Vaccine for the prevention of diphtheria, pertussis and tetanus | Infanrix syringe, 1 dose 0.5 ml
Special Price
$25.22
Regular Price
$33.00
In stock
SKU
BID688918
Release form
suspension for intramuscular injection
suspension for intramuscular injection
Release form
suspension for intramuscular injection
Pharmacological action
Infanrix - a vaccine against diphtheria, tetanus and pertussis.
Immune response to primary immunization
1 month after a three-dose course of primary vaccination given in the first 6 months of life, more than 99% of children with diphtheria and tetanus toxoid toxoids have antibody titers of more than 0.1 IU / ml. Antibodies to pertussis antigens (pertussis toxoid / KA /, filamentous hemagglutinin / PHA / and pertactin) are produced in more than 95% of vaccinees.
Immune response to
revaccination After re-vaccination with the Infanrix vaccine at 2 years of age (13-24 months) in all children who were primarily immunized with the Infanrix vaccine, antibody titers to diphtheria and tetanus toxoid are more than 0. 1 IU / ml. A secondary immune response to pertussis antigens is observed in more than 96% of children.
The protective efficacy of a vaccine is on average 88%.
Special instructions
Before vaccination, the child’s medical history should be examined, paying attention to previous vaccine administration and the associated occurrence of adverse reactions, as well as an examination.
Vaccine administration should be postponed if the child has an acute illness accompanied by fever. With an infectious disease in mild form, vaccination can be carried out after normalizing the temperature.
As with any other vaccine, you should have everything you need to stop a possible anaphylactic reaction to InfanrixВ®. Therefore, the vaccine should be under medical supervision for 30 minutes after immunization.
InfanrixВ® should be used with caution in patients with thrombocytopenia or with disorders of the blood coagulation system, since in such patients IM injections can cause bleeding. To prevent bleeding, press on the injection site without rubbing it for at least 2 minutes.
HIV infection is not a contraindication to vaccination.
When a vaccine is administered to patients undergoing immunosuppressive therapy, or in patients with immunodeficiency conditions, an adequate immune response may not be achieved.
The following conditions are contraindications to the administration of whole-cell DTP vaccines and can be classified as general precautions for the administration of the InfanrixВ® vaccine:
temperature of 40.5 РC or higher for 48 hours after vaccination, unrelated to other reasons other than the administration of the
vaccine collapse or a shock-like state (hypotonic-hypo-responsive episode) that developed within 48 hours after the administration of the
vaccine, continuous crying lasting 3 hours or more, occurring within 48 hours after the administration of the
vaccine, convulsions accompanied by or unaccompanied by a fever that occurred within 3 days after vaccination.
In children with progressive neurological disorders, including infantile cramps, uncontrolled epilepsy or progressive encephalopathy, the introduction of a vaccine with a pertussis component (whole-cell or cell-free) must be postponed until the condition stabilizes. The decision to prescribe a vaccine with a pertussis component should be made on an individual basis after a thorough assessment of the benefits and risks.
The presence of febrile seizures in the anamnesis, as well as seizures in a family history is not a contraindication, but requires special attention.
The potential risk of apnea and the need to monitor respiratory function for 48-72 hours should be taken into account during the initial vaccination of children born prematurely ( 28 weeks of gestation) and, especially, children with respiratory distress syndrome. Due to the need for vaccination of children in this group, vaccination should not be delayed or refused.
Composition
Active ingredients:
diphtheria toxoid, not less than 30 IU
tetanus toxoid 40 IU
pertussis toxoid (KA) 25 μg
filamentous hemagglutinin (PHA) 25 μg :
aluminum (as hydroxide) - 0.5 mg
2-phenoxyethanol - 2.5 mg
sodium chloride - 4.5 mg
water for injection - up to 0.5 ml
Dosage and administration of
Intramuscularly, deeply, alternating the injection site during the course of vaccination.
The recommended dose is 0.5 ml. The primary immunization course consists of 3 doses of the vaccine, administered according to the National Calendar of Preventive Vaccinations of Russia at 3, 4.5 and 6 months of life, revaccination is carried out at 18 months.
Before the introduction of the bottle should be shaken well until a homogeneous turbid suspension is formed, make sure that there are no foreign impurities, unbreakable flakes or changes in appearance (if any, the vaccine is not suitable for use).
Under no circumstances should an iv vaccine be given!
Side Effects of
Clinical Studies of
The safety profile below is based on data from more than 11,400 patients.
An 18-month increase in the incidence of local reactions and fever was observed with a booster dose of InfanrixΠvaccine.
