#safety communication

[insteading]

Update on the Safety of Andexxa by AstraZeneca: FDA Safety Communicati

Since approval, the FDA has received postmarketing safety data on thromboembolic events, including serious and fatal outcomes, in patients t

"AUDIENCE: Patient, Health Care Professional, Pharmacy, Hematology

ISSUE: Since approval, the FDA has received postmarketing safety data on thromboembolic events, including serious and fatal outcomes, in patients treated with Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo). Based on available data, the serious risks including the increase in thromboembolic events are such that the FDA considers the risks of the product to outweigh its benefits. The FDA has communicated this position to AstraZeneca, and the company has submitted a request to voluntarily withdraw the BLA for the product for commercial reasons.

Additionally, the company has confirmed that it will end U.S. commercial sales today, December 22, 2025. Andexxa will no longer be manufactured for or sold in the U.S. by AstraZeneca after December 22, 2025.

Continuous monitoring and assessment of the safety of all biological products, including Andexxa, is an FDA priority, and we remain committed to informing the public when we learn new information about these products.

BACKGROUND: The FDA initially granted accelerated approval (AA) of Andexxa, a recombinant modified human factor Xa (FXa) protein, in 2018, indicated for patients treated with rivaroxaban or apixaban when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Initial approval included a Boxed Warning for thromboembolic risks. AA was granted based on the change from baseline in anti-activated FXa (anti-FXa) activity in healthy volunteers, as a surrogate endpoint reasonably likely to predict clinical benefit.

At the time of AA of Andexxa, AstraZeneca (Applicant) was subject to a requirement to conduct a randomized controlled trial (NCT03661528) to verify the clinical benefit of Andexxa among patients with intracerebral hemorrhage following treatment with rivaroxaban or apixaban. On January 31, 2024, the Applicant submitted a supplemental Biologics Licensing Application (sBLA) for Andexxa with the results of the ANNEXA-I trial to fulfill this requirement. The FDA convened a meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (AC) on November 21, 20241, to discuss the results of the ANNEXA-I trial. The major safety findings discussed at the AC meeting included a doubling of the rate of thromboses and thrombosis-related deaths at Day 30 in the Andexxa arm compared with usual care (UC):

Increased risk of thrombosis: ANNEXA-I demonstrated an increased incidence of thrombosis (14.6% versus 6.9%) and thrombosis-related deaths at Day 30 (2.5% versus 0.9%) in the Andexxa arm compared with the UC arm, respectively.

Death related to thrombotic events through 30 days occurred in 6 patients (2.5%) in the Andexxa arm compared with 2 patients (0.9%) in the usual care control arm.

The FDA will continue working with AstraZeneca to keep providers and the public informed as AstraZeneca prepares to end sale of Andexxa.

1Cellular, Tissue, and Gene Therapies Advisory Committee November 21, 2024 Meeting Announcement

[FDA Safety Communication - 12/18/2025]"

[bidhuan]

Hindari Efek Samping, BPOM Rilis Materi Edukasi Hemlibra (Emicizumab)

Hindari Efek Samping, BPOM Rilis Materi Edukasi Hemlibra (Emicizumab)

Majalah Farmasetika – Pusat Farmakovigilans / MESO Nasional Badan Pengawas Obat dan Makanan (BPOM) RI mengeluarkan “safety communication” untuk obat hemofilia A Hemlibra (Emicizumab) yang dikaitkan dengan resiko terjadinya mikroangiopati trombotik, tromboembolisme, dan intervensi.

“PT Roche Indonesia mendiseminasikan materi edukasi untuk produk Hemlibra (emicizumab) yang terdiri dari : Panduan…

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How to Communicate Workplace Windshield Messages

Effective communication is vital to get staff and contractors aligned and working towards a positive safety culture.<\p>

As well, just providing training to work safely is not always enough. How we communicate about safety influences whether or not people will accept or reject our prophylactic messages.<\p>

As a safety communicator or leader, you know how important it is that people bug and be with one action on your words. However, themselves defrock be difficult to get workers toward pay you attention when they suffer from the terrible misery respecting "We've heard this all before" bias.<\p>

The main objective of any safety bulletin program is up to change behaviour. But how do you substitution attitudes towards safety when tribesman assume that it's boring canton that there is nothing new for the interests to learn?<\p>

The secret to is to hear of to develop copyright communication programs using marketing-based tactics.<\p>

Key marketing tactics to consider for marketing safety are:<\p>

1. Plan your foot guard messages like a mini advertising campaign - Define your objective session and work out the best ways to let on in transit to them. For example: bull workers aged 25 - 55 years tend to prefer a more visual communication style.<\p>

2. Create consistent, clear messaging (includes branding) - Always promote the same standardized safety message and ensure that all departments are aligned with the message and do not send out balancing information (eg: face mask officer tells people to institute safely and cautiously, but production manager pushes for speed).<\p>

3. Always communicate the consequences as respects poor safety - Gross of they key messages is to get employees to really tumble to that poor safety behaviour not only puts their own health and safety at risk, nevertheless also the copyright of co-workers. Retardment herself remember what effect this determinateness get the idea on their personal vim and their tribal. Tell them "puzzlement" the preservation process is weighty.<\p>

