Humalog Mix 50, 100 me/ml suspension 3 ml quikpen syringe pen cartridges 5 pcs

Humalog Mix 50 is a pre-mix consisting of a 50% insulin lispro solution (a fast-acting human insulin analog) and a 50% pro-tamine suspension of insulin lispro (a medium-acting human insulin analog).

The primary action of insulin lispro is to regulate glucose metabolism.

In addition, it has anabolic and anti-catabolic effects on various tissues of the body. In muscle tissue there is an increase of glycogen, fatty acids, glycerol content, increased protein synthesis and increased amino acid consumption, but there is a decrease of glycogenolysis, gluconeogenesis, ketogenesis, lipolysis, protein catabolism and amino acid release.

It has been shown that insulin lispro is equimolar to human insulin, but its effect is faster and lasts less. After a subcutaneous injection of Humalog Mix 50, there is a rapid onset of action and an early onset of peak insulin lispro activity. The onset of action of the drug is about 15 minutes later, allowing the drug to be injected immediately before a meal (0-15 minutes before the meal), compared to regular human insulin. After subcutaneous injection of Humalog Mix 50 there is a rapid onset of action and early onset of peak insulin lispro activity. The action profile of insulin lispro protamine is similar to that of regular isophan insulin with a duration of action of approximately 15 hours

PHARMACOKINETICS

The completeness of absorption and onset of effect of insulin depends on the place of administration (stomach, thigh, buttocks), the dose (volume of insulin administered), the concentration of insulin in the drug, etc. Distributed irregularly in tissues; does not penetrate through placental barrier and into breast milk. It is broken down by insulinase mainly in the liver and kidneys. It is excreted by the kidneys (30-80%).

Indications

Diabetes mellitus requiring insulin therapy.

Active ingredient

Composition

1 ml of suspension for subcutaneous administration contains:

the active ingredient:

insulin lispro biphasic 100 IU (mixture of insulin lispro solution – 50%; insulin lispro protamine suspension – 50%)

auxiliary substances:

metacresol – 2.2 mg,

liquid phenol – 1 mg,

glycerol (glycerin) – 16 mg,

protamine sulfate – 0.19 mg,

sodium hydrophosphate heptahydrate – 3.78 mg,

zinc oxide – q.s. to obtain Zn2+ 30.5 µg,

water for injection – up to 1 ml;

Hydrochloric acid solution 10% and/or sodium hydroxide solution 10% – q.s. to pH 7.0-7.8.

How to take, the dosage

Subcutaneously. The dose of Humalog Mix 50 is determined by the doctor individually, depending on the blood glucose concentration. The mode of administration of insulin is individual.

The drug should only be injected subcutaneously. Intravenous administration of Humalog Mix 50 is not allowed.

The temperature of the drug injected should be at room temperature. Subcutaneous injections should be made in the shoulder, thigh, buttock or abdomen. The injection sites should be alternated so that the same site is not used more often than about once a month. When injecting Humalog Mix 50 subcutaneously, care should be taken to avoid getting the drug into the lumen of the blood vessels. The injection site should not be massaged after the injection.

Please read the insulin injector manufacturer’s instructions for inserting the Humalog Mix 50 cartridge and attaching the needle before injecting. Follow these instructions carefully.

Preparing to inject

Just before use, the Humalog Mix 50 cartridge should be run ten times between the palms of your hands and shaken upside down by 180°, also ten times, to resuspend the insulin until it looks like a homogenous cloudy liquid. Do not shake vigorously as this may cause foam to form, which may interfere with proper dosing. There is a small glass bead inside the cartridge to aid in stirring.

Do not use Humalog Mix 50 if it has flakes in it after mixing.

Dose administration

1. Wash your hands.

2. Choose a location for the injection.

3. Prepare the skin at the injection site according to the doctor’s recommendations.

4. Remove the outer protective cap from the needle.

5. Secure the skin by gathering it in a large fold.

6. Insert the needle subcutaneously into the gathered fold and inject according to the syringe pen instructions.

7. Remove the needle and gently press the injection site with a cotton swab for a few seconds. Do not rub the injection site.

8. Using the outer needle protector, unscrew the needle and dispose of it.

9. Place the cap on the syringe pen.

For HumalogMix 50 in a QuickPen Syringe

You must read the QuickPen Syringe Manual before injecting insulin.

Interaction

Hypoglycemic effect of Humalog Mix 50 is reduced when coadministered with the following drugs: oral contraceptives, glucocorticosteroids, iodine containing thyroid hormones, danazol, beta2-adrenomimetics (e.g., ritodrine, salbutamol, terbutaline), thiazide diuretics, chlorprotixen, diazoxide, isoniazid, nicotinic acid, phenothiazine derivatives.

