Epirubicin package insert pdf

Epirubicin is also involved in oxidationreduction reactions by generating cytotoxic free radicals. Connect the diluent syringe to the vial adapter by inserting the tip of the syringe into the adapter opening while firmly pushing and turning the syringe clockwise until the connection is secured. Store diluted solutions of halaven for up to 4 hours at room temperature or up to 24 hours under refrigeration. Erythrocin lactobionate erythromycin lactobionate for injection, usp, is a soluble salt of erythromycin suitable for intravenous administration. Epirubicin pharmacokinetics are linear over the dose range of 60 to 150 mgm2 and plasma clearance is not affected by the duration of infusion or administration schedule. Adriamycin must not be given by the intramuscular or subcutaneous route. Flolan is a potent pulmonary and systemic vasodilator and can cause hypotension and other. Daunorubicin hydrochloride injection must be given into a rapidly flowing intravenous infusion. Specific package insert requirement for epirubicin caution. Cytotoxic agent epirubicin should be administered only under the supervision of qualified physicians experienced in cytotoxic therapy.

The tubing should be attached to a butterfly needle inserted preferably into. What epirubicin hydrochloride injection is and what it is used for the name of your medicine is epirubicin hydrochloride 2 mgml solution for injection or infusion but in the rest of. Pharmacokinetic parameters for epirubicin following 6 to 10minute, singledose intravenous infusions of epirubicin at doses of 60 to 150 mgm2 in patients with. Ellence epirubicin hydrochloride injection is an anthracycline topisomerase. Can be reconstituted via syringe method or using reconstitution supplies provided with bcg. Lift the package away from the adapter and discard the package. Extravasation of etopophos may result in swelling, pain, cellulitis, and necrosis including skin necrosis. Highlights of prescribing information these highlights do not. Follow applicable special handling and disposal procedures. Epirubicin hydrochloride 2 mgml solution for injection or infusion. Jul 21, 2019 ancobon prescribing information pdf package insert flucytosine ancobon is a the appropriate approved prescribing information should be consulted. Each 20 mg vial contains 20 mg idarubicin hydrochloride, usp and 200 mg of lactose.

Eligible patients can register for valuable savings offers for nearly 40 brand name medications. Gemzar vials contain no antimicrobial preservatives and are intended for single use only. Do not administer epirubicin in combination with other cardiotoxic agents unless the patients cardiac function is closely monitored 7. Care in the intravenous administration of epirubicin will reduce the chance of perivenous infiltration. Ellence epirubicin hcl description pfizer medical information. Epirubicin is cytotoxic in vitro to a variety of established murine and human cell lines and primary cultures of human tumors. Product monograph pr epirubicin hydrochloride injection. Highlights of prescribing information initial dose of 4 mg. Although it is known that anthracyclines can interfere with a number of biochemical and biological functions within eukaryotic cells, the precise mechanisms of epirubicins cytotoxic andor antiproliferative properties have not been completely elucidated. Patient information leaflet epirubicin hydrochloride 2 mg. Epirubicin fda prescribing information, side effects and uses. Epirubicin fda prescribing information, side effects and.

Product profile mylan better health for a better world. It must neverbe given by the intramuscular or subcutaneous route. Product information adriamycin solution for injection warnings 1. Cimetidine a drug usually used to reduce the acid in the stomach and heartburn. The effective maintenance dose for continuous and stepwise dosing is 50 to 200 mcg per kg per minute, although doses as low as 25 mcg per kg per minute have been adequate. How epirubicin hydrochloride injection is given to you 4. In clinical trials, one class iii patients death was judged attributable to the interruption of flolan. Package insert instruction for use revised august 11, 2004 pentetate calcium trisodium injection mg for intravenous or inhalation administration description. Pfizer rxpathways connects eligible patients to a range of assistance programs to help them access their pfizer prescriptions. Dec 18, 2019 erythromycin is produced by a strain of streptomyces erythraeus and belongs to the macrolide group of antibiotics. Idamycin idarubicin hydrochloride for injection, usp.

Each 20 mg vial contains 20 mg idarubicin hydrochloride, usp and 200 mg of lactose nf hydrous as an orangered, lyophilized powder. Severe local tissue necrosis will occur if there is extravasation during administration. It belongs to a group of medicines called cytotoxics used for chemotherapy. The antiproliferative and cytotoxic activity of epirubicin is thought to result from these or other possible mechanisms. Structurally, epirubicin hydrochloride differs from doxorubicin hydrochloride only in the.

Interrupt empliciti elotuzumab for grade 2 or higher and permanently discontinue for severe infusion reaction. Patient information leaflet epirubicin hydrochloride 2 mgml. Monitor for fever and other signs of infection and treat promptly. The specificity of epirubicin hydrochloride toxicity appears to be related. Store undiluted halaven in the syringe for up to 4 hours at room temperature or for up to 24 hours under refrigeration 40f or 4c. Patients treated with cubicin were 69% male and 31% female. Dailymed erythrocin lactobionate erythromycin lactobionate. What epirubicin is and what it is used for epirubicin is an injection that contains epirubicin hydrochloride. Highlights of prescribing information these highlights do not include all the information needed to use cubicin safely and effectively. Epirubicin pack insert ukie dd 1 men who wish to father children in the future should seek advice about freezing sperm before treatment with epirubicin is started. See full prescribing information for complete boxed warning. In study 1, grade 3 peripheral neuropathy occurred in 8% 40503 of patients, and grade 4 in 0.

Infusion reactions and cardiopulmonary arrest 1 indications and usage 1. It is also active in vivo against a variety of murine tumors and human xenografts in athymic mice, including breast tumors. Although some women lived longer and some women did not live as long, women who were treated with halaven lived, on average, 25% longer. Epirubicin is intended for intravenous or intravesical administration only. Invanz ertapenemfor injection for intravenous iv or intramuscular im use initial u.

Dec 30, 2019 epirubicin hydrochloride injection is an anthracycline cytotoxic agent, intended for intravenous administration. Ellence epirubicin hydrochloride injection is an anthracycline topisomerase inhibitor for intravenous administration. Highlights of prescribing information age group dosage. Serious irreversible myocardial toxicity with delayed congestive. Toxic deaths, hepatotoxicity, neutropenia, hypersensitivity reactions, and fluid retention 1 indications and usage 1. Dec 01, 2018 epirubicin clinical pharmacology mechanism of action. In a clinical study of more than 750 women, halaven was compared with other chemotherapies or hormone therapies commonly used to treat metastatic breast cancer mbc. Neulasta pegfilgrastiminjection,for subcutaneous use initial u. Epirubicin hydrochloride for injection is supplied as a sterile, orangered, lyophilized powder in singledose vials containing 50 mg or 200 mg of epirubicin hydrochloride. The dose for mitomycin is 40mg reconstituted in 20 ml sterile water. Ellence is supplied as a sterile, clear, red solution and is available in polypropylene vials containing 50 and 200 mg of epirubicin hydrochloride as a preservativefree, readytouse solution. Etopophos solutions may be administered at infusion rates up to 3.