Oncaspar contains pegaspargase, which is an enzyme asparaginase. Extranodal natural killertcell lymphomanasal type authorization of 12 months may be granted for the treatment of extranodal natural killertcell lymohomanasal type when oncaspar is used in conjunction with multiagent chemotherapy. Oncaspar, innpegaspargase european medicines agency. A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext. Push the blue plastic cannula of the mix2vial firmly through the rubber stopper of the diluent vial fig. Seair exim solutions provides complete details of oncaspar imports in india. Nov 01, 2019 oncaspar pegaspargase injection is supplied as a clear, colorless, preservativefree, isotonic sterile solution in phosphatebuffered saline, ph 7. Do not use trikafta after the expiration date on the package. Intracellularly, abacavir is converted by cellular enzymes to the active metabolite carbovir triphosphate. History of serious thrombosis with prior lasparaginase therapy. General information about the safe and effective use of trikafta. Oncaspar pegaspargase injection, solution for intramuscular and intravenous use.
Implanon etonogestrel implant 68 mg for subdermal use only. Abacavir is a carbocyclic synthetic nucleoside analogue. Administer integrilinby volume according to patient weightsee table1. We would like to show you a description here but the site wont allow us. This patients benefit plan requires prior authorization for certain medications in order for the drug to be covered. Oncaspar prior authorization request send completed form to. It also has direct but less marked positive inotropic and chronotropic effects on cardiac muscle. Dispense in tight, lightresistant container as defined in uspnf. A specially formulated medical food product, consisting of a proprietary formulation of amino acids and polyphenol ingredients in specific proportions, for the dietary management of the metabolic processes associated with sleep disorders. Priftin is only recommended for the treatment of active pulmonary tuberculosis caused by drugsusceptible organisms as part of regimens consisting of a 2month initial phase followed by a 4month continuation phase. Perform venipuncture using the enclosed winged needle with microbore tubing.
Highlights of prescribing information these highlights do not include all the information needed to prescribe dosage forms and strengths oncaspar safely and effectively. Jul 24, 2019 brevital can be used in adults as follows. Samples that have been assayed should be stored upright in the rack under one of the following conditions. Oncaspar is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia all in paediatric patients from birth to 18 years, and adult patients. Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Page 2 of 21 full prescribing information 1 indications and usage 1. Detecting and treating asparaginaserelated toxicities in. Key to symbols used list number calibrator a lot number calibrator b in vitro diagnostic medical device. Patient information is perforated for dispensing to the. Sandimmune soft gelatin capsules cyclosporine capsules, usp and sandimmune oral solution. Continuation of therapy all members including new members requesting authorization for continuation of therapy must meet all initial authorization criteria. Pegaspargase oncaspar, a pegylated form of native escherichia.
Mononine fda prescribing information, side effects and uses. Extravasation of etopophos may result in swelling, pain, cellulitis, and necrosis including skin necrosis. The easiest way to install inert filepath is through package control. The authors make no claims of the accuracy of the information contained herein. History of serious hypersensitivity reactions, including anaphylaxis, to oncaspar or to any of the excipients. This document contains side effect information about pegaspargase. Brevital may be given by infusion or intermittent injection. For those medications having an indefinite duration of use e. Etopophos etoposide phosphate for injection is an antineoplastic agent which is available for intravenous infusion as a sterile lyophile in singledose vials containing etoposide phosphate equivalent to 100 mg etoposide, 32. For further product information and current package insert, please visit. These highlights do not include all the information needed to use. Emcyt capsules are white and opaque, each containing estramustine phosphate sodium as the disodium salt monohydrate equivalent to 140 mg estramustine phosphate, for oral administration.
Highlights of prescribing information these highlights do. Use di water to dilute 5% to 7% sodium hypochlorite solution. Etopophos solutions may be administered at infusion rates up to 3. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Fragmin dalteparin sodium injection for subcutaneous use. Oncaspar aka pegaspargase is a human prescription drug product labeled by baxalta us inc. This package insert must be read carefully prior to use. Keep trikafta and all medicines out of the reach of children. Each 1 ml of the resulting concentrated stock solution contains 88 approximately 300 mg of ticarcillin and 10 mg of clavulanic acid. Store between 15c and 25c and avoid excessive heat.
While holding onto the diluent vial, carefully remove the outer package from the mix2vial, being careful to leave the mix2vial attached firmly to the diluent vial fig. This web page contains comprehensive information about ndc code 0944381001. Do not administer oncaspar if drug has been frozen. If the identification number is missing, or different from the stated number above, the strip should not be used. Oncaspar is used in conjunction with multiagent chemotherapy. For intravenous induction of anesthesia prior to the use of other general anesthetic agents 2.
Oraltox should remain in the sealed pouch until ready for use. Using aseptic technique, peel open the outer pouch and gently drop the inner foil pouch onto a sterile field or surface. Center the spike within the circle on the stopper top. See full prescribing information for complete boxed warning. Oncaspar, 48 patients 81% received all 3 planned doses of oncaspar, 6 10% received 2 doses, 4 7% received 1 dose, and 1 patient 2% did not receive the assigned treatment. Oncaspar pegaspargase prior auth criteria proprietary information. When using an intravenous infusion pump, administer integrilin undiluted directly from the 100ml vial.
