Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
mannitol, Quantity: 0 mg
BTC Speciality Health Pty Ltd
Mannitol
Capsule, hard
Excipient Ingredients: Gelatin
Inhalation
Combination pack: 1x empty capsule (clear/clear), 1x5 mg capsule (white/clear), 1x10 mg capsule (yellow/clear), 1x20 mg capsule (pink/clear), 15x40 mg capsules (red/clear) with 1xOsmohaler device
Not Scheduled after consideration by Committee
Aridol is indicated for identifying bronchial hyperresponsiveness to assist in the diagnosis of asthma.
Visual Identification: Hard gelatin capsule-size 3, Clear body and cap printed with two white bands.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2006-04-11
_Aridol CMI-Australia _ _ _ _Page 1 of 3 _ _Version: 17-May-2021 _ ARIDOL ® MANNITOL CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Aridol. 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 taking Aridol against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING AN ARIDOL TEST, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ARIDOL IS USED FOR Aridol is a TEST to see if you have asthma or not. Aridol contains the active ingredient mannitol. Asthma is a condition causing inflammation of the airways, making it difficult to breathe sometimes. People with asthma are often very susceptible to factors in the environment such as exercise, dust, smoke and other irritants. Your doctor or another specifically trained healthcare professional will ask you to breathe in Aridol, using a small inhaler. For people who DO have ASTHMA, their airways will become narrower and so they may find it harder to breathe. People who DO NOT have ASTHMA will not experience their airways becoming narrower when breathing in Aridol. They will still be able to breathe normally. As part of the test, you will be asked to blow into a tube that will measure the effect of Aridol on your lungs. This medicine is only used to see whether you have asthma. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY AN ARIDOL TEST HAS BEEN ORDERED FOR YOU. BEFORE YOU START TO USE IT WHEN YOU MUST NOT USE IT DO NOT TAKE AN ARIDOL TEST if you have an ALLERGY to: mannitol any of the ingredients listed at the end of this leaflet Some of the symptoms of an allergic reaction to a medicine may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. DO NOT TAKE A Přečtěte si celý dokument
1 AUSTRALIAN PRODUCT INFORMATION – ARIDOL (MANNITOL) POWDER FOR INHALATION IN HARD CAPSULES COMPOSITE PACK 1 NAME OF THE MEDICINE Mannitol 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 0 mg, 5 mg, 10 mg, 20 mg or 40 mg mannitol. The delivered dose from each of the 5, 10, 20 and 40 mg capsules is approximately 3, 8, 16 and 31 mg, respectively. For the full list of excipients, see _section 6.1 List of excipients_. 3 PHARMACEUTICAL FORM Powder for inhalation in hard capsules Hard gelatin capsule-size 3: • Empty capsule: Clear body and cap printed with two white bands. • 5 mg capsule: Clear body/white cap with “5 mg” printed on body. • 10 mg capsule: Clear body/yellow cap with "10 mg" printed on body. • 20 mg capsule: Clear body/pink cap with "20 mg" printed on body. • 40 mg capsule: Clear body/red cap with "40 mg" printed on body. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Aridol is indicated for identifying bronchial hyperresponsiveness to assist in the diagnosis of asthma. 4.2 D OSE AND METHOD OF ADMINISTRATION Aridol is supplied in kit form containing sufficient capsules to complete one complete challenge, and the inhalation device (Osmohaler™). Prior to the challenge, spirometry should be performed and the reproducibility of the resting FEV 1 established. The patient should be seated comfortably and encouraged to maintain good posture to assist the effective delivery of Aridol to the lungs. The test should proceed as follows: 1. Apply nose clip and subject should be directed to breathe through the mouth 2. Insert 0 mg capsule into inhalation device. Puncture capsule by depressing buttons on side of device slowly, and once only (a second puncture may fragment the capsules) 3. The patient should exhale completely, before inhaling from device in a controlled rapid deep inspiration 4. At the end of deep inspiration, start 60 second timer, subject should hold breath for 5 seconds and exhale through mouth before removal of nose clip 5. At the end of 60 seconds, measure the Přečtěte si celý dokument