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Salamol has safety as brand name products

Salamol has the same efficacy and safety as brand name products

Air Flow Products wishes to reassure healthcare professionals and people with asthma that there is no reliable clinical evidence to support recent media reports that Salamol, its CFC-free metered dose inhaler, is deficient or unsafe. These reports have misinterpreted a very small research project undertaken by a student in the UK which simply observed that all CFC-free salbutamol metered dose inhalers (MDIs) will clog unless properly maintained and cleaned. This inconclusive project was not intended for publication1 and has not been verified by any properly controlled clinical trials. The UK Committee on the Safety of Medicines (CSM) has noted the issue of clogging but it has not been regarded as a major issue as long as there is adequate patient education about the need to clean inhalers.

International randomised double-blind studies have shown that generic substitution of salbutamol is often affected by subjective negative perception by both patients and doctors, which are not based on any clinical differences. Such studies demonstrated that respiratory function did not differ between the generic and the brand products and that there was clinical equivalence between the generic and the branded salbutamol 2,3. These do resolve with time as people become accustomed to using the new inhaler and realise that it is as effective as their old one.

In 1995 Salamol was approved by the US Food and Drug Administration (FDA) based on what were then newly developed methods to assess bioequivalence. It was found to be equivalent to the brand name product, Ventolin MDI. The FDA determined that the generic version is bioequivalent to the brand name product based upon a series of laboratory tests and clinical studies in humans. The generic version was, therefore, considered as safe and effective as the brand name product4. CFC-free Salamol was approved by the FDA in 2004.

All CFC-free salbutamol inhalers can clog if not cared for by careful washing5,6,7. Washing each week with warm running water for at least 30 seconds prevents possible clogging. If an inhaler is blocked and is needed immediately, rinse it, shake, test spray by firing twice and then use, then rinse again and allow to dry. Full directions are inside each pack.

In common with a number of pharmaceutical products, including other MDIs, Salamol contains ethanol. The amount used in MDIs is insufficient to have a pharmacological effect8 or affect their driving9.

Further information:


1. Personal communication, Air Flow Products Ltd (Medical Advisor) 2. Williamson I J et al. Generic inhaled salbutamol. A randomised double-blind study. Postgrad Med 1997; 73:156-158 3. Pinto Pereira L M et al. Comparison of innovator and generic salbutamol inhalers: a double-blind randomised study of efficacy and tolerance. In J Clin Pharmacol Res 2002; 22(3-4):73-80 4. http://www.fda.gov/bbs/topics/answers/ans00701.html 5. Data Sheets for Salamol CFC-Free Inhaler, Ventolin® Inhaler (CFC-Free) and Airomir® Inhaler, available at www.medsafe.govt.nz/profs.htm 6. Gilchrist E et al. Remind patients to wash their MDI devices (letter). Pharm J 2003; 270: 792 7. Reminder: Blockage of CFC-free inhalers, Current Problems in Pharmacovigilance, Volume 27, February 2001. 8 Harrison L I. et al. Twenty-eight-day double-blind safety study of an HFA-134g Inhalation Aerosol System in Healthy Subjects. J.Pharm. Pharmacol 1996; 48:596-600 9. Barry, PW. Metered dose inhaler increases breath alcohol levels. Resp Med 1999, 93: 167-168

SalamolTM CFC-Free Inhaler contains 100mcg Salbutamol (as sulphate) per metered dose. Also contains the CFC-free propellant Norflurane (HFA134a) and Ethanol (anhydrous). 200 metered doses. Salbutamol makes it easier to breathe when airways (breathing tubes in your lungs) get tight due to asthma, chronic bronchitis and emphysema. It is suitable for use in the relief of asthmatic symptoms. Many asthmatics also require a preventer inhaler. Check with your doctor that SalamolTM is right for you. Precautions: Use strictly as directed. Your doctor may need to adjust your dose from time-to-time depending on the severity of your asthma. Do not stop using your inhaler without your doctor's advice. See your doctor if a previously effective dose fails to give relief for at least three hours or if you need your inhaler more often than usual. Do not use if you are allergic to Salbutamol or any of the inhaler components. Side effects may include Trembling, headache, fast heart beat. Mouth and throat irritation may occur. See your doctor if you have side effects. Normal doctor's visit fees will apply.

PRESCRIPTION MEDICINE. This medicine is fully funded on prescription. See your doctor or pharmacist for further information. Made in Ireland. Air Flow Products Ltd, PO Box 1485, Wellington. www.air-flow.co.nz. Phone 0800 AIRFLOW (0800 247 3569) or email: afp@air-flow.co.nz. Salamol is a trademark. TAPS NA9529. Ventolin® is a trademark of the GlaxoSmithKline group of companies, Airomir® is a trademark of 3M. Ventolin® and Airomir® both contain 100mcg Salbutamol (as sulphate) per metered dose. 200 metered doses. PRESCRIPTION MEDICINES

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