Federal law restricts this device to sale by or on the order of a licensed practitioner important. It is very soluble in methanol and chloroform, slightly. Vepesid etoposide is indicated for use in the treatment of. Page 2 of 21 full prescribing information 1 indications and usage 1. Actemra can be used alone following discontinuation of glucocorticoids. Information for the patient vepesid 50 mg and 100 mg capsules, soft etoposide read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Importance of package insert information in the european union. These highlights do not include all the information needed to use vimpat safely and effectively.
Daunorubicin hydrochloride injection must be given into a rapidly. It must never be given by the intramuscular or subcutaneous route. The eyecare practitioner should provide the patient with the wearers guide that pertains to the patients prescribed lens. Extravasation of etopophos may result in swelling, pain, cellulitis, and necrosis including skin necrosis. Guidelines for dosing also include consideration of white blood cell count. If you have any further questions, ask your doctor or pharmacist. 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. Etoposide package insert pdf chemotherapy organic compounds.
Loose stools or diarrhea may occur within 3 days after the drug is given. Etopophos etoposide phosphate for injection, for intravenous use. Patients being treated with vepesid must be frequently observed for myelosuppression both during and after therapy. The components of the kit are stable up to the expiration date printed on the kit. Highlights of prescribing information these highlights do not include all the information needed to use sutent safely and effectively. Severe local tissue necrosis will occur if there is extravasation during administration. Videx didanosine, usp pediatric powder for oral solution initial u. Get a printable copy pdf file of the complete article 7k, or click on a page image below to browse page by page.
Amyvid florbetapir f 18 injectionfor intravenous use initial u. Actemra subcutaneous formulation is not intended for intravenous administration. All cases of hypoglycemia resolved with appropriate therapy and if needed. Toposar etoposide injection, usp also commonly known as vp16 is a semisynthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases. What may also help in your search is a website that has most, but not all package inserts. Manufacturing cmc label is not available on this site. Vimpat lacosamide film coated tablet, for oral use, cv. Apr 16, 2020 a dose of 162 mg given once every other week as a subcutaneous injection, in combination with a tapering course of glucocorticoids, may be prescribed based on clinical considerations. Highlights of prescribing information platinumresistant. If a serious infection develops, interrupt xeljanzxeljanz xr until the infection is controlled.
Pdf importance of package insert information in the. Highlights of prescribing information these highlights do not. Toposar is contraindicated in patients who have demonstrated a previous hypersensitivity to it. Lift the package away from the adapter and discard the package. May 15, 2015 the pi is different from the patient package insert ppi, which contains information intended for patients, notwithstanding that the ppi may be required as part of the fdaapproved labeling for the drug. Etoposide package insert pdf free download as pdf file. Please read carefully and keep this information for future use. The dose of vepesid capsules is based on the recommended dose with. Its main effect, however, appears to be at the g 2 portion of the cell cycle in mammalian cells.
Follow applicable special handling and disposal procedures. Dosage should be modified to take into account the myelosuppressive effects of. This package insert is intended for the eye care practitioner, but should be made available to the patient upon request. Highlights of prescribing information patients at risk of. Use standard precautions for collecting and handling a blood sample. Injectafer ferric carboxymaltose injection is an iron replacement product indicated for the treatment of iron deficiency anemia ida in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron, and in adult patients with nondialysis dependent chronic kidney disease. Highlights of prescribing information these highlights do not include all the information needed to use amyvid safely and effectively. Dosage may be reduced andor delayed in patients with bone marrow depression due. Keep the febridx test card in the sealed foil pouch until just before use. Deplin tablets folic acid, when administered in daily doses above 800 mcg, may increase the amount of unmetabolized folic description less likely than folic acid to accelerate the growth of existing neoplasms. Tb 50 are single use items and should be used immediately once opened and not reused.
Vepesid pharmacokinetics on intravenous administration, the disposition of etoposide is best described as a biphasic process with a distribution halflife of about 1. Severe myelosuppression with resulting infection or bleeding may occur. Myelosuppression resulting in death has been reported. Nov 21, 2019 vepesid etoposide should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Vepesid capsules should be taken on an empty stomach. General in all instances where the use of vepesid is considered for chemotherapy, the physician must. The ph of the clear, nearly colorless to yellow liquid is 3 to 4. Public assessment report scientific discussion etoposide fresenius. Emtricitabinetenofovir disoproxil fumarate truvada package insert truvada is a combination of emtriva and viread, both nucleoside analog hiv1 reverse transcriptase inhibitors. Vepesid for injection is available in 100 mg 5 ml, 150 mg 7. Vimpat lacosamide injection, for intravenous use, cv.
Hepatotoxicity see full prescribing information for complete boxed warning. Vepesid etoposide also commonly known as vp16 is a semisynthetic derivative of podophyllotoxin. Questions and answers on vepesid and associated names. Warnings patients being treated with toposar must be frequently observed for myelosuppression both during and after therapy. This module reflects the scientific discussion for the approval of etoposide. Full text full text is available as a scanned copy of the original print version. Etopophos solutions may be administered at infusion rates up to 3. Vepesid fda prescribing information, side effects and uses.
Package insert for the extreme h 2 o 54% hioxifilcon d soft contact lens for daily wear caution. Highlights of prescribing information these highlights do. See full prescribing information for complete boxed warning. Daunorubicin hydrochloride injection rx only warnings 1. Dosage may be reduced, delayed or discontinued in patients with bone. Sep 18, 2008 vepesid etoposide has been shown to cause metaphase arrest in chick fibroblasts. Vepesid is contraindicated in patients who have demonstrated a previous hypersensitivity to etoposide or any component of the formulation.
Individuals using assistive technology may not be able to. Highlights of prescribing information these highlights do not include all the information needed to use videx safely and effectively. Each capsule contains etoposide 50 mg or 100 mg as the active ingredient. Etoposide is a semisynthetic derivative of the podophyllotoxins. The eye care practitioner should provide the patient with the wearers guide that pertains to the patients prescribed lens. Pancreatitis, lactic acidosis and hepatomegaly with steatosis. Vepesid etoposide should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Doselimiting bone marrow suppression is the most significant toxicity associated with etoposide therapy. These highlights do not include all the information needed to use cuvitru safely and effectively.
This package insert is intended for the eyecare practitioner, but should be made available to the patient upon requrest. Each liquidfilled, soft gelatin capsule contains 50 mg of etoposide in a vehicle consisting of citric. Changes to the summary of product characteristics, labeling or package leaflet also known as. Highlights of prescribing information these highlights. Vepesid may be administered either intravenously or orally. The usual dose of vepesid is 100 to 200 mg per m2of body surface area for 5 days in a row or 200 mgm2day on days 1, 3 and 5 every 3 to 4 weeks. It is 4demethylepipodophyllotoxin 94,60rethylidene. Medicinal and pharmaceutical experts questioning results. Tarceva is not recommended for use in combination with platinumbased chemotherapy see clinical studies 14. Elimination halflife of the drug in 10 of 14 patients was approximately 2. Do not use the febridx test card or the buffer solution past the expiration date.
859 1364 1466 490 1105 465 231 866 1354 384 184 431 400 1199 694 668 744 1134 609 1109 728 1244 639 118 1493 325 1201 1067 468 612 709 288 904 1333 1477 526 850 1049 45 429 1162