SERTOGAMMA

 

TRADE NAME

Sertogamma

 

INTERNATIONAL NONPROPRIETARY NAME

-

 

PHARMACEUTICAL FORM

Solution for injections.

Description: Dark red clear solution.

 

COMPOSITION

1 ampoule of the drug contains

Active ingredients:

thiamine hydrochloride (vitamin B₁)                        100 mg

pyridoxine hydrochloride (vitamin B₆)                     100 mg

cyanocobalamin (vitamin B₁₂)                                       1 mg

lidocaine hydrochloride                                               20 mg

Excipients: benzyl alcohol, potassium hexacyanoferrate (III), sodium hexametaphosphate, sodium hydroxide, water for injections.

 

ATC CODE A11DB

 

PHARMACOTHERAPEUTIC GROUP

Vitamin B₁ in combination with vitamins B₆ and B₁₂.

 

PHARMACOLOGICAL PROPERTIES

PHARMACODYNAMICS

Sertogamma is a combined drug of B group vitamins.

Neurotropic vitamins of the B group have a favorable action in case of inflammatory and degenerative nerve and motor apparatus diseases; in high doses they have an analgesic action favoring to the strengthening of blood flow and normalize the work of nervous system and the process of hematopoiesis.

Thiamine hydrochloride (vitamin B₁) is an active substance. In the body in the result of the phosphorylation processes it turns into cocarboxylase that is a coenzyme of many enzyme reactions. It plays an important role in the metabolism of carbohydrates, proteins and fats, as well as in the processes of conduction of nerve excitation in the synapsis. It protects the membranes from toxic influence on the peroxidation products.

Pyridoxine hydrochloride (vitamin B₆) in phosphorylated form is a component of enzymes participating in the processes of decarboxylation and transamination of amino acids, lipid exchange. It is necessary for normal functioning of peripheral nervous system and central nervous system (CNS).

Physiological function of both vitamins is the potentiation of actions of each other that is evident in the positive influence on the neuromuscular system and cardiovascular systems. In case of the deficiency of vitamin В₆ the widespread conditions of the deficiency are rapidly arrested after the injection of these vitamins.

Cyanocobalamin (vitamin B₁₂) is necessary for the processes of cellular metabolism. It influences on the function of hematopoiesis (external antianemic factor), participates in the formation of choline, methionine, creatinine, nucleic acids, has an analgetic action.

Lidocaine actes as a local anaesthetic agent.

PHARMACOKINETICS

After the parenteral injection thiamine hydrochloride is rapidly absorbed from the site of injection and distributed in the body. The blood concentration is relatively low, herewith predominantly free thiamine circulates in the plasma, and its phosphorous esters - in erythrocytes and leukocytes. Phosphorylation occurs in the liver. The most active phosphorous ester is thiamine phosphate, having the coenzyme activity. Approximately 1 mg of vitamin B₁ is metabolized daily. Metabolites are excreted in urine. Biological half-life is 0.35 hour. The accumulation of thiamine hydrochloride in the body doesn’t occur due to the slight dissolution in the lipids. It penetrates through the hematoencephalic barrier (HEB) and placental barrier, and it penetrates into the breast milk.

Vitamin В₆ is phosphorylated and oxidized into pyridoxal-5-phosphate. In the blood plasma В pyridoxal-5-phosphate and pyridoxal are bounded to albumin. To pass through the cell membrane pyridoxal-5-phosphate bounded to albumin is hydrolised by alkaline phosphatase into pyridoxal. About 80% of vitamin is bound to blood plasma proteins. Pyridoxine hydrochloride is distributed throughout the body, penetrates through the placenta and into the breast milk. 40-150 mg of vitamin В₆ is in the body; its daily elimination rate is about 1.7-3.6 mg at the replenishment rate of 2.2-2.4%. It is deposited in the liver and oxidized to 4-pyridoxic acid that is eliminated in the urine in 2-5 hours after the absorption.  

After the parenteral injection vitamin В₁₂ forms the transport protein complexes that are quickly absorbed by the liver, bone marrow and other organs. Vitamin B₁₂ enters the bile and participates in the enterohepatic cycle, penetrates through the placental barrier.

 

THERAPEUTIC INDICATIONS

As pathogenic and symptomatic agent in the complex therapy of nervous system diseases and syndromes of different genesis:

- polyneuropathy (including diabetic and alcoholic and others);

- neurite and polyneurite, including retrobulbar neurite;

- peripheral paresis, including those of facial nerve;

- neuralgia, including those of  trigeminal nerve and intercostal nerves;

- pain syndrome (radicular, myalgia, herpes zoster);

- systemic neurological conditions conditioned by the proved deficiency of vitamins B₁ and B₆, as well as B₁₂.

 

DOSE AND ROUTE OF ADMINISTRATION

The drug is indicated for deep intramuscular injection.

In severe cases and in case of acute pains: 2 ml 1 time per day; after the arresting of exacerbation, as well as in mild forms of disease: 2 ml 2-3 times per week.

The duration of the treatment is established depending on the severity disease.

 

CONTRAINDICATIONS

- increased individual sensitivity to the components of the drug;

- decompensated heart failure.

 

SIDE EFFECTS

In single cases: hyperhidrosis, acne, skin reactions (nettle rash). Rare: the development of hypersensitivity reactions (skin rash, respiratory disturbance, anaphylactic shock, Quincke's edema).

 

INFLUENCE ON THE ABILITY TO DRIVE AND USE MACHINES

There are not any cautions relative to the administration of the drug for the drivers and persons working with potentially dangerous mechanisms.

ADMINISTRATION DURING PREGNANCY AND LACTATION

The drug is not recommended to administer during pregnancy.

If there is a necessity to administer the drug during lactation, it is necessary to cease the breastfeeding.

 

CHILDREN

There is no enough data on the drug safety in children and adolescences.

The drug is prohibited to prescribe to infants and especially premature infants due to the fact that the drug contains benzyl alcohol.

 

INTERACTION WITH OTHER DRUGS

Thiamine hydrochloride is completely disintegrated in the solutions containing sulfites. Other vitamins are inactivated in the presence of the degradation products of the vitamin B₁. Vitamin B₆ lowers the therapeutic efficacy of levodopa. It is possible the drug interaction with cycloserine, D-penicillamine, adrenaline, noradrenaline, sulfonamides.

 

OVERDOSE

It is evident by the strengthening of the adverse drug reaction symptoms.

Treatment: Carry out the symptomatic therapy.

 

PACKAGING

Solution for injections.

5 amber glass ampoules of 2 ml in a contour cellular packaging.

1 contour cellular packaging together with a leaflet in a carton box.

 

STORAGE CONDITIONS 

Store in a place protected from light at a temperature not exceeding 25°С.

Keep out of reach of children!

 

SHELF LIFE

3 years from the date of manufacture.

Don’t use after the expiration date.

 

SALES TERM

Sold under prescription.

 

MANUFACTURER

The holder of trade mark and Marketing Authorization is

“DR SERTUS İLAÇ SANAYİ VE TİCARET LİMİTED ŞİRKETİ”, TURKEY.

Manufactured by

“Mefar İlaç Sanayii A.Ş.”, Ramazanoğlu Mah. Ensar Cad. No: 20, 34906 Kurtköy-Pendik / İstanbul, Turkey.