GlucaGen® 1 mg Hypochitis (GlucaGen® 1 mg HypoKit)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceGlucagonGlucagon
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  • GlucaGen® 1 mg Hypochitis
    lyophilizate for injections 
    Novo Nordisk A / S     Denmark
    • Dosage form: & nbsplyophilizate for solution for injection
    Composition:

    Active substance: glucagon hydrochloride, genetically engineered - 1 mg (corresponding to 1 ME).

    Excipients: lactose monohydrate, water for injection.

    (The composition may also include hydrochloric acid and / or sodium hydroxide, used in the preparation of the preparation for pH adjustment).

    Description:

    Lyophilized powder or porous mass of white color.

    When dissolved in the applied solvent for 1 minute, a clear, colorless solution is formed.

    Pharmacotherapeutic group:Hypoglycemia treatment
    ATX: & nbsp

    H.04.A.A.01   Glucagon

    Pharmacodynamics:

    GlucaGen® 1 mg HypoCyt contains the genetically engineered human glucagon - protein-peptide hormone, physiological antagonist insulin, involved in the regulation of carbohydrate metabolism. Glucagon enhances the cleavage of glycogen in the liver to glucose-6-phosphate (glucogenolysis), which increases the concentration of glucose in the blood.

    Glucagon is ineffective in the treatment of patients in whose liver the glycogen stores are depleted. For this reason glucagon ineffective or ineffective at all in the treatment of patients on an empty stomach or patients with adrenal insufficiency, chronic hypoglycemia or hypoglycaemia caused by alcohol intake.

    Unlike adrenaline, glucagon has no effect on muscle phosphorylase and therefore can not promote the transfer of carbohydrates from the richest glycogen stores of skeletal muscle.

    Glucagon stimulates the release of catecholamines. In the presence of pheochromocytoma glucagon can provoke the release of a large number of tumors catecholamines, which cause a sharp increase in blood pressure.

    Glucagon reduces the contractility of the smooth muscles of the gastrointestinal tract.

    The drug starts in 1 minute after intravenous injection, the duration of the drug is 5-20 minutes, depending on the dose and organ.

    The drug begins in 5-15 minutes after intramuscular injection and lasts from 10 to 40 minutes, depending on the dose and organ.

    In the treatment of severe hypoglycemic action of glucagon on blood glucose is usually seen within 10 minutes.

    Pharmacokinetics:

    The metabolic clearance rate of glucagon in humans is approximately 10 ml / kg / min. Glucagon is metabolized by the enzymatic route in the blood plasma and in the organs in which it is distributed. The main places of glucagon metabolism are the liver and kidneys, the contribution of each organ to the overall rate of metabolic clearance is approximately 30%. The half-life of glucagon is 3-6 minutes.

    Indications:

    Severe hypoglycemic conditions (low blood glucose) that occur in diabetic patients after insulin injection or tableted hypoglycemic drugs.

    For diagnostics: Suppression of motility of the organs of the gastrointestinal tract during the examination by endoscopy and radiography.

    Contraindications:

    Increased individual sensitivity to glucagon or any other component of the drug; hyperglycemia; pheochromocytoma.

    Pregnancy and lactation:

    Glucagon does not pass through the human placental barrier. The available data on the use of glucagon in pregnant women with diabetes indicate that there is no adverse effect both on the course of pregnancy,and on the health of the fetus and the newborn.

    Glucagon is very rapidly excreted from the bloodstream (mainly through the liver, T1/2 = 3-6 min), so the amount of glucagon released with the mother's milk after using the drug for severe hypoglycemia is extremely small. Because the glucagon is destroyed in the digestive tract and, therefore, is not absorbed unchanged, it does not have any metabolic effect on the baby.

    Dosing and Administration:

    For the treatment of severe hypoglycemic conditions

    To prepare the injection solution, 1 mg (1 ME) the lyophilizate is dissolved in 1 ml of a solvent.

    Adults and children weighing more than 25 kg or older 6-8 years 1 mg (1 ml, a mark on a syringe 1/1) is introduced.

    Children with body weight less than 25 kg or younger than 6-8 years 0.5 mg (0.5 ml, mark on the syringe 1/2) is administered subcutaneously or intramuscularly.

    The patient usually regains consciousness within 10 minutes after the administration of the drug. After the patient regains consciousness, he needs to give food rich in carbohydrates to prevent the re-development of hypoglycemia and the recovery of glycogen in the liver. If the patient does not regain consciousness within 10 minutes, he must be administered intravenous dextrose.

    All patients with severe hypoglycemia need medical attention.

    Preparation of solution for injection

    1. Remove the plastic cap from the bottle and the protective needle tip from the syringe. Puncture the rubber plug of the vial containing GlukaGen® with a needle and insert all the liquid in the syringe into the vial (see Figure 1).

    2. Do not remove the needle from the bottle, gently shake the bottle until the drug is completely dissolved GlucaGen® and the formation of a clear solution (see Figure 2).

    3. Make sure that the piston is fully retracted. Collect the entire solution in a syringe. It should be ensured that the piston does not come out of the syringe (see Figure 3).

    4. Release air from the syringe and inject (see Figure 4).

    Dispose of unused remedies and packages in accordance with local regulations.

    For the diagnosis (suppression of the contractility of the organs of the gastrointestinal tract)

    GlucaGen® 1 mg HypoCit should be administered only by medical personnel.

    After intravenous administration 0,2-0,5 mg action of the drug begins within 1 minute and lasts from 5 to 20 minutes, depending on the organ being examined.

    After intramuscular injection 1-2 mg the effect of the drug begins after 5-15 minutes and lasts 10-40 minutes depending on the organ being examined.

