Instructions for use Infanrix IPV suspension for injection, disposable syringe No. 1
Composition
One dose of vaccine (0.5 ml) contains:
Active ingredients:
diphtheria toxoid¹ - not less than 30 IU (25 Lf); tetanus toxoid¹ - not less than 40 IU (10 Lf);
Bordetella pertussis antigens:
pertussis toxoid¹ - 25 μg; filamentous hemagglutinin¹ - 25 μg; pertactin¹ - 8 μg;
polio viruses (inactivated):
type 1 (Mahoney strain)² - 40 D-antigen units; type 2 (MEF-1 strain)² - 8 D-antigen units; type 3 (Saukett strain)² - 32 D-antigen units.
1 adsorbed on aluminum hydroxide, hydrated Al(OH)3 - 0.5 mg Al³+.
2 propagated on Vero cells.
Excipients: sodium chloride, aluminum (in the form of salts), medium 199 and water for injections.
Dosage form
Suspension for injection.
Main physicochemical properties: INFANRIX IPV vaccine is a white, cloudy suspension. A white precipitate and a colorless supernatant may be observed during storage. This is not a sign of deterioration in quality.
Pharmacotherapeutic group
Combined bacterial and viral vaccines. ATX code J07C A02.
Pharmacological properties
Pharmacodynamics
Immune response to DT (diphtheria and tetanus) components:
One month after the primary vaccination course, more than 99% of infants vaccinated with INFANRIX™ IPV had antibody titers ≥ 0.1 IU/ml for both tetanus and diphtheria antigens.
After administration of a booster dose of INFANRIX™ IPV vaccine, more than 99.5% of children had antibody titers ≥ 0.1 IU/ml for both antigens.
Immune response to the Ra (acellular pertussis) component
One month after a 3-dose primary vaccination course with INFANRIX™ IPV, 100% of infants were seropositive for the three pertussis components (PT, FHA, pertactin) and overall response rates to each of the three individual pertussis antigens were ≥ 94%.
A booster response against pertussis antigens was observed in the vast majority of vaccinees; lower levels of response were observed in studies where antibody levels were high prior to vaccination. All subjects were seropositive one month after this dose.
Protective efficacy of the Pa (acellular pertussis) component
Since the immune response to pertussis antigens following administration of INFANRIX™ IPV is equivalent to that following administration of INFANRIX™, it can be assumed that the protective efficacy of these two vaccines will also be equivalent.
Epidemiological protection of the DTPa component against typical pertussis disease as defined by WHO (≥ 21 days of paroxysmal cough) has been demonstrated in:
a prospective blinded family contact study conducted in Germany (3, 4, 5 month vaccination schedule). Based on data collected from secondary contacts in families with an index case of typical pertussis, the protective efficacy of the vaccine was 88.7%; and a National Institutes of Health-sponsored efficacy study conducted in Italy (2, 4, 6 month schedule), in which the vaccine efficacy was 84%. Further follow-up of the same cohort confirmed the efficacy of the vaccine up to and including 4 years of age.
Immune response to the IPV component (Inactivated polio vaccine):
One month after primary vaccination, overall seropositivity for each of the three poliovirus serotypes (types 1, 2, 3) was ≥ 99.5%.
After administration of a booster dose of INFANRIX™ IPV vaccine, 100% of children were seropositive for the three serotypes of polioviruses.
Booster vaccination causes a marked increase in antibody levels compared to the values observed before the booster dose.
Pharmacokinetics
Assessment of pharmacokinetic properties is not mandatory for vaccines.
Indication
INFANRIX IPV vaccine is indicated for active primary immunization against diphtheria, tetanus, pertussis and poliomyelitis in children from 2 months of age.
INFANRIX IPV vaccine is also indicated as a booster (revaccination) dose for children who have previously received vaccination against diphtheria, tetanus, pertussis (DTP) and polio.
Vaccination of children in Ukraine is carried out in accordance with the requirements of the current orders of the Ministry of Health of Ukraine regarding preventive vaccinations.
Contraindication
INFANRIX IPV should not be administered to individuals with known hypersensitivity to any component of the vaccine (including neomycin, polymyxin or formaldehyde) or to individuals who have shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis or inactivated polio vaccines.
INFANRIX IPV is contraindicated if the child has a history of encephalopathy of unknown etiology that occurred within 7 days of previous vaccination with a vaccine containing a pertussis component.
In these circumstances, pertussis vaccination should be discontinued and the vaccination course should be continued with vaccines for the prevention of diphtheria, tetanus, and inactivated polio vaccine.
