Unfortunately, group B hepatitis is one of the most common viral diseases today. According to WHO, more than forty million people are infected with it every year. And, what is most dangerous, there is no exact treatment regimen for this disease.
However, there is a working vaccination scheme that allows you to form stable immunity to it. One of the most effective drugs used for these purposes is the Combiotech vaccine.
Release form, composition and pharmacological action
The Combiotech vaccine is available in glass ampoules with a capacity of 0.5 and 1 ml and is a transparent liquid suspension with whitish inclusions that dissolve when shaken.
Hepatitis B vaccine Combiotech
It is important to remember that Combiotech requires a special storage method. It must be stored at a temperature of three to ten degrees Celsius, in the complete absence of sunlight. Freezing the drug is strictly prohibited. If the above conditions are violated, the effectiveness of one dose is reduced by half.
Once the vaccine is opened, it must be used within an hour, otherwise it must be destroyed immediately. A vaccine that has been frozen or has changed color is strictly prohibited from being used and must be immediately destroyed. The vaccine must be opened immediately before use.
The composition of the drug includes:
- the main active ingredient is the surface antigen HBsAg in an amount of twenty micrograms/ml;
- aluminum hydroxide, in an amount of 50 mg/ml;
- merthiolate as a preservative, in an amount of 50 μg/ml.
Thanks to the properties of the HBsAg antigen, the vaccine affects the cause of the infection and promotes the destruction of the cell membranes of the hepatovirus.
Recombinant yeast vaccine against hepatitis B
For the prevention of hepatitis B in adults and children. Included in the State Register under No. 94/266/1, 96/144/53/7, included in the National Calendar of Preventive Vaccinations. Reg. beat Ministry of Health and Social Development of the Russian Federation R N 000738/01 dated November 19, 2007 Adult dose—1.0 ml ampoules, N10 Children’s dose—0.5 ml ampoules, N10 Shelf life—4 years.
Hepatitis B recombinant yeast vaccine is a protein sorbed on aluminum hydroxide (HBsAg), synthesized by a recombinant yeast strain and containing antigenic determinants of the surface antigen of the hepatitis B virus. A homogeneous suspension of white color with a grayish tint, without visible foreign inclusions, separating when standing into a colorless transparent liquid and a loose precipitate of white color with a grayish tint, easily breaking when shaken. Instructions for use of the drug...
The development of the first domestic recombinant yeast vaccine against hepatitis B was completed by NPK Combiotech in 1992 and after a full cycle of state tests conducted by GISC named after. L.A. Tarasevich, the vaccine is included in the State Register of Medicines under No. 94/266/1, 96/144/53/7. The recombinant yeast vaccine against hepatitis B “Combiotech” meets the requirements of the World Health Organization in its characteristics and is not inferior, and in a number of indicators it is superior to foreign analogues registered on the Russian market. The industrial strain and technology for producing the vaccine are entirely domestic developments and are protected by patents from Russia, South Africa, Pakistan, Kazakhstan and South Korea. By the decision of GISC named after. L.A. Tarasevich, the NPK Combiotech vaccine against hepatitis B has been approved as an industry standard sample of the immunogenic activity of the recombinant yeast liquid hepatitis B vaccine (OSO 42-28-202-98). The stages of vaccine production undergo strict stage-by-stage control. The quality control procedure ensures the release of a vaccine that meets all the requirements of the National Control Authority and WHO recommendations. All batches of produced vaccines must undergo pre-sales control at the National Control Authority - GIK named after L.A. Tarasevich. State clinical trials of the domestic recombinant vaccine against hepatitis B and numerous post-marketing studies have confirmed the low reactogenicity, specific safety and high immunological effectiveness of the vaccine. The results of studying the immunological activity of the domestic recombinant vaccine against hepatitis B in controlled trials indicate that a higher level of antibodies was achieved when immunized with the domestic vaccine than when immunized with a comparison vaccine. Post-marketing studies conducted over seven years did not reveal significant differences from the herd immunity rates established immediately after vaccination. At the same time, not a single newly registered case of disease or infection with the hepatitis B virus was identified in persons who received a full or rudimentary (double-dose) course of vaccination. A number of works especially emphasize the effectiveness of using a two-dose vaccination regimen with an interval of 4-5 months from the first administration: despite the incompleteness of the immunization course, more than 80% of individuals had a level of specific antibodies in the blood exceeding the protective level. Serious studies conducted under the leadership of Professor V.F. Uchaikin when vaccinating children with severe somatic pathology and oncohematological diseases showed the complete safety of the vaccine and demonstrated the possibility of developing immunity against hepatitis B against the background of cytostatic therapy. These studies provide reason to recommend vaccination against hepatitis B as early as possible after diagnosis.