    After completion of the procedure, the patient should be given carbohydrate-rich foods, if this is compatible with the diagnostic procedure being used.

    Depending on the diagnostic method used and the method of administration, the dose of the drug is 0.2-2 mg. The usual diagnostic dose used to relax the muscles of the stomach, the bulb of the duodenum, duodenum and small intestine is 0.2-0.5 mg with intravenous administration and 1 mg with intramuscular injection. The dose for relaxation of rectum muscles is 0.5-0.75 mg with intravenous administration and 1-2 mg with intramuscular injection.

    Side effects:

    The incidence of adverse reactions associated with the use of GlucaGen® 1 mg HypoKit in both clinical trials and postmarketing observations is presented below.

    Adverse reactions that were not observed during clinical trials, but which were reported spontaneously, are presented as "very rare". Reports of adverse reactions during post-marketing use are very rare. However, post-marketing studies are characterized by underreporting of adverse reactions, which should be taken into account when interpreting the results obtained on the number of these reactions.The number of episodes of drug use is estimated at 46.9 million for 16 years.

    The frequency of adverse reactions was determined as follows: very rarely (≤ 1/10000); rarely (> 1/10000, ≤ 1/1000); infrequently (> 1/1000, ≤ 1/100); often (> 1/100, ≤ 1/10).

    Immune system disorders

    Very rarely: hypersensitivity, including anaphylactic shock.

    Disorders from the gastrointestinal tract

    Often: nausea.

    Infrequently: vomiting.

    Rarely: pain in the abdomen.

    In addition to the above, in the diagnostic application, the following adverse reactions were observed:

    From the side of metabolism

    Infrequently: hypoglycaemia.

    After diagnostic procedures, it can be expressed more strongly in patients on an empty stomach (see section "Special instructions").

    Very rarely: hypoglycemic coma.

    From the side of the cardiovascular system

    Very rarely: bradycardia, tachycardia, lowering blood pressure (BP), increasing blood pressure. Side effects from the cardiovascular system were observed only in those cases when GlucaGen® 1 mg of HypoKit was used as an auxiliary tool for endoscopic or radiographic procedures.

    Overdose:

    In case of an overdose of GlucaGen® 1 mg of HypoCit, nausea, vomiting, diarrhea, hypokalemia, tachycardia, increased blood pressure may occur.

    Treatment symptomatic. It is necessary to constantly monitor the potassium level and, if necessary, to correct it. The use of forced diuresis and hemodialysis is ineffective. In the case of vomiting - rehydration and replenishment of potassium losses.

    Interaction:

    On the background beta-blockers the administration of GlucaGen® 1 mg of HypoKit can lead to severe tachycardia and increased blood pressure.

    Insulin: The action of glucagon is opposite to the action of insulin (insulin antagonist of glucagon).

    Indomethacin: when combined glucagon may lose the ability to increase blood glucose and even cause hypoglycemia.

    Warfarin: when combined glucagon can enhance the effect of warfarin anticoagulant.

    Special instructions:

    When treating severe hypoglycemic conditions

    After the patient regained consciousness, in order to prevent the repeated development of hypoglycemia, he should be given carbohydrate-rich foods to restore glycogen stores in the liver.

    Diagnostic application

    Patients who received glucagon in connection with diagnostic procedures, can feel discomfort, especially if the procedures were performed on an empty stomach. There are reports of cases of nausea, hypoglycemia and changes in blood pressure in these situations. After completion of the diagnostic procedure, fasted patients should be given a carbohydrate-rich product if this is compatible with the diagnostic procedure used. If fasting is necessary after examination or in case of severe hypoglycemia, intravenous dextrose (glucose) may be required.

    Glucagon is an insulin antagonist, and caution should be exercised when using GlucaGen® 1 mg HypoKit in patients with insulinoma, as well as with glucagonoma.

    Also, use caution when using GlucaGen® 1 mg HypoKit as an adjuvant for endoscopic or radiographic procedures in patients with diabetes mellitus or in elderly patients with cardiovascular pathology.

    GlucaGen® 1 mg HypoCit should not be administered as an intravenous infusion.

    The bottle with the preparation GlukaGen® is equipped with a plastic cap, which should be removed before the preparation of the solution.

    Do not use the prepared solution if it has a gel-like consistency or contains undissolved particles.

    Effect on the ability to drive transp. cf. and fur:

    Studies of the effect of the drug on the ability to drive vehicles or work with mechanisms have not been carried out. Since there are reports of hypoglycemia after diagnostic procedures, vehicle management should be avoided until the patient eats food containing carbohydrates.

    Form release / dosage:

    Lyophilizate for solution for injection, 1 mg.

    Packaging:1 mg of lyophilizate in vials, complete with a solvent in disposable syringes of 1 ml.

    1 vial with lyophilized powder (lyophilizate) and 1 syringe with a solvent in a plastic pencil case.

    Storage conditions:

    GlucaGen® (in the form of a powder) should be stored at a temperature of no higher than 25 ° C.

    Do not freeze to avoid damage to the syringe.

    The bottle with the preparation GlucaGen® should be stored in a dark place.

    A ready-made solution of GlucaGen® 1 mg HypoKit should be used immediately after preparation. Do not store the finished solution for later use.

    Keep out of the reach of children.

    Shelf life:

    Lyophilizate - 2 of the year.

    Solvent - 3 years.

    Do not use the product after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N015125 / 01
    Date of registration:18.03.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:Novo Nordisk A / SNovo Nordisk A / S Denmark
    Manufacturer: & nbsp
    Representation: & nbspNOVO NORDISK TOVNOVO NORDISK TOVDenmark
    Information update date: & nbsp01.05.2017
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