Instructions for use and information on the medication packaging

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17.06.2015

Each drug undergoes a series of laboratory and clinical tests, the purpose of which is to show its effectiveness and safety, as well as to identify possible undesirable effects. We tell you what the difference is between prescription and over-the-counter drugs, what you need to know about the instructions for use, and why drugs with the same active ingredient may have different names and prices.

Prescription and over-the-counter medications

Medicines are divided into prescription drugs and drugs approved for sale without a doctor's prescription. As a rule, prescription drugs include potent drugs, medications that require strict monitoring by the attending physician. Over-the-counter medications, such as those to relieve headaches or fever or cold symptoms, can be purchased at a pharmacy and used for self-medication without requiring a prescription. Nevertheless, it is important to carefully read the instructions before use; some of its points are especially important for the patient.

Vaccine manufacturers

Today, production of Sputnik V in Russia takes place at 9 industrial sites - this guarantees uninterrupted supplies of the drug to the population of the Russian Federation. In addition, the Russian vaccine is also produced in many foreign countries:

Kazakhstan;
Republic of Korea;
Brazil;
Belarus;
Argentina;
India;
Serbia;
Iran;
Italy;
Armenia;
Mexico;
Vietnam;
Uzbekistan.

Vaccine producers in Brazil not only cover the needs of the domestic market, but also send the drug to other Latin American countries.

Regardless of where the Sputnik V vaccine is produced, the drug has the same composition and effectiveness.

How to read the instructions

Each medicine comes with instructions in Russian; at first glance it may seem that the information in it is intended for specialists, but this is only partly true. The instructions consist of several sections and are intended for use by both the doctor and the patient.

First, you need to check that the name of the drug on the package matches the name in the instructions. Then move on to sections that are especially important to the patient.

Indications for use

Your disease or condition must be among those listed in this section. Otherwise, you should ask your doctor why you need this particular medicine.

Contraindications

All conditions are presented here: allergies, intolerances, concomitant diseases in which taking the drug is impossible or requires special caution or use under the supervision of a doctor.

Use during pregnancy and breastfeeding

Pregnant women and nursing mothers may need to take medications. However, some medications are prohibited for use during pregnancy; the use of others may require a temporary transition to artificial feeding. The active ingredients of certain drugs, along with nicotine and ethyl alcohol, which is contained in alcoholic beverages, can penetrate the hematoplacental barrier that separates the organisms of mother and child. Therefore, it is important to remember that even over-the-counter medications and dietary supplements cannot be taken without consulting your doctor or gynecologist. The doctor will help you choose the safest medicine that will not affect the child’s health and give recommendations on feeding.

Directions for use and doses

Read this section carefully to understand exactly how to use a particular medicine - internally or externally, after meals or on an empty stomach, chew or swallow whole. Check to see if your dose exceeds the daily dose, and if so, be sure to consult your doctor.

Side effect

Do not be alarmed by information about side effects, much less decide on your own to reduce the dose or discontinue the medication. The safety of each medicine is carefully checked. The instructions list all the adverse events that occurred while taking this drug, even if the side effect occurred in one patient out of a million. This does not mean that you will have a similar reaction, but you should still study the list in order to consult a doctor in time if adverse events occur. To reduce the risk of their occurrence, follow the instructions for use and follow the doctor’s recommendations.

Storage conditions

Medicines, like food, tend to spoil. If stored incorrectly, the effectiveness of the drug can be significantly reduced, and its use can cause more harm than good. The rules for storing the medicine are indicated in the instructions and on the packaging.

Combination of several drugs

If the doctor prescribes several medications, they are taken separately. Because the:

their combined use puts a greater burden on the liver and gastrointestinal tract;
under the influence of the individual environment of the stomach, several medications taken simultaneously can cause the formation of toxic agents in the stomach;
Several medications taken at the same time can affect each other, resulting in changes in their effect on the body.

Taking medications should be spaced out so that the interval between doses is at least 15-30 minutes.

What does the packaging say?

On the packaging you will find the most important information about the medicine.

