Elligamine injection solution 2ml, No. 10

In complex therapy:
- mono- and polyneuropathies of various origins;
- dorsalgia;
- plexopathies;
- lumboischialgia;
- radicular syndrome caused by degenerative changes in the spine.

In case of severe pain syndrome, treatment begins with intramuscular injection (deep) of 2 ml of the drug, daily, for 5-10 days with the transition, in the future, either for oral administration, or for more rare injections (2-3 times a week for 2 -3 weeks) with the possible continuation of therapy with the oral dosage form.
Before using ElligaminЃ, it is necessary to conduct a skin test for increased individual sensitivity to the component of the drug - lidocaine hydrochloride, as evidenced by edema and redness of the injection site.

(for 1 ml):

Active ingredients:

Pyridoxine hydrochloride (in terms of dry matter) - 50.0 mg

Thiamine hydrochloride (in terms of anhydrous substance) - 50.0 mg

Cyanocobalamin (in terms of dry matter) - 0.5 mg

Lidocaine hydrochloride (in terms of anhydrous substance) - 10.0 mg

Excipients:

Gasoline alcohol - 20.0 mg

Sodium polyphosphate - 10.0 mg

Potassium hexacyanoferrate III (potassium ferricyanide) - 0.1 mg

Sodium hydroxide - 6.0 mg

Water for injection up to 1.0 ml

Increased individual sensitivity to the components of the drug, severe and acute forms of decompensated chronic heart failure (CHF).
Pregnancy and lactation.
Childhood.
If you have one of the listed diseases, be sure to consult your doctor before taking the drug.

Trade name of the drug:

Elligamine

International non-proprietary or group name:

Pyridoxine + Thiamine + Cyanocobalamin + [Lidocaine]

Dosage form:

solution for intramuscular administration.

Composition (per 1 ml):

Active ingredients:

Pyridoxine hydrochloride (in terms of dry matter) - 50.0 mg

Thiamine hydrochloride (in terms of anhydrous substance) - 50.0 mg

Cyanocobalamin (in terms of dry matter) - 0.5 mg

Lidocaine hydrochloride (in terms of anhydrous substance) - 10.0 mg

Excipients:

Gasoline alcohol - 20.0 mg

Sodium polyphosphate - 10.0 mg

Potassium hexacyanoferrate III (potassium ferricyanide) - 0.1 mg

Sodium hydroxide - 6.0 mg

Water for injection up to 1.0 ml

Description:

transparent solution of red color with a characteristic odor.

Pharmacotherapeutic group:

B vitamins + other drugs

ATX code:

A11DB / N01BB02

Pharmacological properties

Pharmacodynamics
Neurotropic B vitamins have a beneficial effect on inflammatory and degenerative diseases of the nerves and locomotor system.
Thiamine (Vitamin B1) is involved in the regulation of carbohydrate metabolism, in the Krebs cycle, followed by participation in the synthesis of thiamine pyrophosphate and adenosine triphosphate, as well as in the synthesis of nucleic acids, and influences the transmission of neuromuscular excitation.
Pyridoxine (Vitamin B6) is involved in protein metabolism, metabolism of fats and carbohydrates, and has a neurotrophic effect. The physiological function of these vitamins is to potentiate the action of each other, which manifests itself in a positive effect on the nervous, neuromuscular and cardiovascular systems.
Vitamin B12 is essential for cellular metabolism and is involved in the synthesis of the myelin sheath. Reduces pain associated with damage to the peripheral nervous system, stimulates nucleic acid metabolism by activating folic acid. Stimulates hematopoiesis.
Lidocaine is a local anesthetic.

Pharmacokinetics
After intramuscular administration, thiamine is rapidly absorbed from the injection site and enters the bloodstream. The concentration of thiamine is 484 ng / ml 15 minutes after administration of the drug at a dose of 50 mg (on the 1st day of administration).
Thiamine is unevenly distributed throughout the body. The maximum amount of thiamine is found in the heart, liver, kidneys, and brain. Thiamine crosses the blood-brain and placental barriers and is found in breast milk. It is excreted mainly by the kidneys and in small quantities through the intestines. The main metabolites of thiamine are thiamincarboxylic acid, pyramine, and some unknown metabolites. Of all vitamins, thiamine is stored in the body in the smallest amount. The body of an adult 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. Thiamine is excreted in the urine, T1 / 2? -Phase - 0.15 h,? -Phase - 1 h and terminal phase - within 2 days.
After intramuscular administration, pyridoxine is rapidly absorbed into the bloodstream. It is metabolized in the liver with the formation of biologically active metabolites, including pyridoxal phosphate. The latter binds to blood plasma proteins (by 80%), penetrates into the organs and tissues of the body, accumulates in the liver, muscles and neurons of the central nervous system. Passes through the placenta and is found in breast milk. It is deposited in the liver and oxidized to 4-pyridoxinic acid, which is excreted in the urine, a maximum of 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 at a replenishment rate of 2.2-2.4%.
After intramuscular administration, cyanocobalamin binds in the bloodstream with transcobalamins I and II and is transferred to various tissues of the body. It is metabolized mainly in the liver with the formation of adenosylcobalamin, which is the active form of cyanocobalamin. It is deposited in the liver, enters the intestines with bile and is reabsorbed into the blood (the phenomenon of enterohepatic reticulation). The half-life is long, it is excreted mainly by the kidneys and in small quantities through the intestines.
Lidocaine: with intramuscular administration, the maximum plasma concentration of lidocaine is observed 5-15 minutes after injection. Depending on the dose, about 60-80% of lidocaine binds to plasma proteins. Penetrates through the blood-brain and blood-placental barriers. It is metabolized in the liver, excreted mainly as metabolites by the kidneys. The average half-life of lidocaine and its active components is 4-5 hours.

