Ingredients (in 1 ampoule)
Active ingredients: 
100 mg thiamine hydrochloride (vitamin B1), 
100 mg pyridoxine hydrochloride (vitamin B6), 
Contains 1 mg of cyanocobalamin (vitamin B12).
Excipients  substances: lidocaine hydrochloride, benzyl alcohol, potassium
hexacyano-ferrate (III), sodium hexametaphosphate, sodium hydroxide 
10% solution, water for injection.

Description
It is a red transparent solution with practically no visible particles.

pharmacological properties
Pharmacodynamics
Group B neurotropic vitamins have a positive effect on inflammatory and degenerative diseases of nerves and movement apparatus. Thiamine is involved in the metabolism of carbohydrates, as well as later thiamine pyrophosphate 
and plays a leading role in the Krebs cycle by participating in ATF synthesis. Pyridoxine participates in the metabolism of proteins and partly in the metabolism of carbohydrates and fats. The physiological function of both vitamins is to strengthen the effect of each other, which is expressed by a positive effect on the nervous and neuromuscular system. Cyanocobalamin participates in the synthesis of the myelin membrane, reduces the feeling of pain due to the damage of the peripheral nervous system, stimulates nucleic exchange by activating folic acid. Lidocaine is a local anesthetic agent that produces all types of local anesthesia - terminal, infiltration, penetrating anesthesia.
Pharmacokinetics
After intramuscular injection, thiamine is rapidly absorbed from the injection site and enters the blood (484 ng/ml 15 minutes after 50 mg dose on the first day) and is unevenly distributed in the body, including -15% in leukocytes, 75% in erythrocytes, and 10% in plasma. . As the vitamin does not have significant reserves in the body, it must enter the body every day. Thiamine crosses the hematoencephalic and placental barriers and passes into breast milk. Thiamine is excreted in the urine after 0.15 hours in the alpha phase, 1 hour in the beta phase, and 2 days in the terminal phase. The main metabolites are thiamine carbonic acid, pyramine and some unknown metabolites. Of all vitamins, only thiamine is stored in the least amount in the body. The body of an adult contains up to 30 mg of thiamine in the form of thiamine pyrophosphate (80%), thiamine triphosphate (10%) and the rest in the form of thiamine monophosphate. 
During intramuscular injection, pyridoxine is quickly absorbed into the bloodstream and after phosphorylation of the CH2OH group in the 5th position, it is distributed in the body, performing the role of a coenzyme. About 80% of the vitamin is associated with blood plasma proteins.  Pyridoxine is distributed throughout the body, passes through the placenta and passes into breast milk, is stored in the liver and is oxidized to 4-pyridoxine acid, which is excreted in the urine no later than 2-5 hours after absorption. 40-150 mg in the human body. There is vitamin B6, and its daily elimination rate is 1.7-3.6 mg, with a recovery rate of 2.2-2.4%.

Instructions for use
Neurological disorders caused by deficiency of vitamins B1, B6 and B12, which do not disappear with nutritional correction.

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Contraindications
Increased sensitivity to vitamins B1, B6, B12. 
Increased sensitivity to local anesthetics with an amide structure.
Increased sensitivity to the substances contained in the preparation, as well as to other amide-type local painkillers; the presence of epileptiform seizures due to injection of lidocaine hydrochloride in the anamnesis; II and III degree AV block, sinus node weakness syndrome, Wolff-Parkinson-White syndrome, Adams-Stokes syndrome, severe forms of heart failure (II-III degree), pronounced arterial hypotension, bradycardia, cardiogenic shock, complete transverse heart block ; myasthenia; hypovolemia; porphyria, severe kidney and/or liver failure, pregnancy, breastfeeding, patients under 12 years of age.
Malignant tumors.

Special instructions and precautions
Use in patients with psoriasis should be justified, as vitamin B12 may aggravate skin symptoms.
During long-term (more than 5 months) treatment, if the dosage limit of vitamin B6 is exceeded (500 mg per day), sensory neuropathy may develop. In rare cases, anaphylactic shock may occur during repeated use of the drug containing vitamin B1.
 

Auxiliary substances
Patients with heart and liver failure are recommended to use with caution, as the drug contains lidocaine.
The drug is contraindicated for newborns, especially premature   children, as the drug contains benzyl alcohol.
Before using lidocaine, a skin test must be performed to determine individual sensitivity to the drug, edema and redness at the injection site indicate the presence of sensitivity. When injecting into vascularized tissues, it is recommended to perform an aspiration test and to inject with caution to prevent the transfer of lidocaine into the bloodstream. It is recommended to prescribe barbiturates before administering high doses of lidocaine hydrochloride.
When treating the injection site with disinfectant solutions containing heavy metals, the risk of developing a local reaction in the form of pain and edema increases.
When using lidocaine, there should be ECG control.  In case of violation of the activity of the sonus node, prolongation of the PQ interval, QRS widening or the development of a new arrhythmia, it is necessary to reduce the dose or stop using the drug. 
It is used with caution and in low doses for weakened patients with heart failure, arterial hypertension, incomplete atrioventicular blockade, intraventricular conduction disorders, liver and kidney dysfunction, epilepsy, heart surgery patients, genetic predisposition to hyperthermia.
Elderly patients, as well as patients with a history of arrhythmia, should use with caution. 
It is necessary to stop using MAO inhibitors ten days before starting therapy. 

