Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
salbutamol sulfate, Quantity: 6 mg (Equivalent: salbutamol, Qty 5 mg)
Cipla Australia Pty Ltd
salbutamol sulfate
Inhalation, conventional
Excipient Ingredients: water for injections; sodium chloride; sulfuric acid
Inhalation
30 x 2.5mL ampoules
(S4) Prescription Only Medicine
For the relief of bronchospasm in patients with asthma or chronic obstructive pulmonary disease, and for acute prophylaxis against exercise induced asthma or in other situations known to induce bronchospasm.
Visual Identification: Clear colourless to pale yellow solution.; Container Type: Ampoule; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2007-10-23
APO-SALBUTAMOL _INHALATION AMPOULES_ _Contains the active ingredient salbutamol sulfate_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT IS THIS MEDICINE USED FOR Salbutamol is inhaled into your lungs to relieve the symptoms of asthma and other breathing problems. It may also be used before exercise or at other times to keep your air passages open if you start to wheeze or have difficulty breathing each time you exert yourself. Asthma is a disease where the lining of the lungs becomes inflamed (red and swollen), making it difficult to breathe. This may be due to an allergy to house dust mites, smoke, air-borne pollution and other irritants. Salbutamol belongs to a family of medicines called bronchodilators (beta-2-agonists). These work rapidly to open up the air passages in the lungs of people suffering from asthma, bronchitis, emphysema and other breathing problems. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor's prescription. This medicine is not addictive THIS MEDICATION IS DELIVERED DIRECTLY TO YOUR LUNGS THROUGH A DEVICE CALLED A NEBULISER. APO-Salbutamol Inhalation Ampoules may be used in children aged between 4 and 12 years of age. BEFORE YOU USE THIS MEDICINE _WHEN YOU MUST NOT USE IT_ DO NOT USE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • any medicine containing salbutamol • any of the ingredients listed at t Læs hele dokumentet
1 AUSTRALIAN PRODUCT INFORMATION APO-SALBUTAMOL (SALBUTAMOL SULFATE) INHALATION AMPOULES 1 NAME OF THE MEDICINE Salbutamol sulfate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2.5 mL ampoule contains salbutamol sulfate equivalent to either salbutamol 2.5 mg or 5 mg. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Clear, colourless to pale yellow, sterile, isotonic solution for inhalation. It does not contain a preservative. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Relief of bronchospasm in patients with asthma or chronic obstructive pulmonary disease. • Acute prophylaxis against exercise-induced asthma or in other situations known to induce bronchospasm. 4.2 DOSE AND METHOD OF ADMINISTRATION APO-SALBUTAMOL INHALATION SOLUTION is intended for administration by inhalation. DOSAGE Increasing use of β 2 -agonists may be a sign of worsening asthma. Under these conditions a reassessment of the patient’s therapy plan may be required and concomitant glucocorticosteroid therapy should be considered. Salbutamol solution is to be used under the direction of a doctor. The solution may be delivered from any efficient nebulising device. The solution must not be injected or ingested. Salbutamol solution may be used to achieve bronchodilation as part of an inhalation therapy regimen or for patients requiring assisted ventilation. There is a large safety margin between therapeutic effects and unpleasant side effects. Nevertheless, because of the possibility of uncontrolled dosage associated with continuous administration, intermittent administration of appropriate amounts of salbutamol is preferred. ADULTS AND CHILDREN Children (4-12 years): 2.5 mg Adults: 5 mg 2 This dosage may be repeated as necessary every four to six hours. Important: Fresh dilutions should be prepared for each inhalation and any solution remaining in the nebuliser after treatment should be discarded immediately. To avoid contamination, nebulising devices should be thoroughly cleaned after use a Læs hele dokumentet