"Pentaxim": certified French vaccine for patients of the Inpromed center

"PENTAXIM" - vaccination against diphtheria, tetanus, whooping cough, polio, infection caused by Haemophilus influenzae type b

The vaccine is cell-free, contains purified Bordetella pertussis antigens, diphtheria and tetanus toxoids, inactivated polio viruses of three types and a vaccine against Haemophilus influenzae infection.

Manufacturer: Sanofi Pasteur S.A., France.

Protects against diseases: diphtheria and tetanus, whooping cough, polio and infection caused by Haemophilus influenzae type b.

Applicable: primary vaccination and revaccination of children from 3 months of age

Included in the national calendar of preventive vaccinations in Russia.

What diseases does Pentaxim protect against?

• Diphtheria is a severe bacterial infection that affects the mucous membranes of the nose and throat. The mortality rate from diphtheria, even in modern conditions, exceeds 10%.
• Whooping cough is a very dangerous disease for children under two years of age, and the mortality rate from it is also very high. At the same time, whooping cough is very contagious (even casual contact with a patient leads to infection in 100% of cases) and is relatively common.
• Tetanus is a serious infection that kills about 100,000 people worldwide every year. In countries where mass vaccination is carried out, the incidence of tetanus is 100 times lower.
• Poliomyelitis is infantile spinal paralysis, a disease that is currently rare, but highly contagious (very contagious).
• Haemophilus influenzae type B is the causative agent of 25% of pneumonia and sepsis, half of severe meningitis and 80% of epiglottitis in children under 5 years of age. This is why it is so important to vaccinate your child against this infection on time.

Vaccination for the whole family! About the vaccinations that adults and children need

How it works

The plant is a whole complex consisting of several buildings.

At the same time, everything is arranged very conveniently: to move from one building to another, you don’t need to go outside - there is a connecting corridor running along all the buildings.

In the visualization above you can see all the buildings:

No. 1 - warehouse for raw materials and supplies; No. 2 - Administrative building, quality control laboratory;
No. 3 - Production of solid dosage forms; No. 4 - Production of vaccines and genetically engineered drugs; No. 5.
Reserve Corps. Antonina's tour began from building No. 2, where the entire floor is occupied by the quality control service. 120 people work here (which is almost half of all plant employees). The service consists of several laboratories:

• microbiological laboratory
  (here everything that goes into production and everything that is released - the final product - is checked for sterility);
• biochemical laboratory
  (here the concentration of adjuvant and antigens in the vaccine is checked);
• chemical analytical laboratory
  (here tests are carried out to control the level of formaldehyde and 2-phenoxyethanol in vaccines).

The plant does not have its own vivarium (room for keeping laboratory animals). Therefore, such tests are carried out outsourced.

At what age is it better to get the Pentaxim vaccine? How long does it take to do the second Pentax?

The Pentaxim vaccination schedule is as follows: according to the National Vaccination Calendar, it is carried out at 3 months, then at 4.5, then at 6 months. This is followed by revaccination one year after the third administration (approximately one and a half years).

• If the first vaccination took place after 6 months, then for the third vaccination and subsequent revaccination, when diluting Pentaxim, no component is added that protects against Haemophilus influenzae infection.
• If the first vaccination took place after 12 months, this component is not added for the second and all subsequent administrations.

Find out more about the vaccination calendar

Quality Management System

It is difficult to deny that there is some mistrust of Russian production. We are already accustomed to the fact that many people cheat, passing off their work as high-quality. Unfortunately, this is everywhere and it has become the norm. Surprisingly, it turns out that this can be “cured.” To minimize the human factor (negligence, unprofessionalism, selfishness, accidents, etc.), the GMP (Good Manufacturing Practice) QUALITY MANAGEMENT SYSTEM is in place. This is modern protection that reduces risks to a minimum. It does not allow the manufacturer to deviate from protocols, hide information, or produce low-quality products.

GMP implies regular checks (audits), not only internal, but also external. And not only by “regulatory authorities” (Roszdravnadzor), but also by representatives from other pharmaceutical factories. Lists of these audits hang on the information stand at the plant. At the time of Antonina’s presence at the plant, the list consisted of 26 items over 2 years. If you count, this is more than once a month.

Roszdravnadzor, of course, checks on “its” points, but it does not know exactly how production should work. Any flaws can only be seen by people who themselves work every day on the same production lines, equipment, etc. Such additional mutual control, as objective as possible in biopharma, is a necessity, because the cost of errors is very high!

ASKO-MED-PLUS LLC expresses its sincere gratitude
to Antonina Oblasova for providing the materials.

Compatibility and revaccination

• Is it possible to do Pentaxim after DTP? Is it possible to do regular DTP after Pentaxim?

The answer to both questions is yes, you can. If you only have DTP at your disposal, it is better not to wait for an imported vaccine to appear, but to get vaccinated on time. Discuss your polio and hemophilus influenzae vaccination schedule with your pediatrician, as these components are not included in the DPT vaccine.

• Is it possible to do Infanrix Hexa after Pentaxim?

The Infanrix Hexa vaccine can replace Pentaxim for the first, second and third vaccinations, and vice versa. But with one caveat: the Pentaxim vaccine does not have a component that protects against hepatitis B, but Infanrix Hexa does. Therefore, if you are switching from one vaccine to another, ask your pediatrician to create an individual hepatitis B vaccination schedule for you. It is also worth remembering that the timing of administration of the Infanrix Hexa vaccine is up to 36 months, that is, up to 3 years.

• How do Pentaxim and the polio vaccine work together? Is it possible to take Pentaxim after polio?

Pentaxim contains an acellular polio vaccine. You can replace some of the polio vaccinations with the Pentaxim vaccine, and also continue the polio vaccination with Pentaxim.

