Neuromultivitis - instructions for use, doses, side effects, contraindications

Active substancePyridoxine + Thiamine + CyanocobalaminPyridoxine + Thiamine + Cyanocobalamin

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Neuromultiv®

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VALEANT, LLC Russia

Dosage form: & nbspsolution for intramuscular injection

Composition:

1 ampoule contains:

active ingredients:
thiamine hydrochloride	100.00 mg
pyridoxine hydrochloride	100.00 mg
cyanocobalamin	1.00 mg
Excipients:
diethanolamine	5.0 mg
water for injections	up to 2.0 ml

Description:Transparent liquid of red color, with a characteristic smell.

Pharmacotherapeutic group:B vitamins

ATX: & nbsp

A.11.D.B Combination of vitamin B1 with vitamins B6 and / or B12

Pharmacodynamics:

Pharmacological action is determined by the properties of the vitamins that make up the drug. The drug contains vitamins B₁ (thiamine), AT₆ (pyridoxine) and B₁₂ (cyanocobalamin), the deficiency of which can lead to neurological disorders, mainly from the peripheral nervous system.

Neurotropic B vitamins have a beneficial effect on inflammatory and degenerative diseases of the nerves and motor apparatus. Promotes increased blood flow and improves the functioning of the nervous system.

Thiamine is a cofactor of enzymes that carry two-carbon groups in decarboxylation reactions, plays a key role in the metabolism of carbohydrates, as well as in the Krebs cycle with subsequent participation in the synthesis of TPPthiamine pyrophosphate) and ATP (adenosine triphosphate).

Pyridoxine is a cofactor of transaminases involved in protein metabolism, and in part, in the metabolism of carbohydrates and fats.

The physiological function of both vitamins is the potentiation of each other's action, manifested in a positive effect on the nervous, neuromuscular and cardiovascular systems.

The drug quickly replenishes the deficiency of these vitamins.

Cyanocobalamin is a cofactor in the transport reactions of single-carbon groups, participates in the synthesis of the myelin sheath, stimulates hemopoiesis, reduces pain associated with the damage to the peripheral nervous system, stimulates nucleic acid metabolism through the activation of folic acid.

Pharmacokinetics:

After intramuscular injection thiamine is rapidly absorbed from the injection site and enters the blood (484 ng / ml after 15 minutes on the first day of dosing in 50 mg) and is distributed unevenly in the body with its content in leukocytes 15%, erythrocytes 75% and plasma 10%.

Thiamine penetrates through the blood-brain and placental barriers and is found in breast 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: thiaminic acid, pyramine and some unknown metabolites. Of all vitamins thiamine remains in the body in the smallest amount. The adult body contains about 30 mg of thiamine in the form of 80% thiamine pyrophosphate, 10% thiamine triphosphate and the rest in the form of thiamine monophosphate.

After intramuscular injection pyridoxine quickly absorbed into the bloodstream and distributed in the body, performing the role of coenzyme after phosphorylation of the CH group₂The OH in the 5-th position forms a metabolically active pyridoxalphosphate. About 80% of the vitamin binds to blood plasma proteins.

Pyridoxine is distributed throughout the body and crosses the placenta and is found in breast milk, is deposited in the liver and oxidized to 4-pyridoxic acid, which is excreted in the urine, maximum 2-5 hours 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%.

After parenteral administration cyanocobalamin Forms complexes with transport protein transkobalaminom, which are quickly absorbed by the liver, bone marrow and other organs. Cyanocobalamin excreted in bile and takes part in intestinal-hepatic circulation. Penetrates through the placenta.

Indications:

In the complex therapy of the following neurological diseases, accompanied by a deficiency of B vitamins:

- Potilipropathy (diabetic, alcoholic);

- mezherebanaya neuralgia;

- Mr.the trigeminal nerve;

- Mr.euritis of the facial nerve;

- tonut disease, caused by degenerative changes in the spine;

- wher syndrome;

- Pleche-scapular syndrome;

- Plumbar syndrome;

- lyumboishalgia.