Trade and international name of the drug.
The trade, brand name is printed in large letters, the international name - the name of the active substance, the active ingredient - in a smaller font. Drugs with the same international name may be sold under different brand names, and the price will vary.
Amount of active substance.
For example, 1 ml of Omnitus syrup contains 0.8 mg butamirate citrate.
Method of administration
. For example: “For oral administration.”
Quantity and dosage form.
For example: 20 tablets.
Expiration date, storage conditions.
For example: 5 years. Do not use after the expiration date stated on the package.
Series number and name of the manufacturing company

Differences between Sputnik V and other vector vaccines

Vector vaccines are a separate class of drugs for creating immune protection. In their production, viruses that are relatively safe for humans, incapable of replication, are used, which “deliver” one or more protein genes of the infectious agent into the body.

Vector vaccines are highly effective and safe, including in the long term. This has been confirmed by the results of over 250 clinical studies conducted over the past 20 years.⁴

Sputnik V was created on the platform of adenoviruses, the causative agents of common colds in humans. The properties of these viruses are well known, so the body's reactions to their introduction are predictable.

Development of the Institute named after. N. F. Gamaleya differs from other vector vaccines in the method of production - it is based on the principle of heterogeneous boosting. At each of the two stages, people are injected with different vectors. This vaccination option determines a more pronounced immune response and reliable protection against infectious diseases.

The work of biologists at the 48th Central Research Institute of the Russian Ministry of Defense during testing of a vaccine against COVID-19. Photo: Russian Ministry of Defense / YouTube

Operating principle

The adenoviral vector in the vaccine is a “vehicle” that delivers the genetic material of SARS-CoV-2 into the cells of the human body. As a result, they begin to produce the coronavirus S protein - this structure is part of the virus shell and forms its characteristic “spikes”.

If a person who has received the vaccine later encounters coronavirus, the antibodies produced will “recognize” the already familiar S-protein and begin to “attack” it, and then T-lymphocytes will destroy the cells infected with it. Thanks to this, the disease will either not develop at all or will be mild.

After the introduction of the first component, the immune system begins to produce antibodies not only to the S-protein, but also to the “vector”, to the adenovirus proteins. Therefore, for repeated administration of the drug, the original adenoviral component cannot be used - otherwise it can be destroyed by antibodies before it is introduced into the cells. To prevent such developments, they decided to use two different serological types of adenovirus.

After the introduction of the second component of the Sputnik V drug, a larger number of immune memory B cells are formed - they “remember” the causative agent of the disease and give the body long-term immunity. Thus, the first dose of vaccination helps the immune system “get acquainted” with the virus, and the second dose “trains” it to actively defend itself.

Figure 2. The principle of action of a two-vector vaccine. Image: Center named after. N. F. Gamaleyi / RDIF

A full-fledged immune response is formed on the 42nd day from the start of vaccination or 21 days after the administration of the second component of the drug.

To determine post-vaccination immunity, you can do an ELISA test for antibodies to coronavirus S-proteins. But you should carefully approach the analysis and not confuse the research methods. There are test systems that are designed to detect antibodies to the N-protein of coronavirus. They allow us to identify post-infectious immunity - a response that has formed after an illness. In people after vaccination, this indicator is usually negative, but this does not mean a lack of immunity to coronavirus. This difference in test systems must be taken into account when taking the test.¹

What happens in the body after vaccination?

“The principle of action of the Sputnik V vector vaccine is very simple - it imitates infection, forces the cell itself to produce the coronavirus spike protein, so both components of immunity are activated - both humoral and cellular.
After entering the cell, the adenovirus loses its shell, its DNA goes into the cell nucleus, but is not integrated anywhere, but uses the cell factory to produce spike protein in the cytoplasm. It is partially embedded in the cell membrane, secreted into the intercellular fluid, partially destroyed and presented on its surface as a histocompatibility complex. Neither the adenoviral vector nor the spike protein itself leaves the injection site and practically does not enter the bloodstream.

The secreted spike protein is picked up in the intercellular space by dendritic cells and macrophages. They present its epitopes to B and T lymphocytes. B cells themselves can bind the antigen and absorb it, and then present it on the surface. Helper T cells recognize such B lymphocytes, bind to them, and activate their clonal propagation and differentiation. This results in the formation of plasma cells that produce antibodies and memory B cells. A distinctive feature of vector vaccines is the activation of cellular immunity and the formation of memory T cells, both helpers and killers. This sets vector vaccines apart from inactivated ones, where the T-cell response develops much weaker.

