INSULINA LISPRO BULA PDF

aplicação de insulina em diabéticos.1 . *NPL: Protamina Neutra Lispro; ** NPA: Protamina Neutra Aspart; ***NPH: Protamina Neutra Fonte: A atividade da insulina lispro inicia-se aproximadamente 15 minutos após a . médico e leve a embalagem ou bula do medicamento, se possível. Ligue para. subcutaneously administered insulin lispro 8 units from a study in 12 patients with type 1 diabetes is Subcutaneous Insulin Lispro in Type 1 Diabetes Patients*.

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Strengths Available for Humalog |

For the treatment of lispto with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Humalog takes effect rapidly and has a shorter duration of activity 2 to 5 hours given subcutaneously as compared with insjlina insulin. This rapid onset of activity allows a Humalog injection to be given very close to mealtime.

The time course of action of any insulin may vary considerably in different individuals or at different times in the same individual.

The faster onset of action compared to soluble human insulin is maintained regardless of injection site. The duration of action of Humalog is dependent on dose, site of injection, blood supply, temperature, and physical activity. Humalog can be used in conjunction with a longer-acting insulin or oral sulphonylurea medicinal products, on the advice of a physician.

Humalog KwikPen is available in two strengths. The number of insulin units is shown in the dose window of the pen regardless of strength and no dose conversion should be done when transferring a patient to a new strength or to a pen with a different dose step. Insulin requirements may be reduced in patients with hepatic impairment due to reduced capacity for gluconeogenesis and reduced insulin breakdown; however, in patients with chronic hepatic impairment, an increase in insulin resistance may lead to increased insulin requirements.

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Subcutaneous administration should be in the upper arms, thighs, buttocks, or abdomen. Use of injection sites should be rotated so that the same site is not used more than approximately once a month.

When administered subcutaneously care should be taken when injecting Humalog to ensure that a blood insulinz has not been entered. After luspro, the site of injection should not be massaged. Patients must be bkla to use the proper injection techniques.

Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Conditions which may make the early warning symptoms of hypoglycaemia different or less pronounced include long duration of diabetes, intensified insulin therapy, diabetic nerve disease or medicinal products such as beta-blockers.

A few patients who have experienced hypoglycaemic reactions after transfer from animal-source insulin to human insulin have reported that the early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin.

Uncorrected hypoglycaemic liapro hyperglycaemic reactions can cause loss of consciousness, coma, or death. The use of dosages which are inadequate or discontinuation of treatment, especially in insulin-dependent diabetics, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which lispdo potentially lethal.

Adjustment of dosage may also be necessary if patients undertake increased physical activity or change their usual diet. Exercise taken immediately after a meal may increase the risk of hypoglycaemia.

Humalog 200 Units/ml KwikPen, solution for injection in pre-filled pen

A consequence of the pharmacodynamics of rapid-acting insulin analogues is that if hypoglycaemia occurs, it may occur earlier after an ubla when compared with soluble human insulin.

Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure.

This should be kept in mind, if treatment with the combination of pioglitazone and Humalog is considered. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema.

Pioglitazone should be discontinued, if any deterioration in cardiac symptoms occurs. The markings on the insulin syringe will not measure the dose correctly. Overdose can result causing severe hypoglycemia. Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between the two different strengths of Humalog as well as other insulin products.

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Patients must visually verify the jnsulina units on the dose counter of the pen.

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Therefore, the requirement for patients to self-inject is that they can read the dose counter on the pen. This medicinal product contains less than 1 mmol sodium 23 mg per dose, i. Insulin requirements may be increased by medicinal products with hyperglycaemic activity, such as oral contraceptives, corticosteroids, or thyroid replacement therapy, danazol, beta 2 stimulants such as ritodrine, salbutamol, terbutaline.

Insulin requirements may be reduced in the presence of medicinal products with hypoglycaemic activity, such as oral hypoglycemics, salicylates for example, acetylsalicylic acidsulpha antibiotics, certain antidepressants monoamine oxidase inhibitors, selective serotonin reuptake inhibitorscertain angiotensin converting enzyme inhibitors captopril, enalaprilangiotensin II receptor blockers, beta-blockers, octreotide or alcohol.

It is essential to maintain good control of the insulin-treated insulin-dependent or gestational diabetes patient throughout pregnancy. Insulin requirements usually fall during the first trimester and increase during the second and third trimesters. Patients with diabetes should be advised to inform their doctor if they are pregnant or are contemplating pregnancy.

Careful monitoring of glucose control, as well as general health, is essential in pregnant patients with diabetes. Patients with diabetes who are breast-feeding may require adjustments in insulin dose, diet or both.

The patient’s ability to concentrate and react may be impaired as a result of hypoglycaemia. This may constitute a risk in situations where these abilities are of special importance e. Patients should be advised to take precautions to avoid hypoglycaemia whilst driving. This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia.

The advisability of driving should be considered in these circumstances. Hypoglycaemia is the most frequent adverse reaction of insulin lispro therapy that a patient with diabetes may suffer. Severe hypoglycaemia may lead to loss of consciousness, and in extreme cases, death. No specific frequency for hypoglycaemia is presented, since hypoglycaemia is a result of both the insulin dose and other factors e.

