Ganciclovir should not be administered in patients with severe neutropenia anc less than 500l or severe thrombocytopenia platelets less than 25,000l. In 2018, the us food and drug administration fda published a draft guidance, entitled cytomegalovirus in transplantation. Camptosar should be diluted in 5% dextrose injection, usp, preferred or 0. Find patient medical information for cytovene intravenous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Each 20 ml vial contains 200 mg of dacarbazine, usp active ingredient. Highlights of prescribing information these highlights do not include all the information needed to use invanz safely and effectively. Highlights of prescribing information these highlights do not include all the information needed to use ferrlecit safely and effectively.
Call your doctor for instructions if you miss a dose. Cytoveneiv ganciclovir sodium for injection is supplied in 10 ml sterile vials, each containing ganciclovir sodium equivalent to 500 mg of ganciclovir as a white to offwhite powder. As such, the us food and drug administration has published a guidance to encourage and inform the development of therapeutics for the treatment and prevention of cmv disease in this population. Find patient medical information for cytovene oral on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Learn about drug imprint, side effects, uses treating, dosage, interaction, overdose, and warnings. The chemical name is desalanyl1, serine125 human interleukin2.
Ganciclovir is available as 250 mg and 500 mg capsules. Cytomegalovirus cmv remains an important pathogen in the transplant population. May 05, 2015 provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the us food and drug administration. Dosage reductions should also be considered for those with neutropenia, anemia andor thrombocytopenia see package insert for adverse events. Highlights of prescribing information neulasta safely and. Proleukin aldesleukin, a human recombinant interleukin2 product, is a highly purified protein with a molecular weight of approximately 15,300 daltons. May 17, 2019 provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the us food and drug administration. Highlights of prescribing information advanced renal cell. Cytoxan cyclophosphamide for injection, usp cytoxan tablets cyclophosphamide tablets, usp description cytoxan cyclophosphamide for injection, usp is a sterile white powder containing cyclophosphamide monohydrate. Gemzar vials contain no antimicrobial preservatives and are intended for single use only. An abstract of this work was presented at the american college of veterinary internal medicine acvim forum in anaheim, ca, june 2010.
Avoid direct contact of the skin or mucous membranes with cytoveneiv solutions. This includes your doctors, nurses, pharmacists, and dentists. Several fdaapproved drug labels may be available for ganciclovir. Cytovene patient information including if i miss a dose. Ferrlecit sodium ferric gluconate complex in sucrose injection, for intravenous use initial u. Development of therapeutics for the treatment and prevention.
Ganciclovir is a synthetic, acyclic purine nucleoside analogue of guanine. Each vial also contains anhydrous citric acid and mannitol. Abilify maintena is a longacting aripiprazole formulation with 4week dosing intervals indicated for the treatment of schizophrenia and maintenance monotherapy of bipolar i disorder in adults. Oxycodone is available as a single compound, but is often combined with other analgesics like acetaminophen or aspirin.
Minimum ppe required handling only no alteration contained crushsplit crushsplit minimum ppe required abacavir susp 2 ziagenepzicomtrizivir low abacavir tablet 2 ziagenepzicomtrizivir universal low moderate. The recommended dosing schedule is 3 mgkg administered intravenously over a 90minute period every 3 weeks for a total of 4 doses1 assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and. Package insert and patient information 5 ml of sterile water for injection using doubleended needles pdf 348kb package insert and patient information. Cytoxan tablets cyclophosphamide tablets, usp are for oral use and contain 25 mg or 50 mg cyclophosphamide anhydrous. Inclusion or absence of a drug label on the aidsinfo site does not imply endorsement or lack thereof by aidsinfo. Cytoxan tablets cyclophosphamide tablets, usp are for oral use and contain 25 mg or 50 mg cyclophosphamide. This cytovene price guide is based on using the drugs. Every individual package label entry contains a unique identifier which can be used to secure further details directly from. Review the prescribing information for nivolumab for full dosing and schedule information. Camptosar injection 20 mgml is intended for single use only and any unused portion should be discarded. Cidofovir is a white crystalline powder with an aqueous solubility of. Efficacylabeling change with clinical data, labeling package insert.
Dacarbazine for injection usp is a white to an ivory colored solid which is light sensitive. In trials comparing cytoveneiv with cytovene capsules for the maintenance treatment of cmv retinitis in patients with aids, serial urine cultures and other available cultures semen, biopsy specimens, blood and others showed that a small proportion of patients remained culturepositive during maintenance therapy with no statistically significant differences in cmv. Based on animal data, cytoveneiv has the potential to cause birth defects in humans. Cytovene ganciclovir side effects, images, uses, dosage. Tell all of your health care providers that you take cytovene ganciclovir systemic. The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment or prevention of cmv disease in patients who have undergone sot or hsct. Invanz ertapenemfor injection for intravenous iv or intramuscular im use initial u. Minimum ppe required ppe requirements hazardous drug handling.
