Azacitidine is designed to slow the production of leukemia cells and help the bone marrow produce more healthy and normal functioning cells. Open the word document and select insert on the ribbon. Infusion rates for arzerra in previously untreated cll. However, this will only insert the text without the original formatting or graphics if any from the pdf file, so it wont look. Arzerra fda prescribing information, side effects and uses. Infusion rates for arzerra in previously untreated cll, relapsed cll, and extended.
Antitumor activity was also observed in additional patients in study 1 and in a multicenter, openlabel, doseescalation study study 2 conducted in patients with relapsed or refractory cll smithkline beecham corporation product insert for arzerra, 2009. Details of the impact on survival have not yet been published, but the trials monitoring committee has advised all patients in the arzerra arm be offered access to imbruvica. Ofatumumab was granted fast track status for cll by the us food and drug. Arzerra is usually given in a treatment cycle over several weeks, beginning with one infusion per week. First quarter 2015 net sales figures for arzerra ofatumumab. Highlights of prescribing information these highlights do not. Extension of indication to include the combination of arzerra with. In the text group click the dropdown arrow for object and select object.
Do not flush medications down the toilet or pour them into drainage unless instructed to do so. In the object dialogue box, click create from file and then click browse to find the pdf document you want to insert. Do not use past the expiration date indicated on the kit. Ocrevus increases your risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. This will insert the pdf first page only as objects cannot span pages just as in earlier versions, without converting the pdf.
Sep 01, 2019 arzerra is a sterile, clear to opalescent, colorless, preservativefree liquid concentrate for intravenous administration. These low blood cell counts may be severe and, in some cases, lead to death. Lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings. Ofatumumab arzerra medical clinical policy bulletins.
Arzerra is indicated for the treatment of cll in adult patients who are refractory to. The file location will now appear on the object dialog box. Tell your healthcare provider if you have an infection or have any of the following signs of infection including fever, chills, a cough that does not go away, or signs of herpes such as cold. We named this method insertatindex with the signature index, value, array. Now when yor insert into table2 the table you have mentioned in your question, you will insert into table2 selecting values from the table variable. Arzerra ofatumumab is the generic name for the trade chemotherapy drug arzerra. Ofatumumab arzerra medical clinical policy bulletins aetna. By signed i mean selecting and item from a dropdown list appdisapp. Ofatumumab package insert keyword after analyzing the system lists the list of keywords related and the list of websites with related content. Our discount and coupon prices are based on contracts between a pharmacy or pharmacy purchasing group and a pharmacy benefit manager pbm, who provides. Arzerra is an antibody that is made in a laboratory rather than a naturally occurring antibody. Auc, of calan sr was similar to calan immediate release. Before using asunra tablet, inform your doctor about your current list of medications, over the counter products e. Do not interchange components of one kit with those of another kit.
Gazyva obinutuzumab is a prescription medicine used in combination with chemotherapy, followed by gazyva alone in those who responded, to treat stage ii bulky, iii or iv follicular lymphoma fl in adults who have not had previous fl treatment. It is not known whether ofatumumab passes into breast milk or if it could harm a nursing. These package inserts, also called product labels, constitute the formal, governmentapproved definition of a drugs benefits and risks. In december 2006, genmab licensed worldwide rights for ofatumumab to.
The kit comprises five individual vials of sterile, nonpyrogenic, freezedried mixture of exametazime, stannous chloride dihydrate and sodium chloride, ten radiation labels, five radiochemical purity worksheets, five labeling efficiency worksheets, one package insert, five individual vials of methylene blue injection usp 1%, five individual. Abilify has been systematically evaluated and shown to be effective in a dose range of 10 to 30 mgday, when administered as the tablet. Arzerra may cause low blood cell counts white blood cells, platelets, and red blood cells. Arzerra in patients who develop viral hepatitis or reactivation of viral. See full prescribing information for complete boxed warning. Some health conditions may make you more susceptible to the sideeffects of the drug. Ofatumumab is usually given in a treatment cycle over several weeks, beginning with one infusion per week. Loss of drug effect can occur if the inhaler is turned upside down, held with the mouthpiece pointing down, shaken or dropped after the cartridge has been inserted but before the dose has been administered. Do not freeze medicines unless required by package insert. Elotuzumab package insert keyword found websites listing.
The ceretec kit is supplied as five packs of three vials for use in the preparation of a technetium tc99m exametazime intravenous injection as a diagnostic radiopharmaceutical for use as an adjunct in the detection of altered regional cerebral perfusion and for the radiolabeling of autologous leukocytes. Azacitidine is given to help increase blood cell counts, reduce the risk of infection, reduce the amount of blood transfusions needed, and decrease the risk of bleeding. The solution 115 should not be used if discolored or cloudy, or if foreign particulate matter is present. Click on the object button, and a dialog box will open. For outlook, click inside of the body of an item, such as an email message or calendar event. Arzerra ofatumumab is indicated for the treatment of patients with chronic lymphocytic leukemia cll refractory to fludarabine and alemtuzumab. In a randomized, singledose, crossover study using healthy volunteers, administration of 240 mg calan sr with food produced peak plasma verapamil concentrations of 79 ngml.
