Infanrix suspension 1 dose 0.5ml syringes 1pc, 1 dose 0.5ml syringes 1pc

Composition

Active ingredients:  

diphtheria toxoid, not less than 30 IU;

tetanus toxoid 40 IU;

pertussis toxoid (CA)25 mcg;

filamentous hemagglutinin (PHA)25 mcg;

outer membrane protein (pertactin) with a molecular weight of 69 kD 8 mcg;

Auxiliary substances:

aluminum (in the form of hydroxide) – 0.5 mg;

2-phenoxyethanol-2.5 mg;

sodium chloride-4.5 mg;

water for injection – up to 0.5 ml

Pharmacological action

Infanrix is a vaccine against diphtheria, tetanus and pertussis.

Immune response to primary immunization

1 month after a three-dose course of primary vaccination conducted in the first 6 months of life in more than 99% of those immunized with the vaccine In infants, titers of antibodies to diphtheria and tetanus toxoids are 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 vaccinated patients.

Immune response to revaccination

After revaccination with the Infanrix vaccine for 2 years of life (13-24 months), all children who were initially immunized with the Infanrix vaccine, antibody titers to diphtheria and tetanus toxoids are more than 0.1 IU / ml.

A secondary immune response to pertussis antigens is observed in more than 96% of children.

The protective effectiveness of the vaccine reaches an average of 88%.

Indications

Primary vaccination against diphtheria, tetanus and pertussis in children from 3 months of age;revaccination of children who were previously immunized with 3 doses of acellular pertussis-diphtheria-tetanus or whole-cell pertussis-diphtheria-tetanus vaccine.

Contraindications

• known hypersensitivity to any component of this vaccine if the patient has any symptoms of hypersensitivity after previous use of the vaccine, My;
• severe reaction (temperature more than 40°C, redness, or swelling for more than 8 cm in diameter) or complication (collapse or samopodoben condition that developed within 48 h after the introduction of the vaccine; persistent crying lasting 3 hours or more during the 48 hours after vaccination; seizures accompanied or not accompanied by a fever that occurred within 3 days after vaccination) the previous use of the vaccine new year;
• encephalopathy that developed within 7 days after the last injection of vaccine containing the pertussis component. In this case, the course of vaccination should be continued with diphtheria-tetanus vaccine.

Side effects

Clinical trials

The safety profile presented below is based on data from more than 11,400 patients.

With the introduction of a revaccinating dose of Infanrix® vaccine at 18 months, an increase in the incidence of local reactions and fever was observed.

Children who have been vaccinated with the acellular pertussis vaccine are more likely to develop edema at the injection site after the revaccination dose, compared with children who have been vaccinated with the primary whole-cell vaccine. These reactions resolve on their own within 4 days.

Determination of the frequency of adverse reactions: very common (≥10%), often (≥1%, <10%), sometimes (≥0.1%, <1%), rarely (≥0.01%, <0.1%), very rare (

From the lymphatic system:  very rare – lymphadenopathy 1.

Nervous system and mental disorders:  very often – irritability, drowsiness; often-anxiety 2, unusual crying; sometimes-headache 1.

Respiratory system disorders:  sometimes-cough 1, bronchitis 1, rhinitis, pharyngitis.

From the digestive system:  often – loss of appetite 2, diarrhea, vomiting.

Dermatological reactions:  often-itching; sometimes-rash; rarely-urticaria, dermatitis.

General and local reactions:  very common-redness, swelling at the injection site (≤ 50 mm), fever ≥38°C; often-soreness 2, swelling at the injection site (> 50 mm); sometimes – tightness at the injection site, feeling tired 1, fever ≥39.1°C, diffuse swelling at the injection site, in some cases including nearby tissues.

Post-marketing observations

From the hematopoietic system:  thrombocytopenia 3.

Allergic reactions:  hypersensitivity reactions, angioedema, anaphylactic and anaphylactoid reactions.

Nervous system disorders:  collapse or shock-like state (hypotensive-hyporesponsive episode), convulsions (with or without fever) within 2-3 days after the introduction of the vaccine.

Respiratory system disorders:  apnea.

Local reactions:  swelling at the injection site.

Other services:  very rarely-otitis media.

1 – only with the introduction of a revaccinating dose.

2-very often with the introduction of a revaccinating dose.

3-described for vaccines containing diphtheria and tetanus toxoids.

Interaction

In accordance with the rules adopted in Russia, Infanrix® can be administered simultaneously (on the same day) with other vaccines of the National Preventive Vaccination Calendar and inactivated vaccines of the preventive vaccination calendar for epidemic indications. However, other vaccines should be administered in other areas of the body.

It is allowed to mix the Infanrix ® vaccine 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.

How to take, course of use and dosage

Intramuscularly, deeply, alternating injection sites during the course of vaccination.

The recommended dose is 0.5 ml. The course of primary immunization 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 use, the vial should be shaken well until a homogeneous cloudy suspension is formed, make sure that there are no foreign impurities, non-breaking flakes or changes in appearance (if there are any, the vaccine is not suitable for use).

Under no circumstances should the vaccine be administered intravenously!

Special instructions

Before vaccination, the child’s medical history should be studied, paying attention to the previous use of vaccines and the associated occurrence of adverse reactions, as well as an examination.

The introduction of the vaccine should be postponed if the child has an acute illness accompanied by fever. In case of a mild infectious disease, vaccination can be carried out after the temperature normalizes.

As with all other vaccines, you should have everything you need ready to stop a possible anaphylactic reaction to Infanrix®. Therefore, the vaccinated person should be under medical supervision for 30 minutes after immunization.

Infanrix® should be used with caution in patients with thrombocytopenia or with coagulation disorders, since in such patients, the IV injection may cause bleeding. To prevent bleeding, apply pressure on the injection site, without rubbing it, for at least 2 minutes.

HIV infection is not a contraindication to vaccination.

When the vaccine is administered to patients undergoing immunosuppressive therapy or patients with immunodeficiency conditions, an adequate immune response may not be achieved.

The following conditions are contraindications to the use of whole-cell DTP vaccines and can be attributed to general precautions for the use of Infanrix®:

• the temperature of 40.5°C and above during the 48 hours after vaccination is not associated with other causes, besides the introduction of a vaccine;
• the collapse or samopodoben state (hypotonic-hyporesponsive episode) developed within 48 h after the introduction of the vaccine;
• incessant crying lasting 3 hours or more during the 48 hours after vaccination;
• seizures accompanied or unaccompanied fever that occurred within 3 days after vaccination.

In children with progressive neurological disorders, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy, use of the pertussis vaccine (whole-cell or cell-free) should be postponed until the condition stabilizes. The decision to prescribe a pertussis vaccine should be made on a case-by-case basis after careful assessment of the benefits and risks.

The presence of a history of febrile seizures, as well as a family history of seizures, 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 when conducting a course of primary vaccination of children born prematurely (≤ 28 weeks of gestation) and, especially, children with respiratory distress syndrome. Due to the need to vaccinate children in this group, vaccination should not be postponed or refused.

Active ingredient

Vaccine for the prevention of diphtheria, pertussis (cell-free) and tetanus

Conditions of release from pharmacies

By prescription

Dosage form

suspension for injection