As with other vaccines, the administration of INFANRIX IPV should be postponed in patients with an acute febrile illness. The presence of a minor infection is not a contraindication.
Any unused product or waste material should be disposed of in accordance with local requirements.
Interaction with other medicinal products and other types of interactions
It is common practice to vaccinate children at the same time during a single vaccination session, during which injectable vaccines should always be administered at different injection sites.
INFANRIX IPV can be administered simultaneously with vaccines for the prevention of measles, mumps, rubella, varicella, hepatitis B and a vaccine for the prevention of diseases caused by Haemophilus influenzae type b.
As with other vaccines, it can be expected that patients receiving immunosuppressive therapy or patients with immunodeficiency may not achieve an adequate immune response to one or more vaccine antigens.
Application features
In accordance with medical practice standards, it is recommended to collect the patient's history (especially regarding the presence of consequences of previous vaccination and the possible occurrence of adverse reactions) and conduct a medical examination before vaccination.
Under no circumstances should INFANRIX IPV be administered intravascularly.
If any of the following events occur in temporal association with the administration of a DTP-containing vaccine, the decision regarding the subsequent dose of a pertussis-containing vaccine should be carefully considered. There may be circumstances, such as high pertussis incidence, in which the potential benefit outweighs the potential risk, particularly since these events are not associated with long-term 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. The following reactions were previously considered contraindications to the administration of DTPw vaccines (whole-cell) and may now be considered reactions in which the vaccine should be administered with caution:
temperature ≥ 40.0 °C within 48 hours after vaccination, not associated with other identifiable causes; collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours after vaccination; inconsolable crying or screaming lasting ≥ 3 hours, occurring within 48 hours after vaccination; convulsions with or without fever occurring within 3 days after vaccination.
In children with progressive neurological disorders, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy, it is preferable to postpone pertussis immunization (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 careful evaluation of the potential risks and benefits.
A history of febrile seizures in the vaccinated person, a family history of seizures, sudden infant death syndrome, and the presence of adverse reactions after the administration of DTP and/or IPV vaccines are not contraindications.
Infection caused by human immunodeficiency virus (HIV) is not a contraindication.
The expected immunological response may not be achieved after vaccination of immunocompromised patients, for example, patients receiving immunosuppressive drugs.
As with all injectable vaccines, appropriate medical treatment and supervision should be available in case of rare anaphylactic reactions. Therefore, patients should be observed for at least 30 minutes after vaccination.
INFANRIX IPV contains trace amounts of neomycin and polymyxin B. The vaccine should not be used in patients with known hypersensitivity to any of these antibiotics.
As with all vaccines for the prevention of diphtheria, tetanus and pertussis, INFANRIX IPV should be administered deeply intramuscularly.
INFANRIX IPV should be administered with caution to individuals with thrombocytopenia or blood clotting disorders, as bleeding may occur following intramuscular administration in such individuals.
INFANRIX IPV vaccine should not be mixed with other vaccines in the same syringe.
When prescribing primary immunization to very preterm infants (before 28 weeks of gestation), the potential risk of apnoea and the need for monitoring of respiratory function for 48-72 hours after vaccination should be considered, especially if the infant has a history of respiratory failure. Since the benefit of vaccination in this group of infants is high, vaccination should not be withheld or delayed.
Syncope (fainting) may occur during or before any injectable vaccination, as a psychogenic reaction to the needle injection. Vaccination should be performed only with the vaccinee in a sitting or lying position, and the vaccinee should be kept in the same position (sitting or lying) for 15 minutes after vaccination to prevent the risk of injury.
This medicinal product contains less than 1 mmol (23 mg) sodium/dose, i.e. essentially 'sodium-free'.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not apply to this group.
Use during pregnancy or breastfeeding
Since INFANRIX IPV is not intended for use in adults, there are no data on the safety of the vaccine during pregnancy or lactation in humans and no adequate reproductive studies in animals.
Method of administration and doses
Dosage.
One immunizing dose of the vaccine is 0.5 ml. The primary vaccination regimen consists of three doses in the first year of life and can begin from the age of 2 months. An interval of at least 1 month should be observed between subsequent doses.
After completing the primary vaccination course, an interval of at least 6 months should be allowed before administering a booster dose. Clinical data on the use of this vaccine as a booster dose have been obtained in children up to 13 years of age.
Primary and booster vaccination should be carried out according to official recommendations in each country.
Method of application.
INFANRIX IPV is intended for deep intramuscular injection. For infants, the preferred injection site is the anterolateral thigh; for older children, the vaccine should be administered into the deltoid muscle of the shoulder.
Under no circumstances should INFANRIX IPV be administered intravascularly.
