
Sterile, Nonpyrogenic, Preservative-free.
The container closure is not made of natural rubber latex.
Storage of the solution for injection at refrigerated conditions can result in the formation of a gelled product. This gelled product will return to a slightly viscous to mobile solution after 2 to a maximum of 4 hours equilibration at controlled room temperature (15º to 25ºC). Solution for injection should be used within 24 hours after removal from refrigeration.
Inform patients of the expected adverse effects of epirubicin hydrochloride injection, including gastrointestinal symptoms (nausea, vomiting, diarrhea, and stomatitis), alopecia and potential neutropenic complications.
Patients should understand that there is a risk of irreversible myocardial damage associated with treatment with epirubicin hydrochloride injection, as well as a risk of treatment-related leukemia.
Patients should consult their physician if vomiting, dehydration, fever, evidence of infection, symptoms of CHF, or injection-site pain occurs following therapy with epirubicin hydrochloride injection.
Advise patients that their urine may appear red for 1 to 2 days after administration of epirubicin hydrochloride injection and that they should not be alarmed.
Because epirubicin hydrochloride injection may induce chromosomal damage in sperm, advise men undergoing treatment with epirubicin hydrochloride injection to use effective contraceptive methods. Women treated with epirubicin hydrochloride injection may develop irreversible amenorrhea, or premature menopause.
Brands listed are the trademarks of their respective owners.
Made in Italy
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA
Revised – March 2016
Epirubicin Hydrochloride Injection
50 mg/ 25 mL*
For Intravenous Use Only
CAUTION: Cytotoxic Agent
| EPIRUBICIN HYDROCHLORIDE |
epirubicin hydrochloride injection
|Labeler — Actavis Pharma, Inc. (119723554)|
|Actavis Italy Spa A Socio Unico||857007913||ANALYSIS (45963-608), LABEL (45963-608), MANUFACTURE (45963-608), PACK (45963-608)|
Revised: 03/2016 Actavis Pharma, Inc.
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