Contraindications
Boostrix™ Polio vaccine should not be administered to persons with hypersensitivity to any component of the vaccine (including neomycin or polymyxin (see Composition)) or to persons who have shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis or inactivated vaccines. for the prevention of polio.
Boostrix™ Polio is contraindicated if the person has suffered from encephalopathy of unknown etiology that occurred within 7 days of a previous vaccination with a vaccine containing a pertussis component. In these circumstances, the use of anti-squamous vaccine should be stopped and vaccination with anti-diphtheria, anti-tetanus and anti-polio vaccines should be continued.
Boostrix™ Polio should not be administered to persons who have had transient thrombocytopenia or neurological complications after previous administration of diphtheria and/or tetanus vaccine (for information about seizures or hypotensive-hyporesponsive episodes, see section "Peculiarities of use").
As with other vaccines, use of Boostrix™ Polio should be delayed in patients with acute illness accompanied by fever. The presence of a mild infection is not a contraindication.
Interaction with other drugs and other types of interactions
Boostrix™ Polio can be administered concomitantly with human papillomavirus vaccine without a clinically significant effect on the immune response to either component of either vaccine.
The concomitant use of Boostrix™ Polio with other vaccines or immunoglobulins has not been studied. It is unlikely that simultaneous use with other inactivated vaccines will lead to a disruption of the immune response. If necessary, Boostrix™ Polio vaccine can be administered simultaneously with other vaccines or immunoglobulins.
If Boostrix™ Polio is used simultaneously with other injectable vaccines, or with immunoglobulin, these drugs must always be injected into different areas of the body.
As with other vaccines, an adequate immunological response cannot fail to be obtained in immunocompromised patients or those treated with immunosuppressive drugs.
What does “acellular purified inactivated vaccine” mean?
Acellular, that is, cell-free vaccines, are a new generation of vaccines that are much less toxic than their predecessors. The production of such vaccines is more complex and the market price is higher. However, these “disadvantages” of the Boostrix vaccine are not comparable with its much more careful attitude towards the child’s body.
An inactivated vaccine is a vaccine with a microorganism that is completely devoid of infective ability, but retains the property of causing an immune response in the child’s body and creating immunity in him against the disease for which he is vaccinated.
Features of application
In good clinical practice, vaccination should be preceded by a review of the medical history (especially regarding previous vaccination and possible adverse events) and a physical examination.
As with all injectable vaccines, appropriate care and medical supervision should always be readily available if anaphylactic reactions occur after vaccine administration. Therefore, patients should be monitored for at least 30 minutes after vaccination. Vaccination sites must be provided with anti-shock therapy.
If any of the following events occur temporarily in connection with receiving pertussis-containing vaccine in an infant, the decision to receive the next dose of pertussis-containing vaccine should be carefully considered:
- temperature ≥ 40.0 °C within 48 hours after vaccination, not associated with other causes that can be identified;
- collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours after vaccination;
- persistent continuous crying lasting ³ 3:00 is observed within 48 hours after vaccination;
- convulsions with or without fever occurring within 3 days after vaccination.
There may be circumstances (eg, high incidence of whooping cough) where the potential benefit outweighs the possible risk, especially since these events are not associated with serious complications. Based on available clinical data, the risk-benefit ratio for acellular pertussis vaccines is better than the risk-benefit ratio for whole-cell pertussis vaccines.
In children with progressive neurological impairment, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy, it is best to defer immunization against pertussis (Pa-acellular pertussis component, Pw-whole cell pertussis component) until the condition improves or stabilizes. However, the decision to use pertussis vaccine should be made on an individual basis after carefully weighing the possible risks and benefits.
Under no circumstances should Boostrix™ Polio vaccine be administered intravascularly.
Boostrix™ Polio should be administered with caution to persons with thrombocytopenia (see Contraindications section) or bleeding disorders as bleeding may occur when the vaccine is administered to such persons. To prevent bleeding, apply firm pressure to the injection site (without rubbing) for at least two minutes.
