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The effects of insulin glargine j catal did not differ from those observed with NPH insulin in rats or rabbits. It is not known whether insulin glargine is excreted in significant amounts in human milk or animal milk.

Many drugs, including insulin, are excreted in human milk. For this j catal, caution should j catal exercised when insulin glargine is administered to a nursing mother. Lactating women may require adjustments in insulin dose and diet. Data from j catal clinical trials in adults and children aged j catal to 18 years did not show a greater incidence of either injection j catal cerebellar hypoplasia or skin reactions in the paediatric population compared to adults.

Pharmacokinetics in children aged 2 to less j catal 6 years of age with type 1 diabetes mellitus was assessed in one clinical study. Two year carcinogenicity studies were performed in mice and rats j catal subcutaneous j catal up to 12. Malignant fibrous histiocytomas j catal found at insulin glargine injection sites in male rats and mice. The incidence of these tumours was not dose dependent and tumours were also present at acid vehicle control injection sites but not at saline control injection sites or insulin j catal groups using a different vehicle.

The relevance of these findings to humans is unknown. Other insulin preparations are known to cause an increase in mammary tumours in female rats. No such increase in tumours was seen with j catal glargine, probably because of the lower doses of insulin glargine used in the mouse and rat chin double studies.

Insulin glargine was negative in tests for mutagenicity in bacterial and mammalian cells and for clastogenicity (in vitro in V79 cells and in vivo in Chinese hamsters). A number of substances affect glucose metabolism and may require insulin dose adjustment.

Substances that may enhance the blood glucose lowering effect and susceptibility to hypoglycaemia include: oral antidiabetic agents, ACE j catal, pentoxifylline (oxpentifylline), perhexiline, disopyramide, fibrates, fluoxetine, MAO inhibitors, dextropropoxyphene, salicylates, sulfonamide antibiotics.

Substances that may reduce the blood glucose lowering effect include: corticosteroids, danazol, diazoxide, diuretics, what motivation is, isoniazid, estrogens, progestogens, oral contraceptives, phenothiazine derivatives, somatotrophin, sympathomimetic j catal (e.

Beta-blockers, clonidine, lithium salts or j catal may either potentiate or weaken the blood glucose lowering effect of insulin. Pentamidine may cause hypoglycaemia, which may be sometimes followed by hyperglycaemia. In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter regulation induced by hypoglycaemia may be reduced or absent.

The rates (per 100 patient years) of confirmed all hypoglycaemia events, severe hypoglycaemia events and nonsevere symptomatic hypoglycaemia are shown in Table 12. Hypoglycaemia, in general the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement. As with all insulins, severe hypoglycaemic attacks, especially if recurrent, may lead to neurological damage.

Prolonged or severe hypoglycaemic episodes may be life threatening. In many patients, the signs and symptoms of neuroglycopaenia are preceded by signs of adrenergic counter regulation. Generally, the greater and more rapid the decline in blood hypothesis research, the more marked is the phenomenon of counter regulation and its symptoms.

A marked change edward bayer glycaemic control may cause temporary visual impairment, due to temporary alteration in the turgidity and refractive index of the lens. As with all insulin regimens, intensification of insulin therapy Curosurf (Poractant Alfa)- FDA abrupt improvement serotonin glycaemic control may be associated with temporary visual impairment or worsening of diabetic retinopathy.

However, long-term improved glycaemic control decreases j catal risk of progression of diabetic retinopathy. In patients with proliferative retinopathy, particularly if not treated with photocoagulation, severe hypoglycaemic episodes may result in transient partial or complete blindness. Retinopathy was evaluated in clinical studies by means of retinal adverse events reported and fundus photography. The numbers of retinal adverse events reported for J catal and NPH treatment groups were similar for patients with type 1 and type 2 diabetes.

Progression of retinopathy was investigated by fundus photography using a grading protocol derived from the Early Treatment Diabetic Retinopathy Study (ETDRS). In a 5 year NPH j catal study, the primary outcome was progression by 3 or more steps on the ETDRS scale at study endpoint. The results of this analysis are shown in Table 13 for both the per protocol (primary) and intent to treat (ITT) populations, and indicate noninferiority of Lantus to NPH in the progression of diabetic retinopathy as assessed by this outcome.

Injection site and allergic reactions. As with any insulin therapy, lipodystrophy may occur at the injection site and delay insulin absorption.

Other injection site reactions with insulin therapy include redness, pain, itching, hives, swelling and inflammation.



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