It is advisable to inject each subsequent dose into a different area of the body.
INFANRIX IPV should be administered with caution to individuals with thrombocytopenia or bleeding disorders, as bleeding may occur following intramuscular administration. The injection site should be pressed firmly (without rubbing) for at least two minutes.
Instructions for using the vaccine.
INFANRIX IPV vaccine is a white, cloudy suspension in a pre-filled syringe. A white precipitate and a clear, colorless supernatant may be observed upon storage. This is not a sign of deterioration in the quality of the vaccine.
INFANRIX IPV should be inspected visually for any foreign matter and/or abnormal physical appearance prior to administration. If any of the above are observed, the vaccine should not be used.
Since a white precipitate may form during storage of the vaccine, INFANRIX IPV suspension should be shaken well before use.
Any unused product or waste material should be disposed of in accordance with local requirements.
Children
The INFANRIX IPV vaccine is used in children from 2 months of age.
Overdose
Post-marketing surveillance has reported cases of overdose. Adverse reactions, if any, were non-specific but were similar to those seen with routine vaccination.
Adverse reactions
The data presented are obtained from both clinical trials and post-marketing surveillance.
Clinical studies: The safety profile presented below is based on data obtained from immunization of more than 2200 patients.
As with DTPa and DTPa-containing combination vaccines, an increased incidence of local reactions and fever has been reported following booster vaccination with INFANRIX IPV compared to the primary course.
Clinical events were identified with the following frequency per dose:
very common: ≥1/10; common: ≥1/100 and <1/10; uncommon: ≥1/1000 and <1/100; rare: <1/10000.
Disorders of the circulatory and lymphatic systems
Rare: lymphadenopathy 1.
Metabolic and nutritional disorders
Very common: loss of appetite.
Mental disorders
Very common: irritability, abnormal crying, restlessness.
Nervous system dysfunction
Very common: headache 1 (age range 6 to 13 years), drowsiness.
Respiratory, thoracic and mediastinal disorders
Isolated: cough 2, bronchitis 2.
Gastrointestinal disorders
Common: nausea 1, vomiting, diarrhea.
Skin and subcutaneous tissue dysfunction
Uncommon: allergic dermatitis.
Isolated: urticaria, rash 2.3.
General disorders and injection site reactions
Very common: fever (≥ 38.0 °C), pain, redness, swelling at the injection site (≤ 50 mm).
Common: injection site swelling (> 50 mm4), malaise1, injection site reactions including induration, asthenia.
Uncommon: diffuse swelling of the injected limb, sometimes involving the adjacent joint 4 fever 5 (> 39.5 °C).
Post-marketing surveillance data
Disorders of the circulatory and lymphatic systems
Thrombocytopenia 6.
Immune system disorders
Allergic reactions (including anaphylactic and anaphylactoid reactions).
Nervous system dysfunction
Collapse or shock-like state (hypotonic-hyporesponsive episodes), convulsions (with or without fever) within 2-3 days after vaccination.
Respiratory, thoracic and mediastinal disorders
Apnea 2 (see section "Special instructions").
Skin and subcutaneous tissue disorders
Itching, angioedema 2.
General disorders and injection site reactions
Diffuse edema of the injected limb, vesicles at the injection site.
1 Observed only with booster vaccination.
2 Observed with DTPa vaccines manufactured by GSK.
4 Children who have received primary doses of acellular pertussis vaccine are more likely to experience edematous reactions after a booster dose compared with those who have received whole-cell pertussis vaccines. Local edema (> 50 mm) and diffuse edema may occur more frequently (very common and common, respectively), sometimes involving an adjacent joint, if the booster dose is given at 4 to 6 years of age. These reactions resolve on average after 4 days.
5 Commonly observed with booster vaccination.
6 Observed during vaccination with D and T vaccines.
Reporting of adverse reactions.
Post-marketing adverse reaction reporting is an important measure. It allows for continuous monitoring of the benefit/risk balance of a medicinal product. Healthcare professionals should report any adverse reactions using the adverse reaction reporting system in Ukraine.
Expiration date
3 years.
Storage conditions
Store at a temperature of 2 to 8 °C.
Protect from light. Keep out of the reach of children.
Do not freeze. Do not use if INFANRIX IPV has been frozen.
Packaging
Suspension for injection 0.5 ml in pre-filled disposable syringes complete with needle - 1 pc. The needle and pre-filled syringe are hermetically packed in a plastic container and placed in a cardboard box.
Vacation category
According to the recipe.
Producer
GlaxoSmithKline Biologicals S.A.
Location of the manufacturer and its business address
Rue de l'Institut, 89 1330 Rixensart, Belgium.
