Blister

Compilation of quality review of documents (QRD) on stylistic matters in product information

Retrieved on: 
Sunday, March 10, 2024

29 February 2024

Key Points: 
    • 29 February 2024
      EMA/25090/2002 rev.23*
      Human Medicines Division

      Compilation of QRD decisions on stylistic matters in product information
      Issues
      Abbreviations

      Connected problems
      Subscript and superscript

      QRD Suggestions
      Acronyms must be written in their standard form; e.g.

    • Cmax, Cmax
      Abbreviations and

      Not always understood,

      Non-standard abbreviations and acronyms should be avoided, and the term should be written out in full.

    • The same applies when stating the pharmaceutical form in section 3 of the SmPC and section 4 of the labelling;
      i.e.
    • critical steps prior to administration of the product should also be included (section 5 of Annex IIIA).
    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 2/23

      Issues

      Connected problems

      QRD Suggestions

      emphasise in the labelling
      the special handling prior
      to administration of the
      product.

    • Consistency

      Inconsistencies in style are

      Once a particular style or house style has been selected, it must be used consistently throughout the text.

    • Tradename 150 mg solution for injection in pre-filled syringe
      Tradename 150 mg solution for injection in pre-filled pen

      information annexes?

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 3/23

      Issues
      Desiccant

      Connected problems

      QRD Suggestions

      For medicinal products

      The foil of blister packs containing a desiccant must be clearly labelled to show which blister pocket contains

      packaged with a desiccant

      the desiccant.

    • For bottles containing a desiccant, a similar statement should also be considered provided there

      mistake the desiccant for a

      is available space.

    • It can only be included in brackets in section 3 of the

      where can this be

      SmPC and section 4 of the labelling.

    • Direct speech should only
      be used in section 6 of the SmPC for instructions about shelf-life, storage, handling and disposal.
    • The term ?drug? though can be used in the product information annexes when it is part of a standard set of
      terms (e.g.
    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 5/23

      Issues
      Foreign terms

      Connected problems

      QRD Suggestions

      Foreign terms, particularly

      Foreign terms must be written in italics; e.g.

    • Patients can be referred to as ?he? or

      physician is often referred

      as ?she? when the medicinal product is exclusively for use by males or females.

    • if the product in question might be

      measurements are

      used by elderly patients), in brackets after the metric measures in the English text.

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 6/23

      Issues

      Connected problems

      QRD Suggestions

      product name is composed
      of MAH+INN?

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 7/23

      Issues

      Connected problems

      QRD Suggestions
      MT: English
      BG: Bulgarian
      NL: Dutch
      CZ: Czech or English at applicant?s discretion.

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 14/23

      Issues

      Connected problems

      QRD Suggestions
      considered, e.g.

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 16/23

      Issues
      Symbols: Non-Unicode

      Connected problems

      QRD Suggestions

      The use of non-Unicode

      Only Unicode symbols must be used in submitted product information annexes.

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 20/23

      Issues

      Connected problems

      Units: SI base units -

      International Standard

      litre

      base units have been
      introduced in the European
      Union with Council
      Directive 80/181/EEC of
      20.12.79 (O.J.

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 23/23

Socure Names Christian Woodward as Chief Revenue Officer

Retrieved on: 
Thursday, March 7, 2024

INCLINE VILLAGE, Nev., March 7, 2024 /PRNewswire/ -- Socure , the leading provider of artificial intelligence for digital identity verification, sanction screening, and fraud prevention, today announced that Christian Woodward has joined as its new Chief Revenue Officer.

Key Points: 
  • INCLINE VILLAGE, Nev., March 7, 2024 /PRNewswire/ -- Socure , the leading provider of artificial intelligence for digital identity verification, sanction screening, and fraud prevention, today announced that Christian Woodward has joined as its new Chief Revenue Officer.
  • Woodward will lead Socure's worldwide go-to-market efforts, growth, solution consulting, technical account management and customer success teams.
  • I look forward to partnering very closely with Christian as we deliver on our goal to make Socure the world's most accurate and inclusive risk and identity verification company."
  • I am thrilled and humbled to join them during this next phase of hypergrowth," said Woodward.

