Hibericks - instructions for use, doses, side effects, contraindications

Active substanceVaccine for the prevention of infections caused by Haemophilus influenzaeVaccine for the prevention of infections caused by Haemophilus influenzae

Similar drugsTo uncover

Act-HIB

lyophilizate w / m PC

Sanofi Pasteur S.A. France

Hiberix®

lyophilizate w / m PC

GlaxoSmithKline Bayolodikalz s.a. France

Dosage form: & nbsp

Lyophilizate for the preparation of solution for intramuscular and subcutaneous administration

Composition:

One dose of the vaccine contains:

Name of components	The amount in one dose (0.5 ml)
Vaccine for the prevention of infection caused by Haemophilus influenzae a type b
Active substance
Capsular polysaccharide Haemophilus influenzae a type b,	10 μg *
conjugated with tetanus toxoid	~ 25 μg
Excipient
Lactose	not more than 12.6 mg *
Solvent 0.9% solution of sodium chloride
Sodium chloride	4.5 mg
Water for injections	up to 0.5 ml

Note:

* To compensate for losses in the process of reconstitution of the vaccine and to ensure the active substance content of 10 μg / 0.5 ml in the injected dose, during the packing of the vaccine into bottles, 25 % excess (by weight). Total: capsular polysaccharide Haemophilus influenzae a type b (as part of the conjugate) - 12.50 μg / bottle; lactose 15.75 μg / vial.

Hiberici® meets the requirements of the World Health Organization (WHO) relating to the production of biological substances, as well as conjugated vaccines for the prevention of infection caused by Haemophilus influenzae a type b.

Description:

The vaccine is a powder or a dense mass of white color.

Solvent is a clear, colorless liquid with no visible mechanical impurities.

The reconstituted solution is a clear, colorless liquid.

Pharmacotherapeutic group:MIBP vaccine

ATX: & nbsp

J.07.A.G. Vaccine for the prevention of infections caused by Haemophilus influenza B

J.07.A.G.01 Haemophilus influenzae B antigen purified conjugated

Pharmacodynamics:

IMMUNOLOGICAL PROPERTIES

Antibodies in protective titer> 0.15 μg / ml appear 1 month after the end 95-100% of children, and 1 month after revaccination, 100% children. In this case, 94.7% of the last titer

antibodies reaches> 1.0 μg / ml.

Indications:

Prevention of infection caused by Haemophilus influenzae a type b, in children aged 3 months.

Contraindications:

- Hypersensitivity (allergic reaction) to any of the components of the drug and / or to the previous administration of the vaccine to prevent infection caused by Haemophilus influenzae type b.

- Acute infectious and non-infectious diseases, exacerbation of chronic diseases are temporary contraindications for vaccination. Scheduled vaccinations are carried out 2-4 weeks after recovery or during the period of convalescence or remission.With mild ARVI, acute intestinal diseases and other vaccinations are carried out immediately after the normalization of temperature.

Dosing and Administration:

Method of administration

The vaccine is administered to children of the first year of life in upper-outer surface of medium

parts of the hip, the remaining ages - in deltoid muscle.

Patients with thrombocytopenia and other disorders of the blood coagulation system, the vaccine is administered subcutaneously. The solvent must be visually inspected before use for no mechanical inclusions and / or change in appearance. If they are detected, the use of a solvent should be avoided.

Preparation of the vaccine before administration using a solvent in a syringe The Hiberix vaccine8 must be reconstituted by adding a full volume of the solvent from the pre-filled syringe to the vial containing the lyophilizate.

Attention! The packaging of the Hibericks® vaccine can be represented by two types of syringes that differ in the way the needle is connected to the syringe nozzle.

To correctly select the method of connecting the needle and syringe, follow the instructions below.

Instructions for preparing a syringe of type 1 (Figure 1) for use:

- unscrew the protective cap of the syringe by turning it counter-clockwise (while keeping the syringe in the cylinder, avoiding contact with the syringe piston);

- twist clockwise to connect the needle to the syringe until you feel them snap into each other;

- remove the protective cap from the needle (in some cases it can be tightly attached to the needle).

Syringe type 2

In case the package contains a syringe other than that shown in figure 1, after removing the protective cap from the syringe nozzle, the needle is inserted onto the syringe until it stops without additional twisting.

To restore the vaccine immediately before use, it is necessary to remove from the vial containing the lyophilizate, protective immunization consists of three vaccinations at intervals of 1.5 months. Revaccination is carried out in a single dose in the second year of life. For example, vaccination in 5,5-7-8,5 months and revaccination in 18 months of a child's life.