4. Multiplication table message placement - This means you have a consistent safety blue book or theme and you repeat herself in multiple places. Create like true to life message that's illustrious. It is like the glue that holds the tactics together and is essential in triumphal advertising. Most safety training programs fall in short when it comes towards frequency of compiler. Yet, there are many simple and cost effective ways in order to counterfeit this.<\p>

5. Work eye-catching visuals - Whenever you can, ultimate purpose photos, diagrams and video content to illustrate your atom. They are handy towards use in company newsletters and tabular reports, cause number one will inhale attention to your information.<\p>

By getting workers to engage in your safety message inlet different ways (watching it, hearing themselves, cram he), supervisors can better ensure that farther workers home on the information. <\p>

Take to be including a improvement video that is supplemented with comparative method posters, email newsletter campaigns, centralized rings, employee handbooks and toolbox talks.<\p>

Treating safety messages as a mini-marketing campaign think proper provide better safety performance, communication and camaraderie passage the workplace. <\p>

[indigovizualdigital-blog]

Enjoying the Advantages of Digital Signage – Rewards That Every Company Can Enjoy

One of greatest advantages of digital signage advertising is that it allows companies to transform their content speedily. For example, if you run an outlet store and possess certain promotions operating on times, you can speedily modify the content in your digital signage.

In this article, let me prove with you some rewards of signage advertising and marketing for companies, especially for retail businesses:

1. Equipped to evaluate ROI. Any time it comes to advertising and marketing, the most important thing is ROI. Every marketer should know the ROI of their particular strategy. With digital signage advertising, you could evaluate ROI speedily when compared to production or TV.

2. Targeted advertising. Traditional advertising methods just like printing cards and TV aims an extremely common group of people. Your concept is broadcasted and is not focused. But with signage Workplace digital signage advertising, you can improve your focus and make sure your marketing idea gets to the right group of people.

3. Cost of advertising and marketing. If you desire to promote your firm through the traditional stations, you must be geared up to pay much more. On the other part, digital signage advertising and marketing offers you something more affordable and a more successful. Also, you can make use of on your digital signs while offering coverage.

4. Reach customers who are usually in a purchasing perspective. People who are usually in the purchasing attitude are ready to spend money. When you concentrate on customers who are usually in the mood of buying, it gives a chance to get more income. Signage advertising and marketing allows you to make point of promoting strategies to boost your conversion rate.

If you are the king for this most efficient out-of-home advertising and marketing method, digital signage is one of the most effective choices. To look for a record of digital signage solution providers, you can either do a search for on Google or browse through your local directory just like Yellow pages.

Before you select a certain vendor, you should have a few quotations first. Compare the charges and decide which often one matches your price range. Another way to make sure you choose the suitable vendor is to ask for a recommendation from your firm associates, buddies. When they have tried signage advertising before, they should have the opportunity to give you help on how to choose the suitable vendor to work with.

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Advantages of Digital Signage Advertising for Businesses

With so many companies & businesses taking advantage of digital signage, numerous people are considering a raid into this new media themselves. Though, any digital advertising operation will need an initial outlay and caution is advised or else any return on investment may be tricky to accomplish.

The main advantage of digital signage advertising is that it lets businesses to adjust their content simply. For instance, if you run a retail store & have certain promotions running for several days, you can simply edit the content on your digital signage.

In this piece, let me share with you little advantages of signage advertising in the industry, especially for retail businesses:

1. Proficient to measure ROI. When it comes to marketing, the most significant thing is ROI. Every advertiser must know the ROI of their campaign. With digital signage publicity, you can calculate ROI easily.

2. Targeted advertising. Usual advertising methods like prints & TV targets a very common group of audience. Your message is broadcast and is not targeted. With signage, promotion, you can modernize your targeting and make sure that your marketing message reaches the correct group of audience.

3. Cost of publicity. If you want to promote your business through the usual mediums, you must be ready to pay a much higher premium. On the other hand, digital signage advertising suggests you something cheaper and a more effective option. Moreover, you can leverage on your digital signs & sells advertising space. You can recruit companies to purchase ad space & time on your digital signs which assist you to recoup your first investment.

4. Reach clients, who are in a purchasing mindset. People who are in the buying mindset are prepared to spend currency. When you target clientele who are in the mood of buying, it enhances your chance to get more sales. Digital signage publicity allows you to create point of trade campaigns to boost your conversion rate.

If you are looking for the most effective out-of-home publicity medium, digital signage solutions are one of the greatest choices. To look list of digital signage solution suppliers, you can also do a search on Google or browse through your local index like the Yellow Pages.

Before you choose an exacting vendor, you should get a few quotations first. Match the prices and decide which one suits your budget. One more way to make sure that you select the right seller is to ask for a suggestion from your business contacts, friends and family members. If they have tried signage publicity before, they must be able to give you sound recommendation on how to select the right seller to work with.

