Infanrix-IPV+Hib: Immunization for children to prevent diphtheria, tetanus, pertussis

2021-07-04 07:37 PM

Infanrix-IPV+Hib is indicated for the active immunization of infants from 2 months of age against diphtheria, tetanus, pertussis (DTP), polio and Haemophilus influenzae type B.

Producer

GlaxoSmithKline.

Ingredient

Each dose 0.5mL (after reconstitution).

Diphtheria toxoid1: not less than 30 international units (IU) (25 Lf),

Tetanus toxoid1: not less than 40 international units (IU) (10 Lf),

Bordetella pertussis antigen:

Pertussis detox (PT)1: 25 micrograms.

Fibroglobin agglutinin (FHA)1: 25 micrograms.

Pertactin (PRN)1: 8 micrograms.

Polio (inactivated) virus (IPV):

Type 1 (Mahoney strain)2: 40 units of D antigen.

Type 2 (MEF-1 strain)2: 8 units of D antigen.

Type 3 (Saukett strain)2: 32 units of D antigen.

Polysaccharide Haemophilus influenzae type b (polyribosylribitol phosphate) (PRP): 10 micrograms plus transport protein for tetanus toxoid: approx. 25 micrograms.

1. Adsorbed on aluminum hydroxide, hydrated (Al(OH)3) 0.5 milligram Al3+,

2. was replicated on the VERO cell line.

Describe

Infanrix-IPV+Hib: Combination vaccine of diphtheria-tetanus-pertussis acellular, inactivated polio and Haemophilus influenzae type b.

Composition Infanrix-IPV is an opaque white suspension (during storage, a white precipitate and clear supernatant can be observed).

The Hib component of the vaccine is a white powder.

Pharmacodynamic

Pharmacotherapeutic group: Group of combined bacterial and viral vaccines, ATC code: J07CA06.

Results obtained in clinical studies from each ingredient are summarized in.
 
The efficacy of the Hib component (when combined with DTPa, DTPa-IPV, or DTPa-HBV-IPV) was investigated through a large-scale post-marketing surveillance study conducted in Germany. After more than 4.5 years of follow-up, the efficacy of the DTPa+Hib or DTPa-IPV+Hib vaccines, was 96.7% after the primary series and 98.5% after the booster series (regardless of the vaccine type). which vaccines were used in primary immunization). After more than 7 years of follow-up, the efficacy of the Hib component of the two 6-valued vaccines was 89.6% after the primary series and 100% after the primary and booster series (regardless of vaccine type). Please which Hib was used in primary immunization).

Pharmacokinetics

No pharmacokinetic evaluation is required for vaccines.

Preclinical safety

Preclinical data do not indicate a particular adverse effect in humans based on conventional studies of safety pharmacology, local tolerability, and repeated dose toxicity.

Indications and uses

Infanrix-IPV+Hib is indicated for the active immunization of infants from 2 months of age against diphtheria, tetanus, pertussis (DTP), polio and Haemophilus influenzae type b.

Infanrix-IPV+Hib is also indicated for the booster vaccination of children vaccinated against diphtheria, tetanus, pertussis (DTP), polio and Haemophilus influenzae type b.

Infanrix-IPV+Hib does not protect against diseases caused by other types of Haemophilus influenzae as well as meningitis caused by other microorganisms.

Dosage and Administration

Amount

The basic vaccination schedule consists of 3 doses during the first 6 months of life and can be started as early as 2 months of age. The interval between injections is at least 1 month apart.

A booster dose is recommended at the age of 2 years and at least 6 months after the last dose of the primary immunization schedule.

How to use

Infanrix-IPV+Hib is administered by deep intramuscular injection in the anterolateral part of the thigh. Subsequent injections should be repositioned in the thighs alternately.

Infanrix-IPV+Hib should be administered with caution to subjects with thrombocytopenia or bleeding disorders because bleeding may occur following intramuscular injection to these subjects.
 
The injection site should be firmly pressed (do not rub) for at least 2 minutes.

Instructions for use/handling

Before using, the Infanrix-IPV suspension and Hib powder and reconstituted vaccine should be visually inspected for foreign particles and/or any physical changes. Discard the vaccine if there are any changes.

Because the vaccine may cause a white deposit during storage, the Infanrix-IPV suspension should be shaken well before reconstitution.

The vaccine must be reconstituted by placing the entire portion of Infanrix-IPV in the syringe into the vial containing the Hib powder. Only vaccine components should be mixed together without mixing with other vaccines or other batch components. After mixing the Infanrix-IPV suspension into the Hib powder, the mixture should be shaken well.

The reconstituted Infanrix-IPV+Hib vaccine is a slightly more turbid suspension than the original DTPa-IPV suspension. This is a normal observed phenomenon. Discard vaccine if abnormalities are observed.

When administering vaccines, the first needle should be removed and discarded and the second needle should be replaced.

Vaccinations should be administered immediately after reconstitution.

Withdraw all the vaccine from the vial.

Unused product or unused materials should be disposed of as specified.

Warnings

Pre-vaccination medical history (especially prior vaccination and potential adverse events) and physical examination should be obtained.

As with other vaccines, Infanrix-IPV+Hib should be postponed for subjects with acute high fever. Not contraindicated in the presence of mild infections.

Infanrix-IPV+Hib should be administered with caution to subjects with thrombocytopenia or bleeding disorders because bleeding may occur following intramuscular injection to these subjects.

As with all injectable vaccines, appropriate medical treatment and monitoring should always be available to prevent rare anaphylactic reactions that may occur following vaccination.

The vaccinated person may faint after or even before the injection. This is a psychological reaction to the injection. It is important to have procedures in place to prevent injury from fainting.