Age 1 year - 5 years

The vaccine is administered once. plastic cap and aluminum cap. In the vial of the vaccine, apply the applied solvent at a rate of 0.5 ml per dose. The vial is shaken well until the contents are completely dissolved.

The reconstituted vaccine is a clear, colorless liquid. In case of detection of mechanical inclusions and / or change in appearance, the vaccine must be destroyed. After restoration, the vaccine must be completely recruited into the syringe, replaced with a needle and promptly injected. Preparation of the vaccine before administration with the use of a solvent in an ampoule or vial

To restore the vaccine immediately before use, remove from the vial containing the lyophilizate, a protective plastic lid and an aluminum cap. In the vial of the vaccine, apply the supplied solvent with a separate syringe, completed with two needles, (not included) at a rate of 0.5 ml per dose. The vial is shaken well until the contents are completely dissolved. The reconstituted vaccine is a clear, colorless liquid. In case of detection of mechanical inclusions and / or change in appearance, the vaccine must be destroyed.

After restoration, the vaccine must be completely recruited into the syringe, replaced with a needle and promptly injected.The Hiberix vaccine should be removed from the vial with strict adherence to asepsis rules to prevent contamination of the contents.

The Hibericks® vaccine can be administered in a single syringe with the Infanriks vaccine (a vaccine for the prevention of diphtheria, tetanus, pertussis (acellular), a three-component, adsorbed liquid). In this case, to restore the vaccine, instead of the solvent, the Infanriks® vaccine is used, which is available as a suspension for intramuscular injection, with 0.5 ml of suspension in a syringe. To restore the Hibericx® vaccine, all contents of the syringe (0.5 ml) should be used.

The introduction of the reconstituted vaccine is carried out in accordance with the current instructions for use on the Infanriks® vaccine.

Vaccination schedules

A single dose of the vaccine is 0.5 ml.

Children aged 3 to 6 months

The course of primary vaccination, according to the National calendar of preventive vaccinations in Russia, consists of three doses of the vaccine at 3-4.5-6 months with a booster at 18 months.

Vaccination is recommended to be carried out simultaneously with vaccination against poliomyelitis, pertussis, diphtheria and tetanus.

If vaccination against the infection caused by Haemophilus influenzae type b is started after 3 months but up to 6 months of the child's life, the primary immunization schedule consists of three vaccinations at an interval of 1.5 months. Revaccination is carried out in a single dose in the second year of life. For example, vaccination in 5,5-7-8,5 months and revaccination in 18 months of a child's life.

Children aged 6 to 12 months

The primary vaccination course for unvaccinated children consists of two vaccinations with an interval of 1 month and a single booster dose in the second year of life. For example, vaccination at 6 and 7 months and revaccination at 18 months of the child's life.

Children aged 1 to 5 years

The vaccine is administered once.

Side effects:

The undesirable reactions listed below are listed depending on the anatomophysiological classification. Data are generated on the basis of clinical studies of the drug and post-registration surveillance.

Data from clinical trials

Reactions at the site of administration

Within 48 hours after the introduction of the vaccine are possible:

- slight reddening, disappearing on its own;

- slight swelling and tenderness at the injection site.

General reactions

Within 48 hours after the introduction of the vaccine, fever, loss of appetite, anxiety, vomiting, diarrhea, unusual crying may develop. These symptoms are poorly expressed and resolved spontaneously.

The listed general reactions were also recorded when the Hibericks® vaccine was administered concomitantly with other vaccines.

Post-registration data

The adverse events listed below were recorded at a frequency of <1/10 000 (very rarely).

From the immune system

Allergic reactions (including anaphylactic and anaphylactoid reactions), angioedema.

From the nervous system

Hypotensive-hyporesponsive episode, convulsion (with or without fever), syncope or vasovagal reaction to injection, somnolence.

From the respiratory system Apnea (see section "Special instructions").

From the skin and subcutaneous fat

Hives, rash.

Reactions at the site of administration

A common swelling of the extremity in the area of administration, compaction at the site of administration.

Overdose:

No data.

Interaction:

Hiberiks® vaccine may be administered simultaneously (on the same day), with other live or inactivated vaccines National Immunization Schedule (except rabies vaccine)while vaccines should be injected with different syringes into different parts of the body.

Hibericx® can be administered in a single syringe with the Infanriks® vaccine (Vaccine for the prevention of diphtheria, tetanus, pertussis (acellular), three-component, adsorbed liquid).

As with other vaccines, an adequate immune response may not be achieved in persons receiving immunosuppressive therapy.

