Sodium chloride

• 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).
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  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?

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  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.
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  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.

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  Issues

  Connected problems

  QRD Suggestions

  product name is composed
  of MAH+INN?

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  Issues

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

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  Issues

  Connected problems

  QRD Suggestions
  considered, e.g.

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  Issues
  Symbols: Non-Unicode

  Connected problems

  QRD Suggestions

  The use of non-Unicode

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

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  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.

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• Excess salt (sodium) increases the risk of high blood pressure so everyone with hypertension is advised to reduce salt in their diet.
• It can be used just like regular salt and most people don’t notice any important difference in taste.
• Switching to potassium-enriched salt is feasible in a way that cutting salt intake is not.

What is potassium-enriched salt?

• Potassium-enriched salts replace some of the sodium chloride that makes up regular salt with potassium chloride.
• They’re also called low-sodium salt, potassium salt, heart salt, mineral salt, or sodium-reduced salt.

What is the evidence?

We have strong evidence from a randomised trial of 20,995 people that switching to potassium-enriched salt lowers blood pressure and reduces the risks of stroke, heart attacks and early death. The participants had a history of stroke or were 60 years of age or older and had high blood pressure.
An overview of 21 other studies suggests much of the world’s population could benefit from potassium-enriched salt. The World Health Organisation’s 2023 global report on hypertension highlighted potassium-enriched salt as an “affordable strategy” to reduce blood pressure and prevent cardiovascular events such as strokes.

What should clinical guidelines say?

• We teamed up with researchers from the United States, Australia, Japan, South Africa and India to review 32 clinical guidelines for managing high blood pressure across the world.
• While many guidelines recommend increasing dietary potassium intake, and all refer to reducing sodium intake, only two guidelines – the Chinese and European – recommend using potassium-enriched salt.

Why do so few people use it?

• Few people know a simple switch to potassium-enriched salt can help lower blood pressure and reduce the risk of a stroke and heart disease.
• Several Australian retailers stock potassium-enriched salt but there is usually only one brand available, and it is often on the bottom shelf or in a special food aisle.

A 2021 review found potassium-enriched salts were marketed in only 47 countries and those were mostly high-income countries. Prices ranged from the same as regular salt to almost 15 times greater. Even though generally more expensive, potassium-enriched salt has the potential to be highly cost effective for disease prevention.

Preventing harm

• People with serious kidney disease are already advised to avoid regular salt and to avoid foods high in potassium.
• No harm from potassium-enriched salt has been recorded in any trial done to date, but all studies were done in a clinical setting with specific guidance for people with kidney disease.
• In some countries, potassium-enriched salt is recommended to the entire community because the potential benefits are so large.

What will happen next?

• We are working with the taskforce to update Australian hypertension management guidelines, and to promote the new guidelines to health professionals.
• The next switch to iodised and potassium-enriched salt offers at least the same potential for global health gains.
• But we need to make it happen in a fraction of the time.

• Alta Schutte receives funding from the National Health and Medical Research Council of Australia, the Medical Research Future Fund, and NSW Health.
• She is Company Secretary of the Australian Cardiovascular Alliance, Board Member of Hypertension Australia, and Co-Chair of the National Hypertension Taskforce of Australia.

• With the trifecta of Thanksgiving, Christmas and New Years Eve coming up, the toxicology experts at Pet Poison Helpline want to warn pet lovers about the many dangers that face pets during this festive season.
• Meinke also contacted Pet Poison Helpline, who then worked with the medical team at BluePearl to identify the lily, diagnose and treat his pets.
• "Many holiday treats include chocolate, and are often left sitting out on counters and dinner tables," said Dr. Schmid.
• This year, we want pet lovers to remember the holidays for all the joy and happiness, not an emergency room visit."

• But what if I told you this idyllic drive could turn into a nightmare, with the faint smell of something burning?
• This month we have had at least two large lithium-ion battery fires in Australia – one in the Sydney airport car park and another one more recently at the Bouldercombe battery storage site in Queensland.

What causes these fires?

• They’re the same powerhouses that fuel our smartphones
  and laptops – celebrated for their ability to store heaps of energy in a small
  space.
• In fact, from 2010 to June 2023, only four electric vehicle battery fires had been recorded in Australia.
• In extreme cases, it causes the battery to catch fire or explode.
• The onset and intensification of lithium-ion battery fires can be traced to multiple causes, including user behaviour such as improper charging or physical damage.

What to do when a fire has started?

• That’s because lithium-ion batteries have a rather unwelcome talent for chemical reactions when they come into contact with water.
• Instead of snuffing out the flames, water can actually fuel the fire and cause it to intensify.
• This is because the water’s reaction with lithium produces flammable hydrogen gas, adding more of a fire hazard to an already perilous situation.
• This is why these battery fires are a particular concern in confined spaces such as a garage, where noxious gases can accumulate quickly.

What to do if your car catches fire

• First, get to know your EV inside and out.
• What about sensors that could alert you to a problem before it turns into a crisis?
• Avoid using fast chargers as your
  go-to, because these can cause the battery to heat up more quickly.