The hypoglycemic effect of Humalog Mix 50 is increased by: beta-adrenoblockers, ethanol and ethanol-containing drugs, anabolic steroids, phenfluramine, guanethidine, tetracyclines, oral hypoglycemic drugs, salicylates (e.g, acetylsalicylic acid), sulfonamide antibiotics, some antidepressants (monoamine oxidase inhibitors), ACE inhibitors (captopril, enapril), octreotide, angiotensin II receptor antagonists.

Beta-adrenoblockers, clopheline, reserpine may mask the symptoms of hypoglycemia.

The interaction of Humalog Mix 50 with other insulin drugs has not been studied.

Special Instructions

The transfer of a patient to a different type or preparation of insulin with a different brand name must take place under strict medical supervision. Changes in insulin concentration, brand (manufacturer), type (Regular, NPH, etc.), species (animal, human, human insulin analogues) and/or method of production (DNA recombinant or animal insulin) may require dose adjustments.

For some patients, a dose adjustment may be necessary when switching from animal insulin to human insulin. This may occur as early as the first administration of human insulin or gradually over a period of weeks or months after transfer. Symptoms-predictors of hypoglycemia against human insulin administration in some patients may be less pronounced or different from those observed against insulin of animal origin. When blood glucose concentrations are normalized, e.g. as a result of intensive insulin therapy, all or some of the precursor symptoms of hypoglycemia may disappear, of which patients should be informed. Hypoglycemic precursor symptoms may change or be less severe with a long-term course of diabetes mellitus, diabetic neuropathy, or treatment with drugs such as beta-adrenoblockers.

The use of inadequate doses or discontinuation of treatment, especially in patients with type 1 diabetes, can lead to hyperglycemia and diabetic ketoacidosis (conditions potentially life-threatening for the patient). The need for insulin may decrease in adrenal, pituitary, or thyroid insufficiency, or in renal or hepatic insufficiency. Some diseases or emotional stress may increase the need for insulin. Adjustment of insulin dosage may also be necessary if physical activity increases or if the usual diet changes.

Influence on the ability to drive and operate machinery

During hypoglycemia, the patient may have reduced concentration and speed of psychomotor reactions. This may be dangerous in situations in which these abilities are particularly necessary (e.g., driving motor vehicles or operating machinery). Patients should be recommended to take precautions to avoid hypoglycemia while driving motor transport and operating machinery. This is especially important for patients with mild or absent symptoms-predictors of hypoglycemia or with frequent development of hypoglycemia. In such cases, the physician should evaluate the appropriateness of the patient’s driving and operating machinery.

Contraindications

Hypoglycemia; hypersensitivity to insulin or to one of the drug components.

The safety and effectiveness of Humalog Mix 50 in patients under 18 years of age has not been studied.

Side effects

Hypoglycemia is the most common side effect of all insulin products, including Humalog® Mix 50. Severe hypoglycemia can lead to loss of consciousness and, in exceptional cases, death.

Allergic reactions: patients may have local allergic reactions in the form of redness, swelling or itching at the injection site. These minor reactions usually disappear within a few days or weeks. In some cases, these reactions may be caused by causes unrelated to the insulin, such as skin irritation by a cleansing agent or improper administration of injections.

Systemic allergic reactions caused by insulin are less common but are more serious. They may manifest as generalized itching, difficulty breathing, shortness of breath, decreased blood pressure, rapid heart rate, and increased sweating. Severe cases of systemic allergic reactions can be life-threatening. In rare cases of severe allergy to Humalog Mix 50, immediate treatment is required. Insulin changes or desensitization may be necessary.

Long-term use may lead to lipodystrophy at the injection site.

Overdose

Insulin overdose causes hypoglycemia accompanied by the following symptoms: lethargy, increased sweating, tachycardia, pale skin, headache, shivering, vomiting, confusion. Under certain conditions, such as a long duration of the disease or intensive control of diabetes mellitus, the precursor symptoms of hypoglycemia may change.

Mild states of hypoglycemia can usually be controlled with oral glucose or sugar. Adjustment of insulin dose, diet, or physical activity may be necessary. Correction of moderate hypoglycemia can be done by intramuscular or subcutaneous injection of glucagon, followed by ingestion of carbohydrates. Severe hypoglycemia accompanied by coma, seizures or neurological disorders are controlled by intramuscular/subcutaneous injection of glucagon or intravenous administration of concentrated dextrose (glucose) solution.

After recovery of consciousness, the patient should be given food rich in carbohydrates to prevent recurrence of hypoglycemia.

Further carbohydrate intake and follow-up monitoring of the patient may be necessary, as a recurrence of hypoglycemia may occur.

Pregnancy use

Sufficient and well-controlled studies have not been conducted in pregnant women. Patients with diabetes mellitus are advised to inform their physician about an existing or planned pregnancy. During pregnancy it is especially important to monitor the condition of patients receiving insulin therapy.

The need for insulin usually decreases during the 1st trimester and increases during the 2nd and 3rd trimesters. During and immediately after childbirth, insulin needs may decrease dramatically.

In diabetic patients, adjustments in insulin dose, diet, or both may be necessary while breastfeeding.

Similarities