I like being able to prescribe the lower dose of phentermine. If any of the above occur, the cartridge should be replaced before use. The effectiveness of arzerra is based on the demonstration of durable objective responses. Control and prevention of bleeding in patients with hemophilia a or acquired factor viii fviii deficiency 1. Package leaflet and to the risk management plan rmp. To report suspected adverse reactions, contact glaxosmithkline at 18888255249 or fda at 1800fda1088 or. A 24week, phase iii, doubleblind, parallelgroup study of edaravone mci186 for treatment of amyotrophic lateral sclerosis als. The following table lists the ndcs and labelers of arzerra. When you click on object, youll get a dialog box, and here you will want to click on the create from file tab. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for zithromax azithromycin.
Empliciti for injection is supplied as 300 mg per vial and 400 mg per vial and requires reconstitution with sterile water for injection, usp ml and 17 ml. Please see brief summary of prescribing information, including boxed warning, for arzerra on the following pages. Lomaira phentermine hydrochloride usp 8 mg tablets, civ, is an fdaapproved prescription medicine that can be used for a short period of time a few weeks for weight reduction and should be used together with regular exercise and a reducedcalorie diet. The form will be signed by many people15 persons on different dates. Your doctor will check your blood to see if you have low blood cell counts. Bend the loop outward to lock it in the upright position, then suspend container from hanger. The recommended starting and target dose for abilify is 10 or 15 mgday administered on a onceaday schedule without regard to meals. The medicine must be given slowly through an iv infusion, and one dose can take up to several hours to complete. If this is added, we will happily deprecate our version of the method in futil which is a complementary tool for lodash if youre unfamiliar it should be immutable because otherwise, it doesnt add much over splice. The contents of the technescan maa reaction vial are not radioactive. Patients will tear along a perforation, remove a strip 3 cartridges per strip, press on the individual cartridge to remove it from the strip, and insert the cartridge into the inhaler for use. The object dialog box will appear select create from file.
Arzerra should be a clear to opalescent, colorless solution. Low white blood cell count, also called neutropenia, may happen during treatment or even weeks later. It works by binding to cd20, a specific antigen found on the surface of healthy cells and leukemia b cells a type of white blood cell. Many programs are available from federal and state governments, nonprofits, manufacturers, and other organizations to help you get the drugs you need at a reduced cost. There are no human or animal data on the potential shortterm and longterm effects of. About goodrx prices and arzerra coupons goodrx s cash prices are based on multiple sources, including published price lists, purchases, claims records, and data provided by pharmacies.
Arzerra was administered at 2,000 mg beginning with the second dose for 11 doses study 1 n 154 or 3 doses study 2 n 27. Sections or subsections omitted from the full prescribing information are not. Highlights of prescribing information these highlights do. The efficacy of arzerra in the treatment of refractory cll is based on the demonstration of durable. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for afrin oxymetazoline skip to. Medication discarded in this manner may contaminate the environment. Click insert to insert the images into the word document. Ofatumumab must be given slowly through an iv infusion, and one dose can take up to several hours to complete. Longterm efficacy and safety with ibrutinib ibr in. Do not modify the handling and storage conditions for reagents or samples. In order to obtain reliable and consistent results, the instructions in the package insert must be strictly followed. The labeling reactions involved in preparing technescan maa tc 99m depend upon maintain. Here are two steps to insert pdf into word document as an object.
Empliciti elotuzumab is a sterile, nonpyrogenic, preservativefree lyophilized powder that is white to offwhite, whole or fragmented cake in singledose vials. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for afrin oxymetazoline. Mar 01, 2018 product approval information is indicated for. Empliciti fda prescribing information, side effects and uses. Before using cayona injection, inform your doctor about your current list of medications, over the counter products e. Embed pdf in word embed a pdf document into microsoft word. Intramed mannitol 25% mv injection scheduling status. Arzerra ofatumumab is a human monoclonal antibody that is designed to target the cd20 molecule found on the surface of chronic lymphocytic leukemia cll. For previously untreated cll, the recommended dosage and schedule is. The recommended starting and target dose for abilify is 10 or 15 mgday administered on a once a day schedule without regard to meals. Highlights of prescribing information these highlights. May 06, 2015 arzerra ofatumumab is a human monoclonal antibody that is designed to target the cd20 molecule found on the surface of chronic lymphocytic leukemia cll cells and normal b lymphocytes. Extended treatment in cll recommended dosage and schedule is. Each singleuse vial contains either 100 mg ofatumumab in 5 ml of solution or 1,000 mg ofatumumab in 50 ml of solution.
In some cases, health care professionals may use the trade name arzerra when referring to the generic drug name ofatumumab. Find info for hcps about arzerra, a monoclonal antibody for 4 cll treatment. This is how to insert pdf into word as an embedded object. Patient assistance program from pan foundation learn more about this tip on our blog. It works by binding to cd20, a specific antigen found on the surface of. A healthcare provider will give you this injection. Withdraw and discard 15 ml from a 1,000ml bag of 0. Arzerra is supplied at a concentration of 20 mgml in singleuse vials. The data described in table 2 and other sections below are derived from 154 patients in study 1. Summary of adverse events leading to dose reductions by preferred term in at. Now that we have these phase iii studies, we have a comparator, so idelalisib plus rituximab rituxan, to placebo plus rituximab.
Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. Graham mayor microsoft word mvp 20022019 for more word tips and downloads visit my web site. Ofatumumab package insert keyword found websites listing. The content of package inserts from the us food and drug administration fda is vital to the commercial success of a medicinal product. However, after the sodium pertechnetate tc 99m is added, adequate shielding of the final preparation must be maintained.