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What are children and adults vaccinated against?
The Combiotech vaccine is used to activate the production of antibodies to the hepatitis B virus and is considered the main drug against this disease produced by the domestic pharmaceutical industry. This medicine has been tested and recommended by the Ministry of Health for vaccination of adults and children of all ages.
Vaccination is carried out within the framework of the national vaccination calendar, in maternity wards (on the recommendation of a neonatologist) and community clinics (with the consent of the therapist). Vaccination is completely free.
The use of the drug Combiotech is permitted for patients of all age and social groups, however, there are groups of patients whose vaccination is most appropriate, namely:
- persons of any age living in families in which there is a carrier of the virus;
- children raised in orphanages, children's homes and boarding schools;
- patients receiving (one-time or on an ongoing basis) donated blood products;
- patients suffering from blood cancer or regularly undergoing hemodialysis;
- medical workers and employees of diagnostic centers who have constant contact with human biological material;
- workers who, due to their duty of service, are forced to be surrounded by socially disadvantaged citizens (social workers, employees of law enforcement agencies and others);
- persons who have had contact with a person who is a carrier of the disease or has recently recovered from it;
- students of medical universities;
- persons who frequently visit manicure and dental offices, patients undergoing planned operations;
- drug addicts who inject drugs and people who are promiscuous;
- tourists before visiting disadvantaged countries.
Indications
The Combiotech vaccine against hepatitis B is considered the main drug in the domestic pharmaceutical industry that produces medications to eliminate the causative agent of this disease.
This product is produced on the basis of a recombinant strain of bread yeast and is used for routine vaccination in clinics for both adults and children from birth.
The vaccination schedule depends on the characteristics of the human body and the urgency of obtaining a protective reaction. Usually 3 or 4 vaccinations are performed with certain breaks, after which the patient acquires the necessary immunity, which prevents infection for 20 years.
Combiotech vaccine
This service is provided in all clinics of the Russian Federation free of charge.
The main active component of the drug is the surface antigen HBsAg. This substance acts on the cause of the infection and promotes the destruction of the hepadnavirus protein.
The main disadvantage of this drug is the presence of yeast protein in the finished solution for vaccinations, which causes allergic reactions in the body of some patients.
Preventive vaccinations of this drug are used to vaccinate children and citizens belonging to the group of patients with an increased risk of infection.
Vaccinations are carried out for the following categories:
- pupils of boarding schools and orphanages;
- adults and children living with carriers of the infection;
- medical personnel who have access to work with blood;
- persons who regularly require blood transfusions;
- students of medical colleges and higher educational institutions;
- persons who regularly inject drugs.
Instructions for use of the Combiotech vaccine (Combiotex)
If you follow the rules and regimen of vaccination with Combiotech, the immune response reaches ninety-seven percent, and stable resistance to the hepatitis virus lasts for twenty years. After which the vaccination course is repeated.
In medical practice, there are three vaccination schemes:
- standard – involves the introduction of the vaccine according to the scheme: 0 months – 1 month – 6 months – 7 years;
- accelerated – ensures faster formation of immune protection, the vaccine is administered according to the following scheme: 0 days – 1 month – 2 months – 12 months (used with a moderate risk of contact with the causative agent of the virus);
- emergency - vaccination is carried out according to the scheme: 0 days - 7 days - 21 days - 12 months (used if there is a high probability of the child coming into contact with the pathogen and only under strict medical supervision).
Adults under the age of fifty-five receive the vaccine once.
Vaccine "COMBITECH"
The COMBITECH vaccine against hepatitis B was developed in Russia in 1992 and is produced by domestic manufacturers. The vaccine was developed on instructions from the government of the Russian Federation. It is a product of genetic engineering, for its development the company received a diploma, One Hundred Best Inventions of Russia. The hepatitis B vaccine is administered to infants one day after birth. Repeated vaccination is carried out according to the schedule according to the national calendar of preventive vaccinations. After vaccination, it creates an immune response and produces antibodies that begin to fight them. Thus, the vaccinated child receives immunity against this disease.
