20210408 CSL Statement in relation to updated ATAGI advice on AstraZeneca COVID-19 Vaccine

Source: CLS Limited

CSL remains committed to meeting its contracted arrangements with the Australian Government and AstraZeneca for locally produced AstraZeneca COVID-19 vaccines. We will continue our focused and important efforts to manufacture this vaccine which remains critical for the protection of our most vulnerable populations.

We are proud of our unique role in Australia as the only onshore manufacturer that can produce this vaccine and remain dedicated to our ongoing contribution towards this effort.

– ends –

About CSL

CSL (ASX:CSL; USOTC:CSLLY) is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our two businesses, CSL Behring and Seqirus – provides life-saving products to more than 70 countries and employs more than 27,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For inspiring stories about the promise of biotechnology, visit Vita at CSLBehring.com/Vita and follow us on Twitter.com/CSL

For more information about CSL Limited, visit www.csl.com

Trientine-Reddy’s, Trientine-RZ, Trientine Dr.Reddy’s and Trientine-DRLA

Source: Australian Department of Health

The doses are expressed in terms of trientine dihydrochloride and the equivalent dose of trientine free base. It should be noted that a dose of 250 mg trientine dihydrochloride corresponds to a dose of 167 mg trientine free base. This should be considered if a patient is transferred from one trientine formulation to another.

Children > 5 years

500 to 750 mg trientine dihydrochloride /day (2 to 3 capsules) given in divided doses two or three times daily. This may be increased to a maximum of 1500 mg/day for children aged > 5 years. The paediatric dosage in terms of trientine free base is 333 to 500 mg/day to a maximum of 1000 mg/day.

The initial dose for children > 5 years can be expressed on a weight basis as 20 mg/kg body weight trientine dihydrochloride in 2 to 3 divided doses, rounded up to the nearest number of whole capsules

Adults

750 to 1250 mg trientine dihydrochloride /day (3 to 5 capsules) given in divided doses two, three or four times daily. This may be increased to a maximum of 2000 mg/day for adults. The adult dosage in terms of trientine free base is 500 to 833 mg/day to a maximum of 1333 mg/day.

The daily dose of trientine dihydrochloride capsules should be increased only when the clinical response is not adequate or the concentration of free serum copper is persistently above 20 µg/dL (3.1 µmol/L). Optimal long-term maintenance dosage should be determined at 6 to 12 month intervals (see 4.4 special warnings and precautions for use; effects on laboratory tests).

It is important that trientine dihydrochloride capsules be given on an empty stomach, at least one hour before meals or two hours after meals and at least one hour apart from any other drug, food, or milk. The capsules should be swallowed whole with water and should not be opened or chewed.

For further information refer to the Product Information.

LIFEPAK CR2 Defibrillator

Source: Australian Department of Health

Product defect correction – lid magnet may dislodge and cause early battery depletion

Stryker, in consultation with the Therapeutic Goods Administration, is undertaking a Product Defection Correction to update the operating instructions of all LIFEPAK CR2 defibrillators and will be providing replacement parts where appropriate.

LIFEPAK CR2 defibrillators are automated external defibrillators (AEDs) used in cases of life-threatening irregular heartbeat (also known as cardiac arrhythmia or cardiac dysrhythmia) that leads to cardiac arrest. Defibrillators work by applying electricity to stop the arrhythmia, allowing the heart to re-establish an effective rhythm.

The LIFEPAK CR2 AED has a lid which usually automatically powers on and off the device as it is opened and closed, which is controlled by a lid magnet.

It has been identified that some LIFEPAK CR2 AEDs have a defect that may result in the lid magnet becoming dislodged. If the magnet becomes dislodged, there is a risk that the battery may become prematurely depleted and the device may not turn on automatically or work correctly. Instead, users must press the on/off button to operate the device.

To address this, Stryker recommends all LIKEPAK CR2 AEDs be checked carefully to ensure their lid magnets are securely in place. Where a lid magnet has been dislodged, Stryker will be providing replacement lids at no charge.