Package insert phentolamine mesylate injection sandoz standard 5 mg ml therapeutic classification alphaadrenoreceptor blocker actions and clinical pharmacology phentolamine produces an alphaadrenergic block of relatively short duration. The eye care professional should provide the patient with the appropriate instructions that pertain to the patients prescribed lenses. Or o used as additional therapy in patients with a positive biopsy following a partial or no. Pharmacodynamics and safety of intravenous pegaspargase. This products label may have been revised after this insert was used in production. Hypersensitivity reactions, coagulopathy, hyperglycemia, elevated serum transaminase concentrations. These highlights do not include all the information needed to use cuvitru safely and effectively. Highlights of prescribing information coadministration of. Genscreen ultra hiv agab 1 plate 96 tests 72386 5 plates. Although it has been administered intraarterially, this is not recommended pending further evaluation of the possibility that adverse renal effects may be evoked more rapidly by this route of administration. Each vial of oncaspar contains 3,750 international units of pegaspargase in 5 ml of solution. Hepatitis b virus hbv reactivation has been reported, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Oncaspar pegaspargase is indicated as a component of a multiagent chemotherapeutic regimen for. Information for the user oncaspar 750 uml solution.
Human secretin is a gastrointestinal peptide hormone produced by cells in the duodenum in response to acidification. Quickly insert relative filepath from current folder into file. Sandimmune cyclosporine should be administered with adrenal corticosteroids but not with other immunosuppressive agents. This package insert is intended for the eye care professional, but should be made available to patients upon request. Lovenox is indicated for the prophylaxis of ischemic complications of unstable angina and nonqwave myocardial infarction, when concurrently administered with aspirin. Pdf asparaginaseassociated toxicity in children with acute. All members including new members requesting authorization for continuation of therapy must meet all initial authorization criteria. For intravenous induction of anesthesia and as an adjunct to subpotent inhalational anesthetic agents such as nitrous oxide in oxygen for short surgical procedures. Nov 28, 2006 pegaspargase oncaspar is a modified form of native e coli asparaginase in which the enzyme is covalently linked to polyethylene glycol. Oncaspar pegaspargase is indicated as a component of a multiagent chemotherapeutic regimen for the treatment of pediatric and adult patients with. Study 2 is an ongoing, multifactorial design study in which all patients received oncaspar as a component of various. Oncaspar pegaspargase injection is supplied as a clear, colorless, preservativefree, isotonic sterile solution in phosphatebuffered saline, ph 7.
These highlights do not include all the information needed to use advate safely and effectively. Withdraw the reconstituted solution into the syringe. See full prescribing information for 3,750 international units5 ml solution in a singleuse vial. Mar 06, 2018 package insert and patient information 5 ml of sterile water for injection using doubleended needles pdf 348kb package insert and patient information 10ml of sterile water for injection. Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Dailymed oncaspar pegaspargase injection, solution for. A prospective study on drug monitoring of pegasparaginase and erwinia asparaginase and asparaginase antibodies in pediatric acute lymphoblastic leukemia. Pegaspargase dosage adjustments are not required in patients with. The ndc code 0944381001 is assigned to oncaspar also known as. Integra meshed bilayer wound matrix package insert instructions for use integra meshed bilayer wound matrix without negative pressure therapy application 1. Pegaspargase, a human prescription drug labeled by baxalta us inc. Sentra pm product information sentra pm capsules by oral administration. Highlights of prescribing information take with food. The products dosage form is injection, solution, and is administered via intramuscular.
Emcyt estramustine phosphate sodium capsules description. In this insert, all dosages for ziagen are expressed in terms of abacavir. Integra meshed bilayer wound matrix package insert. Brevital sodium methohexital sodium injection, powder. Pegaspargase is contraindicated in patients with a history of allergy to. Zanosar sterile powder should be administered intravenously by rapid injection or shortprolonged infusion. Oncaspar can only be obtained with a prescription and only healthcare professionals with experience of cancer treatments should prescribe and give the medicine. Restricted access do not disseminate or copy without approval. Package insert instructions must be followed accordingly. A specially formulated medical food product, consisting of a proprietary blend of amino acids in specific proportions, for the dietary. Download the chirhostim human secretin for injection package insert in pdf form chirho stim human secretin for injection description. Mar 23, 2020 insert the vented filter spike into the stopper of the mononine vial, invert the vial, and position the filter spike so that the orifice is at the inside edge of the stopper.
Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert. For ease of reconstitution, the diluent may 87 be added in 2 portions. The binding preserves the enzymatic function of the drug, but decreases the immunogenicity of the protein, thus potentially reducing the risk of hypersensitivity reactions. Do not mix reagents from different lots within a given test run. Oncaspar is normally given every 14 days by injection into a muscle or by infusion drip into a vein, with the dose depending on age and body surface area. Unless prescribed otherwise, the following dosage schedule applies. Follow applicable special handling and disposal procedures. In vivo, abacavir sulfate dissociates to its free base, abacavir. Highlights of prescribing information these highlights do not include all the information needed to use kisqalisafely and effectively. Package insert materials not p rovided positive and n egative oral fluid controls timer precautions do not use the device after the expiration date printed on the pouch. Some of the dosage forms listed on this page may not apply to the brand name oncaspar for the consumer. Please click here for full prescribing information. Specific id number 53 verify the specific identification number before use.
Changes may be necessary because of hypersensitivity reactions or availability. Onivyde was withheld or delayed for adverse reactions in 62% of patients receiving onivyde5fulv. Ziagen abacavir sulfate tablets ziagen prescribing. Oncaspar is indicated as a component of a multiagent chemotherapeutic regimen for the treatment of pediatric and adult patients with all and hypersensitivity to native forms of lasparaginase. Dailymed oncaspar pegaspargase injection, solution. Priftin should not be used in the treatment of active pulmonary tuberculosis caused by rifampinresistant strains. Oncaspar fda prescribing information, side effects and uses. Inflectra infliximab dyyb this product information is intended only for residents of the united states.