Instructions Tambro solution for injection ampoules 2 ml No. 5
Composition
active ingredients: thiamine hydrochloride, pyridoxine hydrochloride, cyanocobalamin;
1 ml of solution contains thiamine hydrochloride 50 mg, pyridoxine hydrochloride 50 mg, cyanocobalamin 0.5 mg;
Excipients: lidocaine hydrochloride, benzyl alcohol, potassium hexacyanoferrate III, sodium hexametaphosphate, sodium hydroxide, water for injection.
Dosage form
Solution for injection.
Main physicochemical properties: transparent red solution.
Pharmacotherapeutic group
Vitamin B1 preparations in combination with vitamins B6 and/or vitamin B12. ATX code A11D B.
Pharmacological properties
Pharmacodynamics.
Neurotropic B vitamins have a beneficial effect on inflammatory and degenerative diseases of the nerves and musculoskeletal system. They are used to eliminate deficiency states, and in large doses they have analgesic properties, help improve blood circulation, and normalize the functioning of the nervous system and the process of hematopoiesis.
Vitamin B1 is a very important active substance. In the body, vitamin B1 is phosphorylated to form biologically active thiamine diphosphate (cocarboxylase) and thiamine triphosphate (TTP).
Thiamine diphosphate as a coenzyme participates in important functions of carbohydrate metabolism, which are of crucial importance in the metabolic processes of nervous tissue, affecting the conduction of nerve impulses in synapses. With a deficiency of vitamin B1 in tissues, metabolites accumulate, primarily lactic and pyruvic acid, which leads to various pathological conditions and disorders of the nervous system.
Vitamin B6 in its phosphorylated form (pyridoxal-5'-phosphate (PALP)) is a coenzyme for a number of enzymes that interact in the general non-oxidative metabolism of amino acids. Through decarboxylation, they are involved in the formation of physiologically active amines (adrenaline, histamine, serotonin, dopamine, tyramine), through transamination - in anabolic and catabolic metabolic processes (for example, glutamate oxaloacetate transaminase, glutamatepyruvate transaminase, γ-aminobutyric acid, a-ketoglutarate transaminase), as well as in various processes of amino acid breakdown and synthesis. Vitamin B6 acts at 4 different sites of tryptophan metabolism. Within the framework of hemoglobin synthesis, vitamin B6 catalyzes the formation of a-amino-b-ketoadenic acid.
Vitamin B12 is necessary for cellular metabolic processes. It affects the function of hematopoiesis (extrinsic anti-anemic factor), participates in the formation of choline, methionine, creatinine, nucleic acids, and has an analgesic effect.
Pharmacokinetics.
After parenteral administration, thiamine is distributed in the body. Approximately 1 mg of thiamine is broken down daily. Metabolites are excreted in the urine. Dephosphorylation occurs in the kidneys. The biological half-life of thiamine is 0.35 hours. Thiamine does not accumulate in the body due to its limited solubility in fats.
Vitamin B6 is phosphorylated and oxidized to pyridoxal-5-phosphate. In blood plasma, pyridoxal-5-phosphate and pyridoxal are bound to albumin. The form that is transported is pyridoxal. To pass through the cell membrane, pyridoxal-5-phosphate bound to albumin is hydrolyzed by alkaline phosphatase to pyridoxal.
Vitamin B12 after parenteral administration forms transport protein complexes that are rapidly absorbed by the liver, bone marrow and other proliferative organs. Vitamin B12 enters the bile and participates in the enterohepatic circulation. Vitamin B12 crosses the placenta.
Indication
Systemic neurological diseases caused by established deficiencies of vitamins B1, B6 and B12, if they cannot be corrected by dietary nutrition.
Contraindication
Hypersensitivity to the components of the drug; acute cardiac conduction disorders; acute form of decompensated heart failure.
Vitamin B1 is contraindicated in allergic reactions.
Vitamin B6 is contraindicated for use in cases of gastric and duodenal ulcers in the acute stage (since increased acidity of gastric juice is possible).
Vitamin B12 is contraindicated for use in erythremia, erythrocytosis, and thromboembolism.
Lidocaine. Increased individual sensitivity to lidocaine or other amide local anesthetics, history of epileptiform seizures to lidocaine, severe bradycardia, severe arterial hypotension, cardiogenic shock, severe forms of chronic heart failure (II-III degree), sick sinus syndrome, Wolff-Parkinson-White syndrome, Adams-Stokes syndrome, atrioventricular (AV) block II and III degree, hypovolemia, severe liver/kidney dysfunction, porphyria, myasthenia gravis.
Pregnancy and breastfeeding.
Interaction with other medicinal products and other types of interactions
When lidocaine is administered parenterally, cardiac side effects may be enhanced by the use of adrenaline or noradrenaline. Other interactions exist with sulfonamides.
In case of overdose of local anesthetics, adrenaline and noradrenaline should not be used.
Application features
Tambro contains lidocaine hydrochloride, and therefore the drug should be administered only intramuscularly. Intravenous administration into the circulatory system is not allowed. In case of accidental intravenous injection, depending on the severity of the symptoms that have arisen, medical supervision or observation in a stationary environment is necessary. Long-term use of the drug, more than 6 months, may lead to reversible peripheral sensory neuropathy.
Tambro contains benzyl alcohol. Do not use in premature babies and newborns. May cause toxic and allergic reactions in infants and children under 3 years of age.
Due to the risk of accumulation and toxicity (metabolic acidosis), large amounts of benzyl alcohol should only be used with caution and only when absolutely necessary, especially in patients with impaired liver or kidney function, as well as in pregnant and breastfeeding women.
This medicinal product may contain less than 1 mmol (23 mg) sodium/dose, i.e. essentially sodium-free.
