Nevaron ® Neo – injection

INSTRUCTIONS FOR MEDICAL USE

NEVARON® NEO

Trade name of the drug: Nevaron® Neo

Active ingredients (INN): thiamine hydrochloride + pyridoxine hydrochloride + cyanocobalamin + lidocaine hydrochloride

Dosage form: solution for injection

Contents:

2 ml of the drug contains:

Active ingredients: thiamine hydrochloride 100.0 mg, pyridoxine hydrochloride 100.0 mg, cyanocobalamin 1.0 mg, lidocaine hydrochloride 20.0 mg;

Excipients: benzyl alcohol, sodium polyphosphate, potassium ferricyanide, sodium hydroxide, water for injection up to 2 ml.

Description: clear red solution.

Pharmacotherapeutic group: vitamin.

ATX code: A11E

Pharmacological properties

B-group neurotropic vitamins have a beneficial effect on inflammatory and degenerative diseases of the nerves and the motor system. Contribute to increased blood flow and improve nervous system function.

Thiamine plays a key role in metabolism of carbohydrates, as well as in the Krebs cycle, with subsequent participation in the synthesis of TPP (thiamine pyrophosphate) and ATP (adenosine triphosphate).

Pyridoxine is involved in protein metabolism and, in part, in carbohydrate and fat metabolism. The physiological function of both vitamins is to potentiate each other’s action, manifesting itself in a positive effect on the nervous, neuromuscular and cardiovascular systems. In vitamin B6 deficiency, widespread deficiency states are quickly ameliorated after administration of these vitamins.

Cyanocobalamin is involved in the synthesis of myelin sheath, stimulates hematopoiesis, reduces pain associated with lesions of the peripheral nervous system, stimulates nucleic metabolism through activation of folic acid.

Lidocaine is a local anesthetic agent, causing all types of local anesthesia: terminal, infiltration, conduction.

Pharmacokinetics

After intramuscular administration, thiamine is rapidly absorbed from the injection site and enters the blood (484 ng/ml after 15 min on the first day of administration of a dose of 50 mg) and is irregularly distributed in the body, containing 15% in leukocytes, 75% in erythrocytes and 10% in plasma. Because of the lack of significant stores of the vitamin in the body, it must be administered daily. Thiamine penetrates the blood-brain and placental barriers and is found in mother’s milk. Thiamine is excreted in the urine in the alpha phase after 0.15 hours, in the beta phase after 1 hour, and in the terminal phase within 2 days. The main metabolites are thiamine carboxylic acid, pyramine and some unknown metabolites. Of all vitamins, thiamine is retained in the body in the smallest amounts. The adult body contains about 30 mg of thiamine as 80% thiamine pyrophosphate, 10% thiamine triphosphate, and the remainder as thiamine monophosphate.

After intramuscular injection, pyridoxine is rapidly absorbed into the bloodstream and distributed in the body, acting as a coenzyme after phosphorylation of the CH2ON group at the 5th position. About 80% of the vitamin is bound to plasma proteins. Pyridoxine is distributed throughout the body and crosses the placenta and is found in the mother’s milk, deposited in the liver and oxidized to 4-pyridoxic acid, which is excreted in the urine, 2-5 hours maximum after absorption. The human body contains 40-150 mg of vitamin B6 and its daily elimination rate is about 1.7-3.6 mg with a replenishment rate of 2.2-2.4%.

Indications for use

As a pathogenetic and symptomatic agent in the treatment of diseases and syndromes of the nervous system of various origins: neuralgia, neuritis, facial nerve paresis, retrobulbar neuritis, ganglionitis (including shingles), plexopathy, neuropathy, polyneuropathy (diabetic, alcoholic, etc.), night-time muscle cramps. ), nocturnal muscle cramps, especially in older age groups, neurological manifestations of spinal osteochondrosis: radiculopathy, lumboishalgia, muscle-tonic syndromes.

Dosage and administration

Injections are performed deeply intramuscularly, once a day.