Contraindications:

- Hypersensitivity to active or auxiliary substances of the drug;

- severe and acute forms of decompensated chronic heart failure (CHF);

- the period of pregnancy and breastfeeding;

- childhood.

Pregnancy and lactation:

Application during pregnancy and breastfeeding is contraindicated.

Dosing and Administration:

Dosing regimen

In severe pain syndrome, treatment begins with intramuscular injection (deep) of 2 ml of the drug, daily, for 5-10 days and further, with the transition to more rare injections (2-3 once a week) for 2-3 weeks.

It is recommended to carry out weekly medical supervision.

It is recommended as soon as possible to switch to the ingestion Neuromultivit in the form of a drug-coated tablet.

Intravenous administration is not allowed.

Side effects:

The following concepts and frequencies are used: very often (≥1 / 10), often (≥1 / 100, <1/10), infrequently (≥1 / 1000, <1/100), rarely (≥1 / 10000, < 1/1000), very rarely (<1/10000) and the frequency is unknown (can not be estimated from the available data).

From the immune system:

rarely: allergic reactions (hives, itching, angioedema, difficulty breathing, anaphylactic shock).

From the gastrointestinal tract:

in some cases: nausea, vomiting.

From the cardiovascular system:

in some cases: tachycardia, increased sweating.

From the skin and subcutaneous tissues:

Rarely: increased sweating, acne.

From the nervous system:

Rarely: dizziness, confusion.

General disorders and disorders at the site of administration:

in some cases: irritation may occur at the injection site; with rapid administration (for example, due to unintentional intravascular injection or introduction into tissues with rich blood supply) or when the dose is exceeded, systemic reactions may develop: confusion, vomiting, bradycardia, arrhythmia, dizziness, convulsions.

Overdose:

Symptoms of overdose: confusion, vomiting, bradycardia, arrhythmia, dizziness, convulsions.

Treatment: symptomatic.

Interaction:

In the presence of sulfite-containing solutions thiamine completely disintegrates. In the presence of the products of the decomposition of vitamin B₁ other vitamins may be inactivated.

Thiamin is incompatible with oxidizing and reducing compounds, including: iodides, carbonates, acetates, tannic acid, iron ammonium citrate, phenobarbital, refluxin, benzylpenicillin, dextrose, disulfites.

Copper accelerates the destruction of thiamine; Besides, thiamine Loses its effectiveness with increasing pH (more than 3).

Therapeutic doses of vitamin B₆ can reduce the action of levodopa while receiving.

Possible interaction with cyclosporine, penicillamine, isoniazid, epinephrine, norepinephrine, sulfonamides.

Cyanocobalamin is incompatible with salts of heavy metals. Riboflavin also has a destructive effect, especially with simultaneous exposure to light; nicotinamide accelerates photolysis, while antioxidants have an inhibitory effect.

Special instructions:

The drug should be administered exclusively intramuscularly and not to enter the vascular bed.

In case of unintentional intravenous administration, medical supervision should be performed (for example, in a hospital setting), depending on the severity of the symptoms.

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

Information about caution regarding the use of the drug Neuromultivit by drivers of vehicles and persons working with potentially dangerous mechanisms is missing.

Form release / dosage:

Solution for intramuscular injection.

Packaging:

For 2 ml of the drug in the ampoule of the light-protective glass with a light blue breakpoint and a ring of light blue.

For 5 ampoules in PVC blister, covered with a transparent film; 1 or 2 or 5 blisters together with instructions for use in a cardboard box.

Storage conditions:

At a temperature of 2 ° C to 8 ° C.

For patients: it is allowed to store the drug at a temperature of no higher than 25 ° C for 14 days.

Keep out of the reach of children.

Shelf life:

2 years.

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

Terms of leave from pharmacies:On prescription

Registration number:LP-004102

Date of registration:25.01.2017

Expiration Date:25.01.2022

The owner of the registration certificate:VALEANT, LLC VALEANT, LLC Russia

Manufacturer: & nbsp

G.L.PHARMA, GmbH Austria

Representation: & nbspVALEANT LLC VALEANT LLC Russia

Information update date: & nbsp28.02.2017

Illustrated instructions

Instructions

Neuromultiv® (Neuromultivit®)