Description
Injection form for srdlp
Packaging
3 ml – cartridge, QuickPen ¢ integrated into the syringe pen (5) – a cardboard pack.
Pharmacological action
Humalog has a hypoglycemic effect. It increases the utilization of glucose by tissues, stimulates the synthesis of glycogen, and inhibits glycogenolysis.
Indications
Diabetes mellitus in adults and children, requiring insulin therapy to maintain normal glucose levels.
Contraindications
Hypoglycemia hypersensitivity to the components of the drug.
Use during pregnancy and lactation
To date, no adverse effects of insulin lispro on pregnancy or the health of the fetus / newborn have been identified. No relevant epidemiological studies have been conducted.
The goal of insulin therapy during pregnancy is to maintain adequate glucose control in patients with insulin-dependent diabetes mellitus or with gestational diabetes. The need for insulin usually decreases in the first trimester and increases in the second and third trimesters of pregnancy. During and immediately after birth, insulin requirements may decrease dramatically.
Women of childbearing age with diabetes should inform their doctor about a new or planned pregnancy. During pregnancy, patients with diabetes require careful monitoring of blood glucose levels, as well as general clinical monitoring. In patients with diabetes mellitus during breastfeeding, a dose adjustment of insulin and / or diet may be required.
Special instructions
Transfer of the patient to another type or brand of insulin should be carried out under strict medical supervision. Changes in activity, brand (manufacturer), type (e.g. Regular, NPH, Tape), species (animal, human, human insulin analogue) and / or production method (DNA recombinant insulin or insulin of animal origin) may necessitate dose changes.
Conditions in which the early warning signs of hypoglycemia may be nonspecific and less severe include the continued existence of diabetes mellitus, intensive care for insulin, diseases of the nervous system in diabetes mellitus, or the use of medications, such as beta-blockers.
Composition
1 ml of injection contains insulin lyspro 100 IU
Excipients: glycerol (glycerin) – 16 mg, metacresol – 3.15 mg, zinc oxide (qs for Zn2 + 0.0197 ?g), sodium hydrogen phosphate heptahydrate – 1 mg. acid solution of 10% and / or sodium hydroxide solution of 10% – qs to pH 7.0-8.0, water d / and – qs to 1 ml.
Dosage and administration
Humalog is administered subcutaneously. Immediately before meals (the dose is selected individually).
Side effects
Side effect associated with the main effect of the drug: hypoglycemia. Severe hypoglycemia can lead to loss of consciousness (hypoglycemic coma) and, in exceptional cases, to death.
Allergic reactions: local allergic reactions are possible – redness, swelling or itching at the injection site (usually disappear within a few days or weeks) systemic allergic reactions (occur less often, but are more serious) – generalized itching, urticaria, angioedema, fever, shortness of breath, decreased blood pressure, tachycardia, increased sweating. Severe cases of systemic allergic reactions can be life threatening.
Local reactions: lipodystrophy at the injection site.
Drug interactions
Humalog’s hypoglycemic effect is reduced by oral contraceptives, corticosteroids, thyroid hormone preparations, danazol, beta2-adrenergic agonists (including rhytodrin, salbutamol, terbutaline), tricyclic antidepressants, thiazide diuretics, chlorprotixen, diazoxide, isoniazid, lithium carbonate, nicotinic acid, phenothiazine derivatives.
The hypoglycemic effect of Humalog is enhanced by beta-blockers, ethanol and ethanol-containing drugs, anabolic steroids, fenfluramine, guanethidine, tetracyclines, oral hypoglycemic drugs, salicylates (e.g. acetylsalicylic acid, capillaryl azides, inhibitors, capillamyridopril, inhibitol, capillorylipritol, inhibit, capitriyl azide, inhibit, angiotensin II receptor antagonists. Humalog ® should not be mixed with animal insulin preparations.
X oral hypoglycemic drugs, salicylates (e.g. acetylsalicylic acid), sulfonamides, MAO inhibitors, ACE inhibitors (captopril, enalapril), octreotide, angiotensin II receptor antagonists. Humalog ® should not be mixed with animal insulin preparations.
X oral hypoglycemic drugs, salicylates (e.g. acetylsalicylic acid), sulfonamides, MAO inhibitors, ACE inhibitors (captopril, enalapril), octreotide, angiotensin II receptor antagonists. Humalog ® should not be mixed with animal insulin preparations.
XUmalog ® can be used (under the supervision of a doctor) in combination with longer-acting human insulin or in combination with oral hypoglycemic agents, sulfonylurea derivatives.
Overdose
Symptoms: hypoglycemia, accompanied by the following symptoms: lethargy, excessive sweating, tachycardia, headache, vomiting, confusion. Treatment: mild hypoglycemia is usually stopped with glucose or other sugars or foods, containing sugar.
Correction of moderately severe hypoglycemia can be accomplished by using m / m or n / a glucagon followed by carbohydrate intake after stabilization of the patient’s condition. Patients who do not respond to glucagon are injected into / into a solution of dextrose (glucose). If the patient is comatose, glucagon should be given in / m or p / k. In the absence of glucagon or if there is no reaction to its introduction, it is necessary to enter in / in a solution of dextrose (glucose). Immediately after regaining consciousness, the patient should be given carbohydrate-rich foods. Further supportive carbohydrate intake and patient monitoring may be required as well. hypoglycemia recurrence may occur.
Storage Conditions
Do not freeze at 2-8 ° C in a dark place.
In-use preparation should be stored at room temperature from 15 ° to 25 ° C and protected from direct sunlight and heat. Expiration – no more than 28 days.
Shelf life
2 years.
Active ingredient
insu yn lispro
Terms and conditions
prescription
dosage form
injection