Depending on the degree of activation of the immune system, many or few antibodies and memory cells are formed. When encountering an antigen, memory cells are able to quickly activate, multiply and give a strong response - this is the basis for the effect of boost, or strengthening of the immune response upon repeated encounter with the antigen. Therefore, people who have recovered from the disease and already have memory cells develop a stronger response after vaccination than those who have not been ill. The vaccination isolates and strengthens their protective component from their already existing immunity to Covid.”

Dudnakova Tatyana Valerievna

expert

Research Fellow at the University of Edinburgh, UK

Side effects of the Sputnik V vaccine

During clinical trials, it was revealed that side effects after vaccination with Sputnik V are usually mild or moderate in severity. They may occur in the first 48 hours after vaccination, but resolve on their own within the next 72 hours.

Among the side effects from the administration of the drug, the development of a short-lived flu-like syndrome with symptoms is most often observed:

general malaise;
headache and muscle pain;
“ache” in the joints;
increase in body temperature.

This syndrome does not require treatment and does not pose a danger to humans. To improve your well-being, when your body temperature rises to 38.0 °C or higher, you should take an antipyretic drug, for example, paracetamol.

After vaccination, a local reaction may also develop. It is manifested by pain, swelling and redness of the tissue at the injection site. To eliminate these symptoms, taking antihistamines—drugs with antiallergic effects—is indicated.

Rare side effects that may occur after administration of Gam-Covid-Vac include:

decreased appetite;
nausea;
swollen lymph nodes;
the appearance of red blood cells in the urine.

No serious side effects were observed after administration of the Sputnik V vaccine during clinical trials.

Sources

Sputnik V. Wikipedia
Instructions for medical use of the drug Gam-Covid-Vac, a combined vector vaccine for the prevention of coronavirus infection caused by the SARS-CoV-2 virus. Ministry of Health of the Russian Federation.
Official information about coronavirus in Russia. FAQ.
Sputnik V. Official website.
COVID-19 pandemic. Wikipedia
Temporary guidelines “Procedure for vaccinating the adult population against COVID-19.” https://minzdrav.gov.ru/news/2021/07/02/16927-utverzhdeny-vremennye-metodicheskie-rekomendatsii-poryadok-provedeniya-vaktsinatsii-vzroslogo-naseleniya-protiv-covid-19
Gushchin VA, Dolzhikova IV, Shchetinin AM, Odintsova AS, Gintsburg AL. Neutralizing Activity of Sera from Sputnik V-Vaccinated People against Variants of Concern (VOC: B.1.1.7, B.1.351, P.1, B.1.617.2, B.1.617.3) and Moscow Endemic SARS-CoV- 2 Variants.Vaccines. 2021; 9(7):779. https://doi.org/10.3390/vaccines9070779

What not to do after vaccination

Within 2-3 days after vaccination, it is important to give the body the opportunity to rest - eliminate high loads and not expose it to stressful situations. This will create optimal conditions for a full immune response, and the effect of the vaccination will be maximum. It is not recommended for 3 days after the vaccine:

drink alcoholic beverages;
sunbathing or visiting a solarium;
wet the injection site;
swim in a pool or open water;
carry out intense physical training.

Also, after administering the drug, it is important to eat well with enough protein foods. You cannot follow a strict diet - the lack of vitamins and beneficial nutrients can prevent the formation of antibodies.

Revaccination

Some time after vaccination, the amount of antibodies in the blood begins to decrease. To maintain it at a level sufficient for full protection, repeated administration of the vaccine is necessary - revaccination.

In accordance with the temporary methodological recommendations of the Ministry of Health of the Russian Federation, the rule of “emergency revaccination” is currently in effect. Therefore, repeated administration of the vaccine should be carried out every 6 months.

Once collective immunity is achieved, that is, at least 60% of the country’s adult population has been vaccinated and the epidemic begins to decline, the rules of “routine vaccination” will begin to apply. Then the vaccine will be reintroduced once a year⁶.

After vaccination with Sputnik V, revaccination is performed with Sputnik Light. Repeat immunization results in a more than 40-fold increase in antigen-specific IgG antibody levels in 100% of immunized individuals⁴.

The essence of the Sputnik V vaccine

Pathogenic microorganisms that can cause the development of disease are called antigens. When they enter the body, the immune system begins to form protective antibodies. She, like soldier-defenders, attacks antigens and thereby prevents the occurrence of the disease, or ensures its easy course.

