Land: Europeiska unionen
Språk: engelska
Källa: EMA (European Medicines Agency)
Insulin human
Pfizer Limited
A10AF01
insulin human
Drugs used in diabetes
Diabetes Mellitus
EXUBERA is indicated for the treatment of adult patients with type 2 diabetes mellitus notadequately controlled with oral antidiabetic agents and requiring insulin therapy.EXUBERA is also indicated for the treatment of adult patients with type 1 diabetes mellitus, inaddition to long or intermediate acting subcutaneous insulin, for whom the potential benefits ofadding inhaled insulin outweigh the potential safety concerns (see section 4.4).
Revision: 6
Withdrawn
2006-01-24
Medicinal product no longer authorised 53 B. PACKAGE LEAFLET Medicinal product no longer authorised 54 PACKAGE LEAFLET: INFORMATION FOR THE USER EXUBERA 1 MG INHALATION POWDER PRE-DISPENSED EXUBERA 3 MG INHALATION POWDER PRE-DISPENSED Insulin human READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have further questions, please ask your doctor, diabetes nurse or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What EXUBERA is and what it is used for 2. Before you take EXUBERA 3. How to take EXUBERA 4. Possible side effects 5 How to store EXUBERA 6. Further information Taking three separate 1 mg unit dose blisters delivers more insulin to your lungs than a single 3 mg unit dose blister does. Three 1 mg unit dose blisters should not be substituted for one 3mg blister (see section 2, “Take special care with EXUBERA”, section 3, “How to take EXUBERA” and section 6 “Further information”). A unit dose blister is the individual container in which the insulin powder is packaged and will be called a blister in the rest of this leaflet. 1. WHAT EXUBERA IS AND WHAT IT IS USED FOR EXUBERA is an inhalation powder contained in blisters. The contents of the blisters should be breathed in through your mouth into your lungs using the insulin inhaler. EXUBERA is an anti-diabetic agent that lowers your blood sugar. EXUBERA is a fast-acting insulin. This means that it will start to lower your blood sugar 10-20 minutes after you take it, with a maximum effect at 2 hours and the effect will last for around 6 hours. EXUBERA is often given in combination with other diabetes treatments. EXUBERA is used to reduce high blood sugar in adult patients with type 2 diabetes mellitus who nee Läs hela dokumentet
Medicinal product no longer authorised 1 _ _ _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT EXUBERA 1 mg inhalation powder pre-dispensed. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each unit dose blister contains 1 mg insulin human. The exposure of human insulin following administration of three 1 mg blisters is significantly greater than that following a single 3 mg blister. Therefore, the 3 mg blister is not interchangeable with three 1 mg blisters (see sections 4.2, 4.4 and 5.2). Produced by recombinant DNA technology in _Escherichia coli._ _ _ For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder, pre-dispensed. White powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS EXUBERA is indicated for the treatment of adult patients with type 2 diabetes mellitus not adequately controlled with oral antidiabetic agents and requiring insulin therapy. EXUBERA is also indicated for the treatment of adult patients with type 1 diabetes mellitus, in addition to long or intermediate acting subcutaneous insulin, for whom the potential benefits of adding inhaled insulin outweigh the potential safety concerns (see section 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION EXUBERA (inhaled human insulin) is a fast-acting human insulin for use in type 1 or type 2 diabetes. Inhaled human insulin may be used alone or in combination with oral antidiabetic agents and/or long or intermediate acting subcutaneously administered insulins to optimise glycaemic control. EXUBERA is available in 1 mg and 3 mg unit dose blisters which are for administration via the lungs by oral inhalation only with the insulin inhaler. Consecutive inhalation of three 1 mg unit dose blisters causes a significantly higher insulin exposure than inhalation of one 3 mg unit dose blister. Therefore three 1 mg unit dose blisters should not be substituted for one 3 mg unit dose blister (see sections 2, 4.4 and 5.2). Inhaled human insulin has a faster ons Läs hela dokumentet