Țară: Uniunea Europeană
Limbă: engleză
Sursă: EMA (European Medicines Agency)
Insulin human
Novo Nordisk A/S
A10AE01
insulin human (rDNA)
Drugs used in diabetes
Diabetes Mellitus
Treatment of diabetes mellitus.
Withdrawn
2002-10-07
Medicinal Product no longer authorised 30 B. PACKAGE LEAFLET Medicinal Product no longer authorised 31 Ultratard Read all of this leaflet carefully before you start using your insulin. 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 is prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. _ _ Ultratard 40 IU/ml Suspension for injection in a vial Suspension for injection in a vial. Insulin human, rDNA. Ultratard is a zinc suspension consisting of crystalline particles. The active substance is insulin human made by recombinant biotechnology. 1 ml contains 40 IU of insulin human. 1 vial contains 10 ml equivalent to 400 IU. Ultratard also contains zinc chloride, sodium chloride, methyl parahydroxy benzoate, sodium actetate, sodium hydroxide, hydrochloric acid and water for injections. The suspension for injection comes as a white, cloudy suspension in packs of 1 or 5 vials of 10 ml (not all packs may be marketed). The marketing authorisation holder and manufacturer is Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark. 1 What Ultratard is Ultratard is human insulin to treat diabetes. It comes in a 10 ml vial that you use to fill a syringe. Ultratard is a very long-acting insulin. This means that it will start to lower your blood sugar about 4 hours after you take it, and the effect will last for approximately 28 hours. Ultratard is often given in combination with fast-acting insulins. 2 Before you use Ultratard Do not use Ultratard_ _ ► If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is symptoms of low blood sugar). See 4 What to do in an emergency for more about hypos ► If you have ever had an allergic reaction to this insulin product or any of the ingredients (see box, below left). Some people are allergic to the ingredient methyl parahydroxy benzoate. Look out for the signs of allergy in 5 Possi Citiți documentul complet
Medicinal Product no longer authorised 1 _ _ _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal Product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Ultratard 40 IU/ml Suspension for injection in a vial 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Insulin human, rDNA (produced by recombinant DNA technology in _Saccharomyces cerevisiae_). 1 ml contains 40 IU of insulin human 1 vial contains 10 ml equivalent to 400 IU One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin. Ultratard is an insulin zinc suspension. The suspension consists of crystalline particles. For excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Suspension for injection in a vial. Ultratard is a cloudy, white, aqueous suspension. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of diabetes mellitus. 4.2 Posology and method of administration Ultratard is a long-acting insulin. Dosage Dosage is individual and determined by the physician in accordance with the needs of the patient. The average range of total daily insulin requirement for maintenance therapy in type 1 diabetic patients lies between 0.5 and 1.0 IU/kg. In pre-pubertal children it usually varies from 0.7to 1.0 IU/kg. During the period of partial remission, the insulin requirements can be much lower, whereas in insulin resistant states e.g. during puberty or due to obesity, the daily insulin requirement may be substantially higher. Initial dosages for type 2 diabetic patients are often lower, e.g. 0.3 to 0.6 IU/kg/day. The physician determines whether one or several daily injections are necessary. Ultratard may be used alone or mixed with fast-acting insulin. In intensive insulin therapy the suspension may be used as basal insulin (evening and/or morning injection) with fast-acting insulin given at meals. In patients with diabetes mellitus optimised glycaemic control delays the onset and slows the progression of late diabetic complications. Blood glucose monitoring is therefore recommended. Dosage adjustment Conco Citiți documentul complet