Potassium iodide

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

Retrieved on: 
Sunday, March 10, 2024
Capsule, HPRA, EXP, NAAM, Pi, CS, ATMP, Table, Unicode, Health education, Potassium iodide, Syringe, VIAL, Inn, Potassium, NRG, Powder, Translation, Blister, Patient, Guideline, Abbreviation, SIDC, WHO, COPD, ISO, Compilation, Diabetes, DA, Prohibition, Times New Roman, Excipient, Narcotic, FAQ, Approximation error, Sodium chloride, PI, Cmax, Microsoft Word, NOT, Veterinary medicine, European Medicines Agency, Council, PFU, QRD, Helicobacter pylori, Tablet, Microsoft, Total, Medication package insert, European, DIE, Language, Single Supervisory Mechanism, Plaque, Vaccine, MAH, Safety, Printing, International standard, Sodium, Osteoporosis, Reproduction, Name, Marketing authorisation, Marketing, Caregiver, Imperial, NCA, Food, EDQM, Confusion, Risk, Cell, Medicine, Disease, Public, Medical device

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

RedHill Accelerates Opaganib's Nuclear Radiation Protection Program - Positive Data Published

Retrieved on: 
Monday, November 14, 2022
Cell, Awareness, Thallium, Literature, Acceleration, Half-life, Caesium, Americium, Infection, TBI, International Journal of Molecular Sciences, La Trobe Institute for Molecular Science, Face, Strategic National Stockpile, Radiation, Survival, Government, Radiation exposure, B cell, Iodine, FDA, Filgrastim, Apsis, TEL, Chemoradiotherapy, Head, Mouse, Acute radiation syndrome, TNF, Total body irradiation, Safety, Extrapyramidal system, Nutrient, Toxicity, Inflammation, Homeland, Redhill, Chronic radiation syndrome, Opaganib, Plutonium, Animal, DTPA, Stem cell, Company, Nasdaq, Potassium iodide, Canadian International Council, Disease, Radiation damage, COVID-19, Bone marrow, Curium, MCM, Medical imaging, Pharmaceutical industry, Food preservation, Prussian blue (disambiguation)

The publication highlights observations from numerous studies undertaken in both protection against radiation toxicity and cancer radiotherapy settings.

Key Points: 
  • The publication highlights observations from numerous studies undertaken in both protection against radiation toxicity and cancer radiotherapy settings.
  • Much of the damage caused by radiation exposure is caused by inflammation secondary to the effects of ionizing radiation itself known as Acute Radiation Syndrome.
  • Again, opaganib was not associated with a diminished tumor response to fractionated radiation treatment and increased weight loss from radiation treatment was not observed.
  • Data from the opaganib global Phase 2/3 study has been submitted for peer review and recently published in medRxiv .

Global Potassium Iodide Market to 2030 - by Product Type, Application and Region - ResearchAndMarkets.com

Retrieved on: 
Monday, March 21, 2022
Manufacturing, Other Health, Health, Fitness & Nutrition, Chemicals, Plastics, Vomiting, CAGR, Iodine, Potassium iodide, Goitre, Growth, Erythema nodosum, Hospital, Pain scale, Industry, Drinking water, Chest pain, Allergy, Porter's five forces analysis, Food-feed system, Mark (given name), Potassium, Sporotrichosis, Food, Rash, Nodular vasculitis, Lithium, Salt

The "Potassium Iodide Market by Product Type and Application: Global Opportunity Analysis and Industry Forecast, 2021-2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Potassium Iodide Market by Product Type and Application: Global Opportunity Analysis and Industry Forecast, 2021-2030" report has been added to ResearchAndMarkets.com's offering.
  • The global potassium iodide market was valued at $0.8 billion in 2020, and is projected to reach $1.5 billion by 2030, growing at a CAGR of 6.1% from 2021 to 2030.
  • The growth of the global potassium iodide market is due to rise in demand for pharmaceutical and polymer end-use industries.
  • The potassium iodide market analysis is done on the basis of product type, application, and region.

Doctors for Disaster Preparedness Responds to Spike in Potassium Iodide Sales

Retrieved on: 
Wednesday, March 23, 2022
Adult, Skin, Physician, Policy, SSKI, Sodium iodide, Iodine, Tablet, KI, Potassium iodide, Thyroid, Salt

It is important to understand what potassium iodide (KI) does and does not do, states Doctors for Disaster Preparedness.

Key Points: 
  • It is important to understand what potassium iodide (KI) does and does not do, states Doctors for Disaster Preparedness.
  • It is important to note that KI does not prevent radiation sickness or protect against external radiation, Dr. Orient states.
  • A supply of potassium iodide is a worthwhile insurance policy to have in your medicine cabinet, Dr. Orient advises.
  • Doctors for Disaster Preparedness is a group of scientists (including physicians) founded in 1984, which provides information to help save lives in the event of natural or man-made disasters.

$771.6 Million Worldwide Potassium Iodide Industry to 2027 - Impact of COVID-19 on the Market

Retrieved on: 
Monday, December 21, 2020
Chemical compounds, Chemistry, Potassium compounds, Physical sciences, Disaster preparedness, Potassium iodide, Radiobiology

DUBLIN, Dec. 21, 2020 /PRNewswire/ -- The "Potassium Iodide - Global Market Trajectory & Analytics" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Dec. 21, 2020 /PRNewswire/ -- The "Potassium Iodide - Global Market Trajectory & Analytics" report has been added to ResearchAndMarkets.com's offering.
  • The 193-page report presents concise insights into how the pandemic has impacted production and the buy side for 2020 and 2021.
  • The U.S. Market is Estimated at $208.8 Million, While China is Forecast to Grow at 9.5% CAGR
    The Potassium Iodide market in the U.S. is estimated at US$208.8 Million in the year 2020.
  • China, the world`s second largest economy, is forecast to reach a projected market size of US$252.6 Million by the year 2027 trailing a CAGR of 9.5% over the analysis period 2020 to 2027.

Global Potassium Iodide Industry (2020 to 2027) - Market Trends and Drivers - ResearchAndMarkets.com

Retrieved on: 
Thursday, December 3, 2020
Chemicals, Plastics, Manufacturing, Chemistry, Physical sciences, Natural sciences, Dietary minerals, Disaster preparedness, Potassium iodide, Radiobiology, Potassium in biology, Potassium

The "Potassium Iodide - Global Market Trajectory & Analytics" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Potassium Iodide - Global Market Trajectory & Analytics" report has been added to ResearchAndMarkets.com's offering.
  • The 193-page report presents concise insights into how the pandemic has impacted production and the buy side for 2020 and 2021.
  • The U.S. Market is Estimated at $208.8 Million, While China is Forecast to Grow at 9.5% CAGR
    The Potassium Iodide market in the U.S. is estimated at US$208.8 Million in the year 2020.
  • In the global Nutrition segment, USA, Canada, Japan, China and Europe will drive the 5.9% CAGR estimated for this segment.