This medicinal product also contains less than 1 mmol (39 mg)/dose of potassium, i.e. it is essentially potassium-free.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect the ability to drive or operate complex mechanisms.
Use during pregnancy or breastfeeding
During pregnancy, the recommended daily allowance of vitamin B1 is 1.2 mg in the 2nd trimester and 1.3 mg in the 3rd trimester, and of vitamin B6 – 1.9 mg from the 4th month of pregnancy. During pregnancy, the drug can be used only if the patient has a confirmed deficiency of vitamins B1 and B6, since the safety of dosages exceeding the recommended daily dose has not yet been established.
During breastfeeding, the recommended daily intake of vitamin B1 is 1.3 mg and vitamin B6 is 1.9 mg.
Vitamins B1, B6 and B12 pass into breast milk. High doses of vitamin B6 may reduce milk supply.
The drug contains 100 mg of vitamin B6 per ampoule, so it should not be used during pregnancy or breastfeeding.
The use of this drug during pregnancy and breastfeeding should be decided only after a benefit/risk assessment by a doctor.
Children.
Not used to treat children.
Method of administration and doses
Dosage
In case of severe and acute pain, to achieve a rapid increase in the level of the drug in the blood, one injection (2 ml) is initially used once a day. After the acute stage is over and in mild diseases, 1 injection is used 2–3 times a week.
Weekly medical monitoring is recommended during therapy.
One should strive for the earliest possible transition to oral therapy.
Method of application
Injections are given deep into the muscles (intramuscularly).
Warning to prevent accidental intravenous injection
Only intramuscular administration of Tambro is allowed. Intravenous administration into the circulatory system is not allowed. In case of accidental intravenous injection, medical supervision or observation in a hospital setting is necessary, depending on the severity of the symptoms.
To maintain or continue the therapeutic course of injections or to prevent relapse, oral therapy should be switched.
Overdose
Vitamin B1 has a wide therapeutic range. Very high doses (more than 10 g) exhibit a curare-like effect, inhibiting the conduction of nerve impulses.
Vitamin B6 has very low toxicity.
Excessive use of vitamin B6 in doses exceeding 1 g per day for several months can lead to neurotoxic effects. Neuropathies with ataxia and sensory disorders, cerebral seizures with EEG changes, and in isolated cases hypochromic anemia and seborrheic dermatitis have been described after administration of more than 2 g per day.
Vitamin B12. After parenteral administration (in rare cases after oral administration) of doses exceeding the recommended ones, allergic reactions, eczematous skin disorders and benign acne have been observed.
With prolonged use in high doses, liver enzyme activity disorders, pain in the heart area, and hypercoagulation are possible.
Treatment: therapy is symptomatic.
Lidocaine. Symptoms: psychomotor agitation, dizziness, general weakness, decreased blood pressure, tremor, visual impairment, tonic-clonic convulsions, coma, collapse, possible atrioventricular block, central nervous system depression, respiratory arrest. The first symptoms of overdose in healthy people occur when the concentration of lidocaine in the blood exceeds 0.006 mg/kg, convulsions - at 0.01 mg/kg.
Treatment: discontinuation of the drug, oxygen therapy, anticonvulsants, vasoconstrictors (noradrenaline, mezaton), in case of bradycardia – anticholinergics (0.5–1 mg of atropine). Intubation, artificial ventilation of the lungs, resuscitation measures are possible. Dialysis is not effective.
Side effects
Very common (≥ 1/10).
Common (≥ 1/100 to < 1/10).
Uncommon (≥ 1/1000 to < 1/100).
Rare (≥ 1/10,000 to < 1/1,000).
Very rare (< 1/10,000).
Not known (frequency cannot be estimated from the available data).
On the part of the immune system
Unknown: Benzyl alcohol may cause allergic reactions.
Very rare: hypersensitivity reactions (e.g. rash, dyspnoea, shock, angioedema).
Cardiovascular system
Very rare: tachycardia.
Skin and subcutaneous tissue disorders
Very rare: sweating, acne, skin reactions with itching and urticaria.
General disorders and administration site conditions
Unknown: Systemic reactions are possible due to rapid accumulation (accidental intravenous injection, injection into tissue with high blood supply) or overdose. Dizziness, vomiting, bradycardia, cardiac arrhythmias, convulsions are possible.
Burning at the injection site.
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
2 years.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Incompatibility.
Thiamine is incompatible with oxidizing and reducing compounds: mercuric chloride, iodide, carbonate, acetate, tannic acid, ferric ammonium citrate, as well as with sodium phenobarbital, riboflavin, benzylpenicillin, glucose and metabisulfite, since it is inactivated in their presence. Copper accelerates the decomposition of thiamine; in addition, thiamine loses its effect with increasing pH values (more than 3).
Vitamin B12 is incompatible with oxidizing and reducing compounds and with heavy metal salts.
In solutions containing thiamine, vitamin B12, like other B complex factors, is rapidly destroyed by thiamine breakdown products (low concentrations of iron ions may protect against this). Riboflavin, particularly in combination with light, also has a destructive effect; nicotinamide accelerates photolysis, while antioxidants have an inhibitory effect.
Packaging
2 ml in ampoules; 5 ampoules in a contour blister pack; 1 contour blister pack together with instructions for medical use in a cardboard box.
Vacation category
According to the recipe.
Producer
K.T. Rompharm Company S.R.L.
Location of the manufacturer and its business address.
Eroilor St. No. 1A, Otopeni, 075100, Ilfov County, Romania - Romfarm 1 and Romfarm 2 buildings.
Applicant.
"FORCE-PHARMA DISTRIBUTION" LLC.
Location of the applicant.
Ukraine, 03127, Kyiv, Holosiivskyi Avenue, 132.