Special instructions:

Hiberix® under no circumstances should not be administered intravenously.

In connection with the possibility of developing in the rarest cases of an anaphylactic reaction, the vaccinated should be under medical supervision for 30 minutes, and the treatment rooms should be provided with anti-shock therapy. Although the administration of the Hibericx® vaccine may cause a slight immune response to tetanus toxoid, its administration can not replace vaccination against tetanus.

In persons who received Hiberix®, a capsular polysaccharide is excreted in the urine, so the determination of the antigen in the urine within 1-2 weeks after vaccination is of no diagnostic value in case of suspected infection caused Haemophilus influenzae a type b.

It is necessary to take into account the potential risk of apnea and the need to monitor respiratory function for 72 hours with the primary vaccination of children born prematurely (<28 weeks gestation), and especially children with respiratory distress syndrome. Due to the need to vaccinate the children of this group, the primary vaccination should not be postponed or denied. The primary vaccination of vaccination course for such children should be carried out in a hospital under the supervision of a doctor within 72 hours.

After vaccination, or sometimes in front of it, fainting or severe weakness is possible as a psychological reaction to injection. Before vaccination it is important to make sure that the patient does not get injured in the event of a syncope.

HIV infection is not a contraindication to the introduction of the Hibericx® vaccine. Hibericx® does not protect against diseases caused by other types Haemophilus influenzae. Also, the vaccination of Hibericx® does not prevent bacterial infections (including bacterial purulent meningitis) caused by other microorganisms, except Haemophilus influenzae type b.

Form release / dosage:

Lyophilizate for the preparation of solution for intramuscular and subcutaneous injection.

Packaging:

Lyophilizate

For 1 dose of vaccine in a neutral-type glass of type I (Eur.F.), sealed with a rubber stopper and an aluminum cap for running in, equipped with a protective plastic lid.

Solvent

For 0.5 ml in a bottle of neutral glass type I (Hev.F.), corked with a rubber stopper and an aluminum cap for running in, equipped with a protective plastic lid.

For 0.5 ml in a neutral glass syringe type I (Hept. F.). The nose of the syringe is sealed with a cork made of rubber.

For 0.5 ml in an ampoule of neutral glass type I (Hept. F.).

Completeness

1 bottle with a vaccine and 1 bottle with a solvent in a blister, closed with a film.

For 1 blister, along with instructions for use in a cardboard bundle.

1 bottle with a vaccine and 1 ampoule with a solvent in a blister, closed with a film.

For 1 blister, along with instructions for use in a cardboard bundle.

1 bottle with a vaccine and 1 syringe with a solvent complete with 1 needle in a separate plastic container in a blister, closed with a film.

For 1 blister, along with instructions for use in a cardboard bundle.

1 bottle with a vaccine and 1 syringe with a solvent complete with 2 needles in separate plastic containers in a blister, closed with a film.

For 1 blister, along with instructions for use in a cardboard bundle.

For treatment and prophylactic institutions

For 100 bottles of vaccine in a carton box along with instructions for use. 25 ampoules with the solvent in the blister. For 4 blisters in a cardboard box.

Storage conditions:

STORAGE CONDITIONS

The vaccine is stored at a temperature of 2 to 8 ° C in a dark place.

Freezing is allowed.

The solvent is stored at a temperature of 2 to 25 ° C. Do not freeze.

The vaccine, complete with a solvent, is stored at a temperature of 2 to 8 ° C in a dark place. Do not freeze.

Keep the vaccine and thinner out of the reach of children.

CONDITIONS OF TRANSPORTATION

The vaccine is transported at a temperature of 2 to 8 ° C in a dark place. Freezing is allowed.

The solvent is transported at a temperature of 2 to 25 ° C. Do not freeze.

The vaccine, complete with a solvent, is transported at a temperature of 2 to 8 ° C in a dark place. Do not freeze.

Shelf life:

Shelf life of the vaccine is 3 years, solvent - 5 years.

Do not use after the expiration date stated on the package.

Expiration date is the last day of the month indicated on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N 015829/01

Date of registration:18.05.2009

The owner of the registration certificate:GlaxoSmithKline Bayolodikalz s.a.GlaxoSmithKline Bayolodikalz s.a. France

Manufacturer: & nbsp

GlaxoSmithKline Biologicals, s.a. France

Representation: & nbspGlaxoSmithKline Trading, ZAOGlaxoSmithKline Trading, ZAO

Information update date: & nbsp27.05.2014

Illustrated instructions

Instructions

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Hiberix® (Hiberix® )