The use of Infanrix-IPV+Hib is not recommended for adults, adolescents and children 5 years of age and older.

As with all diphtheria, pertussis, and tetanus vaccines, Infanrix-IPV+Hib is administered by deep intramuscular injection in the anterolateral part of the thigh. Subsequent injections should be repositioned in the thighs alternately.

The expected immune response may not be achieved after vaccination in immunocompromised patients, eg patients on immunosuppressive therapy.

If any of the following symptoms occur around the time of vaccination with a vaccine containing diphtheria, pertussis, or tetanus, caution should be exercised when deciding to continue using the vaccine containing the pertussis component. Symptoms include:

Temperature ≥ 40.0oC (rectal measurement) within 48 hours without any other cause detected;

Vascular collapse or shock-like condition (hypotonic attack - hyporesponsiveness) within 48 hours of vaccination;

Persistent fussing and coaxing ≥3 hours, occurring within 48 hours of vaccination;

Convulsions with or without fever, occurring within 3 days of vaccination.

However, because these events are not associated with long-term complications, there are situations, for example when the frequency of pertussis is high, where the potential benefits outweigh the possible risks.

In children with progressive neurological disorders, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy, it is preferable to delay pertussis vaccination (acellular or cells) until the disease is cured or stabilized. However, the decision to vaccinate is not on a case-by-case basis after carefully weighing the risks and benefits of vaccination.

Infanrix-IPV+Hib is not contraindicated in children with a history of febrile convulsions, a family history of seizures or sudden infant death syndrome (SIDS), or a family history of adverse events when immunized with DTP, IPV and/or Hib.

Human immunodeficiency virus (HIV) infection is not considered a contraindication.

The Hib polysaccharide envelope antigen is excreted in the urine after vaccination, so within 1-2 weeks after vaccination, a urine antigen test may not be of diagnostic value. in case of suspected Hib disease.

Under no circumstances should Infanrix-IPV+Hib be injected intravenously.

When primary immunization is performed for extremely preterm infants (born ≤28 weeks gestation), especially in preterm infants with a history of pulmonary immaturity, there is a potential risk of apnea and respiratory monitoring during 48-72 hours after vaccination. The benefits of vaccination in these populations are high, so vaccination should not be delayed or denied.

Effects on ability to drive and use machines: not applicable.

Overdose

Several cases of overdose have been reported during post-marketing surveillance. The adverse events reported after Overdosage were similar to those observed after the recommended doses of Infanrix-IPV+Hib.

Contraindications

Hypersensitivity to any component of the vaccine or to subjects showing signs of hypersensitivity following a previous dose of diphtheria, tetanus, pertussis, inactivated polio or Hib vaccines.

Infanrix-IPV+Hib is contraindicated if a child develops unexplained encephalopathy within 7 days of previous vaccination with pertussis-containing vaccine.

Use in pregnant and lactating women

Because Infanrix-IPV+Hib is not for use in adults, there is no information on the safety of the vaccine during pregnancy or breast-feeding.

Interactive

According to current childhood immunization practice that different vaccines can be given in the same session, Infanrix-IPV+Hib can be given together with the hepatitis B vaccine.

Reconstituted Infanrix-IPV+Hib and other injectable vaccines should be administered at different injection sites.

As with other vaccines, the expected immune response may not be achieved in patients who are immunocompromised or on immunosuppressive therapy.

Incompatibility

Do not mix Infanrix-IPV+Hib with other vaccines in the same syringe.

Side effects

Clinical trial data

The safety profile shown below is based on data from more than 3500 children.

As observed with DTPa vaccine and DTPa-containing conjugate vaccines, increased local reactivity and fever have been reported after booster vaccination with Infanrix-IPV+Hib compared with primary vaccination. copy.

The reported adverse events are classified by frequency as follows: Very common: ≥1/10, Common: ≥1/100 to <1/10, Uncommon: ≥1/1000 to <1 /100, Rare: ≥1/1000 to <1/1000, Very rare: <1/1000.

Bacterial and parasitic infections

Uncommon: upper respiratory tract infection.

Blood and lymphatic system disorders

Uncommon: swollen lymph nodes.

Metabolic and nutritional disorders

Very common: anorexia.

Psychosis

Very common: irritability, unusual fussiness, restlessness.

Nervous disorders

Very common: somnolence.

Respiratory, thoracic and mediastinal disorders

Uncommon: cough, bronchitis, runny nose.

Digestive disorders

Common: vomiting, diarrhea.

Skin and subcutaneous tissue disorders

Uncommon: rash, urticaria.

Rare: pruritus, dermatitis.

Systemic and injection site disorders

Very common: injection site reactions such as pain, redness, swelling at the injection site (≤50mm), fever (≥38oC).

Common: injection site reactions including tenderness and swelling at the injection site (>50mm).

Uncommon: fever2 >39.5oC, fatigue, diffuse swelling of injected extremities, sometimes to adjacent joints

Preservation

Infanrix-IPV and Hib components should be stored at +2oC to +8oC.

Do not freeze Infanrix-IPV components. Discard if this ingredient is frozen.

Avoid light.

The recommended storage conditions for vaccines during transport should be followed.

Presentation and packaging

Lyophilized powder (Hib) and suspension (DTPa-IPV) for suspension for injection: box of 1 syringe (Infanrix-IPV), 2 needles and 1 vial of lyophilized powder (Hib).

The Infanrix-IPV component is pre-packed in a syringe.

The Hib component is packaged in a glass vial.

(The vials and pre-filled syringes are made from class I neutral glass, in accordance with the standards of the European Pharmacopoeia).