Salbutamo Albuterol Aerosol West Medicine GMP Certificate

• Application: Internal Medicine
• Suitable for: Elderly, Children, Adult
• State: Liquid
• Type: Organic Chemicals
• Pharmaceutical Technology: Chemical Synthesis
• Standard: Bp, USP, CHP.
• Model NO.: Aerosol
• OEM: Available
• Transport Package: 200 Packs Per Carton
• Specification: 100 micrograms per actuation in
• Origin: China
• Production Capacity: 2, 000, 000units

Product Description

 Therapeutic indications
Symptomatic treatment of asthma attacks and exacerbations of asthma in adults and children aged 4 years and over. Prevention of exercise-induced bronchospasm or before exposure to a known unavoidable allergen challenge. Symptomatic treatment of broncho-asthma and other conditions associated with reversible airways obstruction.
 

Albuterol  provides a short-acting bronchodilation with fast onset of action in reversible airways obstruction due to asthma.

 

Albuterol should be used to relieve symptoms when they occur and to prevent them in those circumstances recognised by the patient to precipitate an attack (e.g. before exercise or unavoidable allergen exposure).

Albuterol is valuable as a rescue medication in mild, moderate or severe asthma, provided that reliance on it does not delay the introduction and use of regular inhaled corticosteroid therapy.

 

Albuterol is indicated in adults, adolescents and children aged 4 to 11 years.

 Posology and method of administration
Posology

Adults and Older people:
For the relief of acute bronchospasm and for managing intermittent episodes of asthma, one inhalation (100 micrograms) may be administered as a single starting dose; this may be increased to two inhalations (200 micrograms) if necessary.
To prevent exercise-induced bronchospasm or allergen bronchospasm two inhalations (200 micrograms) should be taken before challenge, this dose (200 micrograms) may be repeated if necessary.

Paediatric Population:
Relief of acute bronchospasm
Children aged 4 to 11 years 100 micrograms as required. The dose may be increased to two inhalations if required.
Children aged 12 years and over: Dose as per adult population.
Prevention of allergen or exercise-induced bronchospasm

Children aged 4 to 11 years 100 micrograms before challenge or exertion. The dose may be increased to two inhalations if required.
Children aged 12 years and over: Dose as per adult population.

Chronic therapy
Children aged 4 to 11 years up to 200 micrograms four times a day.
On-demand use of Easyhaler Albuterol should not exceed four times daily. Reliance on such frequent supplementary use, or a sudden increase in dose, indicates poorly controlled or deteriorating asthma.
Children aged 12 years and over: Dose as per adult population.
On demand use of Easyhaler Albuterol  should not exceed eight inhalations (800 micrograms) in any 24 hour period.
For optimum results in most patients Easyhaler Albuterol  Sulfate inhaler should be used regularly during asthmatic attacks. The bronchodilator effect of each administration of inhaled Albuterol  lasts for four hours, except in patients whose asthma is becoming worse. Such patients should be warned not to increase their usage of Albuterol , but should seek medical advice in case treatment with an inhaled and/or systemic glucocorticosteroid is indicated.

Method of administration
For oral inhalation only.
This preparation is particularly useful for patients unable to use metered dose inhalers properly and for patients in whom the use of an inhalation aerosol causes irritation of airways. Inhaled Albuterol  should be used only on as-needed basis at the lowest dose and frequency required.
Precautions to be taken before handling or administering the medicinal product

Instructions for use:
The protective cover of the inhaler should be opened and the dust cap removed immediately prior to use.
The inhaler should be shaken vigorously up and down 3-5 times. Whilst holding the inhaler in an upright position, between the finger and thumb, press once until a click is heard. Let inhaler click back again whilst continuing to hold in an upright position.
Inhalation should take place from either a sitting or standing position. The patient should breathe out normally and place the mouthpiece between their teeth whilst using their lips to form a seal around the mouthpiece. Patients are instructed to perform a rapid and forced inhalation through the Easyhaler device. After holding their breath for at least 5 seconds the patient can resume normal breathing. Patients should not to exhale into the device.

The mouthpiece of the inhaler should be cleaned once a week using a dry cloth or tissue.
Patients should be instructed in the proper use of their inhaler (see patient information leaflet) and children should always have adult supervision when using the device. Illustrated instructions for use accompany each package.

Contraindications
Hypersensitivity to Albuterol  or to the excipient listed in section 6.1 (lactose monohydrate, which contains small amounts of milk proteins).

Albuterol  inhalation is contraindicated in treatment of threatened abortion or premature labour.

Our factory
This product is produced in our GMP factory, all our facility has past China GMP, and also officially certificated by more than ten countries' MOH. 
Our Service
We can specially develop the products per customers' specification.
We can offer OEM service with customers' private brands and labels.
We can offer excellent after-sale service and professional technical support.

Our Quality control system
In manufacturing, quality is what sustains our life.  Starting from the material selection, there are many factors that contribute to the quality control process.  Our manufacturing facility is GMP certified. Quality Control (QC) and monitoring procedures are built into every aspect of our work.
Our Quality Control System is outlined below:

Initial inspection (such as raw material, excipients, package materials, etc.)
In-process inspection (make sure that each testing items should be qualified )
Final inspection before shipment of each order. 
Provide temperature control recorder when it is necessary for special market before loading.

Our Registration Team and technical support
We have experienced team to provide qualified and professional registration documents for most of countries. Up to present, we have registered more than hundred products and exported to more than 20 countries. Especially including those in Asia, Africa, South America, Middle east area and East Europe.

We can provide regulatory documents
GMP Certificate / CE Certificate
Free sales certificate 
Certificate of Pharmaceutical Products
Manufacture License
CTD Dossier.