Epirubicin package insert pdf

Jul 21, 2019 ancobon prescribing information pdf package insert flucytosine ancobon is a the appropriate approved prescribing information should be consulted. Highlights of prescribing information these highlights do not. Interrupt empliciti elotuzumab for grade 2 or higher and permanently discontinue for severe infusion reaction. Monitor for fever and other signs of infection and treat promptly. Patient information leaflet epirubicin hydrochloride 2 mg. 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. Specific package insert requirement for epirubicin caution. Cimetidine a drug usually used to reduce the acid in the stomach and heartburn. Pfizer rxpathways connects eligible patients to a range of assistance programs to help them access their pfizer prescriptions. Lift the package away from the adapter and discard the package. Dailymed erythrocin lactobionate erythromycin lactobionate.

Epirubicin fda prescribing information, side effects and uses. Highlights of prescribing information initial dose of 4 mg. Extravasation of etopophos may result in swelling, pain, cellulitis, and necrosis including skin necrosis. 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. Dec 18, 2019 erythromycin is produced by a strain of streptomyces erythraeus and belongs to the macrolide group of antibiotics. Cytotoxic agent epirubicin should be administered only under the supervision of qualified physicians experienced in cytotoxic therapy. 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. Each 20 mg vial contains 20 mg idarubicin hydrochloride, usp and 200 mg of lactose.

Idamycin idarubicin hydrochloride for injection, usp. Daunorubicin hydrochloride injection must be given into a rapidly flowing intravenous infusion. Product monograph pr epirubicin hydrochloride injection. Can be reconstituted via syringe method or using reconstitution supplies provided with bcg. Store diluted solutions of halaven for up to 4 hours at room temperature or up to 24 hours under refrigeration. Epirubicin hydrochloride 2 mgml solution for injection or infusion.

See full prescribing information for complete boxed warning. Package insert instruction for use revised august 11, 2004 pentetate calcium trisodium injection mg for intravenous or inhalation administration description. Each 20 mg vial contains 20 mg idarubicin hydrochloride, usp and 200 mg of lactose nf hydrous as an orangered, lyophilized powder. Care in the intravenous administration of epirubicin will reduce the chance of perivenous infiltration.

Pharmacokinetic parameters for epirubicin following 6 to 10minute, singledose intravenous infusions of epirubicin at doses of 60 to 150 mgm2 in patients with. What epirubicin is and what it is used for epirubicin is an injection that contains epirubicin hydrochloride. Infusion reactions and cardiopulmonary arrest 1 indications and usage 1. Ellence epirubicin hcl description pfizer medical information. Do not administer epirubicin in combination with other cardiotoxic agents unless the patients cardiac function is closely monitored 7. Follow applicable special handling and disposal procedures.

The dose for mitomycin is 40mg reconstituted in 20 ml sterile water. Neulasta pegfilgrastiminjection,for subcutaneous use initial u. In clinical trials, one class iii patients death was judged attributable to the interruption of flolan. Structurally, epirubicin hydrochloride differs from doxorubicin hydrochloride only in the. Highlights of prescribing information age group dosage. Highlights of prescribing information these highlights do not include all the information needed to use cubicin safely and effectively. Product information adriamycin solution for injection warnings 1. Invanz ertapenemfor injection for intravenous iv or intramuscular im use initial u.

It belongs to a group of medicines called cytotoxics used for chemotherapy. Patients treated with cubicin were 69% male and 31% female. Flolan is a potent pulmonary and systemic vasodilator and can cause hypotension and other. The antiproliferative and cytotoxic activity of epirubicin is thought to result from these or other possible mechanisms. Although some women lived longer and some women did not live as long, women who were treated with halaven lived, on average, 25% longer. 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. Erythrocin lactobionate erythromycin lactobionate for injection, usp, is a soluble salt of erythromycin suitable for intravenous administration. Serious irreversible myocardial toxicity with delayed congestive. Toxic deaths, hepatotoxicity, neutropenia, hypersensitivity reactions, and fluid retention 1 indications and usage 1. The tubing should be attached to a butterfly needle inserted preferably into. 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. Dec 01, 2018 epirubicin clinical pharmacology mechanism of action. Highlights of prescribing information neulasta safely and.

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. Adriamycin must not be given by the intramuscular or subcutaneous route. Dec 30, 2019 epirubicin hydrochloride injection is an anthracycline cytotoxic agent, intended for intravenous administration. Gemzar vials contain no antimicrobial preservatives and are intended for single use only.

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. Epirubicin is also involved in oxidationreduction reactions by generating cytotoxic free radicals. The tubing should be attached to a butterfly needle inserted preferably into a large vein. It must neverbe given by the intramuscular or subcutaneous route. 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. Ellence epirubicin hydrochloride injection is an anthracycline topisomerase. Epirubicin fda prescribing information, side effects and. It is also active in vivo against a variety of murine tumors and human xenografts in athymic mice, including breast tumors. The specificity of epirubicin hydrochloride toxicity appears to be related. How epirubicin hydrochloride injection is given to you 4.

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. Epirubicin is cytotoxic in vitro to a variety of established murine and human cell lines and primary cultures of human tumors. It must not be administered by the intramuscular, subcutaneous or oral routes. In study 1, grade 3 peripheral neuropathy occurred in 8% 40503 of patients, and grade 4 in 0. Severe local tissue necrosis will occur if there is extravasation during administration. Epirubicin is intended for intravenous or intravesical administration only. Patient information leaflet epirubicin hydrochloride 2 mgml.

Ellence epirubicin hydrochloride injection is an anthracycline topisomerase inhibitor for intravenous administration. Eligible patients can register for valuable savings offers for nearly 40 brand name medications. Epirubicin hydrochloride for injection is supplied as a sterile, orangered, lyophilized powder in singledose vials containing 50 mg or 200 mg of epirubicin hydrochloride. Etopophos solutions may be administered at infusion rates up to 3.