The following related adverse reactions from clinical trials are listed below as MedDRA preferred term by system organ class and in order of decreasing incidence very common: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

MedDRA system organ classes. Local allergy in patients is common. Redness, swelling, and itching can occur at the site of insulin injection.

This condition usually resolves in a few days to a few weeks. In some instances, this condition may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection technique. Systemic allergy, which is rare but potentially more serious, is a generalised allergy to insulin. It may cause a rash over the whole body, shortness of breath, wheezing, reduction in blood pressure, fast pulse, or sweating.

Severe cases of generalised allergy may be life-threatening. Cases of oedema have been reported with insulin therapy, particularly if previous poor metabolic control is improved by intensified insulin therapy.

Reporting suspected adverse reactions after authorisation of the medicinal product is important. Healthcare professionals are asked to report any suspected adverse reactions via Ireland: Yellow Card Scheme, website: Insulins have no specific overdose definitions because serum glucose concentrations are a result of complex interactions between insulin levels, glucose availability and other metabolic processes.

Hypoglycaemia may occur as a result of an excess of insulin activity relative to food intake and energy expenditure. Hypoglycaemia may be associated with listlessness, confusion, palpitations, headache, sweating and vomiting.

Mild hypoglycaemic episodes will respond to oral administration of glucose or other sugar or saccharated products. Correction of moderately severe hypoglycaemia can be accomplished by intramuscular or subcutaneous administration of glucagon, followed by oral carbohydrate when the patient recovers sufficiently. Patients who fail to respond to glucagon must be given glucose solution intravenously. If the patient is comatose, glucagon should be administered intramuscularly or subcutaneously.

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However, glucose solution must be given intravenously if glucagon is not available or if the patient fails to respond to glucagon. The patient should be given a meal as soon as consciousness is recovered.

Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery. Drugs used in diabetes, insulins and analogues for injection, fast-acting, ATC code: In addition, insulins have several anabolic and anti-catabolic actions on a variety of different tissues.

Within muscle tissue this includes increasing glycogen, fatty acid, glycerol and protein synthesis and amino acid uptake, while decreasing glycogenolysis, gluconeogenesis, ketogenesis, lipolysis, protein catabolism and amino acid output.

Insulin lispro has a rapid onset of action approximately 15 minutesthus allowing it to be given closer to jnsulina meal within zero to 15 minutes of the meal when compared to soluble insulin 30 to 45 minutes before.

Insulin lispro takes effect rapidly and has a shorter duration of activity 2 to 5 hours when compared to soluble insulin. Clinical trials in patients with type 1 and type 2 diabetes have demonstrated reduced postprandial hyperglycaemia with insulin lispro compared to soluble human insulin. The time course of insulin lispro action may vary in different individuals or at different times in the same individual and is dependent on dose, site of injection, blood supply, temperature and physical activity.

The typical activity profile following subcutaneous injection is illustrated below. In patients with type insuliina diabetes on maximum doses of sulphonyl urea agents, studies have shown that the addition of insulin lispro significantly reduces Inshlina compared to sulphonyl urea alone. The reduction of HbA1c would also be expected with other insulin products e.

Insulinz trials in patients with type 1 and type 2 diabetes have demonstrated a reduced number of episodes of nocturnal hypoglycaemia with insulin lispro compared to soluble human insulin. In some studies, reduction of nocturnal hypoglycaemia was associated with increased episodes of lispdo hypoglycaemia. Lospro glucodynamic response to insulin lispro is not affected by renal or hepatic function impairment.

Glucodynamic differences between insulin lispro and soluble human insulin, as measured during a glucose clamp procedure, were maintained over a wide range of renal function. Insulin lispro has been shown to be equipotent to human insulin on a molar basis but its effect is more rapid and of a shorter duration. The pharmacokinetics of insulin lispro reflect a compound that is rapidly absorbed, and achieves peak blood levels 30 to 70 minutes following subcutaneous injection.

When considering the clinical relevance of these kinetics, it is more appropriate to examine the glucose utilisation curves as discussed in 5. Insulin lispro maintains more rapid absorption when compared to soluble human insulin in patients with renal impairment.

In patients with type 2 diabetes over a wide range liapro renal function the pharmacokinetic differences between insulin lispro and soluble human insulin were generally maintained and shown to be independent of renal function.

Insulin lispro maintains more rapid absorption and elimination when compared to soluble human insulin in patients with hepatic impairment. Time to maximum concentration was also similar between formulations.

In in vitro tests, including binding to insulin receptor sites and effects on growing cells, insulin lispro behaved in a manner that closely resembled human insulin. Studies also demonstrate that the dissociation of binding to the insulin receptor of insulin lispro is equivalent to human insulin.

Acute, one month and twelve bhla toxicology studies produced no significant toxicity findings. Insulin lispro did not induce fertility impairment, embryotoxicity or teratogenicity in animal studies. This medicinal product should not be mixed with any other insulin or any other medicinal product. The solution for injection should not be diluted.