Availability of Clexane® 60mg

HPS Pharmacies wishes to advise that Sanofi Australia is experiencing a supply interruption for Clexane® 60mg injection syringes as follows:

Clexane® Pre-filled Syringes
Enoxaparin sodium 60mg/0.6mL
ARTG 56709

Normal supplies of Clexane® 60mg are expected to return by 5 June 2024. All other strengths of Clexane® and Clexane® Forte remain available.

Retain this notice in a prominent position, including in other related business units, until supplies return to normal. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact Sanofi Australia on 1800 640 791, or your pharmacist at HPS Pharmacies.

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Discontinuation of Oruvail® SR and Orudis® SR

HPS Pharmacies wishes to advise that Sanofi Pharmaceuticals are discontinuing ketoprofen capsules as follows:

Oruvail® SR Capsules
Ketoprofen 200mg
ARTG 42422 

Orudis® SR Capsules
Ketoprofen 200mg
ARTG 27535

Sanofi estimates that supplies of each brand will be depleted by December 2024.

There is no direct equivalent product available in Australia. Patients are encouraged to speak with their prescriber regarding appropriate clinical alternatives.

Retain this notice in a prominent position, including in other related business units for at least one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact Sanofi Pharmaceuticals on 1800 641 791 or your pharmacist at HPS Pharmacies.

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Availability of Orencia®

Further to DrugAlert Volume 929, HPS Pharmacies wish to advise that Bristol-Myers Squibb is experiencing a supply interruption for Orencia® as follows:

Orencia® ClickJect®
Abatacept 125mg
ARTG 236039 

Orencia® Prefilled Syringe
Abatacept 125mg
ARTG 206764

Normal supplies of Orencia® ClickJect® are expected to return by end-August 2024, and Orencia® prefilled syringes are expected to return by end-September 2024.

The Therapeutic Goods Administration (TGA) advises that some patients may need to be switched to other therapies. To conserve Orencia® for patients who cannot switch to an alternative treatment, Bristol-Myers Squibb has created an Orencia® Stock Hypercare Plan (OSHP) to manage supply. The TGA provides more information on the OSHP plan.

Recommendations from the Australian Rheumatology Association include:

  • No new patients should be started on subcutaneous or intravenous abatacept;
  • Patients should be switched to an alternative biological or targeted synthetic disease-modifying anti-rheumatic drug (b/tsDMARD) where possible; and
  • Stock should be conserved for patients who have previously used two other b/tsDMARDs, or have a relative or absolute contraindication to other b/tsDMARDs.

Patients using Orencia® should be encouraged to speak to their prescriber as soon as possible.

This supply issue only affects the subcutaneous presentations of Orencia®. Bristol-Myers Squibb advises that there is sufficient stock of Orencia® 250mg vials for intravenous infusion to support patients currently receiving it.

Retain this notice in a prominent position, including in other related business units until supplies return to normal. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact Bristol-Myers Squibb on 1800 067 567, or your pharmacist at HPS Pharmacies.

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Availability of Octreotide Ampoules

HPS Pharmacies wishes to advise that there is a supply interruption for octreotide ampoules as follows:

Product ARTG Anticipated availability
Octreotide GH 50 micrograms/1 mL 148404 Early March 2025*
Octreotide GH 100 micrograms/1 mL 148402 End May 2024
Octreotide GH 500 micrograms/1 mL 14803 End December 2024
Sandostatin® 50 microgram/1mL 42192 Presently*
Sandostatin® 100 microgram/1mL 42193 Mid-June 2024

*Limited Octreotide GH 50 mcg/1 mL stock is currently available in some states. However, a long-term supply interruption is expected to affect all states from late May 2024 until early March 2025. Warehouse supplies of Sandostatin® 50 mcg/1mL are currently being replenished and are expected to be available shortly.

An internationally registered alternative of each strength is awaiting final approval from the TGA for supply under Section 19A of the Therapeutic Goods Act 1989. The S19A alternative brand is Octreotide Acetate Omega (Canada), and stock is expected to be released by mid to late May 2024. This product is supplied as vials which are labelled for subcutaneous and intravenous use. The Australian product information should be referred to for dosing and administration recommendations.

Octreotide modified-release injection (Sandostatin® LAR) is not affected by this notice.

Retain this notice in a prominent position, including in other related business units until supplies return to normal. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact your pharmacist at HPS Pharmacies.

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Defect Correction and Recall Update for Panadol® Children 100mg/mL

Further to DrugAlert Volume 930, HPS Pharmacies wish to provide an update on the action required for the product defect correction and recall of Panadol® Children 1 Month – 1 Year:

Panadol Children 1 Month – 1 Year
Paracetamol 100 mg/mL
ARTG 83363

The following batches are affected by this notice:

  • DR562 (Exp 30/04/2024)
  • DR563 (Exp 30/04/2024)
  • DT528 (Exp 30/04/2024)
  • DS947 (Exp 31/07/2024)
  • DS956 (Exp 31/08/2024)
  • DT334 (Exp 30/09/2024)
  • DT469 (Exp 30/09/2024)
  • DT762 (Exp 31/10/2024)
  • DT912 (Exp 31/10/2024)
  • DU128 (Exp 30/11/2024)
  • DT913 (Exp 31/10/2024)
  • DW301 (Exp 28/02/2025)
  • DW507 (Exp 28/02/2025)
  • DW487 (Exp 28/02/2025)

This defect correction was initiated as the supplied dosing syringe may be stiff and difficult to use. This may make it difficult to control the delivery of the medicine and may pose a risk of choking. There are no safety or quality problems with the liquid medicine itself.

