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External sources (not reviewed)

It had provided data on all imports of CFC-MDI products during the past three years; however, the product used, salbutamol, was available in a non-CFC form worldwide.

CFC-MDIs have been produced in Mexico by Laboratorios Salus since 1999, containing the following three active ingredients: salbutamol, beclomethasone and cromoglycate.

[...] [...] concentration of salbutamol (free plus glucuronide) greater than 1000 ng/mL will be considered an Adverse Analytical Finding unless the Athlete proves that the abnormal result was the consequence of the therapeutic use of inhaled salbutamol.

The presence in urine of salbutamol in excess of 1000 ng/mL or formoterol in excess of 30 ng/mL is presumed not to be an intended therapeutic use of the substance and will be considered as an Adverse Analytical Finding unless the Athlete proves, through a controlled pharmacokinetic study, that the abnormal result was the consequence of the use of the therapeutic inhaled dose up to the maximum indicated above.

[...] of CFCs at Laboratorio Pablo Cassará for the production of salbutamol CFC-MDIs to isobutane; to replace the use of CFCs at Laboratorio Denver Farma for the production [...] [...]

(ii) EU: No further import, sale or distribution of CFC-MDIs with salbutamol as the sole active ingredient from 2006.

The objectives of the project are: to eliminate the use of CFCs at Laboratorio Pablo Cassará for the production of salbutamol CFC-MDIs; to eliminate the use of CFCs at Laboratorio Denver Farma for the production of salbutamol and budesonide CFC-MDIs; to provide technical support for alternative formulations for four locally-owned laboratories filling their own MDIs through third parties; and to support the MDI transition strategy.

The project is to assist Laboratorios Chalver to convert the CFC-MDI manufacturing line to HFA technology by 2012, including the development of HFA-MDIs for beclomethasone, ipratropium, salbutamol and salbutamol/beclomethasone.

All beta-2 agonists (including both optical isomers where relevant) are prohibited except salbutamol (maximum 1600 micrograms over 24 hours), formoterol (maximum 36 micrograms over 24 hours) and salmeterol when taken by inhalation in accordance with the manufacturers’ recommended therapeutic regime.

(a) Funding will only be provided for the development of HFA-MDIs for salbutamol and budesodine that were filled by 3M for Denver Farma.

The level of CFC consumption forecast in the 2010 – 2015 period remains high because of essential uses of CFC MDIs containing not only salbutamol (up until 2014), but also other active ingredients, and the company’s estimated growth on the basis of expected local and international business.

The objective of the investment project is to phase out 7.42 ODP tonnes of CFCs used in the manufacture of MDIs with the following active ingredients: beclomethasone, salbutamol, salbutamol/beclomethasone and ipratropium.

The project proposes the phase-out of 97.1 ODP tonnes of CFCs used in the manufacturing of salbutamol MDIs at Cassará, using isobutane as a propellant.

[...] [...] based on HFA for salbutamol and budesonide [...]

This one non-CFC MDI using salbutamol represented about 13 percent of the salbutamol-MDI market in 2007, priced at about 65 percent higher than a CFC-based product from the same manufacturer (Cipla), also offered in Yemen.

Additionally, a number of multinational corporations offer several medications for asthma and CODP, including CFC-based salbutamol MDIs, salbutamol and fluticasone both as HFC-134a-based MDIs and as dry powder inhalers (DPI), and budesonide DPIs.

It had provided data on all imports of such products during the past three years; however, both products used were imported from the same source, although one of those products, salbutamol, was available in a non-CFC form worldwide.

The active ingredients in MDIs are salbutamol (manufactured by the three enterprises), salbutamol/beclomethasone (manufactured by Macter and Zafa), and beclomethasone, salmetrol/fluticasone, ipratropium, salmeterol and triamcinolone acetonite (manufactured only by Macter).

The use In- and Out-of-Competition, as applicable, of any quantity of a substance subject to threshold limits (i.e. salbutamol, morphine, cathine, ephedrine, methylephedrine and pseudoephedrine) in conjunction with a diuretic or other masking agent requires the deliverance of a specific Therapeutic Use Exemption for that substance in addition to the one granted for the diuretic or other masking agent.

The Secretariat requested additional details and a preliminary assessment on whether Bangladesh will be in a position to comply with the essential use exemption level authorized for 2011 (57.0 ODP tonnes) and the non-request of further essential use nominations for the manufacturing of salbutamol, beclomethasone and levosalbutamol (decision XXII/4).

8.2 The Prohibited Substances or Prohibited Methods which may be permitted by this abbreviated process are strictly limited to the following: Beta-2 agonists (formoterol, salbutamol, salmeterol and terbutaline) by inhalation, and glucocorticosteroids by non-systemic routes.

UNDP also indicated that the conversion to non-CFC based salbutamol, beclomethasone and levosalbutamol will be completed in 2011 and therefore it is estimated that no CFCs will be required for these MDIs in 2012.

(a) Dissemination strategy (radio, television, newspaper) to create awareness of the benefits of using CFC-free MDIs; letters to pharmacists to communicate the phase-out of 6 salbutamol CFC MDIs, its rationale and the environmental advantages of CFC-free alternatives; promotional material to be distributed to doctors, patients and the general public.

For trade, they should use ingredients that were low in asparagines and reducing sugars when producing products processed at high temperature and should not cook food excessively.

[...] effects (e.g. methamidophos and triazophos, [...] [...]