Use during pregnancy and lactation
Use of the drug during pregnancy is contraindicated. If the use of the drug is necessary, breastfeeding should be stopped.

Method of use and dosage
In severe cases and during acute pain, one injection (2 ml) is injected deep into the muscle to rapidly increase the level of the drug in the blood. 
After the acute stage has passed and in milder forms of the disease, 1 injection is given 2-3 times a week. Intravenous administration is contraindicated. 

 

Side effects
Depending on the frequency of occurrence of the additional effect, it is classified as follows:
Rarely: hypersensitivity reaction, especially after repeated intramuscular injection (skin rash, urticaria, bronchospasm, anaphylactic shock). These hypersensitivity reactions have been reported after repeated administration of parenteral preparations containing vitamin B1, vitamin B12 or lidocaine.
To the nervous system
Rarely: paresthesia, peripheral sensory neuropathy when using high doses of vitamin B6 (500 mg per day).
To the cardiovascular system
Rarely: transient hypotension
To the skin
Rarely: dizziness
Systemic   reactions are usually associated with accidental injection into a vein, highly perfused tissues, and overdose. These reactions include dizziness, vomiting, bradycardia, arrhythmias, and seizures.
Adverse reactions associated with the injection of lidocaine
To the central and peripheral nervous system: dizziness, headache, weakness, movement disorder, euphoria, nystagmus, loss of consciousness, drowsiness, sleep disturbance, tremor, trismus, convulsions (the risk of their development increases during hypercapnia and acidosis), paresthesia, paralysis of respiratory muscles, movement blockade, insensitivity, respiratory paralysis (often develops during subarachnoid anesthesia), numbness of the tongue and lips (when used in dentistry).
To the cardiovascular system: when using high doses - lowering of AT, bradycardia; when used with a vasoconstrictor - tachycardia, slowing of cardiac conduction, transverse heart block, arterial hypertension, peripheral vasodilatation, chest pain, arrhythmia, heart block, cardiac arrest.
To the respiratory organs: shortness of breath, cessation of breathing, shortness of breath.
Gastrointestinal tract: nausea, vomiting.
Allergic reactions: skin rash, urticaria, skin itching, angioneurotic edema, generalized exfoliative dermatitis, anaphylactic reactions, conjunctivitis, rhinitis.
Local reactions: slight burning sensation with development of anesthetic effect.
Other: hypothermia, fever, feeling cold or numbness of the limbs. When using high doses - ringing in the ears, awakening.

 

Overdose
In case of overdose, systemic reactions may occur. Adverse reactions such as dizziness, bradycardia, vomiting or shock may occur. Peripheral sensory neuropathy may occur during long-term (more than 5 months) use of vitamin B6 in high doses (600 mg per day).
Treatment is symptomatic and supportive. There is no specific antidote.
Lidocaine overdose
The main symptoms related to the weakening of the nervous system and cardiovascular system: general weakness, dizziness, disorientation, tonic-clonic convulsions, coma, tremor, visual impairment, atrioventicular blockade, asphyxia, nausea, vomiting, euphoria, psychomotor awakening, asthenia. , apnea, bradycardia, drop in arterial pressure, collapse. In healthy people, the first symptoms of overdose  lidocaine hydrochloride occur when the blood accumulates at 0.006 mg/kg, and convulsions occur at 0.01 mg/kg.
Treatment: stopping the use of the drug, oxygen therapy, vasoconstrictors (noradrenaline, mezaton), cholinolytics. The patient should be in a horizontal position; fresh air should be given, oxygen and/or artificial respiration should be given. Symptoms of the central nervous system are corrected by the short-term effects of benzodiazepines or barbiturates. Atropine (0.5-1.0 mg.) to correct bradycardia and conduction disturbances, during arterial hypotension - sympathomimetics are used in combination with beta-adrenoceptor agonists. When the heart stops, resuscitation measures should be taken immediately.
Lungs should be intubated and artificially ventilated. Dialysis is ineffective in the acute phase of lodocaine overdose. There is no specific antidote.

 

Release form
2 ml of solution for intramuscular administration in a dark colored glass ampoule with a break circle.  
10 ampoules in blister packaging. 
2 blisters containing 5 ampoules are packed in a cardboard box with an insert. 

 

Storage conditions: Store below 250C and out of the reach of children.
Shelf life: 2 years.
 

Manufacturer: Republic of Belarus