Action required:

  • Affected stock located within pharmacies should be quarantined for return to the supplier.
  • Imprest stock from the affected batches may continue to be used. However, the supplied dosing syringe must be discarded and replaced with an appropriate alternative.

Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact Haleon on 1800 028 533 or your pharmacist at HPS Pharmacies.

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Defect Correction for Ryaltris® Nasal Spray

HPS Pharmacies wish to give notice that Seqirus Pty, in consultation with the Therapeutic Goods Administration (TGA), has issued a product defect correction for Ryaltris® nasal spray, as follows:

Ryaltris Nasal Spray
Olopatadine 600mcg + Mometasone furoate 25mcg/actuation
ARTG 312690

 The following batches are affected by this notice:

240 Metered Dose Spray 56 Metered Dose Spray
  • 12230928 (Expiry 08/2026)
  • 12230929 (Expiry 08/2026)
  • 12230941 (Expiry 08/2026)
  • 12231020 (Expiry 09/2026)
  • 12231116 (Expiry 10/2026)
  • 12231020 (Expiry 09/2026)
  • 12230943 (Expiry 0/2026)

This defect correction was initiated due to a technical labelling issue. The batch number and expiry date on the affected batches can be smudged or blurred upon contact with an alcohol-based solvent.

Seqirus advises customers to:

  • Ensure that alcohol-based sanitisers or wipes do not come into contact with the bottle label; and
  • Retain the carton for the duration of use to maintain a durable record of the batch number and expiry details.

Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact Seqirus on 1800 008 275 or your pharmacist at HPS Pharmacies.

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Defect Correction for Panadol® Children 100mg/mL

HPS Pharmacies wish to give notice that Haleon Australia, in consultation with the Therapeutic Goods Administration (TGA), has issued a product defect correction and recall for Panadol® Children 1 Month – 1 Year, as follows:

Panadol Children 1 Month – 1 Year
Paracetamol 100 mg/mL
ARTG 83363

The following batches are affected by this notice:

  • DR562 (Exp 30/04/2024)
  • DR563 (Exp 30/04/2024)
  • DT528 (Exp 30/04/2024)
  • DS947 (Exp 31/07/2024)
  • DS956 (Exp 31/08/2024)
  • DT334 (Exp 30/09/2024)
  • DT469 (Exp 30/09/2024)
  • DT762 (Exp 31/10/2024)
  • DT912 (Exp 31/10/2024)
  • DU128 (Exp 30/11/2024)
  • DT913 (Exp 31/10/2024)
  • DW301 (Exp 28/02/2025)
  • DW507 (Exp 28/02/2025)
  • DW487 (Exp 28/02/2025)

This defect correction was initiated as the supplied dosing syringe may be stiff and difficult to use. This may make it difficult to control the delivery of the medicine and may pose a risk of choking. There are no safety or quality problems with the liquid medicine itself.

Please inspect your stock and quarantine all affected products. If HPS Pharmacies provide imprest management services to your facility, an HPS representative will inspect all stock stored in the designated imprest areas at the earliest opportunity. All affected products will be quarantined for return to the supplier, and HPS Pharmacies will arrange for replacement stock as soon as possible. An HPS Pharmacies staff member will contact senior medical and nursing staff if there is an immediate impact to your facility.

Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact Haleon on 1800 028 533 or your pharmacist at HPS Pharmacies.

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Availability of Orencia®

HPS Pharmacies wish to advise that Bristol-Myers Squibb is anticipating a supply interruption for Orencia® as follows:

Orencia® ClickJect®
Abatacept 125mg
ARTG 236039 

Orencia® Prefilled Syringe
Abatacept 125mg
ARTG 206764

Manufacturing issues are expected to impact supplies of Orencia® ClickJect® from early June to end-August 2024. Orencia® prefilled syringes are expected to be in short supply from mid-June to end-September 2024 due to increased demand.

Bristol-Myers Squibb is working to control the supply of these products. The Therapeutic Goods Administration (TGA) is also investigating strategies to minimise patient impact, which may include the creation of a Serious Scarcity Substitution Instrument (SSSI). Further information is available on the TGA website.

These supply issues only affect the subcutaneous presentation of Orencia®. Bristol-Myers Squibb advises that there is sufficient stock of Orencia® 250mg vials for intravenous infusion to support patients currently receiving it.

Retain this notice in a prominent position, including in other related business units until supplies return to normal. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact Bristol-Myers Squibb on 1800 067 567, or your pharmacist at HPS Pharmacies.

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Discontinuation of Lasix® 40mg Ampoules

HPS Pharmacies wishes to advise that Sanofi-Aventis is discontinuing Lasix® 40mg ampoules as follows:

Lasix® Ampoules
Furosemide 40mg/4mL
ARTG 76767

Other strengths of furosemide ampoules are not affected by this notice.

Retain this notice in a prominent position, including in other related business units for at least one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact Sanofi-Aventis on 1800 818 806 or your pharmacist at HPS Pharmacies.

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Discontinuation of Tracleer® Tablets

HPS Pharmacies wishes to advise that Janssen-Cilag is discontinuing Tracleer® tablets as follows:

Tracleer® Tablets
Bosentan 62.5mg
ARTG 91919

Tracleer® Tablets
Bosentan 125mg
ARTG 91920

The decision to discontinue Tracleer® tablets is a commercial one and not related to any safety, efficacy, or quality issues. Generic alternatives of each strength continue to be marketed in Australia.

Retain this notice in a prominent position, including in other related business units for at least one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact Janssen-Cilag on 1800 226 334 or your pharmacist at HPS Pharmacies.

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