Страна: Нова Зеландия
Език: английски
Източник: Medsafe (Medicines Safety Authority)
Theophylline 250mg; ; Theophylline 250mg
iNova Pharmaceuticals (New Zealand) Limited
Theophylline 250 mg
250 mg
Modified release tablet
Active: Theophylline 250mg Excipient: Cellacefate Lactose monohydrate Magnesium stearate Active: Theophylline 250mg Excipient: Guar gum Magnesium stearate
Blister pack, PVC/PVDC, 100 tablets
Prescription
Prescription
Siegfried PharmaChemikalien Minden GmbH
NUELIN-SR tablets are indicated for the relief and prophylaxis of reversible bronchospasm associated with asthma, chronic bronchitis and emphysema.
Package - Contents - Shelf Life: Blister pack, PVC/PVDC - 100 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE - 100 tablets - 36 months from date of manufacture stored at or below 30°C
1979-07-16
NUELIN-SR™ 1 NUELIN-SR™ TABLETS _(NEW-LIN) _ _Theophylline (thee-off-o-lin) Tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Nuelin-SR tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. IF YOU NEED ANY MORE INFORMATION ABOUT NUELIN-SR TABLETS, PLEASE ASK YOUR DOCTOR OR PHARMACIST. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Nuelin-SR tablets against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT NUELIN-SR TABLETS ARE USED FOR Nuelin-SR tablets are used to treat asthma and other conditions where breathing is difficult. It also helps to prevent asthma attacks. The active ingredient in Nuelin-SR tablets is theophylline, which causes the muscle lining of the airways to relax. Nuelin-SR tablets are a slow release medicine which means each tablet works for about 12 hours. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may prescribe Nuelin- SR tablets for another purpose. Nuelin-SR tablets are available only with a doctor's prescription. IF YOU ARE NOT SURE WHY YOU ARE TAKING THIS MEDICINE, ASK YOUR DOCTOR. BEFORE YOU TAKE NUELIN-SR TABLETS _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE NUELIN-SR TABLETS IF YOU HAVE AN ALLERGY TO: Any medicine containing theophylline, aminophylline or caffeine Any of the ingredients listed at the end of this leaflet Any other similar medicines used to treat asthma and other conditions where breathing is difficult Some of the symptoms of an allergic reaction 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 THIS MEDICINE AFTER THE EXPIRY DATE PR Прочетете целия документ
NEW ZEALAND DATA SHEET NEULIN TM -SR NUELIN-SR Page 1 of 8 1 PRODUCT NAME NUELIN-SR 250 mg sustained release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains theophylline BP 250 mg. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Sustained release tablet. White, round, biconvex tablets marked 250 on one face and no markings on the other face. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications NUELIN-SR tablets are indicated for the relief and prophylaxis of reversible bronchospasm associated with asthma, chronic bronchitis and emphysema. 4.2 Dose and method of administration Desirable therapeutic levels are considered to be between 10-20 µg/mL (55-110 µmol/L). Higher levels may produce toxic effects. Toxic effects may also occur at therapeutic levels. When maximum response is required, dose levels should be individually titrated. Serum theophylline may be monitored to confirm that levels are within the therapeutic range. Monitoring is recommended, in particular when dose levels exceed 1g daily in adults or 24 mg/kg daily in children. NUELIN-SR doses should be adjusted for factors known to affect theophylline clearance (see sections 4.4 and 4.5). Dose Adults: 13 mg/kg per 24 hours. _Paediatric Population _ Children over 2 years: Starting dose 16 mg/kg every 24 hours to a mean 20 mg/kg every 24 hours. Children under 2 years: Not to be given except on the advice of a physician. Children (from 6 months to 16 years) have a more rapid clearance of theophylline resulting in the need for higher per kg doses. _Special Populations _ Where possible patients should be commenced on a lower dose and gradually increased to the maintenance dose to minimise the incidence of side effects. Extra caution is required with the elderly as they may have slower clearance rates. Obese patients should be dosed on the basis of ideal rather than actual body weight. Smokers often require higher doses than non-smokers due to more rapid clearance of theophylline. _ _ NEW ZEALAND DATA SHEET NEULIN TM Прочетете целия документ