Compligam B solution for injection, 2ml # 10

As a pathogenetic and symptomatic agent in the treatment of syndromes and diseases of the nervous system of various origins:

• neuropathy and polyneuropathy, incl. diabetic, alcoholic;

• neuritis and polyneuritis, incl. retrobulbar neuritis;

• peripheral paresis, incl. facial nerve;

• neuralgia, incl. trigeminal nerve and intercostal nerves;

• pain syndrome (radicular, myalgia);

• nocturnal muscle cramps, especially in older age groups;

• plexopathies, ganglionitis (including herpes zoster);

• neurological manifestations of osteochondrosis of the spine (radiculopathy, lumboishalgia, muscle-tonic syndromes).

V / m (deep).

In case of severe pain syndrome, it is advisable to start treatment with intramuscular injection of 2 ml of the drug daily, for 5-10 days, with the transition in the future either to oral administration, or to more rare injections (2-3 times a week for 2-3 weeks).

1 ampoule (2 ml) contains as an active substance:

thiamine hydrochloride - 100 mg, pyridoxine hydrochloride - 100 mg, cyanocobalamin - 1 mg, lidocaine hydrochloride - 20 mg.

excipients: benzyl alcohol, sodium polyphosphate, sodium tripolyphosphate, potassium hexacyanoferrate, sodium hydroxide solution 1 M, water for injection.

• Hypersensitivity to any component of the drug;

• severe and acute forms of decompensated chronic heart failure;

• childhood (due to lack of research).

Trade name : CompligamVЃ

MNI or Generic Name : Multivitamins [Parenteral]

Dosage form : solution for intramuscular administration.

Ingredients :

1 ampoule (2 ml) contains as an active substance: thiamine hydrochloride - 100 mg, pyridoxine hydrochloride - 100 mg, cyanocobalamin - 1 mg, lidocaine hydrochloride - 20 mg.
excipients: benzyl alcohol, sodium polyphosphate, sodium tripolyphosphate, potassium hexacyanoferrate, sodium hydroxide solution 1 M, water for injection.

Description : transparent solution of pinkish-red color with a characteristic specific odor.

Pharmacotherapeutic group : multivitamin + other drugs

ATX code : ј11?’

Pharmacological action
Neurotropic B vitamins have a beneficial effect on inflammatory and degenerative diseases of the nerves and locomotor system. They are not used to eliminate deficiency conditions, but in high doses have analgesic properties, enhance blood flow, normalize the functioning of the nervous system and the process of hematopoiesis (vitamin B12).
Thiamine (B1) plays a key role in the processes of carbohydrate metabolism, which are of decisive importance in the metabolic processes of the nervous tissue, as well as in the Krebs cycle with subsequent participation in the synthesis of TPP (thiamine pyrophosphate) and ATP (adenosine triphosphate). Pyridoxine (B6) is involved in the metabolism of proteins, and partially in the metabolism of carbohydrates and fats. The physiological function of both vitamins (B1, B6) is to potentiate the action of each other, which manifests itself in a positive effect on the nervous, neuromuscular and cardiovascular systems.
Cyanocobalamin (B12) is involved in the synthesis of the myelin sheath, stimulates hematopoiesis, reduces pain associated with damage to the peripheral nervous system, stimulates nucleic acid metabolism through the activation of folic acid. Lidocaine is a local anesthetic that produces all types of local anesthesia.

