Arzerra discontinued

Jan 19, 2016 · Arzerra now approved by U.S. FDA for use for extended treatment of patients with recurrent or progressive CLL Approval based on data from interim analysis of Phase III PROLONG study Company Announcement . Novartis intends to transition availability of Arzerra ® (ofatumumab) to an oncology access program for chronic lymphocytic leukemia patients in the U.S. . Genmab receives ...September-15-2022 FDA-Approved Indications ARZERRA (ofatumumab) is a CD20-directed cytolytic monoclonal antibody indicated: In combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate;Arzerra is used to treat chronic lymphocytic leukemia (CLL), sometimes in ... Your cancer treatments may be delayed or permanently discontinued if you have ...01 հլս, 2013 թ. ... Treatment of RA patients with SC ofatumumab doses of 30 mg or higher resulted in ... MTX was discontinued and these events resolved.Copenhagen, Denmark; August 20, 2020 – Genmab A/S (Nasdaq: GMAB) announced today that Novartis intends to transition availability of Arzerra® (ofatumumab) to an oncology patient access program...Sep 20, 2010 · The partners said GlaxoSmithKline will discontinue development of IV ofatumumab for autoimmune indications to instead focus on a subcutaneous formulation. As a result, further enrollment will be discontinued for a Phase III trial of IV ofatumumab in RA. Arzerra (ofatumumab; Genmab/Novartis) is a fully human immunoglobulin G1 and high-affinity antibody that targets a novel epitope on cluster of differentiation 20 (CD20) on the B-cell membrane. Arzerra binds effectively to both the small and large extracellular loops on CD20 and releases very slowly over time. Preclinical and clinical data have ...no formation of anti ofatumumab antibodies in patients with CLL after ... ARZERRA should be discontinued and referral to a neurologist should be considered. casino extreme mobile loginCompany Announcement . Novartis intends to transition availability of Arzerra ® (ofatumumab) to an oncology access program for chronic lymphocytic leukemia patients in the U.S. ; Genmab receives ...Sep 20, 2010 · The partners said GlaxoSmithKline will discontinue development of IV ofatumumab for autoimmune indications to instead focus on a subcutaneous formulation. As a result, further enrollment will be discontinued for a Phase III trial of IV ofatumumab in RA. In the event of a severe infusion-related reaction, the infusion of Arzerra must be interrupted immediately and symptomatic treatment instituted (see section 4.2). If an anaphylactic reaction occurs, Arzerra should be immediately and permanently discontinued and appropriate medical treatment should be initiated. 23 հնվ, 2018 թ. ... Novartis is planning to stop marketing ofatumumab (Arzerra®) outside the US, but the drug will still be available for certain patients.Arzerra (ofatumumab; Genmab/Novartis) is a fully human immunoglobulin G1 and high-affinity antibody that targets a novel epitope on cluster of differentiation 20 (CD20) on the B-cell membrane....If PML is suspected, Arzerra treatment should be discontinued. Arzerra has been shown to increase the risk of Hepatitis B infection and reactivation. High-risk patients should be screened (1-4). Prior approval is required to ensure the safe, clinically appropriate and cost-effective use of Arzerra while maintaining optimal therapeutic outcomes.Because of this move to discontinue sales of ofatumumab, Novartis will pay Genmab a lump sum of $30 million as payment for lost potential royalties. References Genmab announces plan to transition...Sep 20, 2010 · The partners said GlaxoSmithKline will discontinue development of IV ofatumumab for autoimmune indications to instead focus on a subcutaneous formulation. As a result, further enrollment will be discontinued for a Phase III trial of IV ofatumumab in RA. yolo v7 code 22 սեպ, 2020 թ. ... Ofatumumab should be discontinued if PML is confirmed in the patient. In clinical trials, the rate of infections and serious injections were ...The partners said GlaxoSmithKline will discontinue development of IV ofatumumab for autoimmune indications to instead focus on a subcutaneous formulation. As a result, further enrollment will be discontinued for a Phase III trial of IV ofatumumab in RA.Arzerra (Ofatumumab) belongs to the class of medications called monoclonal antibodies.It is used to treat Chronic Lymphocytic Leukemia (CLL), which is a cancer