However, if you have previously been vaccinated with a live polio vaccine, you need to wait at least a month with Pentaxim, as after any vaccine.

• Is it possible to do Pentaxim after Mantoux?

Yes, you can. You can get vaccinated with Pentaxim on the day of the Mantoux test.

• Is it possible to take Prevenar and Pentaxim at the same time? Is it possible to use Pentaxim and hepatitis at the same time?

Yes, you can. If the time has come for vaccination, any number of vaccines can be administered simultaneously, provided they are compatible. It has been proven that the frequency and severity of reactions to vaccination (and even more so, rare complications) do not depend on the number of vaccines administered at one time. Generally, vaccines work well together. There are rare exceptions, such as BCG.

• Is it possible to take Pentaxim if you have a runny nose? Is it possible to do Pentaxim if teething?

Yes, you can. Neither colic, nor an umbilical hernia, nor small residual cysts in the baby’s brain, nor a runny nose without fever will in any way affect the child’s condition after vaccination. Such challenges have no medical basis. Unfortunately, most cases of severe childhood infections are detected in children whose parents decided to “just wait a little.”

Meet our team of pediatricians who administer vaccinations

Compound

As part of the Pentaxim vaccine, which is available in the form of a suspension: toxoids (toxoids) of diphtheria (Diphtheria), tetanus (Tetanus) and whooping cough (Pertussis) are present in a concentration of ≥ 30 IU/≥40 IU/25 μg/dose, respectively.
The concentration of filamentous hemagglutinin in one dose is 25 mcg of Filamentous hemagglutinin. The concentration of inactivated polio type 1-3 in ELISA units is, respectively, 40, 8 and 32 IU*.

The absorption and effect of the active components are optimized by the excipients included in Pentaxim: formaldehyde , aluminum hydroxide, Hanks medium 199*, sodium hydroxide or acetic acid, phenoxyethanol , water d/i.

*The suspension does not contain phenol red.

The vaccine for the prevention of diseases caused by HIB contains HIB polysaccharide conjugated with tetanus toxoid at a concentration of 10 μg/dose, as well as trometamol and sucrose.

Contraindications to the administration of Pentaxim

• Progressive severe encephalopathy;
• Encephalopathy that developed within a week after administration of any vaccine containing a pertussis component (Bordetella pertussis antigens);
• A severe reaction (fever up to 40 degrees, convulsions, decreased blood pressure) that develops within 48 hours after administration of any vaccine containing a pertussis component;
• Allergic reactions to previous administrations of any vaccines containing components against diphtheria, tetanus, whooping cough, polio and Hib infection;
• Any disease that occurs with elevated body temperature (you can start vaccinating the child 5 days after the temperature has returned to normal, regardless of residual cough and runny nose).

Quality control

How does the quality control department work at ? The laboratories are equipped with a computer system to which all the equipment used to test products is connected. The results of all tests immediately go there and this “primary data” can no longer be deleted. If suddenly during the release control process it turns out that something is wrong with a batch of vaccine, it will be impossible to hide it. In addition, samples from each series are archived. They will be needed for investigation if the vaccine is suddenly suspected of causing harm. And they are stored for the entire shelf life of the vaccine!

What might be the reaction to the Pentaxim vaccine?

Pentaxim is usually easily tolerated. Possible reactions: pain and hardness at the injection site; redness of the injection site; increased body temperature, irritability, sleep disturbances or drowsiness. Post-vaccination reactions requiring medical attention develop in only 0.6% of vaccinated children.

The older the child, the more pronounced the reactions to vaccinations are, precisely because of the “ripe” immunity. This in itself is not scary, but redness and pain at the injection site, high fever and other reactions are much more common in children with delayed vaccinations, and are not typical for infants.

special instructions

To prevent possible adverse reactions (including hypersensitivity reactions), the doctor must assess the child’s health and medical history, check the medical history of his immediate family (including allergy) and immunization history, and clarify cases of side effects after previous immunization.

When conducting vaccinations, the doctor is required to have tools and medications that may be necessary in the event of an allergic reaction .

For children taking immunosuppressants , vaccination should be postponed until the end of treatment or remission of the disease. for parents of children with chronic immunodeficiency , even though the immune system may be weak.

Comparative table of different vaccines

*Only the first two vaccinations are given free of charge (the third vaccination and revaccination are paid) **Although the age is not limited, in practice it is done up to 6 years

Even more articles about vaccination:

• Vaccination in questions and answers
• The Gardasil vaccine, or how to protect yourself from the human papillomavirus

Release form

Pentaxim vaccine for immunization against diphtheria (Diphtheria) and tetanus (Tetanus), adsorbed, pertussis (Pertussis), acellular, and polio (Poliomyelitis), inactivated, is a cloudy, whitish suspension. Intended for intramuscular administration, it is available in 0.5 ml doses in 1 ml glass syringes (the syringe can come with or without a fixed needle).

The vaccine for the prevention of diseases caused by HIB is a homogeneous, white, lyophilized mass for the preparation of a suspension for intramuscular administration. Available in glass bottles, 1 dose per bottle.

Each cardboard package is equipped with one bottle of lyophilisate and one glass syringe with a suspension, placed in a closed cell packaging.

In the case when the syringe comes without a needle, the delivery set additionally includes 2 separate sterile needles, sealed in cell packaging.

Do I need to get tested before immunization?

To finally make sure that the child is completely healthy and can undergo immunization, you should take a general urine test and a clinical blood test.

The pediatrician gets acquainted with the results of the laboratory test and gives or does not give the child permission to be vaccinated. If tests show that there is an inflammatory process in the body, vaccination will be postponed.

In addition, the listed tests also help to determine pathological changes in the composition of the blood, immunity and urinary system.