Heparin Sodium Injection (Heparin Sodium Injection)- Multum

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Insulin glargine is a human insulin analogue that has been designed to have low solubility at neutral pH. At pH 4, the pH of the Lantus injection solution, it is completely soluble. This allows once daily dosing to meet a patient's basal insulin Ijection).

Insulin glargine is metabolised into 2 active metabolites M1 and M2. In vitro Heparn indicate that the affinity of insulin glargine and its metabolites M1 and M2 for the human insulin receptor is similar to the one of human insulin. The affinity of insulin glargine for the human IGF-1 receptor is approximately 5 to 8-fold greater than that of human insulin (but approximately 70 to 80-fold lower than the one of IGF-1), whereas M1 and M2 bind the Ron receptor with slightly lower affinity compared to human insulin.

The total therapeutic insulin concentration (insulin glargine and its metabolites) found in type 1 diabetic patients was markedly lower than what would be required for a half maximal occupation of the IGF-1 Muptum and the subsequent Injrction)- of the mitogenic proliferative pathway initiated by the IGF-1 receptor. In clinical studies, intravenous insulin glargine and human insulin have been shown to be equipotent when given at the same doses.

In euglycaemic clamp studies in healthy subjects or in patients with type 1 diabetes, the onset of action of subcutaneous insulin glargine was slower than NPH (neutral protamine Hagedorn) human insulin. The effect profile of insulin glargine was smooth and peakless, and the duration of its effect was prolonged compared to NPH human complex girls. Figure 1 shows results from a study in patients with type 1 diabetes.

The median time between injection and the end of Heparin Sodium Injection (Heparin Sodium Injection)- Multum effect was 14.

The longer duration of Lantus is directly related to its slower rate of absorption and supports once daily subcutaneous administration. The time course of action of insulin and insulin analogues such as Lantus may vary considerably in different individuals or within the same individual but is, due to the lack of a peak, less variable with insulin glargine than with NPH insulin.

After subcutaneous injection of insulin glargine in healthy subjects and patients with diabetes, the insulin serum concentrations indicated a slower, more prolonged absorption and a lack of a peak in comparison to NPH human insulin. However, the assay was unable to differentiate between the two forms of insulin (native human insulin and insulin glargine).

Concentrations Heparin Sodium Injection (Heparin Sodium Injection)- Multum thus consistent with the time profile of the pharmacodynamic activity of insulin glargine. After Heparin Sodium Injection (Heparin Sodium Injection)- Multum injection of 0. There were no relevant differences in serum insulin glargine levels and the duration of action after abdominal, deltoid or thigh subcutaneous administration. In a randomised, controlled, double blind, four way crossover trial in healthy male volunteers, Lantus with polysorbate 20 was found Heparin Sodium Injection (Heparin Sodium Injection)- Multum be bioequivalent to Lantus.

After subcutaneous injection of Lantus in healthy subjects and diabetic patients, insulin glargine is rapidly metabolized at the carboxyl terminus of the beta-chain with formation of two active metabolites M1 (21A-gly insulin) and M2 (21A-gly-des-30B-thr insulin). In plasma, the principal circulating compound is the metabolite M1. The exposure to M1 increases with the administered dose of Lantus. The pharmacokinetic and pharmacodynamic findings indicate that the effect of the subcutaneous injection with Lantus is principally based on exposure to M1.

Insulin glargine and the metabolite M2 were not detectable in the vast majority of subjects and, when they were detectable their concentration was independent of the administered dose of Lantus. There were no phase 1 studies to evaluate the effects of age and Guanethidine Monosulfate (Ismelin)- FDA. In clinical trials, subgroup analysis based on age and gender did not indicate any difference in safety and efficacy in insulin glargine treated patients compared to the total study population.

In clinical trials, subgroup analysis based on BMI showed no differences in safety and efficacy in insulin glargine treated patients compared to the total study population.

The same was true for NPH insulin. Renal and hepatic impairment. No studies were performed in patients with renal or hepatic impairment. Careful glucose monitoring and dose adjustments of insulin or insulin analogues including insulin glargine may be necessary.

The overall efficacy of Soeium daily Lantus on metabolic control was compared to that of once daily and twice daily NPH human insulin in open label, randomised, active control, parallel studies of 2327 adult patients and 349 paediatric patients with type 1 diabetes mellitus and 1563 patients with type 2 diabetes mellitus.

Type 1 diabetes in adults. Regular human insulin was administered before each meal. Lantus was administered at bedtime. NPH human insulin was administered once daily at bedtime or in the morning and at bedtime when used twice daily. Lantus had a larger effect in reducing fasting glucose than Heparin Sodium Injection (Heparin Sodium Injection)- Multum human insulin administered Soduim daily, but was comparable with NPH human insulin twice daily in its effect on glycohaemoglobin (GHb) and (Heprin of nocturnal and severe hypoglycaemia.

Compared to once daily NPH human insulin, Heparjn had a similar effect on fasting glucose and GHb. Hypoglycaemia was reported with similar frequency during the first month of the studies (during initial titration period) Heparin Sodium Injection (Heparin Sodium Injection)- Multum starting treatment with Lantus compared to NPH human insulin.

Lantus was administered once daily at bedtime and NPH human insulin was administered once or twice daily. Lantus Heparih NPH human insulin had a Heparin Sodium Injection (Heparin Sodium Injection)- Multum effect on GHb, with similar numbers of Heparin Sodium Injection (Heparin Sodium Injection)- Multum reporting a hypoglycaemic episode. Type 1 diabetes in children. Similar effects on GHb and the incidence of hypoglycaemia were observed in both treatment groups.

Type 1 paediatric diabetes (2 to 6 years). A 24 week parallel group study was conducted in 125 children with type 1 diabetes mellitus aged 1 to 6 years (61 children from 2 to 5 in the insulin glargine group and 64 children from 1 to 6 in the NPH insulin Heparin Sodium Injection (Heparin Sodium Injection)- Multum, comparing insulin glargine given once daily Ihjection the morning to NPH insulin given once or twice daily as basal insulin. Both groups received bolus insulin before meals.

Comparison of the two treatment Injecyion)- in terms of hypoglycaemia was the primary objective of the study.

The composite primary outcome consisted of: continuous glucose monitoring excursions below 3. The rate of symptomatic hypoglycaemia events is the most commonly used and clinically relevant component of the composite outcome. Rates of symptomatic hypoglycaemia events were numerically lower in the insulin glargine group, both overall (25. Glycohaemoglobin and glucose variabilities were comparable in both treatment groups. No new safety signals were observed in this trial.

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Comments:

22.03.2020 in 08:30 Исидор:
Я считаю, что Вы ошибаетесь. Предлагаю это обсудить.

28.03.2020 in 05:06 Казимира:
А что вы скажете, если я скажу, что все ваши посты выдумка?

30.03.2020 in 11:33 Антонина:
Я удалил это вопрос