of the blood that affects white blood cells.In CLL, white blood cells are made too quickly and live too long.WebIf a diagnosis of PML is suspected Arzerra should be discontinued and referral to a neurologist should be considered. Immunisations 1 The safety of, and ability to generate a primary or anamnestic response to, immunisation with live attenuated or inactivated vaccines during treatment with ofatumumab has not been studied. Hepatitis B 12.2 Administration. Administer ARZERRA in an environment where facilities to adequately monitor and treat infusion reactions are available [see Warnings and Precautions (5.1)]. Previously Untreated CLL, Relapsed CLL, and Extended Treatment in CLL: For initial 300-mg dose: Initiate infusion at a rate of 3.6 mg/hour (12 mL/hour). For subsequent infusions of 1,000 mg: Initiate infusion at a rate ...Web sihir koji se obnavlja WebWebArzerra should be discontinued in patients who develop or experience a reactivation of viral hepatitis (1). Safety and effectiveness of Arzerra have not been established in children (1). Related policies Gazyva, Rituximab, Rituxan Hycela Policy This policy statement applies to clinical review performed for pre-service (Prior Approval,Arzerra now approved by U.S. FDA for use for extended treatment of patients with recurrent or progressive CLL Approval based on data from interim analysis of Phase III PROLONG study midnight suns review ignSince 1960, the Monthly Index of Medical Specialities, containing impartial information on drugs available for prescription here in Ireland, has served as a valuable tool for Irish doctors and other healthcare professionals across the country.September-15-2022 FDA-Approved Indications ARZERRA (ofatumumab) is a CD20-directed cytolytic monoclonal antibody indicated: In combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate;General information. Class/mechanism: Anti-CD20 monoclonal antibody that binds to small and large extracellular loops of the CD20 molecule which is expressed on B-cells. The Fc domain of ofatumumab has been observed in vitro to mediate immune effector functions and B-cell lysis, which is hypothesized to involve complement-dependent cytotoxicity ... Arzerra now approved by U.S. FDA for use for extended treatment of patients with recurrent or progressive CLL Approval based on data from interim analysis of Phase III PROLONG study10 մրտ, 2016 թ. ... The Phase III trial is being discontinued, a decision that Genmab said has nothing to do with the safety or tolerability of Arzerra.Arzerra 100 mg concentrate for solution for infusion. Each vial contains 100 mg of ofatumumab in 5 ml. Arzerra 1000 mg concentrate for solution for infusion. Each vial contains 1000 mg of ofatumumab in 50 ml. Ofatumumab is a human monoclonal antibody produced in a recombinant murine cell line (NS0). Excipient with known effectOn this page about Arzerra you will find information relating to side effects, age restrictions, food interactions, whether the medicine is available at a government subsidised price on the pharmaceutical benefits scheme (PBS) as well as other useful information. ... Support for this browser is being discontinued. Support for this browser is ...WebWebCompany Announcement Novartis intends to transition availability of Arzerra ® (ofatumumab) to an oncology access program for chronic lymphocytic leukemia patients in the U.S. Genmab receives USD 30 million from Novartis as payment for lost potential royalties and improves 2020 financial guidance If PML is suspected, Arzerra treatment should be discontinued. Arzerra has been shown to increase the risk of Hepatitis B infection and reactivation. High-risk patients should be screened (1-4). Prior approval is required to ensure the safe, clinically appropriate and cost-effective use of Arzerra while maintaining optimal therapeutic outcomes.In the event of a severe infusion-related reaction, the infusion of Arzerra must be interrupted immediately and symptomatic treatment instituted (see section 4.2). If an anaphylactic reaction occurs, Arzerra should be immediately and permanently discontinued and appropriate medical treatment should be initiated.Web android 13 update download Arzerra should be discontinued in patients who develop or experience a reactivation of viral hepatitis (1). Safety and effectiveness of Arzerra have not been established in children (1). Related policies Gazyva, Rituximab, Rituxan Hycela