If you have a device with a dislodged lid magnet or that is not turning on when you open the lid, you can continue to use it by using its power button to turn it on and off and following the updated operating instructions.

Supplemental instructions are being sent to all owners of these devices, along with a letter about this issue (including details of which serial numbers have defective lid magnets and which do not, but should still be checked). This will help reduce the risk until replacement parts can be provided.

There have been two reported deaths in relation to this issue worldwide. There have been no reported injuries or deaths within Australia.

If you have a LIFEPAK CR2 AED and have any questions or concerns about this issue, contact your Stryker representative or Stryker’s ProCare Service team by phone on 1800 667 558 or at ssptechservices@stryker.com.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA’s monitoring of these products. For more information, see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual’s medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.

Consultation: Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Methyl salicylate

Source: Australian Department of Health

This consultation closes on 18 May 2021.

The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on proposed new advisory statements for labels of over the counter (OTC) and registered complementary medicines containing methyl salicylate for dermal use, for inclusion in the Required Advisory Statements for Medicine Labels (RASML). The proposal to include advisory statements for methyl salicylate-containing medicines in RASML follows previously implemented requirements for advisory statements on labels of methyl salicylate-containing listed medicines.

For more information and to participate in the consultation, please visit consultation hub.

The consultation opens on Tuesday 6 April 2021. Interested parties should respond by close of business, Tuesday 18 May 2021.

Enquiries

Any questions relating to submissions should be emailed to rasml@health.gov.au.

Consultation: Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Lidocaine (lignocaine)

Source: Australian Department of Health

This consultation closes on 18 May 2021.

The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on addition of a proposed new required advisory statement for labels of non-prescription medicines containing more than 1.5 per cent lidocaine (lignocaine) for topical oral use, for inclusion in the Required Advisory Statements for Medicine Labels (RASML) document.

The required advisory statement “Do not use for teething pain in children” is proposed for preparations for topical oral use containing 1.5 per cent or more of lidocaine, to ensure that consumers and health professionals are aware that these medicines are not suitable for use for teething in children.

For more information and to participate in the consultation, please visit consultation hub.

The consultation opens on Tuesday 6 April 2021. Interested parties should respond by close of business, Tuesday 18 May 2021.

Enquiries

Any questions relating to submissions should be emailed to rasml@health.gov.au.

Consultation: Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Sedating antihistamines

Source: Australian Department of Health

This consultation closes on 18 May 2021.

The Therapeutic Goods Administration (TGA) is conducting a public consultation seeking comments from interested parties on changes to current requirements for advisory statements for labels of non-prescription medicines containing antihistamines indicated for short term use in insomnia (diphenhydramine, doxylamine and promethazine), as included in the Required Advisory Statements for Medicine Labels (RASML) document.

For more information and to participate in the consultation, please visit consultation hub.

The consultation opens on Tuesday 6 April 2021. Interested parties should respond by close of business, Tuesday 18 May 2021.

Enquiries

Any questions relating to submissions should be emailed to rasml@health.gov.au.

Consultation: Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Menthol

Source: Australian Department of Health

This consultation closes on 18 May 2021.

The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on the addition of proposed new advisory statements for labels of over the counter (OTC) and registered complementary medicines containing menthol for dermal use, for inclusion in the Required Advisory Statements for Medicine Labels (RASML). The proposal to include advisory statements for menthol in RASML follows previously implemented requirements for advisory statements on labels of menthol-containing listed medicines.

For more information and to participate in the consultation, please visit consultation hub.

The consultation opens on Tuesday 6 April 2021. Interested parties should respond by close of business, Tuesday 18 May 2021.

Enquiries

Any questions relating to submissions should be emailed to rasml@health.gov.au.

Statement by Acting Australian Government Chief Medical Officer, Professor Michael Kidd and Head of the Therapeutic Goods Administration Adjunct Professor John Skerritt

Source: Australian Department of Health

Australia’s vaccine safety and regulatory process is world class and people can be confident that vaccines approved for use are safe and effective. Our vaccines will save lives and are an essential part of tackling this global pandemic.