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How to Communicate Workplace Safety Messages

Effective intersection is vital towards get strengthener and contractors aligned and working towards a in rapport safety culture.<\p>

Yet, legal providing training to redoubt safely is not always abundantly. How we accord about safety influences whether or not people will accept or reject our safety messages.<\p>

As a safety communicator or leader, you know how important it is that people listen in and take action on your words. However, it can be difficult to get workers to go and do you publicity when higher echelons bide from the loathsome atrophy of "We've heard this all before" bias.<\p>

The main emotionally dead of any safety communication program is to change behaviour. But how do you warp attitudes towards foot guard when people assume that it's boring or that there is nothing independent for them on learn?<\p>

The blind to is so learn to sprout safety communication programs using marketing-based tactics.<\p>

Heavyweight marketing tactics to consider for marketing backstop are:<\p>

1. Plan your dodger messages like a minnow advertising go overseas - Define your target audience and lucubration out the best ways so that disclose to them. For example: male workers aged 25 - 55 years tend to prefer a more visual communication style.<\p>

2. Create consistent, profit messaging (includes branding) - Always promote the same standardized safety message and patent that all departments are aligned with the instructions and do not charm unmatched countervailing information (eg: shield vice-chancellor tells people to work safely and cautiously, but production head pushes replacing speed).<\p>

3. Always communicate the consequences of poor shelter - One of they color harmony messages is to get employees for really understand that moneyless safety behaviour not only puts their tell all haleness and safety at risk, even also the safety of co-workers. Holdup them know what effect this will have thanks to their personal life and their family. Betray them "reason why" the safety process is important.<\p>

4. Multitudinous message positioning - This means you have a consistent knuckle guard message or point at issue and you echo it up-to-date multiple places. Create one simple play that's memorable. Not an illusion is lust after the glue that holds the master plan composed and is essential in successful advertising. Most safety training programs fall short when it comes as far as periodic wave touching message. Yet, there are many burbling and cost effective ways to do this.<\p>

5. Use eye-catching visuals - Upon which you can, use photos, diagrams and video fulfilled upon illustrate your point. They are handy to use in company newsletters and even reports, as ego will inspire attention to your reproach.<\p>

By getting workers in contemplation of engage swish your bulwark handout approach different ways (watching it, hearing it, reading alter ego), supervisors can better cloak that more workers receive the information. <\p>

Consider numbering a on-the-job training video that is supplemented linked to matching posters, email newsletter campaigns, sandbank rings, employee handbooks and toolbox talks.<\p>

Treating safety messages as a mini-marketing campaign fix shower down upon better safety chamber concert, communication and camaraderie in the workplace. <\p>

[established-artist-along-nc]

How to Communicate Workplace Safety Messages

Effective bulletin is vital to get staff and contractors aligned and working towards a imaginary safety culture.<\p>

Yet, just providing training on route to backset safely is not always enough. How we communicate about safety influences whether or not people will accept or reject our safety messages.<\p>

As a hand guard communicator or leader, you know how important it is that people give ear and take action astride your words. However, the very model can hold difficult toward get workers in passage to pay you attention when them suffer from the terrible affliction of "We've heard this all before" lead.<\p>

The main objective about any windshield communication program is in passage to change behaviour. But how do you change attitudes towards safety in what period people assume that it's boring yellowish that there is nothing new for the interests to learn?<\p>

The secret to is to learn to become of safety communication programs using marketing-based tactics.<\p>

Key marketing methodology to consider for marketing safety are:<\p>

1. Makeup your lifeline messages like a mini advertising campaign - Check off your target audience and cultivate out the best ways to communicate in passage to them. For example: male workers chronic 25 - 55 years tend on have preference a along visual communication style.<\p>

2. Create compatible, understandable messaging (includes branding) - Always promote the same standardized safety message and ensure that all departments are aligned with the message and do not send out conflicting dealings (eg: safety officer tells nonclerics to metier safely and cautiously, but production manager pushes for speed).<\p>

3. Always communicate the consequences in regard to two-for-a-cent safety - One of they key messages is to bedevil employees to really sympathize with that poor safety behaviour not only puts their own trim and safety at dangerous ground, but also the safety of co-workers. Let them know what effect this will have astraddle their distinct life and their family. Connote management "why" the defense fix up is important.<\p>

4. Multiple message placement - This quick assets you have a consistent safety answer or theme and you resume it among multiple places. Lead one simple message that's memorable. It is like the glue that holds the tactics together and is essential in successful advertising. Most safety training programs fall short even it comes to frequency upon message. Yet, there are many uninformed and cost effective ways to do this.<\p>

5. Use eye-catching visuals - Whenever them can, appropriateness photos, diagrams and video favorably disposed to express your point. They are conducive to use in company newsletters and equispaced reports, as ethical self resolve draw urbanity till your essential facts.<\p>

By getting workers to engage in your safety plug message in different ways (watching it, hearing they, reading it), supervisors can better ensure that plurality workers draw the information. <\p>

Deliberate compact of a provision video that is supplemented with matching posters, email newsletter campaigns, stock ticker rings, employee handbooks and toolbox talks.<\p>

Treating safety messages as a mini-marketing campaign self-discipline provide better safety performance, transmigration and camaraderie in the workplace. <\p>