Policy This policy statement applies to clinical review performed for pre-service (Prior Approval,Copenhagen, Denmark; August 20, 2020 –Genmab A/S (Nasdaq: GMAB) announced today that Novartis intends to transition availability of Arzerra®(ofatumumab) to an oncology patient access program that will provide Arzerra at no cost to chronic lymphocytic leukemia (CLL) patients in the U.S.Sep 20, 2010 · The partners said GlaxoSmithKline will discontinue development of IV ofatumumab for autoimmune indications to instead focus on a subcutaneous formulation. As a result, further enrollment will be discontinued for a Phase III trial of IV ofatumumab in RA. WebArzerra (ofatumumab) is in a class of drugs called anti-CD20-directed monoclonal antibodies. It is used to treat chronic lymphocytic leukemia (CLL) in patients who have further disease after...Arzerra is a prescription drug used to treat chronic lymphocytic leukemia. Learn about the mild and serious side effects it can cause and how to manage them.Jan 19, 2016 · Arzerra now approved by U.S. FDA for use for extended treatment of patients with recurrent or progressive CLL Approval based on data from interim analysis of Phase III PROLONG study WebArzerra is a colourless concentrate for solution for infusion. Arzerra 100 mg is available in a pack containing 3 vials and two extension sets. Each glass vial is closed with a latex-free rubber stopper and aluminium over-seal, and contains 5 ml of concentrate (100 mg of ofatumumab). Arzerra 1,000 mg is available in a pack containing 1 vial and ... hollywood casino online pa Arzerra is used to treat chronic lymphocytic leukemia (CLL), sometimes in ... Your cancer treatments may be delayed or permanently discontinued if you have ...The partners said GlaxoSmithKline will discontinue development of IV ofatumumab for autoimmune indications to instead focus on a subcutaneous formulation. As a result, further enrollment will be discontinued for a Phase III trial of IV ofatumumab in RA.General information. Class/mechanism: Anti-CD20 monoclonal antibody that binds to small and large extracellular loops of the CD20 molecule which is expressed on B-cells. The Fc domain of ofatumumab has been observed in vitro to mediate immune effector functions and B-cell lysis, which is hypothesized to involve complement-dependent cytotoxicity ... Copenhagen, Denmark; August 20, 2020 –Genmab A/S (Nasdaq: GMAB) announced today that Novartis intends to transition availability of Arzerra®(ofatumumab) to an oncology patient access program that will provide Arzerra at no cost to chronic lymphocytic leukemia (CLL) patients in the U.S. WebArzerra (ofatumumab) is in a class of drugs called anti-CD20-directed monoclonal antibodies. It is used to treat chronic lymphocytic leukemia (CLL) in patients who have further disease after... gcse english past papers pdf Because of this move to discontinue sales of ofatumumab, Novartis will pay Genmab a lump sum of $30 million as payment for lost potential royalties. References Genmab announces plan to transition...WebSep 20, 2010 · The partners said GlaxoSmithKline will discontinue development of IV ofatumumab for autoimmune indications to instead focus on a subcutaneous formulation. As a result, further enrollment will be discontinued for a Phase III trial of IV ofatumumab in RA. Dive Brief: Novartis plans to stop commercial marketing of its leukemia drug Arzerra in markets outside the U.S, reacting to changes in treatment standards brought by the entry of more potent new medicines for the blood cancer. "Novartis' intention to transition Arzerra to compassionate use programs in the non-US markets reflects the fact that many more drugs have become available for CLL over the last five years and that there is a low number of patients using Arzerra outside of the US ...Consider permanent discontinuation of ARZERRA if the severity of the infusion reaction does not resolve to less than or equal to Grade 2 despite adequate clinical intervention. Permanently discontinue therapy for patients who develop an anaphylactic reaction to ARZERRA.22 հնվ, 2018 թ. ... Blockbuster drug owner Genmab developed Arzerra for the treatment of chronic lymphocytic leukemia (CLL) but the drug will be taken off the ...The partners said GlaxoSmithKline will discontinue development of IV ofatumumab for autoimmune indications to instead focus on a subcutaneous formulation. As a result, further enrollment