In cases of pronounced pain syndrome to quickly reach high levels of the drug in the blood, it is advisable to start treatment with 2.0 ml daily for 5-10 days. Further, after pain syndrome has subsided and in mild forms of the disease, the therapy is transferred either to oral dosage form or to more rare injections (2-3 times a week for 2-3 weeks) with possible continuation of therapy with oral dosage form. Weekly monitoring of therapy by a physician is recommended. Transition to therapy by oral dosage form is recommended to be carried out as soon as possible.

Side effects

Frequency of manifestation of adverse reactions is given in accordance with the WHO classification:

Very oftenMore than 1 in 10 of those treated
OftenLess than 1 in 10, but more than 1 in 100 treated
In some casesLess than 1 in 100, but more than 1 in 1000 treated
RarelyLess than 1 in 1,000, but more than 1 in 10,000 treated
Very rarelyless than 1 in 10,000, including individual cases

*In some cases, symptoms occur with unknown frequency;

Immune system disorders:

Rarely: allergic reactions (skin rash, difficulty in breathing, anaphylactic shock, Quincke’s edema);

Nervous system disorders:

In some cases: dizziness, confusion;

Cardiovascular system disorders:

Very rarely: tachycardia;

In some cases: bradycardia, arrhythmia;

Gastrointestinal tract:

In some cases: vomiting;

Skin and subcutaneous tissue:

Very rare: increased sweating, acne, itching, urticaria;

Musculoskeletal and connective tissue disorders:

In some cases: seizures;

General disorders and disorders at the injection site:

In some cases: irritation at the site of administration may occur; Systemic reactions are possible with rapid administration or in case of overdose.

If any of the side effects mentioned in the instructions are aggravated, or if you notice any other side effects not specified in the instructions, inform your doctor.

Contraindications

Pregnancy and breastfeeding (See “Administration during pregnancy and breastfeeding”). Childhood age under 16 years old. Decompensated heart failure. Increased individual sensitivity to the components of the drug.

Drug interactions

Thiamine is completely disintegrated in solutions containing sulfites. As a consequence, the products of thiamine decomposition inactivate the activity of other vitamins. Thiamine is incompatible with oxidizing reducing compounds, including: iodides, carbonates, acetates, tannic acid, ammonium iron citrate, phenobarbital, riboflavin, benzylpenicillin, dextrose, desulfites, etc. Copper accelerates thiamine breakdown; in addition, thiamine loses its effectiveness when pH values (more than 3) increase. Therapeutic doses of pyridoxine weaken the effect of levodopa (the antiparkinsonian effect of levodopa is reduced) when taken simultaneously. Interaction with cycloserine, penicillamine, isoniazine is also observed. When parenteral administration of lidocaine in case of additional use of norepinephrine, an increased side effect on the heart is possible. Interaction with sulfonamides is also observed. Cyanocobalamin is incompatible with salts of heavy metals. Riboflavin also has a destructive effect, especially when simultaneously exposed to light; nicotinamide accelerates photolysis, while antioxidants have an inhibitory effect.

There is no information about caution regarding the use of the drug by drivers of vehicles and persons working with potentially dangerous mechanisms.

Special Indications

In case of accidental intravenous administration, the patient should be monitored by a doctor or hospitalized depending on the severity of symptoms.

Administration during pregnancy and breastfeeding

The drug is contraindicated during pregnancy and breastfeeding (see section “Contraindications”).

Influence on the reaction rate while driving motor transport or operating other mechanisms

There is no information concerning caution as to the use of the drug by drivers of vehicles and persons working with potentially dangerous mechanisms.

Overdose

Treatment of overdose consists in withdrawal of the drug and symptomatic therapy.

Form of production

Solution for injection of 2 ml in a contour cell pack.

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25°C. Keep out of reach of children.

Shelf life

2 years.

Do not use after the expiration date.

Conditions for dispensing from pharmacies

Released by a doctor’s prescription.

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