How Cinesteam® Helps Manage Smells From Diabetic Foot

Retrieved on: 
Thursday, February 29, 2024

FORT LAUDERDALE, Fla., Feb. 29, 2024 /PRNewswire/ -- Diabetic foot is a common concern for those with diabetes. The condition can lead to chronic wounds that produce highly unpleasant smells. Cinesteam® is a natural-based secondary dressing designed to simply and effectively manage smells like those that come from diabetic foot.

Key Points: 
  • FORT LAUDERDALE, Fla., Feb. 29, 2024 /PRNewswire/ -- Diabetic foot is a common concern for those with diabetes.
  • Cinesteam® is a natural-based secondary dressing designed to simply and effectively manage smells like those that come from diabetic foot.
  • The medical condition comes with many health concerns, one of which is commonly referred to as "diabetic foot."
  • Mayo Clinic reports that as much as 50% of those with diabetes can be affected by diabetic neuropathy, opening the doors for diabetic foot to develop.

UAE MDO PET Films Market to hit $32.6 Million by 2027: Fueled by 58% E-commerce Surge and Booming Pharma Industry: Ken Research

Retrieved on: 
Monday, February 12, 2024

The UAE's population is booming at 1.4% annually, fueling demand for diverse packaging solutions, with MDO PET Films rising as a star player.

Key Points: 
  • The UAE's population is booming at 1.4% annually, fueling demand for diverse packaging solutions, with MDO PET Films rising as a star player.
  • Food and beverage giants are driving the market, accounting for a 45% share, with MDO PET Films offering superior barrier properties to keep food fresh.
  • EcoFlex Films lead the way with environmentally friendly MDO PET Films, a multi-billion dollar market segment.
  • Ken Research's comprehensive report offers an in-depth exploration of the UAE MDO PET Films market, including:
    Detailed segmentation by film type, distribution channel, application, and end-user

UAE MDO PET Films Market to hit $32.6 Million by 2027: Fueled by 58% E-commerce Surge and Booming Pharma Industry: Ken Research

Retrieved on: 
Monday, February 12, 2024

The UAE's population is booming at 1.4% annually, fueling demand for diverse packaging solutions, with MDO PET Films rising as a star player.

Key Points: 
  • The UAE's population is booming at 1.4% annually, fueling demand for diverse packaging solutions, with MDO PET Films rising as a star player.
  • Food and beverage giants are driving the market, accounting for a 45% share, with MDO PET Films offering superior barrier properties to keep food fresh.
  • EcoFlex Films lead the way with environmentally friendly MDO PET Films, a multi-billion dollar market segment.
  • Ken Research's comprehensive report offers an in-depth exploration of the UAE MDO PET Films market, including:
    Detailed segmentation by film type, distribution channel, application, and end-user

Krystal Biotech Announces Publication in the New England Journal of Medicine on the Application of B-VEC to Treat Ocular Complications in Patient with Dystrophic Epidermolysis Bullosa

Retrieved on: 
Thursday, February 8, 2024

PITTSBURGH, Feb. 08, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today announced data on the compassionate use of beremagene geperpavec (B-VEC), administered as an eyedrop to treat a patient with dystrophic epidermolysis bullosa (DEB) with cicatrizing conjunctivitis has been published in the New England Journal of Medicine (NEJM). The full manuscript, titled “Ocular Gene Therapy in a Patient with Dystrophic Epidermolysis Bullosa,” can be found in the February 8, 2024 issue of the NEJM.

Key Points: 
  • The full manuscript, titled “Ocular Gene Therapy in a Patient with Dystrophic Epidermolysis Bullosa,” can be found in the February 8, 2024 issue of the NEJM.
  • Over 25% of patients with DEB develop ocular complications such as corneal erosions, abrasions, blistering and scarring that can lead to impaired vision.
  • The NEJM publication describes the first application of B-VEC to treat ocular complications in a patient with DEB under a compassionate use program.
  • If approved, this approach could drastically benefit these patients.”
    A patient presented with severe cicatrizing conjunctivitis secondary to DEB.

Shriners Children's Doctor Alerts Parents of Overlooked Dangers of Microwave Soups and Noodles During National Burn Awareness Week

Retrieved on: 
Monday, February 5, 2024

Dr. David Greenhalgh, Chief of Burns at Shriners Children's Northern California, has spent more than 35 years working with pediatric burn patients.

