Dosage reductions should also be considered for those with neutropenia, anemia andor thrombocytopenia see package insert for adverse events. Oxycodone is a semisynthetic narcotic analgesic generally prescribed for the relief of moderate to severe pain. Based on animal data, cytoveneiv has the potential to cause birth defects in humans. Dacarbazine for injection usp is a white to an ivory colored solid which is light sensitive. Advate antihemophilic factor recombinant is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia a congenital factor viii deficiency for. Minimum ppe required ppe requirements hazardous drug handling. Cytovene patient information including if i miss a dose. 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. Each 20 ml vial contains 200 mg of dacarbazine, usp active ingredient. Cytoveneiv fda prescribing information, side effects. Drug name active ingredients strength dosage formroute marketing status te code rld rs. Based on animal data, cytoveneiv may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females. Seek emergency medical attention or call the poison help line at 18002221222.
Call your doctor for instructions if you miss a dose. Cytovene prices, coupons and patient assistance programs. In 2018, the us food and drug administration fda published a draft guidance, entitled cytomegalovirus in transplantation. Highlights of prescribing information neulasta safely and. Due to the halflife of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability. Follow applicable special handling and disposal procedures. Camptosar should be diluted in 5% dextrose injection, usp, preferred or 0. This summary of product characteristics, labelling and package leaflet is the outcome of the referral procedure to which this commission decision relates. 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. Highlights of prescribing information these highlights do not. Gemzar vials contain no antimicrobial preservatives and are intended for single use only. Ganciclovir is a polar hydrophilic compound with a solubility of 2. Each vial also contains anhydrous citric acid and mannitol.
Ganciclovir should not be administered in patients with severe neutropenia anc less than 500l or severe thrombocytopenia platelets less than 25,000l. Cytoveneiv should also be used with caution in patients with preexisting cytopenias and in patients receiving myelosuppressive drugs or irradiation. Inclusion or absence of a drug label on the aidsinfo site does not imply endorsement or lack thereof by aidsinfo. Cidofovir is a white crystalline powder with an aqueous solubility of.
Ganciclovir is available as 250 mg and 500 mg capsules. 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. Aidsinfo provides the following drug label solely as an example of the labels available for ganciclovir. Package insert and patient information 5 ml of sterile water for injection using doubleended needles pdf 348kb package insert and patient information. Cytoxan cyclophosphamide for injection, usp cytoxan. Highlights of prescribing information valcytefor oral. Avoid direct contact of the skin or mucous membranes with cytoveneiv solutions. Although the antineoplastic drugs remain the principal focus of the alert, other drugs may also be considered hazardous because they are potent. Cytovene ganciclovir side effects, images, uses, dosage. Accidental release measures contain spill and collect, as appropriate. Camptosar injection 20 mgml is intended for single use only and any unused portion should be discarded.
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. Cytovene iv ganciclovir, formulated as monosodium salt, using sodium hydroxide as a salt forming agent, is a sterile white to offwhite lyophilized powder. 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. 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. Niosh list of antineoplastic and other hazardous drugs in. The compound is heat stable, has a high melting point, and is freely soluble in organic solvents. An abstract of this work was presented at the american college of veterinary internal medicine acvim forum in anaheim, ca, june 2010. 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. Learn about drug imprint, side effects, uses treating, dosage, interaction, overdose, and warnings. Cytoveneiv is supplied in cartons of 5 vials ndc 0004694004. The product information may be subsequently updated by the member state competent authorities, in.
Oxycodone is available as a single compound, but is often combined with other analgesics like acetaminophen or aspirin. Cytovene, ganciclovir dosing, indications, interactions. Invanz ertapenemfor injection for intravenous iv or intramuscular im use initial u. This cytovene price guide is based on using the drugs. Minimum ppe required ppe requirements hazardous drug. Proleukin aldesleukin, a human recombinant interleukin2 product, is a highly purified protein with a molecular weight of approximately 15,300 daltons. May 05, 2015 provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the us food and drug administration. 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.
Find patient medical information for cytovene oral on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Cytoxan cyclophosphamide for injection, usp cytoxan tablets. Each vial of cytoveneiv contains the equivalent 21 of 500 mg ganciclovir as the sodium salt 46 mg sodium. An abstract of this work was presented at the american college of veterinary internal medicine acvim forum in. Cytoveneiv fda prescribing information, side effects and uses. Highlights of prescribing information these highlights do not include all the information needed to use invanz safely and effectively. Ganciclovir is a synthetic, acyclic purine nucleoside analogue of guanine. Dailymed dacarbazine injection, powder, for solution. 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. General approach to handling hazardous drugs early concerns about occupational exposure to antineoplastic drugs first appeared in the 1970s. May be harmful by inhalation, ingestion, or skin absorption. Pharmacokinetics of ganciclovir and valganciclovir in the. It is structurally and pharmacologically similar to acyclovir and is active against herpesviruses. Highlights of prescribing information these highlights do not include all the information needed to use valcyte safely and effectively.
Cytoxan tablets cyclophosphamide tablets, usp are for oral use and contain 25 mg or 50 mg cyclophosphamide anhydrous. Valcytevalganciclovirtablets, valcytevalganciclovir hydrochloride fororal solution initial u. Nov 01, 2014 dacarbazine for injection usp is a white to an ivory colored solid which is light sensitive. Cytomegalovirus cmv remains an important pathogen in the transplant population. Cytovene capsules, cytoveneiv roche laboratories, drug. The chemical name is desalanyl1, serine125 human interleukin2.
Highlights of prescribing information these highlights do not include all the information needed to use ferrlecit safely and effectively. Highlights of prescribing information these highlights do not include all the information needed to use blincyto safely and effectively. Cytoveneiv ganciclovir, formulated as monosodium salt, using sodium hydroxide as a salt forming agent, is a sterile white to offwhite lyophilized powder. Tell all of your health care providers that you take cytovene ganciclovir systemic. Review the prescribing information for nivolumab for full dosing and schedule information. Its potency is approximately equivalent to morphine. Several fdaapproved drug labels may be available for ganciclovir. It is supplied in clear glass vials, each containing 375 mg. Ferrlecit sodium ferric gluconate complex in sucrose injection, for intravenous use initial u. Because ganciclovir shares some of the properties of antitumor agents ie. If such contact occurs, wash thoroughly with soap and water. Cellcept mycophenolate mofetil mmf is indicated for the prophylaxis of organ rejection,in recipients of allogeneic kidneysee clinical studies 14. Camptosar injection must be diluted prior to infusion. 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.
Find patient medical information for cytovene intravenous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Vistide is a sterile, hypertonic aqueous solution for intravenous infusion only. 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. This includes your doctors, nurses, pharmacists, and dentists. Dacarbazine for injection usp is reconstituted and administered intravenously ph 3. Cytovene ganciclovir is a member of the purine nucleosides drug class and is commonly used for cmv prophylaxis and cmv retinitis. 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. Proleukin, a lymphokine, is produced by recombinant dna technology using a genetically engineered e.
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 recurrent or. 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. 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. Cytoxan cyclophosphamide for injection, usp cytoxan tablets cyclophosphamide tablets, usp description cytoxan cyclophosphamide for injection, usp is a sterile white powder containing cyclophosphamide monohydrate. Development of therapeutics for the treatment and prevention. 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.
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