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BECLOMETASONE dipr.100mcg/FORMOTEROL fum. 6mcg/puff 120p,aer

https://medicalguidelines.msf.org/en/node/363
https://unicat.msf.org/cat/product/81439
STD DORABEFT16SF1

Valid Article

21
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
25.1 - Antiasthmatic medicines and medicines for chronic obstructive pulmonary disease
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.
R03AK08
Anatomical Therapeutic Chemical Classification according to WHOCC
UN1950
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).
0208
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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BECLOMETASONE / FORMOTEROL aerosol

Therapeutic Action

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

  • Beclometasone: a glucocorticoid with an anti-inflammatory action in the lungs, resulting in reduced symptoms and exacerbations of asthma with less adverse effects than with systemic corticosteroids.
  • Formoterol: a selective beta2-adrenergic agonist that produces relaxation of bronchial smooth muscle in patients with reversible airways obstruction. The bronchodilation effect sets in rapidly, within 1-3 minutes after inhalation, and has a duration of 12 hours after a single dose.

Indications

Maintenance and symptomatic treatment of chronic asthma.

For adults 18 years and above.

Instructions for use

The combination of beclometasone and formoterol is available as a suspension or solution (pressurised metered-dose inhaler) or as a dry powder (dry-powder inhaler) to inhale by mouth using a specially designed inhaler:

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

Manufacturers may express the content per puff as a "metered dose" (excluding the valve, i.e the quantity of drug substance contained in the device metering chamber) or as a "delivered dose" (excluding the mouthpiece, i.e. the quantity of drug substance delivered to the user). Always consult 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/inhalation according the inhaler model.

Pressurised metered-dose inhalers are CFC free presentation. Chlorofluorocarbons (CFCs) are harmful to the ozone layer and HFA (hydrofluoroalkane) propellant is a more effective, and environmentally-friendly alternative.

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Precautions for Use

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

Do not administer in children.

In patients who have difficulty coordinating the actuation on the metered-dose inhaler and inhalation (e.g elderly patients), use an inhalation chamber/spacer to facilitate administration and improve the effectiveness of the product.

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

  • Before first use: keep in upright position between 2ºC and 8°C for a maximum of 18 months. Do not freeze.
  • After first use: below 25ºC for a maximum of 3 months
  • Read the manufacturer's instructions on the packaging.
  • Shelf life: 21 months. The remaining shelf life at delivery should be at least 1/3 of the total shelf life
  • Used pressurised aerosols: do not pierce or incinerate. Empty all residual gas, then bury.
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