Following immunization of children with vaccines containing one or more of the antigenic components contained in Boostrix™ Polio, there have been very rare reports of collapse or shock-like states (hypotonic-hyporesponsive episodes) and seizures.
A family history of febrile seizures - seizures, sudden infant death syndrome, and a family history of adverse reactions after administration of DTP vaccines are not a contraindication.
HIV infection is not a contraindication for vaccination with the Boostrix ™ Polio vaccine.
The expected immunological response may not be achieved after vaccination in immunosuppressed patients, for example, in patients being treated with immunosuppressive drugs.
As with any vaccine, a protective immune response may not be achieved in vaccinated individuals.
Syncope (fainting) may occur during or before any injection vaccination, especially in adolescents, as a psychogenic reaction to needle injection. It may be accompanied by several neurological symptoms such as temporary visual disturbances, paresthesias and tonic-clonic movements of the limbs during recovery from this state. Vaccination should be carried out only with the vaccinated person sitting or lying down, and leaving him in the same position (sitting or lying down) for 15 minutes after vaccination to prevent the risk of injury.
This medicinal product contains less than 1 mmol (23 mg)/dose sodium, i.e. practically sodium-free.
Side effects and complications after vaccination
As a rule, Boostrix is well tolerated. But in some people it provokes the development of adverse reactions. Usually unpleasant symptoms go away on their own. But in some cases it is necessary to seek medical help.
In children aged 4 to 9 years, the most common adverse reactions are:
- drowsiness;
- weakness;
- irritability;
- redness and swelling at the injection site;
- nausea;
- intestinal disorder;
- loss of appetite;
- temperature rise to 37.5-39 degrees;
- vomit.
Less commonly, children experience the following symptoms:
- rash;
- attention disorder;
- pain at the injection site;
- upper respiratory tract infection;
- conjunctivitis.
The most common side effects in adolescents and adults are:
- general malaise;
- headache;
- formation of a compaction in the injection area;
- nausea.
- temperature rise to 37.5 degrees;
- disorders in the gastrointestinal tract.
Very rarely occur:
- hyperhidrosis;
- skin itching, rashes;
- arthralgia;
- pharyngitis;
- diarrhea;
- lymphadenopathy;
- cough;
- myalgia;
- temperature rise to 39 degrees.
Severe complications of Boostrix vaccination are:
- angioedema;
- convulsions;
- asthenia;
- anaphylactic shock.
These conditions are rare but require emergency medical attention.
Use during pregnancy and lactation
Pregnancy
As with other inactivated vaccines, no adverse effects on the fetus are expected from vaccination.
However, there are no sufficient data from clinical studies of the use of Boostrix™ Polio vaccine during pregnancy. Therefore, the vaccine can be used during pregnancy only when the expected benefit to the mother outweighs the possible risk to the fetus.
Animal studies do not indicate direct or indirect harmful effects on pregnancy, embryonic/fetal development, labor or postnatal development (see section "Immunological and biological properties")
Lactation
The safety of the Boostrix™ Polio vaccine in women who are breastfeeding has not yet been studied. However, because Boostrix™ Polio contains toxoids or inactivated antigens, no risk to a breast-fed baby is expected.
It is unknown whether Boostrix™ Polio is excreted in breast milk.
Boostrix ™ Polio should be used while breastfeeding only when the benefit outweighs the potential risk.
There is no data on the administration of Boostrix ™ Polio to women while breastfeeding infants. Boostrix ™ Polio should be administered to women during lactation only if there are clear medical indications.
Fertility
There are no data from human clinical studies. Animal studies do not indicate direct or indirect harmful effects on female fertility (see "Immunological and biological properties").
Impact on the ability to drive vehicles and operate machinery
The effect on the ability to drive vehicles and operate machinery is unlikely.
Directions for use and doses
A single dose of 0.5 ml of vaccine is recommended.
Boostrix ™ Polio vaccine can be prescribed starting from 4 years of age, according to official recommendations and / or current medical practice of using vaccines containing a reduced (adult) dose of diphtheria toxoid along with tetanus toxoid in combination with anti-slucovirus and polio antigens.
