NEOHEMODEX

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NEOGEMODEZ (NEOHAEMODES)

Composition:

Active substances: povidone, sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium bicarbonate;

100 ml of solution contain povidone – 6 g; sodium chloride – 0.55 g; potassium chloride – 0.042 g; calcium chloride dihydrate – 0.0336 g; magnesium chloride hexahydrate – 0.0005 g; sodium bicarbonate – 0.023 g;

Ionic composition per 1 ml of the preparation: Na+ – 2.22 mg, K+ – 0.22 mg, Ca++ – 0.0913 mg, Mg++ – 0.0006 mg, Cl− – 3.7 mg;

Excipient: water for injections.

Pharmaceutical form. Infusion solution.

Main physicochemical properties: clear pale yellow to yellow liquid; theoretical osmolarity — 212 mosmol/L; pH 5.0–7.0.

Pharmacotherapeutic group. Electrolytes in combination with other agents.

ATC code B05B B04.

Pharmacological Properties

Pharmacodynamics

Neogemode belongs to plasma-substitute solutions, improves blood suspension properties, and reduces its viscosity. As a detoxifying agent, it binds toxic substances present in the bloodstream and eliminates them from the body through the kidneys.

Pharmacokinetics

After intravenous administration, the drug's effect manifests as it enters the bloodstream. The effect persists for 3–12 hours, depending on renal function and rate of blood circulation. The drug is excreted from the body through the kidneys.

Clinical characteristics.

Indications.

Detoxification of the body in infectious diseases accompanied by toxemia; burn disease during the intoxication phase (days 2–5); acute radiation sickness during the intoxication phase; peritonitis and intestinal obstruction (in pre- and postoperative periods); edema caused by chronic kidney disease; thyrotoxicosis; sepsis; liver diseases during the phase of hepatic insufficiency.

Contraindications.

Hypersensitivity to the drug (especially history of reactions to povidone), severe cardiovascular and pulmonary insufficiency, hemorrhagic stroke, bronchial asthma, acute nephritis, acute kidney injury, severe allergic and immunosuppressive conditions.

Interaction with other medicinal products and other forms of interaction.

Not established. No medicinal products should be added to the Neogemodез solution.

Special precautions.

The medicinal product should be administered with caution to patients with impaired renal excretory function. Treatment of severe intoxications must be carried out under medical supervision.

Arterial hypotension, tachycardia, and respiratory distress may occur during rapid infusion, which requires immediate discontinuation of the drug and administration of calcium chloride (intravenously), ephedrine, agents affecting the cardiovascular system, and polyglucin.

Use during pregnancy or breastfeeding.

This drug must not be used during pregnancy.

It is unknown whether the drug passes into breast milk; therefore, it should not be used during breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

During treatment, patients should refrain from driving or operating machinery, as the drug may cause undesirable effects such as dizziness and headache.

Method of Administration and Dosage.

The drug should be administered intravenously by drip infusion at a rate of 20–40 drops per minute. The solution should be warmed to 35–37 °C prior to administration. The single dose for adults is 400 ml; for children aged 6–9 years — up to 100 ml; for children aged 10–15 years — up to 150 ml.

Repeat infusions of Neogemodes should be performed as indicated, but not earlier than 10–12 hours after the previous administration. The treatment course should not exceed 5 days.

Drug administration, especially in patients with severe conditions, must be performed under physician supervision.

Children.

The drug may be used in children aged 6 years and older.

Experience with the use of the drug in children under 6 years of age is lacking.

Overdose.

Symptoms: Hypervolemia (fluid overload), arterial hypotension.

Treatment: Discontinuation of the drug; if necessary, administration of cardiac agents, calcium chloride, and reopolyglucin.

Side effects.

Immune system side effects: hypersensitivity reactions, anaphylactic shock, angioneurotic edema, hyperthermia.

Skin and subcutaneous tissue side effects: pallor, skin rashes, urticaria, hyperemia, maculopapular and petechial rashes, itching sensation.

Cardiovascular system side effects: tachycardia, chest pain, arterial hypotension.

Respiratory system side effects: dyspnea, bronchospasm.

Nervous system side effects: headache, dizziness.

Gastrointestinal tract side effects: nausea, vomiting.

General side effects: general weakness, sweating, increased body temperature, chills, local reactions at the injection site.

Shelf life. 3 years.

Storage conditions. Store at a temperature not exceeding 25 °C in a place inaccessible to children.

Incompatibility. Do not mix with other medicinal products.

Packaging. 200 ml or 400 ml in bottles; or 200 ml, 400 ml in bottle; 1 bottle per carton.

Prescription status. Prescription only.

Manufacturer. Private Joint-Stock Company "Infuziya".

Manufacturer's address and place of business.
Ukraine, 23219, Vinnytsia region, Vinnytsia district, village Vinnytski Khutory, Nemirovskе Highway, bld. 84A.