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BUVENTOL EASYHALER 100 mcg/inhalation dose

Prescription Only
Drug type: Therapeutic
ATC code: R03AC02
Dosage form: POWDER, METERED
Route of administration: RESPIRATORY (INHALATION)
Active ingredient: SALBUTAMOL SULPHATE EQV SALBUTAMOL; SALBUTAMOL SULPHATE EQV SALBUTAMOL

4.1 Therapeutic Indications

  • Symptomatic treatment of acute asthma attack.

  • Prevention of exercise-induced bronchospasm.

  • Symptomatic treatment of bronchial asthma and other conditions, such as bronchitis and emphysema, associated with reversible airways obstruction.

4.3 Contraindications

Known hypersensitivity to salbutamol or to milk proteins (the excipient lactose contains milk proteins)

Non-i.v. formulations of salbutamol must not be used to arrest uncomplicated premature labour or threatened abortion.

4.2 Posology and method of administration

The preparation is intended for oral inhalation only. This preparation is particularly useful for patients who are unable to use metered dose inhaler properly and for patients to whom the use of inhalation aerosol causes irritation of airways. The lowest effective doses of inhaled salbutamol are recommended and instead of regular use it is recommended to use inhaled salbutamol when needed.

Adults: For the relief of acute asthma or before exercise 100 – 400 mcg. The recommended dose for maintenance treatment or prophylactic therapy is 100 – 400 mcg two to four times a day. Maximum dose is 2.4 mg / day.

Children: In the treatment of episodic asthma or before exercise 100 – 200 mcg. The recommended dose for maintenance or prophylactic treatment is 100 – 200 mcg two to four times daily. Maximum dose is 1.2 mg / day.

Instruction for use/ handling:

Patients have to be instructed to perform a strong and deep inhalation through the Easyhaler device. Patients have to be instructed not to exhale into the device. Illustrated user’s instructions for use accompany each package.

Registrant
ORION PHARMA (SG) PTE. LTD.
Approval Date
1996-04-24
Approval Number
SIN08676P
Manufacturer
ORION CORPORATION (ESPOO PLANT)
Licence Holder
ORION PHARMA (SG) PTE. LTD.