Pharmacokinetics
After intramuscular administration, thiamine is rapidly absorbed from the injection site and enters the bloodstream (484 ng / ml after 15 minutes on the first day of the 50 mg dose) and is unevenly distributed in the body when it is contained in leukocytes 15%, erythrocytes 75% and in blood plasma ten %. Due to the lack of significant reserves of vitamin in the body, it must be supplied to the body daily. Thiamine crosses 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 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% as thiamine pyrophosphate, 10% thiamine triphosphate and the rest 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 CH2OH group in the 5th position. About 80% of the vitamin binds to blood plasma proteins. Pyridoxine is distributed throughout the body, crosses 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, its daily elimination rate is about 1.7 - 3.6 mg with a replenishment rate of 2.2 - 2.4%.After intramuscular injection, pyridoxine is rapidly absorbed into the bloodstream and distributed in the body, acting as a coenzyme after phosphorylation of the CH2OH group in the 5th position. About 80% of the vitamin binds to blood plasma proteins. Pyridoxine is distributed throughout the body, crosses 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, its daily elimination rate is about 1.7 - 3.6 mg with a replenishment rate of 2.2 - 2.4%.After intramuscular injection, pyridoxine is rapidly absorbed into the bloodstream and distributed in the body, acting as a coenzyme after phosphorylation of the CH2OH group in the 5th position. About 80% of the vitamin binds to blood plasma proteins. Pyridoxine is distributed throughout the body, crosses 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, its daily elimination rate is about 1.7 - 3.6 mg with a replenishment rate of 2.2 - 2.4%.About 80% of the vitamin binds to blood plasma proteins. Pyridoxine is distributed throughout the body, crosses 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, its daily elimination rate is about 1.7 - 3.6 mg with a replenishment rate of 2.2 - 2.4%.About 80% of the vitamin binds to blood plasma proteins. Pyridoxine is distributed throughout the body, crosses 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, its daily elimination rate is about 1.7 - 3.6 mg with a replenishment rate of 2.2 - 2.4%.7 - 3.6 mg at a replenishment rate of 2.2 - 2.4%.7 - 3.6 mg at 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:

• Neuropathies and polyneuropathy (diabetic, alcoholic and others);

• neuritis and polyneuritis, incl. retrobulbar neuritis;

• peripheral paresis, incl. facial nerve;

• neuralgia, incl. trigeminal nerve and intercostal nerves;

• pain syndrome (radicular, myalgia);

• nocturnal muscle cramps, especially in older age groups;

• plexopathies, ganglionitis (including herpes zoster);

• neurological manifestations of spinal osteochondrosis (radiculopathy, lumboishalgia, muscle-tonic syndromes);

Contraindications

• Hypersensitivity to any component of the drug;

• severe and acute forms of decompensated chronic heart failure;

• childhood (due to lack of research).

Application during pregnancy and lactation
It is not recommended to use.

Dosage and administration
In case of severe pain syndrome, it is advisable to start treatment with intramuscular (deep) injection of 2 ml of the drug daily for 5-10 days, with the transition in the future either to oral administration, or to more rare injections (2-3 times a week for 2-3 weeks).

Side effect
Allergic reactions. In some cases, there may be increased sweating, tachycardia, acne appears. Skin reactions are described in the form of itching, urticaria. In rare cases, there may be phenomena of hypersensitivity to the drug, for example, rash, shortness of breath, angioedema, anaphylactic shock.

Overdose
Symptoms: in cases of very rapid administration of the drug, systemic reactions (dizziness, arrhythmia, convulsions) may occur, they may also result from an overdose.
Treatment: symptomatic therapy.

Interaction with other medicinal products
Thiamine completely decomposes in solutions containing sulfites.
Thiamine is unstable in alkaline and neutral solutions; appointment with carbonates, citrates, barbiturates, copper preparations is not recommended.
Pyridoxine is not prescribed simultaneously with levodopa, since the effect of the latter is weakened.
Taking into account the presence of lidocaine in the composition of the drug, in the case of additional use of adrenaline and norepinephrine, an increase in side effects on the heart is possible. In case of an overdose of local anesthetics, adrenaline and norepinephrine should not be additionally used.
Vitamin B12 is incompatible with ascorbic acid, heavy metal salts.

Release form
Solution for intramuscular injection.
2 ml in light-protective glass ampoules. 5 ampoules are placed in a blister strip made of polyvinyl chloride film and aluminum foil or without foil. 1 or 2 blister packs together with instructions for use are placed in a cardboard box.

Shelf life is
2 years. Do not use after the expiration date.

Storage conditions
List B. In the dark place at a temperature of 2 to 8 ? C. Keep out of the reach of children.

Terms of dispensing
By prescription.

Manufacturer : CJSC 'PharmFirma' Sotex
Legal address: 115533, Moscow, Andropova Avenue, 22
Production address: 141345, Moscow region, Sergiev Posad district, village Svatkovo, p / o Svatkovo
Consumer claims should be sent to the address of production.