- Approval Id
- 4d76745a58d3645a
- Drug Name
- BUVENTOL EASYHALER 100 mcg/inhalation dose
- Product Name
- BUVENTOL EASYHALER 100 mcg/inhalation dose
- Approval Number
- SIN08676P
- Approval Date
- 1996-04-24
- Registrant
- ORION PHARMA (SG) PTE. LTD.
- Licence Holder
- ORION PHARMA (SG) PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- POWDER, METERED
- Dosage
- **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.
- Route Of Administration
- RESPIRATORY (INHALATION)
- Indication Info
- **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.
- Contraindications
- **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.
- Atc Code
- R03AC02
- Atc Item Name
- salbutamol
- Pharma Manufacturer Name
- ORION PHARMA (SG) PTE. LTD.
- Company Detail Path
- /organization/orion-pharma-sg-pte-ltd