will be discontinued for a Phase III trial of IV ofatumumab in RA.Sep 20, 2010 · The partners said GlaxoSmithKline will discontinue development of IV ofatumumab for autoimmune indications to instead focus on a subcutaneous formulation. As a result, further enrollment will be discontinued for a Phase III trial of IV ofatumumab in RA. Published on Jan 25, 2017This guidance has been withdrawn because Novartis has discontinued ofatumumab (Arzerra). Ofatumumab will continue to be available for people who need it. Contact Clinigen at [email protected] or 01932 842100 for details.Arzerra Combination FDA Approved in Chronic Lymphocytic Leukemia. August 31, 2016. Silas Inman. Arzerra was approved in combination with fludarabine and cyclophosphamide to treat patients with CLL. After an improvement in progression-free survival (PFS) was seen in the phase 3 COMPLEMENT-2 study, the U.S. Food and Drug Administration (FDA ... el chorro thanksgiving September-15-2022 FDA-Approved Indications ARZERRA (ofatumumab) is a CD20-directed cytolytic monoclonal antibody indicated: In combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate;The ad for Arzerra (ofatumumab) targeted healthcare professionals, running in the December 1, 2009, issue of Journal of Clinical Oncology. Without identifying Arzerra explicitly, the ad mentions the availability of a new drug for adult chronic lymphocytic leukemia (CLL) that is resistant to fludarabine and alemtuzumab and features the GSK logo ...COPENHAGEN, Denmark I January 19, 2016 I Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for the use of Arzerra® (ofatumumab) for extended treatment of patients who are in complete or partial response after at least two lines ...WebWeb unblurred picture of meowbahh and techno WebIf a diagnosis of PML is suspected Arzerra should be discontinued and referral to a neurologist should be considered. Immunisations 1 The safety of, and ability to generate a primary or anamnestic response to, immunisation with live attenuated or inactivated vaccines during treatment with ofatumumab has not been studied. Hepatitis B 1Novartis laid out $16 billion for GlaxoSmithKline’s oncology portfolio in 2015 and has spent much of the last four years laboring to make a success of one of the drugs it picked up, Arzerra.Web liraglutide indications Novartis intends to transition availability of Arzerra ® to an oncology access program for chronic lymphocytic leukemia patients in the U.S. Genmab receives USD 30 million from Novartis as ...If a diagnosis of PML is suspected Arzerra should be discontinued and referral to a neurologist should be considered. Immunisations 1 The safety of, and ability to generate a primary or anamnestic response to, immunisation with live attenuated or inactivated vaccines during treatment with ofatumumab has not been studied. Hepatitis B 1 Note: As of 10/15/2020, ofatumumab is no longer available for commercial purchase as Arzerra. Novartis will continue providing drug directly, at no cost to patient, but only for the diagnosis of chronic lymphocytic leukemia. Contents 1 General information 2 Diseases for which it is used 3 Diseases for which it was used 4 Patient drug informationFind a number to call for information about the ARZERRA® (ofatumumab) Oncology Access Program from Novartis.ARZERRA Oncology Access Program For US residents only. Prescribing Information Prescribing Info Patient Support Line 1-800-282-7630, 9 am - 8 pm ET Contact Us Non-US Residents Use of website is governed by the Terms of Use and Privacy Policy. Copyright © 2020 Novartis Pharmaceuticals Corporation. All rights reserved. 8/20 ARZ-123401223 հնվ, 2018 թ. ... Novartis is planning to stop marketing ofatumumab (Arzerra®) outside the US, but the drug will still be available for certain patients.The partners said GlaxoSmithKline will discontinue development of IV ofatumumab for autoimmune indications to instead focus on a subcutaneous formulation. As a result, further enrollment will be discontinued for a Phase III trial of IV ofatumumab in RA.If PML is suspected, Arzerra treatment should be discontinued. Arzerra has been shown to increase the risk of Hepatitis B infection and reactivation. High-risk patients should be screened (1-4). Prior approval is required to ensure the safe, clinically appropriate and cost-effective use of Arzerra while maintaining optimal therapeutic outcomes.ARZERRA Oncology Access Program For US residents only. Prescribing Information Prescribing Info Patient Support Line 1-800-282-7630, 9 am - 8 pm ET Contact Us Non-US Residents Use of website is governed by the Terms of Use and Privacy Policy. Copyright © 2020 Novartis Pharmaceuticals Corporation. All rights reserved. 