BUDESONIDE 80mcg/FORMOTEROL 4.5 mcg/p, 120 puffs, aer.

STD DORABUFT84SF1

Valid Article


Article is intended to be used with children (<12 years) ONLY.
Classification of the medicines in groups and subgroups according to their therapeutic use. The classification used by MSF is based on the WHO Model List of Essential Medicines.
R03AK07
Anatomical Therapeutic Chemical Classification according to WHOCC
Hazardous materials and products (identified by their 4-digit transport UN-number) must be transported under certain conditions as specified in the MSDS sheet (Material Safety Data Sheet).
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.

OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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BUDESONIDE / FORMOTEROL aerosol

Therapeutic Action

Combination of inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA) inhaled bronchodilator:

  • Budesonide: a glucocorticoid with anti-inflammatory effects in the lungs, resulting in reduced asthma symptoms and exacerbations, with less adverse effects compared to systemic corticosteroids.
  • Formoterol: a selective beta2-adrenergic agonist that produces relaxation of bronchial smooth muscle in patients with reversible airways obstruction. Its bronchodilation effect begins rapidly, within 1-3 minutes after inhalation, and lasts for up 12 hours after a single dose.

Indications

Treatment of moderate to severe persistent asthma in children

Instructions for use

The combination of budesonide and formoterol is available in two forms for inhalation:

  • Pressurised Metered-Dose Inhaler (MDI): a small canister containing a mixture of the medicine and pressurised propellant. The pressure from the propellant delivers the medicine when the canister is pushed down into the boot/actuator.
  • Dry-Powder Inhaler (DPI): a breath-actuated device that delivers the medicine as a fine, dry powder contained in a capsule or blister, which is punctured by the device before use.

Manufacturers may express the content per puff as a "metered dose" (the quantity of the drug in the device metering chamber, excluding the valve) or as a "delivered dose" (the quantity of drug delivered to the user, excluding the mouthpiece). Always refer to the product leaflet.

The inhalers generally supplied by MSF are pressurised metered-dose inhalers (MDI). Refer to the information leaflet for appropriate instructions for use according to the inhaler model.

The pressurised metered-dose inhalers are CFC free. Chlorofluorocarbons (CFCs) are harmful to the ozone layer, and HFA (hydrofluoroalkane) propellants are a more effective, environmentally friendly alternative.

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Precautions for Use

Do not use for the treatment of an acute asthma attack.

In children, use an inhalation chamber/spacer with or without a mask (depending on the age of the child) with every administration of pressurised metered-dose inhalers.

Do not use any mouthpiece other than the one supplied with the inhaler.

Transport Dangerous Goods

UN transport code:

  • UN 1950 - Aerosols, non-flammable (each not exceeding 1 L capacity)
  • Transport Class 2.2 - Non-flammable, non-toxic gases

Transport is only regulated for large quantities of aerosols.

Storage

  • Below 25ºC
  • Used pressurised aerosols: do not pierce or incinerate. Empty any residual gas, then dispose of by burying.
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