Key Points: 
  • Dr. David Greenhalgh, Chief of Burns at Shriners Children's Northern California, has spent more than 35 years working with pediatric burn patients.
  • Now, the primary culprit is scalding injuries from simple items people forget are dangerous, such as hot liquids and microwave foods.
  • He says while convincing companies to change their packaging for products is a difficult and lengthy process, parents need to be aware of the dangers.
  • All three Shriners Children's burn care locations across the country are accredited by the American Burn Association (ABA) and the American College of Surgeons (ACS) as verified pediatric burn centers.

Relax'in Naturally Reinforces Mental Health

Retrieved on: 
Wednesday, January 31, 2024

FORT LAUDERDALE, Fla., Jan. 31, 2024 /PRNewswire/ -- Mental health has been in the spotlight in recent years. As conditions like anxiety and depression become more common and diagnosable, it's important for consumers to have options to address them based on the severity of each case. With milder mental health concerns, solutions like Relax'in can help naturally restore a sense of peace and balance to everyday life.

Key Points: 
  • With milder mental health concerns, solutions like Relax'in can help naturally restore a sense of peace and balance to everyday life.
  • With mental health concerns on the rise, it's important for consumers to have options.
  • Restoring mental health balance with a natural alternative like Relax'in can also help avoid harmful habits rooted in mental instability, such as excessive alcohol consumption and smoking.
  • This ensures that Relax'in provides genuine, powerful, and natural support for those with mental health concerns.

CORRECTION BY SOURCE: Solta Medical's Thermage(R) FLX and TR-4 Return Pad Receive Registration Certifications in China

Retrieved on: 
Monday, January 22, 2024

[See *Correction above: The TR-4 Return Pad is not approved for use by the U.S. Food & Drug Administration.]

Key Points: 
  • [See *Correction above: The TR-4 Return Pad is not approved for use by the U.S. Food & Drug Administration.]
  • "The approval of Thermage FLX, and the TR-4 return pad, marks a significant milestone for Solta Medical," Thomas J. Appio, Bausch Health Chief Executive Officer, said.
  • "The approval from NMPA means we are able to continue the momentum of the growth of Thermage in China," Jiny Kim, Senior Vice President, Solta Medical, said.
  • Ask your doctor for more information about Thermage FLX and see www.thermage.com for additional details.

What is frostbite, what are the signs and how should we treat it?

Retrieved on: 
Wednesday, January 17, 2024

Thankfully, with the right preventative and protective measures, the human body can survive these icy temperatures.

Key Points: 
  • Thankfully, with the right preventative and protective measures, the human body can survive these icy temperatures.
  • Here’s what you need to know about identifying and treating the most common cold injury: frostbite.
  • However, despite our bodies’ inherent temperature controls, without the right protection, we might still be vulnerable to cold weather injuries.
  • For frostbite to occur, exposed body parts need to be subjected to a temperature that is below minus 0.55°C.
  • At this temperature it will take several hours for exposed skin to become frostbitten.
  • For example, temperatures in the -20s can cause frostbite on exposed skin in under 30 minutes.

Who does it affect?

  • However, with the global population beginning to live in harsher environments and an increase in winter and snow sports, this is likely to increase in the general population.
  • Reduced ability to sense the cold also increases the frostbite vulnerability of those who’ve had a stroke or have peripheral nerve damage.
  • The consumption of alcohol also reduces blood pressure, which may also reduce the amount of blood pumped to extremities.

Symptoms

  • Preserving the core body temperature is key to keeping the brain, heart, kidneys and lungs functioning and preventing hypothermia.
  • This cooling brings about tingling and numbness of the exposed areas, and skin flushes red or white as the body frantically tries to rewarm itself.
  • This initial stage is known as frostnip, and, although uncomfortable, leaves no permanent damage to tissues.

Treatment and prevention

  • For frostbite, immediate medical treatment should be sought – sadly the pain of recovery is often far worse than the injury.
  • Rewarming is the process of bringing the affected parts back to functioning body temperature.
  • However, where ice crystals have damaged tissue, blisters are common and the nerves become hypersensitive, causing excruciating pain.


Adam Taylor does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.