Guidelines for the use of ganciclovir cytovene recommended neonatal dose, route, and interval 6 mgkgdose every 12 hours for a minimum of 6 weeks administer by iv infusion by syringe pump over 1 hour reduce the dose by 50% for significant neutropenia oct 20, 2011 ganciclovir is a synthetic guanine derivative active against cytomegalovirus cmv. Cytoveneiv should also be used with caution in patients with preexisting cytopenias and in patients receiving myelosuppressive drugs or irradiation. Aidsinfo provides the following drug label solely as an example of the labels available for ganciclovir. The recommended dosing schedule is 3 mgkg administered intravenously over a 90minute period every 3 weeks for a total of 4 doses1 assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including lfts and thyroid function tests at baseline and before each dose. Nov 01, 2014 dacarbazine for injection usp is a white to an ivory colored solid which is light sensitive. Highlights of prescribing information these highlights do not include all the information needed to use valcyte safely and effectively. Pharmacokinetics of ganciclovir and valganciclovir in the. Cytovene ganciclovir is a member of the purine nucleosides drug class and is commonly used for cmv prophylaxis and cmv retinitis. Cytoveneiv fda prescribing information, side effects and uses. General approach to handling hazardous drugs early concerns about occupational exposure to antineoplastic drugs first appeared in the 1970s. Ganciclovir is a polar hydrophilic compound with a solubility of 2. Proleukin, a lymphokine, is produced by recombinant dna technology using a genetically engineered e.
An abstract of this work was presented at the american college of veterinary internal medicine acvim forum in. Drug name active ingredients strength dosage formroute marketing status te code rld rs. Each vial of cytoveneiv contains the equivalent 21 of 500 mg ganciclovir as the sodium salt 46 mg sodium. Based on animal data, cytoveneiv may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females. Cytovene prices, coupons and patient assistance programs. Dacarbazine for injection usp is reconstituted and administered intravenously ph 3. Cytoveneiv fda prescribing information, side effects. Highlights of prescribing information recurrent or. Minimum ppe required ppe requirements hazardous drug. Minimum ppe required handling only no alteration contained crushsplit crushsplit minimum ppe required abacavir susp 2 ziagenepzicomtrizivir low abacavir tablet 2 ziagenepzicomtrizivir universal low moderate acitretin capsule 3 soriatane universal moderate anastrazole tablet 1 arimidex low moderate high android capsule 3 methyltestosterone universal moderate. Seek emergency medical attention or call the poison help line at 18002221222. Vistide is a sterile, hypertonic aqueous solution for intravenous infusion only. Guidelines for the use of ganciclovir cytovene recommended neonatal dose, route, and interval 6 mgkgdose every 12 hours for a minimum of 6 weeks administer by iv infusion by syringe pump over 1 hour reduce the dose by 50% for significant neutropenia cytoxan cyclophosphamide for injection, usp cytoxan tablets cyclophosphamide tablets, usp description cytoxan cyclophosphamide for injection, usp is a sterile white powder containing cyclophosphamide mono hydrate. The product information may be subsequently updated by the member state competent authorities, in.
Cytomegalovirus cmv infection is a common complication of immunosuppression, and is frequently seen in transplant recipients, patients with the acquired immunodeficiency syndrome aids, and those who have received steroids. Accidental release measures contain spill and collect, as appropriate. Cellcept mycophenolate mofetil mmf is indicated for the prophylaxis of organ rejection,in recipients of allogeneic kidneysee clinical studies 14. Cytoveneiv ganciclovir, formulated as monosodium salt, using sodium hydroxide as a salt forming agent, is a sterile white to offwhite lyophilized powder. Cytovene iv ganciclovir, formulated as monosodium salt, using sodium hydroxide as a salt forming agent, is a sterile white to offwhite lyophilized powder. Cytovene capsules, cytoveneiv roche laboratories, drug. The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication education rems cme, and. Its potency is approximately equivalent to morphine. Cytoxan cyclophosphamide for injection, usp cytoxan. After the first abilify maintena injection, administer oral aripiprazole 10 mg to 20 mg for 14 consecutive days to achieve therapeutic aripiprazole concentrations during initiation of therapy. Oxycodone is a semisynthetic narcotic analgesic generally prescribed for the relief of moderate to severe pain. Follow applicable special handling and disposal procedures. Camptosar injection must be diluted prior to infusion. Highlights of prescribing information these highlights do not include all the information needed to use blincyto safely and effectively.
It is structurally and pharmacologically similar to acyclovir and is active against herpesviruses. Cytoxan cyclophosphamide for injection, usp cytoxan tablets. Highlights of prescribing information these highlights do not. Cytovene, ganciclovir dosing, indications, interactions.
Cytoveneiv is not recommended if the absolute neutrophil count is less than 500 cellsl, hemoglobin is less than 8 gdl, or the platelet count is less than 25,000 cellsl. Valcytevalganciclovirtablets, valcytevalganciclovir hydrochloride fororal solution initial u. This summary of product characteristics, labelling and package leaflet is the outcome of the referral procedure to which this commission decision relates. Cytoveneiv is supplied in cartons of 5 vials ndc 0004694004.
Highlights of prescribing information known hypersensitivity. Avoid driving and doing other tasks or actions that call for you to be alert until you see how cytovene ganciclovir systemic affects you. Although the antineoplastic drugs remain the principal focus of the alert, other drugs may also be considered hazardous because they are potent. May be harmful by inhalation, ingestion, or skin absorption. Because ganciclovir shares some of the properties of antitumor agents ie. Due to the halflife of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability. Dailymed dacarbazine injection, powder, for solution. Niosh list of antineoplastic and other hazardous drugs in.
428 769 66 1512 1384 1543 517 1120 355 611 1159 1475 222 957 1416 1106 919 1490 274 984 187 1044 924 833 586 1398 215 370 1418 715 1497 1321 853 1232 309 755