Epirubicin Hydrochloride (Page 8 of 8)

15 REFERENCES

  1. 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.
  2. 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
  3. American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006; 63:1172-1193.
  4. 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.

16 HOW SUPPLIED/STORAGE AND HANDLING

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

Storage Conditions

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.

17 PATIENT COUNSELING INFORMATION

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

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Revised – March 2016

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Actavis

Rx Only

NDC 45963-608-68

Epirubicin Hydrochloride Injection

50 mg/ 25 mL*

(2 mg/mL)

REFRIGERATE

For Intravenous Use Only

CAUTION: Cytotoxic Agent

25 mL
Single-Dose Vial

1
(click image for full-size original)
EPIRUBICIN HYDROCHLORIDE
epirubicin hydrochloride injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45963-608
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPIRUBICIN HYDROCHLORIDE (EPIRUBICIN) EPIRUBICIN HYDROCHLORIDE 2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
WATER
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45963-608-68 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE
1 25 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (45963-608-68)
2 NDC:45963-608-60 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE
2 100 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (45963-608-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065445 11/28/2011
Labeler — Actavis Pharma, Inc. (119723554)
Establishment
Name Address ID/FEI Operations
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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