8/20 ARZ-1234012 WebWebCopenhagen, Denmark; August 20, 2020 – Genmab A/S (Nasdaq: GMAB) announced today that Novartis intends to transition availability of Arzerra® (ofatumumab) to an oncology patient access program...Arzerra is used to treat chronic lymphocytic leukemia (CLL), sometimes in ... Your cancer treatments may be delayed or permanently discontinued if you have ...WebPML is suspected, Arzerra treatment should be discontinued. Arzerra has been shown to increase the risk of Hepatitis B infection and reactivation. High-risk patients should be screened. Arzerra should be discontinued in patients who develop or experience a reactivation of viral hepatitis (1).Since 1960, the Monthly Index of Medical Specialities, containing impartial information on drugs available for prescription here in Ireland, has served as a valuable tool for Irish doctors and other healthcare professionals across the country.Arzerra is a prescription drug used to treat chronic lymphocytic leukemia. Learn about the mild and serious side effects it can cause and how to manage them.WebWebWebThe FDA has announced that the anti-CD20-directed monoclonal antibodies rituximab (Rituxan) and ofatumumab (Arzerra) will carry a boxed warning for immunosupression-related reactivation of...Progressive multifocal leukoencephalopathy (PML) resulting in death has occurred with Arzerra. If PML is suspected, Arzerra should be discontinued and initiate evaluation for PML, including...WebWeb scribe ex wife Web yachts for sale PML is suspected, Arzerra treatment should be discontinued. Arzerra has been shown to increase the risk of Hepatitis B infection and reactivation. High-risk patients should be screened. Arzerra should be discontinued in patients who develop or experience a reactivation of viral hepatitis (1).The partners said GlaxoSmithKline will discontinue development of IV ofatumumab for autoimmune indications to instead focus on a subcutaneous formulation. As a result, further enrollment will be discontinued for a Phase III trial of IV ofatumumab in RA.Jan 19, 2016 · Arzerra now approved by U.S. FDA for use for extended treatment of patients with recurrent or progressive CLL Approval based on data from interim analysis of Phase III PROLONG study Note: As of 10/15/2020, ofatumumab is no longer available for commercial purchase as Arzerra. Novartis will continue providing drug directly, at no cost to patient, but only for the diagnosis of chronic lymphocytic leukemia. Contents 1 General information 2 Diseases for which it is used 3 Diseases for which it was used 4 Patient drug informationagents ofatumumab or rituximab. ... and Anticancer Drugs Arzerra (Ofatumumab) and Rit- ... should be immediately discontinued and appropriate.Note: As of 10/15/2020, ofatumumab is no longer available for commercial purchase as Arzerra. Novartis will continue providing drug directly, at no cost to patient, but only for the diagnosis of chronic lymphocytic leukemia. Contents 1 General information 2 Diseases for which it is used 3 Diseases for which it was used 4 Patient drug informationIf PML is suspected, Arzerra treatment should be discontinued. Arzerra has been shown to increase the risk of Hepatitis B infection and reactivation. High-risk patients should be screened (1-4). Prior approval is required to ensure the safe, clinically appropriate and cost-effective use of Arzerra while maintaining optimal therapeutic outcomes.30 հնվ, 2018 թ. ... Novartis will remove its chronic lymphocytic leukemia treatment, Arzerra, from non-U.S. markets, limiting its availability outside of the ...Arzerra® Arzerra® 2. Qualitative And Quantitative Composition. One ml of concentrate contains 20 mg of ofatumumab. Each vial contains 100 mg of ofatumumab in 5 ml. Each vial contains 1,000 mg of ofatumumab in 50 ml. Ofatumumab is a human monoclonal antibody produced in a recombinant murine cell line (NS0). Excipients: azure ad policy 02 մրտ, 2010 թ. ... The loss for discontinued operation amounted to DKK 662 million (USD ... as follows: Arzerra (ofatumumab) Approved by FDA Filed Biologics ...was discontinued. Reference: Medicines Safety Update, TGA, Vol. 8, No. 1, February 2017 (www.tga.gov.au) (See WHO Pharmaceuticals Newsletters No.3, 2016: Risk of impulse-control problems in the US and No.6, 2015: Risk of certain impulse control behaviours in Canada) Canagliflozin Risk of lower limb amputation Malaysia. The NPRA hasDo not exceed the infusion rates in Table 1. Table 1. Infusion Rates for ARZERRA in Previously Untreated CLL, Relapsed CLL, and Extended Treatment in CLL. a Initial 300 mg: median durations of infusions = 4.8 to 5.2 hours. b Subsequent infusions of 1,000 mg: median durations of infusions = 4.2 to 4.4 hours.Note: As of 10/15/2020, ofatumumab is no longer available for commercial purchase as Arzerra. Novartis will continue providing drug directly, at no cost to patient, but only for the diagnosis of chronic lymphocytic leukemia. Contents 1 General information 2 Diseases for which it is used 3 Diseases for which it was used 4 Patient drug informationSep 20, 2010 · The partners said GlaxoSmithKline will discontinue development of IV ofatumumab for autoimmune indications to instead focus on a subcutaneous formulation. As a result, further enrollment will be discontinued for a Phase III trial of IV ofatumumab in RA. do you need a license to sell supplements uk If PML is suspected, Arzerra treatment should be discontinued. Arzerra has been shown to increase the risk of Hepatitis B infection and reactivation. High-risk patients should be screened (1-4). Prior approval is required to ensure the safe, clinically appropriate and cost-effective use of Arzerra while maintaining optimal therapeutic outcomes.WebWebWeb what is love Published on Jan 25, 2017Arzerra should be discontinued in patients who develop or experience a reactivation of viral hepatitis (1). Safety and effectiveness of Arzerra have not been established in children (1). Related policies Gazyva, Rituximab, Rituxan Hycela Policy This policy statement applies to clinical review performed for pre-service (Prior Approval,02 մրտ, 2010 թ. ... The loss for discontinued operation amounted to DKK 662 million (USD ... as follows: Arzerra (ofatumumab) Approved by FDA Filed Biologics ...What is Arzerra used for? What type of medication is Arzerra? Is chlorambucil a chemotherapy? Who makes Ibrutinib? Is Kesimpta better than Ocrevus? Can Kesimpta cause hair loss? What are the risks of Arzerra? What happens if Arzerra is discontinued? guillotine mma The partners said GlaxoSmithKline will discontinue development of IV ofatumumab for autoimmune indications to instead focus on a subcutaneous formulation. As a result, further enrollment will be discontinued for a Phase III trial of IV ofatumumab in RA.If a diagnosis of PML is suspected Arzerra should be discontinued and referral to a neurologist should be considered. Immunisations 1 The safety of, and ability to generate a primary or anamnestic response to, immunisation with live attenuated or inactivated vaccines during treatment with ofatumumab has not been studied. Hepatitis B 1 Copenhagen, Denmark; August 20, 2020 –Genmab A/S (Nasdaq: GMAB) announced today that Novartis intends to transition availability of Arzerra®(ofatumumab) to an oncology patient access program that will provide Arzerra at no cost to chronic lymphocytic leukemia (CLL) patients in the U.S.Copenhagen, Denmark; August 20, 2020 – Genmab A/S (Nasdaq: GMAB) announced today that Novartis intends to transition availability of Arzerra® (ofatumumab) to an oncology patient access program...Web ignatian spirituality institute dallas Jan 19, 2016 · Arzerra now approved by U.S. FDA for use for extended treatment of patients with recurrent or progressive CLL Approval based on data from interim analysis of Phase III PROLONG study Arzerra now approved by U.S. FDA for use for extended treatment of patients with recurrent or progressive CLL Approval based on data from interim analysis of Phase III PROLONG study12 փտվ, 2018 թ. ... trum Pharmaceuticals, Henderson, NV), ofatumumab (Arzerra ... were discontinued by the manufacturer in 2014 (Table 1). Ritux-.WebCopenhagen, Denmark; August 20, 2020 – Genmab A/S (Nasdaq: GMAB) announced today that Novartis intends to transition availability of Arzerra® (ofatumumab) to an oncology patient access program...September-15-2022 FDA-Approved Indications ARZERRA (ofatumumab) is a CD20-directed cytolytic monoclonal antibody indicated: In combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate; why is there no sound when i screen record on mac