The essence of the Sputnik V vaccine is that a person is given a “program” for the cells to produce the coronavirus antigen. It will not cause the development of the disease, but will “train” the immune system to recognize and actively attack the SARS-CoV-2 virus when it encounters it. Thanks to this, vaccinated people significantly reduce the risk of developing severe forms of coronavirus infection.

Is the Sputnik V vaccine effective?

“The effectiveness of the Sputnik V vaccine is high, although there were questions about it regarding the conduct of clinical trials. But now the results of phase 1-2 and the intermediate stage of phase 3 clinical trials have already been published, and quite a lot of evidence has accumulated from other countries, and in Russia too. People vaccinated with Sputnik V practically do not end up in the hospital with coronavirus. This is already quite enough to consider this vaccine quite effective. Among those who were vaccinated with Sputnik V, less than 1% were hospitalized with coronavirus. These are isolated cases among people who have a compromised immune system or were unlucky in developing immunity. It may seem like there are a lot of such messages, but compared to the number of vaccinated people, this is a fraction of a percent. And I would advise anti-vaxxers to go on an excursion to the intensive care unit of a Covid hospital, where unvaccinated people lie in terrible agony. They wheeze and lack air. Anyone who visited there was truly shocked by what he saw.”

Yasny Ilya Evgenievich

expert

head of scientific examination of the pharmaceutical investment fund "Inbio Ventures".

Vaccine effectiveness

The full course of Gam-Covid-Vac vaccination provides a high level of protection for adults against the new coronavirus infection. Research results report that the effectiveness of this Russian vaccine reaches 97.6%.4 According to the director of the National Research Center for Epidemiology and Microbiology. N.F. Gamaleya Alexander Ginzburg, the effectiveness of Sputnik V against the delta strain is 83-94%.

Employees of NICEM named after. N. F. Gamaleya conducted studies during which they studied the effectiveness of the Sputnik V vaccine against new mutations of coronavirus infection:

English - Alpha B. 1.1.7;
South African - Beta B.1.351;
Brazilian - Gamma P.1;
Indian - Delta B.1.617.2 and B.1.617.3;
Russian - B.1.1.141 and B.1.1.317.

The results showed that vaccination with Sputnik V leads to the development of a sufficiently high titer of antibodies to all new strains of coronavirus. These findings were published in the international journal Vaccines.6

Only Sputnik V. There is no alternative

“In Russia, only Sputnik V should be chosen as the first vaccine.”
This is the only Russian vaccine with published data and proven effectiveness and safety. The effectiveness of CoviVac is unclear. EpiVacCorona is an unsuccessful vaccine; it does not produce neutralizing antibodies. For people who have recovered from the disease with high antibodies, the Sputnik Light vaccine will be enough; for those with low antibodies, it is better to take Sputnik V. Dudnakova Tatyana Valerievna

expert

Research Fellow at the University of Edinburgh, UK

Indications for use

It has antiemetic, sedative and antitussive effects. The reaction to external stimuli decreases, as does psychomotor agitation, affective tension, the feeling of fear is suppressed, and a weakening of aggressiveness is noted. Teraligen is used as a sleeping pill, but in a general sense it is not. Neuroleptics simply induce drowsiness and speed up the onset of sleep. And this must be taken into account in certain specialties.

Teraligen may induce drowsiness and accelerate the onset of sleep

That is, the pharmacological use of Teraligen is quite wide. The medicine is available in the form of dark pink, film-coated tablets. It contains 5 mg of alimemazine tartrate.

Teraligen is effective for neurotic disorders due to trauma, intoxication, vascular disorders in combination with autonomic disorders, anxiety and mild depressive disorders.

This medicine is used to treat the following diseases:

somatized mental disorders;
states of excitement and anxiety against the background of somatic pathologies;
sleep disorders of various origins;

The drug is used to treat mental disorders and depression

psychopathy with asthenic and psychoasthenic disorders;
anxiety-depressive conditions within the framework of borderline endogenous and vascular diseases;
senestopathic depression;
allergic reactions (symptomatic treatment);
neuroses and neurosis-like conditions of endogenous and organic origin with a predominance of senestopathic, hypochondriacal, phobic and psychovegetative disorders.