Indications for use

In complex therapy:
- mono- and polyneuropathies of various origins;
- dorsalgia;
- plexopathies;
- lumboischialgia;
- radicular syndrome caused by degenerative changes in the spine.

Contraindications

Increased individual sensitivity to the components of the drug, severe and acute forms of decompensated chronic heart failure (CHF).
Pregnancy and lactation.
Childhood.
If you have one of the listed diseases, be sure to consult your doctor before taking the drug.

Application during pregnancy and during breastfeeding

Do not use if pregnant or breastfeeding.

Method of administration and dosage

In case of severe pain syndrome, treatment begins with intramuscular injection (deep) of 2 ml of the drug, daily, for 5-10 days with the transition, in the future, either for oral administration, or for more rare injections (2-3 times a week for 2 -3 weeks) with the possible continuation of therapy with the oral dosage form.
Before using ElligaminЃ, it is necessary to conduct a skin test for increased individual sensitivity to the component of the drug - lidocaine hydrochloride, as evidenced by edema and redness of the injection site.

Side effect

From the immune system:
allergic reactions (skin reactions in the form of itching, urticaria; angioedema; shortness of breath; anaphylactic shock).
From the nervous system:
dizziness, confusion.
On the part of the cardiovascular system:
tachycardia.
From the organs of the gastrointestinal tract:
in some cases - vomiting.
On the part of the skin and subcutaneous tissue:
increased sweating, acne.
General disorders and disorders at the injection site:
irritation may occur at the injection site.
With rapid administration (for example, due to inadvertent intravascular administration or injection into tissues with rich circulation) or when the dose is exceeded, systemic reactions may develop, including confusion, vomiting, bradycardia, arrhythmia, dizziness, convulsions.
Due to the content of lidocaine in the preparation, the following are possible: nausea, vomiting, drowsiness, diplopia, headache, dizziness, numbness of the tongue and mucous membrane of the mouth, tremors, euphoria, disorientation, impaired cardiac conduction, anaphylactic reactions.
If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects not listed in the instructions, inform your doctor.

Overdose

Symptoms: dizziness, confusion, vomiting, bradycardia, arrhythmia, convulsions.
Treatment: In case of symptoms of an overdose, drug treatment should be canceled. If necessary, symptomatic therapy is prescribed.

Interaction with other medicinal products

¬итамины группы ¬.
“иамин полностью распадаетс¤ в растворах, содержащих сульфиты.
Ќе совместим с окисл¤ющими и восстанавливающими соединени¤ми, в том числе с йодидами, карбонатами, ацетатами, таниновой кислотой, аммони¤ железа цитратом, фенобарбиталом, рибофлавином, бензилпенициллином, декстрозой, дисульфитами. ћедь (Cu2+) ускор¤ет разрушение тиамина; кроме того, тиамин утрачивает свое действие при увеличении значений pH (более 3).
Ћеводопа снимает эффект терапевтических доз витамина ¬6.
“акже наблюдаетс¤ взаимодействие с циклосерином, пеницилламином, изониазидом, эпинефрином, норэпинефрином, сульфонамидами.
¬итамин ¬12 несовместим с сол¤ми т¤желых металлов.
Ћидокаин.
With parenteral use of lidocaine, in the case of additional use of norepinephrine and epinephrine, an increase in side effects on the heart is possible.

special instructions

The drug must be administered only intramuscularly. In case of accidental intravenous administration, the patient should be under medical supervision or hospitalized depending on the severity of the symptoms. The drug can cause neuropathy if used for more than 6 months.

Influence on the ability to drive vehicles, mechanisms

There are no data on the effect of the drug on the patient's ability to drive a vehicle, moving machinery or other operator activities, however, it is recommended to be careful, given the possible development of side effects of the drug.

Release form

Solution for intramuscular injection.
2 ml in ampoules of SNS-1 neutral light-protective glass or glass with HGA1 hydrolysis resistance class (the first hydrolytic).
5 ampoules are placed in a blister strip made of polyvinyl chloride (PVC) film or polyethylene terephthalate (PET) film.
1 or 2 blister packs together with instructions for use and an ampoule scarifier are placed in a cardboard box.
5 or 10 ampoules together with instructions for use and an ampoule scarifier are placed in a cardboard box with a corrugated insert.
When packing ampoules with a break point or ring, the ampoule scarifier is not inserted.

Packing for hospitals
4, 5 or 10 blister packs together with instructions for use in an amount equal to the number of blister packs are placed in a cardboard box for consumer packaging.
50 or 100 blister packs together with instructions for use in an amount equal to the number of blister packs are placed in a corrugated cardboard box.

Storage conditions

Store in a place protected from light, at a temperature not exceeding 15 ? C.
Keep out of the reach of children.

Shelf life

2 years. Do not use after the expiration date printed on the package.

Conditions of dispensing from pharmacies

Dispensed by prescription.