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Rx Item-Ellence 50Mg/25Ml epirubicin HCl IV Vial 25Ml By Pfizer Pharma Inj

NDC 00009-5091-01 UPC/GTIN No.3-00095-09101-4 Mfg.Part No.1928BRAND: ELLENCE NDC: 00009-5091-01,9509101 UPC: 3-00095-09101-4,300095091014 Pfizer PharmaceuticalOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Ellence 50Mg/25Ml epirubicin HCl IV Vial 25Ml By Pfizer Pharma Inj

$66.03$58.99

Item No.:RX760272 NDC No.9509101 UPC No.:300095091014 NDC No. 00009-5091-01 UPC/GTIN No. 3-00095-09101-4 MPN 1928 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item No. Rx760272 Ellence 50mg/25ml Vial 25ml by Pfizer Pharm/Inj Item No. 3760272 NDC No. 00009509101 UPC No. 300095091014 Other Name Ellence, EP

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Clinical Information
Gen. Code and Des.
61490 epirubicin HCl INTRAVEN VIAL 50 MG/25ML
GCN and Des.
97278 epirubicin HCl INTRAVEN VIAL 50 MG/25ML
Strength
50MG/25M
Dose Form
VIAL (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
10000000 ANTINEOPLASTIC AGENTS
Active Ingredients
3717 epirubicin HCl 56390091
Inactive Ingredients
18822 rubber, unspecified





ELLENCE- epirubicin hydrochloride injection, solution
Pharmacia and Upjohn Company

WARNING: RISK OF TISSUE NECROSIS, CARDIAC TOXICITY, SECONDARY ACUTE MYELOGENOUS LEUKEMIA, AND MYELOSUPPRESSION

Severe local tissue necrosis will occur if there is extravasation during administration. ELLENCE must not be given by the intramuscular or subcutaneous route [see Warnings and Precautions (5.9)].
Cardiac toxicity, including fatal congestive heart failure (CHF), may occur either during therapy with ELLENCE or months to years after termination of therapy. The probability of developing clinically evident CHF is estimated as approximately 0.9% at a cumulative dose of 550 mg/m2 , 1.6% at 700 mg/m2 , and 3.3% at 900 mg/m2. In the adjuvant treatment of breast cancer, the maximum cumulative dose used in clinical trials was 720 mg/m2. The risk of developing CHF increases rapidly with increasing total cumulative doses of ELLENCE in excess of 900 mg/m2 ; this cumulative dose should only be exceeded with extreme caution. Active or dormant cardiovascular disease, prior or concomitant radiotherapy to the mediastinal/pericardial area, previous therapy with other anthracyclines or anthracenediones, or concomitant use of other cardiotoxic drugs may increase the risk of cardiac toxicity. Cardiac toxicity with ELLENCE may occur at lower cumulative doses whether or not cardiac risk factors are present [see Warnings and Precautions (5.3)].
Secondary acute myelogenous leukemia (AML) has been reported in patients with breast cancer treated with anthracyclines, including epirubicin. The occurrence of refractory secondary leukemia is more common when such drugs are given in combination with DNA-damaging antineoplastic agents, when patients have been heavily pretreated with cytotoxic drugs, or when doses of anthracyclines have been escalated. The cumulative risk of developing treatment-related AML or myelodysplastic syndrome (MDS), in 7110 patients with breast cancer who received adjuvant treatment with ELLENCE-containing regimens, was estimated as 0.27% at 3 years, 0.46% at 5 years, and 0.55% at 8 years [see Warnings and Precautions (5.4)].
Severe myelosuppression may occur [see Warnings and Precautions (5.2)].
1 INDICATIONS AND USAGE



ELLENCE Injection is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer [see Clinical Studies (14.1)].

2 DOSAGE AND ADMINISTRATION

When possible, to reduce the risk of developing cardiotoxicity in patients receiving ELLENCE after stopping treatment with other cardiotoxic agents, especially those with long half-lives such as trastuzumab, ELLENCE-based therapy should be delayed until the other agents have cleared from the circulation [see Warnings and Precautions (5.3)].

Administer ELLENCE Injection by intravenous infusion. Give ELLENCE in repeated 3- to 4-week cycles. The total dose of ELLENCE may be given on Day 1 of each cycle or divided equally and given on Days 1 and 8 of each cycle. The recommended dosages of ELLENCE are as follows:

NDC 00009-5091-01 UPC/GTIN No.3-00095-09101-4 Mfg.Part No.1928
RX ITEM-Ellence 50Mg/25Ml Vial 25Ml By P
NDC 00009-5091-01 UPC/GTIN No.3-00095-09101-4 Mfg.Part No.1928

BRAND: ELLENCE NDC: 00009-5091-01,9509101 UPC: 3-00095-09101-4,300095091014 Pfizer Pharmaceutical
Ellence 50Mg/25Ml Vial 25Ml By Pfizer Ph
BRAND: ELLENCE NDC: 00009-5091-01,9509101 UPC: 3-00095-09101-4,300095091014 Pfizer Pharmaceutical

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
EPIRUBICIN HCL INTRAVEN V
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.