Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
nicotine, Quantity: 114 mg (Equivalent: nicotine, Qty 21 mg/24 h)
Haleon Australia Pty Ltd
Drug delivery system, transdermal
Excipient Ingredients: polyethylene; ethylene dioleamide; ethylene/vinyl acetate copolymer; polyisobutylene; titanium dioxide; ethyl acetate; ethanol; isopropyl alcohol; methoxyisopropanol; ethylcellulose; pyroxylin
Transdermal
1 pouch, 28, 7 pouches, 3 pouches, Bonus pack of 8 pouches, 14 pouches
Not scheduled. Not considered by committee, Not Scheduled after consideration by Committee
For the treatment of nicotine dependence as an aid to smoking cessation.
Visual Identification: 'Clear patch with marking "NCQ 21"'; Container Type: Sachet; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2001-12-07
*Nicabate P is only available on the PBS PC1007113 1 NICABATE AND NICABATE P TRANSDERMAL PATCH 7 MG/24 HOUR, 14 MG/24 HOUR AND 21 MG/24 HOUR NICOTINE CONSUMER MEDICINE INFORMATION _PLEASE READ THIS INFORMATION BEFORE YOU START USING THIS MEDICINE. _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about NICABATE Patches. It does not contain all the available information. It does not take the place of talking to your pharmacist or doctor. All medicines have risks and benefits. Your pharmacist or doctor has weighed the risks of you using NICABATE Patches against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR PHARMACIST OR DOCTOR. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ARE NICABATE PATCHES USED FOR? NICABATE Patches *are tan or clear square patches for sticking on your skin. They are a stop smoking aid which helps you to give up smoking by replacing some of the nicotine you are used to getting from cigarettes. It is the nicotine in cigarettes that can make you physically addicted to them. This type of treatment is called Nicotine Replacement Therapy (NRT). NICABATE Patches provide a steady amount of nicotine to your body, generally at a level lower than from cigarettes. This nicotine relieves some of the unpleasant symptoms such as feeling ill or irritable that smokers often feel when they try to give up. The nicotine can also reduce your cravings for a cigarette and help you to resist the urge to smoke. Because NICABATE Patches do not contain the tar, carbon monoxide or other toxins in cigarette smoke, they do not have the health dangers of tobacco. If possible, when giving up smoking, NICABATE Patches should be used with a stop smoking behavioural support programme. There are no health benefits to smoking. It is always better to give up smoking and using NRT can help. In general, any possible side effects associated with NRT are far outweighed by the well established dangers of continuing to smoke. Your Baca dokumen lengkap
1 AUSTRALIAN PRODUCT INFORMATION NICABATE CLEAR PATCH, NICABATE PRE-QUIT AND NICABATE P RATE CONTROLLED NICOTINE TRANSDERMAL PATCHES 1 NAME OF THE MEDICINE Nicotine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredients: Nicotine is S-3-(1-methyl-2-pyrrolidinyl)-pyridine and is the major pharmacologically active alkaloid of tobacco. Dose Absorbed in 24 Hours (mg/day) System Area (cm 2 ) Total Nicotine Content: (mg) 21 14 7 22 15 7 114 78 36 Nicotine is the active ingredient; other components of the system are pharmacologically inactive. The Nicabate Pre-Quit patch has the same formulation as the Nicabate Clear Patch 21 mg/24 hour patch. *Nicabate P transdermal nicotine patch is only available in 21mg patches. For the full list of excipients, see section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM The free alkaloid is absorbed rapidly through the skin and respiratory tract. The rate of delivery of nicotine to the patient from each system (40 mcg/cm 2 - h) is proportional to the surface area. About 73% of the total amount of nicotine remains in the system 24 hours after application. Nicabate* is labelled by the dose actually absorbed by the patient (i.e. 7 mg/d, 14 mg/d or 21 mg/d). The dose of nicotine absorbed from Nicabate represents 68% of the amount released in 24 hours. The other 32% evaporates from the edge of the system. Nicabate is a multilayered rectangular film containing nicotine as the active agent. For the three doses the composition per unit area is identical. Proceeding from the visible surface toward the surface attached to the skin are: (1) an occlusive backing consisting of polyethylene / aluminium / polyethylene terephthalate/ ethylene-vinyl acetate copolymer; for Nicabate and Nicabate P and polyethylene terephthalate / ethylene-vinyl acetate copolymer for Nicabate Clear Patch; (2) a drug reservoir containing nicotine (in an ethylene-vinyl acetate copolymer matrix containing ethylene dioleamide as slip agent): (3) a rate-controlling membrane (polyethylene); (4) a polyisobutylene 2 adhes Baca dokumen lengkap