Children who have been vaccinated with acellular pertussis vaccine have a greater likelihood of developing edema at the injection site after the booster dose is given, compared with children who underwent primary vaccination with the whole-cell vaccine. These reactions are resolved on their own within 4 days.
Determination of the frequency of adverse reactions: very often (? 10%), often (? 1%, <10%), sometimes (? 0.1%, <1%), rarely (? 0.01%, <0.1%), very rarely ( <0.01%).
From the lymphatic system: very rarely - lymphadenopathy 1.
From the side of the nervous system and psyche: very often irritability, drowsiness often anxiety2, unusual crying sometimes headache1.
From the respiratory system: sometimes - cough1, bronchitis1, rhinitis, pharyngitis.
From the digestive system: often - loss of appetite2, diarrhea, vomiting.
Dermatological reactions: often - itching sometimes - rash rarely - urticaria, dermatitis.
General and local reactions: very often - redness, swelling at the injection site (? 50 mm), fever? 38 РC often - soreness2, swelling at the injection site (> 50 mm) sometimes - tightening at the injection site, feeling tired 1, fever ? 39.1 РC, diffuse edema at the injection site, in some cases including nearby tissues.
Post-marketing observation
From the hematopoietic system: thrombocytopenia 3.
Allergic reactions: hypersensitivity reactions, angioedema, anaphylactic and anaphylactoid reactions.
From the nervous system: collapse or a shock-like state (hypotensive-hyporesponsive episode), convulsions (with or without fever) within 2-3 days after the vaccine is administered.
From the respiratory system: apnea.
Local reactions: edema at the injection site.
Other: very rare - otitis media.
1 - only with the introduction of a booster dose.
2 - very often with the introduction of a booster dose.
3 - described for vaccines containing diphtheria and tetanus toxoids.
Drug interaction
According to the rules adopted in Russia, Infanrix® can be administered simultaneously (on the same day) with other vaccines of the National vaccination calendar and inactivated vaccines of the vaccination calendar for epidemic indications. However, other vaccines should be administered in other parts of the body.
Infanrix® vaccine may be mixed with the Hiberix® vaccine (Haemophilus influenzae type b vaccine). In this case, the solvent supplied with the Hiberix® vaccine should be replaced with the Infanrix® vaccine.
Storage conditions
At 2–8 РC (do not freeze).
Expiration
3 year
Deystvuyuschee substances
Vaccine for Prevention diphtheria, pertussis and stolbnyaka
drugstore conditions
drugstore
dosage form
solution for injection
suspension for intramuscular injection
Pharmacological action
Infanrix - a vaccine against diphtheria, tetanus and pertussis.
Immune response to primary immunization
1 month after a three-dose course of primary vaccination given in the first 6 months of life, more than 99% of children with diphtheria and tetanus toxoid toxoids have antibody titers of more than 0.1 IU / ml. Antibodies to pertussis antigens (pertussis toxoid / KA /, filamentous hemagglutinin / PHA / and pertactin) are produced in more than 95% of vaccinees.
Immune response to
revaccination After re-vaccination with the Infanrix vaccine at 2 years of age (13-24 months) in all children who were primarily immunized with the Infanrix vaccine, antibody titers to diphtheria and tetanus toxoid are more than 0. 1 IU / ml. A secondary immune response to pertussis antigens is observed in more than 96% of children.
The protective efficacy of a vaccine is on average 88%.
Special instructions
Before vaccination, the child’s medical history should be examined, paying attention to previous vaccine administration and the associated occurrence of adverse reactions, as well as an examination.
Vaccine administration should be postponed if the child has an acute illness accompanied by fever. With an infectious disease in mild form, vaccination can be carried out after normalizing the temperature.
As with any other vaccine, you should have everything you need to stop a possible anaphylactic reaction to InfanrixВ®. Therefore, the vaccine should be under medical supervision for 30 minutes after immunization.
InfanrixВ® should be used with caution in patients with thrombocytopenia or with disorders of the blood coagulation system, since in such patients IM injections can cause bleeding. To prevent bleeding, press on the injection site without rubbing it for at least 2 minutes.
HIV infection is not a contraindication to vaccination.
When a vaccine is administered to patients undergoing immunosuppressive therapy, or in patients with immunodeficiency conditions, an adequate immune response may not be achieved.
The following conditions are contraindications to the administration of whole-cell DTP vaccines and can be classified as general precautions for the administration of the InfanrixВ® vaccine:
temperature of 40.5 РC or higher for 48 hours after vaccination, unrelated to other reasons other than the administration of the
vaccine collapse or a shock-like state (hypotonic-hypo-responsive episode) that developed within 48 hours after the administration of the
vaccine, continuous crying lasting 3 hours or more, occurring within 48 hours after the administration of the
vaccine, convulsions accompanied by or unaccompanied by a fever that occurred within 3 days after vaccination.