Australia is taking a phased approach to the vaccination program roll out. Australia is currently utilising two vaccines – the Pfizer and the AstraZeneca vaccines.

Our clear focus during the vaccine rollout remains the safety of all Australians. As throughout the whole of the COVID-19 pandemic, we have relied upon our medical experts for advice and guidance to ensure a safe and effective program delivery.

A small number of people, predominantly overseas (in the United Kingdom and Europe) have presented with clotting disorders following vaccination with the AstraZeneca vaccine.

One case has been reported in Australia today and is being investigated by the Therapeutic Goods Administration (TGA).

Medical experts within the European Medicines Agency and the UK Healthcare Products Regulatory Agency have not confirmed a causal link with the AstraZeneca COVID-19 vaccine but continue to look in great detail at the available data and clinical circumstances around these reports.

Similarly, our expert committees, the Australian Technical Advisory Group on Immunisation (ATAGI) and the National Vaccine Safety Investigation Group (VSIG), in conjunction with our independent regulator, the TGA are monitoring the situation closely, both in Australia and internationally.

ATAGI has released a statement to support health professionals in responding to any instances of clotting disorders following vaccine administration. This provides more information on clinical management and raises awareness of the potential for this condition.

This ATAGI advice was discussed at a meeting of the Australian Health Protection Principal Committee today. ATAGI has reaffirmed the current settings for and safety of the immunisation program.

The TGA will shortly release an updated statement.

Anyone who has received a COVID vaccine should be aware of the common side effects, which include fever, sore muscles, tiredness and headache. These side effects are expected and are not of concern unless severe or persistent.

Both ATAGI and the TGA will continue to monitor the situation closely over the next few days. We remind anyone receiving a vaccination that the reports of possible clotting complications are rare and have occurred in a very small number of cases.

Community leaders invited to help spread vaccination message

Source: New South Wales Health – State Government

​NSW Chief Health Officer Dr Kerry Chant has reached out to the leaders of culturally and linguistically diverse communities across the state to help spread accurate information on COVID-19 vaccination.
NSW Health and the NSW Multicultural Health Communication Service (MHCS) have been closely working and engaging with multicultural groups throughout the pandemic, providing COVID-19 information in 57 languages.
Dr Chant said community leaders had been invaluable in ensuring information reached everyone, regardless of the language they spoke.
“Over the past year, I’m so grateful that they have helped us by sharing information on subjects like the symptoms of COVID‑19, how to get tested and how to keep COVID safe,” she said.
“Now we are asking them to help us again to make sure everyone gets accurate information they can trust on vaccines and the vaccination process.
“Not all the information circulating out there is correct, so it’s important that people know where to go for the right advice.
“I’m very proud of the work that NSW Health and the NSW Multicultural Health Communication Service have done to ensure that COVID-19 information is accessible to everyone in the community.
“I also want to thank the continuous support of the multicultural health services across the local health districts and state-wide agencies including Multicultural NSW and Service NSW in reaching our communities.”
State Health Emergency Operations Centre Controller Susan Pearce, who is managing the state-wide COVID-19 vaccine rollout, said vaccination would be free for everyone in Australia, including those without Medicare cards.
“We urge everyone who can to be vaccinated when it becomes available to them,” Ms Pearce said.
“Vaccination is one of the key steps to helping us protect our loved ones and being able to resume a more normal life.”
Information on vaccination is available in various languages at https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/covid-19-vaccine-information-in-your-language

Video interview with Dr Kerry Chant

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Webinar presentation: Special Access Scheme Portal

Source: Australian Department of Health

Disclaimer

This presentation paper is provided on the TGA’s website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The paper is not legislative in nature and should not be taken to be statements of any law or policy in any way.

The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation paper should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.

Presentation

  • Presented by: Petra Bismire
  • Presented at: Online
  • Presentation date: 11 March 2021
  • Presentation summary: Walkthrough changes to the SAS Category B forms and Authorised Application form.