Salbutamol with ipratropium bromide (Duolin) nebuliser: Supply issue

Affected product

Rex Medical, the supplier, advises that the manufacturing site for Duolin nebuliser solution has temporarily halted production to facilitate annual validation. Rex Medical has moved production of this medicine to a second registered site. This has caused a delay in resupply.

• Chemical: Salbutamol with ipratropium bromide
• Presentation: Nebuliser soln, 2.5 mg with ipratropium bromide 0.5 mg per vial, 2.5 ml ampoule - Up to 20 neb available on a PSO
• Brand: Duolin
• Pharmacode: 2039281

Schedule listings for Duolin(external link)

This issue also affects salbutamol nebuliser solution 1 mg (Asthalin) 

Alternative treatment

Rex Medical has secured an alternative supply of Duolin nebuliser solution. It is listed on the Pharmaceutical Schedule from 1 September 2023. This product is chemically identical to the funded brand but is not Medsafe approved

• Chemical: Salbutamol with ipratropium bromide 
• Brand: Duolin Respules
• Presentation: Nebuliser soln, 2.5 mg with ipratropium bromide 0.5 mg per vial, 2.5 ml ampoule
• Pharmacode: 2662159
• Pack size: 60 ampoules
• Subsidy: $33.12 per pack
• Section 29 rules apply

Prescribing and supplying an unapproved medicine

Section 29 of the Medicines Act 1981 allows for medicines that are not Medsafe approved to be prescribed and supplied to people. The medicine must be prescribed by someone registered with the Medical Council of New Zealand – such as, a doctor. 

We know supplying a medicine under section 29 is not ideal. In this case, however, this will allow patients to be able to access an appropriate treatment. 

We apologise for any inconvenience this causes. 

Advice for prescribing under section 29 – BPAC website(external link) 

Prescriber and pharmacist requirements for section 29 medicines – Medsafe website (external link)

Medsafe’s section 29 Declaration / Notification Form [DOC](external link)

What patients need to know about unapproved medicines – Healthify website(external link)

Expected resupply

Pharmac is working with Rex Medical to understand when a Medsafe-approved product will return to Aotearoa New Zealand.

Who to contact

If you have questions about this issue, email enquiry@pharmac.govt.nz

Please include as much information as you can about the product (presentation, brand, pharmacode) and who your wholesaler is.  

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