Contraindications for use
The use of Combiotech is prohibited if even one of the following symptoms is present:
- increased temperature, fever and loss of strength;
- allergy to the active substance used or to any components included in the serum;
- the occurrence of obvious negative reactions after receiving the vaccine (jumps in body temperature, pain, swelling, vomiting and redness at the injection site);
- transition of chronic diseases into the active phase;
- due to the fact that no studies have been conducted on the effect of the Combiotech vaccine on the condition of the fetus during pregnancy or breastfeeding, its use during this period is not recommended;
- if the patient or parents (in the case of vaccination of an infant) are allergic to yeast and baked goods.
Contraindications
The preventive measure should be abandoned if the following contraindications are present:
- Infectious diseases accompanied by high temperature and fever or exacerbation of chronic pathologies - vaccination can be done a month after the symptoms disappear.
- Negative reaction of the body to the previous administration of the drug: pain at the injection site, temperature above 40 C, severe allergic reaction.
- Yeast intolerance.
- Pregnancy and lactation - strictly according to doctor's indications.
In order to promptly identify the presence of contraindications, you should see a therapist/pediatrician on the day of vaccination.
Side effects and complications
The occurrence of complications after using the Combiotech drug is an extremely rare phenomenon, occurring in less than one percent of vaccinated people and often associated with violations committed during the vaccination procedure.
When using the vaccine in accordance with the instructions, the following side effects may occur:
- loss of strength and increased fatigue;
- muscle aches;
- the appearance of compactions at the injection site;
- headache and dizziness;
- indigestion;
- painful sensations in the joints.
The above complications most often appear during the first three days after using the drug and in most cases disappear after a few days.
According to the instructions, medical personnel responsible for vaccination are instructed to monitor the patient for half an hour after administration of the vaccine. This measure is necessary to identify at an early stage the first signs of intolerance to this drug.
Note that in order to relieve the first signs of allergic reactions and prevent the development of anaphylactic shock, vaccination rooms are supplied with antihistamines and anti-shock drugs.
How to use
The Combiotech vaccine is used by vaccination companies and privately. It is important that the injections are done in a certain order; only in this case can the desired result be achieved.
Vaccination is carried out according to three schemes:
- Standard option. In this case, three injections are given. Two months pass between the first and second, and the last takes place six months later. This vaccination option is considered the most effective. The accumulation of antibodies occurs gradually, which does not have a strong effect on the body and contributes to better protection against the hepatitis B virus.
- Quick option. Here you need to make four injections. The first injection is given immediately, the second – after a month, the third – after two months, and the last – with a break of a year. This option is used for those patients who are at high risk of infection.
- Emergency scheme. Used for emergency intervention. Only a week passes between the first and second injection, the third injection is carried out after 21 days, and the last one after a year.
If there is no need to rush, then it is better to choose the first option. This is what is used for general vaccination. In this case, protection against the virus lasts twenty years.
Reviews from medical workers and patients about the Combiotech vaccine are positive. But even here there were some difficulties, including a number of side effects. Patients, but not all, experience headaches, fever, increased sweating and pain in the muscles and intestines. To minimize the risk of side effects, it is necessary to undergo examination before vaccination. If the patient is completely healthy, unwanted manifestations will not bother you.
Price and analogues
The price of the hepatitis B vaccine from Combiotech ranges from eight hundred eighty rubles to one thousand five hundred rubles.
Hepatitis B vaccine “Engerix B”
If for some reason the use of the Combiotech vaccine is impossible, there are several analogue drugs, namely: Engerix, recombined live - Regevak, Biovac-V, Bubo-M others.
Regevak or Combiotech: which is better for hepatitis?
The drug Regevak is an analogue of the Combiotech vaccine with an absolutely similar composition, indications for use, contraindications, side effects and patterns of use.
Vaccine “Regevac B”
However, these drugs belong to different price categories. The average price for a package of Combiotech products is approximately one thousand to one thousand two hundred rubles, and the price of a package of Regevak is from one and a half thousand to two.
Considering that the composition of the drugs is absolutely the same, it makes sense to use the drug Combiotech.
Compound
The drug Combiotech was developed in laboratories of the domestic pharmaceutical industry. This medicine contains the following components:
- surface antigen HBsAg, which is the main active substance of the vaccine - 20 μg/ml;
- aluminum hydroxide – 50 mg/ml;
- preservative merthiolate – 50 mcg/ml.
This medication is produced at a single dosage for a child - 0.5 ml and for an adult - 1 ml. Patients undergoing hemodialysis to cleanse the liver of toxic substances receive a double dose of the vaccine.
