BUDESONIDE 80mcg/FORMOTEROL 4.5 mcg/p, 120 puffs, inhaler

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 inhaler

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 device equipped with a small canister containing a mixture of the medicine and a 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 often pre-loaded in a capsule or blister within the device and punctured by the device prior to use.

Manufacturers may express the content per puff as either:

  • in metered dose: the quantity of medicine in the device metering chamber, excluding the valve
  • in delivered dose: (the quantity of medicine delivered to the user, excluding the mouthpiece.
  • Always refer to the product leaflet.

Budesonide/Formoterol inhalers generally supplied by MSF are Dry-Powder Inhalers (DPI). Refer to the information leaflet for appropriate instructions for use, according to the inhaler model.

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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 child's age) for every administration of a pressurised metered-dose inhaler.

Only use the mouthpiece supplied with the inhaler. Do not substitute it with any other mouthpiece.

Transport Dangerous Goods

UN transport code (for Pressurised Metered-Dose Inhaler - MDI):

  • 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 inhaler: do not pierce or incinerate. Empty any residual gas before disposal. Dispose of by burying.
  • The pressurised metered-dose inhalers are CFC free. Chlorofluorocarbons (CFCs) are harmful to the ozone layer. Instead, these inhalers use HFA (hydrofluoroalkane) propellants, which are a more effective and environmentally friendly alternative.
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