Boostrix™ Polio may be co-administered with human tetanus immune globulin to prevent tetanus in the event of injury in individuals who are eligible for booster vaccination against pertussis, diphtheria and polio and have previously received a primary course of tetanus toxoid vaccine in accordance with official recommendations.
Repeated vaccinations against diphtheria, tetanus, whooping cough and polio should be carried out at a period determined in accordance with official recommendations (usually every 10 years).
The Boostrix™ Polio vaccine is intended for deep injection into the deltoid muscle area (see “Peculiarities of use”).
If 2 needles of different lengths are included in the kit, you need to select the appropriate size needle to ensure deep insertion depending on the size and weight of the patient.
In patients ≥ 40 years of age who have not received a diphtheria or tetanus vaccine in the past 20 years (including those who have never been immunized or whose vaccination status is unknown), one dose of BUSTRIX™ Polio vaccine will in most cases cause the appearance of antibodies against whooping cough and provides protection against tetanus and diphtheria. Two additional doses of diphtheria-tetanus vaccine given 1 and 6 months after the first dose will maximize vaccination protection against diphtheria and tetanus (see Immunological and Biological Properties section).
Children
The safety and effectiveness of Boostrix ™ Polio in children under 4 years of age have not been established (see Sections “Indications”, “Dosage and Administration”).
Instructions for use
Boostrix™ Polio should be inspected visually before administration for the presence of any foreign particles and/or physical abnormalities. If any of the above is observed, do not use the vaccine.
Because a white precipitate may form during storage of the vaccine, Boostrix™ Polio suspension should be shaken well before use until a uniform, cloudy white suspension is obtained. Before use, it is advisable that the vaccine be at room temperature.
Once removed from the refrigerator, the vaccine is stable for 8:00 at 21°C.
Any remaining unused product or waste must be disposed of in accordance with local regulations.
Features of child vaccination at the ISIDA clinic
The level of the medical institution in which the child will be vaccinated is of great importance not only from the point of view of creating a high level of immunity in the baby, but also from the point of view of minimizing the risks of post-vaccination reactions. Therefore, when choosing a clinic where your child will receive the vaccine, pay attention to the following factors:
Vaccine production. The most important factor in the safety and effectiveness of the vaccine is its compliance with European quality standards at all stages of production. is the Belgian company GlaxoSmithKline Biologicals S.A. It is one of the best vaccine developers and manufacturers in the world. GlaxoSmithKline Biologicals S.A. has been producing vaccines for more than 60 years, during which it has built an impeccable reputation that now allows this company to supply products to 170 countries around the world.
Compliance with cold chain rules during transportation and storage of vaccines is another important rule, for which all conditions have been created at the ISIDA clinic. We are talking about the availability of the necessary refrigeration and equipment that controls the vaccine storage process, as well as the qualifications and level of professional responsibility of medical personnel.
An individual vaccination schedule for a child is developed by doctors at the ISIDA clinic in the event that the child’s medical history during the neonatal period, as well as his state of health in subsequent months, do not allow him to comply with the vaccination schedule recommended by the National Vaccination Calendar, the Ministry of Health of Ukraine. In this case, an individual vaccination calendar will be created for the baby.
Parents' access to reliable information about the quality of the vaccine used in the clinic, its characteristics and possible post-vaccination reactions in the child is another principle of safe and effective vaccination at the ISIDA clinic. Before the child is vaccinated, his parents, at the initiative of the doctor, receive all the necessary information. Particular emphasis is placed on the baby’s possible post-vaccination reactions. If questions arise after immunizing the baby, parents have the opportunity to immediately contact the clinic’s pediatrician, and, if necessary, call him home.
Taking into account indirect indicators is a distinctive feature of child vaccination at the ISIDA clinic. During a flu epidemic, as well as if there are cases of chicken pox, mumps or other infectious diseases in the children's group that the child attends, vaccination will be postponed. The presence of a sick person in the family is also a reason to make changes to the child’s vaccination schedule. Such measures minimize post-vaccination reactions and also ensure a high level of child immunization.
