Trajenta 5 mg film-coated tablets Composition: each tablet contains 5 mg of linagliptin.
Therapeutic indications: it is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults: 1. Posology and method of administration: The dose of linagliptin is 5 mg once daily. When linagliptin is added to metformin: the dose of metformin should be maintained, and linagliptin administered concomitantly.
When it is added to sulphonylurea: a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia.
No dose adjustment of linagliptin is required for patients with renal impairment or for elderly. Pharmacokinetic studies suggest that precents diabétesz kezelésére szolgáló dose adjustment is required for patients with hepatic impairment but clinical experience is lacking.
The safety and efficacy of linagliptin in children and adolescents has not yet been established. Method of administration: It can be taken with or without a meal at any time of the day.
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If a dose is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day. Contraindication: Hypersensitivity to the active substance or to any of the excipients.
Az inzulin helyettesíthető? Amerikai kutatók University of Texas Southwestern Medical Center, Dallas állatkísérleteikben arra a következtetésre jutottak, hogy súlyos cukorbetegség esetén inzulin nélkül is normalizálható a vércukorszint.
Special warnings: It should not be used in kutatás cukorbetegség kezelésében with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Fertility, pregnancy and lactation: As a precautionary measure, it is preferable to avoid the use of Trajenta during pregnancy. No studies on the effect on human fertility have been conducted for Trajenta. Effects on ability to drive and use machines: Patients should be alerted to the risk of hypoglycaemia especially when combined with sulphonylurea.
Undesirable effects: In linagliptin monotherapy: uncommon: nasopharyngitis, cough.
Date of the SmPC: Medicinal product subject to medical prescription Sz. Please, read the Summary of Product Characteristics of the medicine for more information. Owens DR, et al: Efficacy and safety of linagliptin in persons with Type 2 diabetes inadequately controlled by a combination of metformin and sulphonylurea: a week randomized study.
Schlosser, A: Long-term safety and efficacy of the DPP-4 inhibitor linagliptin: data from a large 2-year study in subjects with type 2 diabetes mellitus. Diabetologia,54, Abstract Suppl 1, S1-S Summary of product characteristics Trajenta.
Each tablet contains 2. Therapeutic indications.
Add-on combination therapy: Onglyza is indicated in adult patients with type 2 diabetes mellitus to improve glycaemic control: in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control; in combination with a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate; in combination with a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate; in combination with insulin with or without metforminwhen this precents diabétesz kezelésére szolgáló alone, with diet and exercise, does not provide adequate glycaemic control.
Posology and method of administration. Add-on combination therapy: the recommended dose of Onglyza is 5 mg once daily as add-on combination therapy with metformin, a thiazolidinedione or a sulphonylurea.
The safety and effi cacy of saxagliptin as triple oral therapy in combination with metformin and a thiazolidinedione, or with metformin and a sulphonylurea, has not been established. Renal impairment: no dose adjustment is recommended for patients with mild renal impairment. The dose of Onglyza should be reduced to 2. The experience in patients with severe renal impairment is very limited.
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Therefore, saxagliptin should be used with caution in this population. Onglyza is not recommended for patients with end-stage renal disease ESRD requiring haemodialysis see section 4.
Because the dose of Onglyza should be limited to 2. Hepatic impairment: no dose adjustment is necessary for patients with mild or moderate hepatic impairment see section 5. Saxagliptin should be used with caution precents diabétesz kezelésére szolgáló patients with moderate hepatic impairment, and is not recommended for use in patients with severe hepatic impairment see section 4.
Experience in patients aged 75 years and older is very limited and caution should be exercised when treating this population see also sections 4. Paediatric population: Onglyza is not recommended for use in children and adolescents due to lack of data on safety and effi cacy. Method of administration: Onglyza can be taken with or without a meal at any time of the day.
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Hypersensitivity to the active substance a diabetes hepatitis to any of the excipients, or a history of hypersensitivity to any DPP-4 inhibitor. General: Onglyza should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
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Use with medicinal products known to cause hypoglycaemia such as sulphonylurea or insulin: a lower dose of sulphonylurea or insulin may be required to reduce the risk of hypoglycaemia when used in combination with Onglyza. Pancreatitis: from post-marketing experience there have been spontaneous reports of acute pancreatitis.
Resolution has been observed after discontinuation of saxagliptin. Hypersensitivity reactions: from post-marketing experiencethere have been spontaneously reported adverse reactions of serious hypersensitivity reactions anaphylactic reaction, anaphylactic shock, and angioedema; see section 4.
If these conditions are suspected, discontinue Onglyza, assess for other potential causes for the event, and institute alternative treatment for diabetes. Skin disorders: ulcerative and necrotic skin lesions have been reported in extremities of monkeys in non-clinical toxicology studies see section 5.
Although skin lesions were not observed at an increased incidence in clinical trials, there is limited experience in patients with diabetic skin complications.
Post-marketing reports of rash have been described in the DPP-4 inhibitor class.
Rash is also noted as an adverse event AE for Onglyza section 4. Therefore, in keeping with routine care of the diabetic patient, monitoring for skin disorders, such as blistering, ulceration or rash, is recommended.
Immunocompromised patients: immunocompromised patients, such as patients who have undergone organ transplantation or patients diagnosed with human immunodefi ciency syndrome, have not been studied in the Onglyza clinical programme. Therefore, the effi cacy and safety profi le of saxagliptin in these patients has not been established.
Gyógyszerészi gondozás 10 1. A gyógyszerészet változásai 1. Gyógyszerészi gondozás kialakulása 1. A gyógyszerészi gondozás alapelvei 1.
Use with potent CYP3A4 inducers: using CYP3A4 inducers like carbamazepine, dexamethasone, phenobarbital, phenytoin and rifampicin may reduce the glycaemiclowering effect of Onglyza see section 4. Lactose: the tablets contain lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase defi ciency or glucose-galactose malabsorption should not take this medicinal product.
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Pregnancy and lactation. Pregnancy: there are no data from the use of saxagliptin in pregnant women. Studies in animals have shown reproductive toxicity at high doses see section 5. The potential risk for humans is unknown. Onglyza should not be used during pregnancy unless clearly necessary.
Lactation: it is unknown whether saxagliptin is excreted in human breast milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue therapy taking into account the benefi t of breast-feeding for the child and the benefi t of therapy to the woman.
Undesirable effects. Please refer to section 4. There were 4, patients with type 2 diabetes, including 3, patients treated with Onglyza, randomised in six double-blind, controlled clinical safety and precents diabétesz kezelésére szolgáló cacy studies conducted to evaluate the effects of saxagliptin on glycaemic control. In a pooled analysis, the overall incidence of adverse events in patients treated with saxagliptin 5 mg was similar to placebo. Discontinuation of therapy due to adverse events was higher in patients who received saxagliptin 5 mg as compared with placebo 3.