In children with progressive neurological disorders, including infantile cramps, uncontrolled epilepsy or progressive encephalopathy, the introduction of a vaccine with a pertussis component (whole-cell or cell-free) must be postponed until the condition stabilizes. The decision to prescribe a vaccine with a pertussis component should be made on an individual basis after a thorough assessment of the benefits and risks.
The presence of febrile seizures in the anamnesis, as well as seizures in a family history is not a contraindication, but requires special attention.
The potential risk of apnea and the need to monitor respiratory function for 48-72 hours should be taken into account during the initial vaccination of children born prematurely ( 28 weeks of gestation) and, especially, children with respiratory distress syndrome. Due to the need for vaccination of children in this group, vaccination should not be delayed or refused.
Composition
Active ingredients:
diphtheria toxoid, not less than 30 IU
tetanus toxoid 40 IU
pertussis toxoid (KA) 25 μg
filamentous hemagglutinin (PHA) 25 μg :
aluminum (as hydroxide) - 0.5 mg
2-phenoxyethanol - 2.5 mg
sodium chloride - 4.5 mg
water for injection - up to 0.5 ml
Dosage and administration of
Intramuscularly, deeply, alternating the injection site during the course of vaccination.
The recommended dose is 0.5 ml. The primary immunization course consists of 3 doses of the vaccine, administered according to the National Calendar of Preventive Vaccinations of Russia at 3, 4.5 and 6 months of life, revaccination is carried out at 18 months.
Before the introduction of the bottle should be shaken well until a homogeneous turbid suspension is formed, make sure that there are no foreign impurities, unbreakable flakes or changes in appearance (if any, the vaccine is not suitable for use).
Under no circumstances should an iv vaccine be given!
Side Effects of
Clinical Studies of
The safety profile below is based on data from more than 11,400 patients.
An 18-month increase in the incidence of local reactions and fever was observed with a booster dose of InfanrixΠvaccine.
Children who have been vaccinated with acellular pertussis vaccine have a greater likelihood of developing edema at the injection site after the booster dose is given, compared with children who underwent primary vaccination with the whole-cell vaccine. These reactions are resolved on their own within 4 days.
Determination of the frequency of adverse reactions: very often (? 10%), often (? 1%, <10%), sometimes (? 0.1%, <1%), rarely (? 0.01%, <0.1%), very rarely ( <0.01%).
From the lymphatic system: very rarely - lymphadenopathy 1.
From the side of the nervous system and psyche: very often irritability, drowsiness often anxiety2, unusual crying sometimes headache1.
From the respiratory system: sometimes - cough1, bronchitis1, rhinitis, pharyngitis.
From the digestive system: often - loss of appetite2, diarrhea, vomiting.
Dermatological reactions: often - itching sometimes - rash rarely - urticaria, dermatitis.
General and local reactions: very often - redness, swelling at the injection site (? 50 mm), fever? 38 РC often - soreness2, swelling at the injection site (> 50 mm) sometimes - tightening at the injection site, feeling tired 1, fever ? 39.1 РC, diffuse edema at the injection site, in some cases including nearby tissues.
Post-marketing observation
From the hematopoietic system: thrombocytopenia 3.
Allergic reactions: hypersensitivity reactions, angioedema, anaphylactic and anaphylactoid reactions.
From the nervous system: collapse or a shock-like state (hypotensive-hyporesponsive episode), convulsions (with or without fever) within 2-3 days after the vaccine is administered.
From the respiratory system: apnea.
Local reactions: edema at the injection site.
Other: very rare - otitis media.
1 - only with the introduction of a booster dose.
2 - very often with the introduction of a booster dose.
3 - described for vaccines containing diphtheria and tetanus toxoids.
Drug interaction
According to the rules adopted in Russia, Infanrix® can be administered simultaneously (on the same day) with other vaccines of the National vaccination calendar and inactivated vaccines of the vaccination calendar for epidemic indications. However, other vaccines should be administered in other parts of the body.
Infanrix® vaccine may be mixed with the Hiberix® vaccine (Haemophilus influenzae type b vaccine). In this case, the solvent supplied with the Hiberix® vaccine should be replaced with the Infanrix® vaccine.
Storage conditions
At 2–8 РC (do not freeze).
Expiration
3 year
Deystvuyuschee substances
Vaccine for Prevention diphtheria, pertussis and stolbnyaka
drugstore conditions
drugstore
dosage form
solution for injection
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