Acdp-biolik

Instructions for Medical Use of the Medicinal Product ACDP-Biolik

Composition:

Active substances: pertussis suspension (Bordetella pertussis), diphtheria toxoid (obtained by formaldehyde inactivation of toxin), tetanus toxoid (obtained by formaldehyde inactivation of toxin);

0.5 mL (1 dose) of the preparation contains:

Active substances: pertussis suspension (Bordetella pertussis) − 10 international optical units (IOU), diphtheria toxoid (obtained by formaldehyde inactivation of toxin) − 15 flocculating units (Lf), tetanus toxoid (obtained by formaldehyde inactivation of toxin) − 5 binding units (BU);

Excipients: aluminum hydroxide gel (calculated as aluminum) − 0.5 mg, thiomersal (preservative) − 0.05 mg, sodium chloride − 4.5 mg, water for injections − up to 0.5 mL.

Pharmaceutical form. Injection suspension.

Main physicochemical properties: the preparation consists of a mixture of killed pertussis bacteria and purified diphtheria and tetanus toxoids, adsorbed onto aluminum hydroxide gel. The preparation is a yellowish-white suspension, which separates upon standing into a clear supernatant liquid and a fluffy sediment that completely disperses upon shaking.

Pharmacotherapeutic group.

Bacterial vaccines. Inactivated whole-cell pertussis vaccine, combined with toxoids.

ATC code J07A J51.

Immunological and biological properties.

Pharmacodynamics.

Administration of the preparation according to the approved vaccination schedule induces the formation of specific immunity against pertussis, diphtheria, and tetanus.

Pharmacokinetics.

Assessment of pharmacokinetic data is not applicable.

Clinical characteristics.

Indications.

Prevention of diphtheria, tetanus, and pertussis in children according to the recommendations of the National Calendar of Preventive Vaccinations.

Contraindications.

Severe complications after a previous dose of ACDT-Biolik, such as anaphylactic reaction or toxic erythema.

Allergic reaction to any component of the vaccine.

Acute illness or exacerbation of a chronic disease.

Congenital combined immunodeficiencies, primary hypogammaglobulinemia.

Immunosuppressive therapy (see section "Special precautions").

History of seizures (vaccination should be performed with ADT or a vaccine containing acellular pertussis component).

Special safety precautions.

The vaccine must not be used if the vial is damaged, unlabelled, or if there are changes in physical properties (change in color, presence of an insoluble precipitate upon shaking), if the expiry date has passed, or if storage conditions have been violated.

Opening of vials and vaccination procedures must be performed under strict adherence to aseptic and antiseptic rules. The vaccine in an opened vial must not be stored.

Disposal of all unused vaccines or waste must be carried out in accordance with national requirements.

Interaction with other medicinal products and other types of interactions.

Simultaneous administration of ACDT-Biolik with other inactivated vaccines and/or anatoxins, as well as with live vaccines (except BCG), is permitted. When ACDT-Biolik is administered simultaneously with other injectable vaccines, these products should be injected at different body sites, unless otherwise specified in the instructions for a specific vaccine/anatoxin.

ACDT-Biolik vaccination may be administered with an interval of at least 1 month before or after BCG vaccination.

Special precautions for use.

Appropriate clinical practice recommends considering the child's medical history and previous vaccination history prior to immunization. Laboratory tests (complete blood count and urinalysis) are also recommended.

Vaccination is administered by healthcare professionals in vaccination rooms of medical and preventive institutions. Preventive vaccinations must be carried out in compliance with sanitary and anti-epidemic regulations and standards.

To identify contraindications, the physician must interview the parents and perform a medical examination of the child on the day of vaccination, including mandatory temperature measurement. Children who have been temporarily exempted from vaccination should be placed under medical supervision and recorded, and vaccinated promptly after contraindications have been resolved.

Syncope (fainting) may occur during or before vaccination as a psychogenic response to needle injection. To prevent patient injury, it is recommended that vaccination be performed with the patient in a sitting or lying position, and the patient should remain in this position for at least 15 minutes after vaccination.

Due to the possibility of immediate-type allergic reactions, medical observation of vaccinated children is required for 30 minutes after vaccination. Vaccination rooms must be equipped with emergency anti-shock therapy supplies.

Premature infants should be vaccinated with АКДП-Біолік after stabilization of their condition, adequate weight gain, and absence of contraindications.

Human immunodeficiency virus (HIV) infection is not considered a contraindication. HIV-infected children should receive pertussis, diphtheria, and tetanus vaccination according to the standard schedule.

As with other vaccines, administration of АКДП-Біолік should be postponed in individuals with an acute serious illness accompanied by fever.

Children who have recovered from acute illnesses should be vaccinated 2–4 weeks after recovery. Vaccination may be performed after resolution of clinical symptoms in cases of mild illness.

Vaccination in individuals with chronic diseases should be performed once clinical and laboratory remission is achieved; if necessary, under inpatient conditions.

Vaccination in individuals with neurological disorders should be performed after ruling out disease progression.

For patients with thrombocytopenia or coagulation disorders (due to risk of bleeding following intramuscular injection), the injection site should be firmly pressed (without rubbing) for at least two minutes.

Following vaccination, individuals with immunosuppression may not develop an adequate immune response.

Due to the use of formaldehyde in the manufacturing process, residual amounts of this substance may be present in the vaccine. Therefore, the product should be administered with caution to individuals hypersensitive to formaldehyde.

Administration of the product must be recorded in the established documentation forms, including the batch number, dose, expiration date, manufacturer, date of administration, and nature of the reaction to the product, which is checked the following day after vaccination by nurses of outpatient clinics or childcare and educational institutions.

Protective immune response may not be achieved in all vaccinated individuals.

This medicinal product contains less than 1 mmol (23 mg)/dose of sodium, i.e., it is practically sodium-free.

Under no circumstances should АКДП-Біолік be administered intravenously or intradermally.

When conducting immunization in Ukraine, the immunization schedule, contraindications, and interactions with other medicinal products should be in accordance with current regulatory documents issued by the Ministry of Health of Ukraine.

Use during pregnancy or breastfeeding.

Not applicable.

Ability to affect reaction speed when operating vehicles or machinery.

Data are lacking.

Method of Administration and Dosage

Vaccination with ACDP-Biolik is administered at the age of 3 months (first dose), 4 months (second dose), 5 months (third dose), and 18 months (fourth dose). The interval between the first and second, and second and third doses of ACDP-Biolik should be at least 1 month. The interval between the third and fourth doses should be no less than 12 months. Shortening of intervals is not permitted. If it is necessary to extend vaccination intervals, the next dose should be administered as soon as possible, depending on the child's condition.

ACDP-Biolik vaccination is administered to children up to 6 years 11 months and 29 days of age.

Vaccination of children under 7 years of age outside the schedule specified in the Calendar should be prescribed by a physician so that the child receives four doses of ACDP-Biolik before reaching the age of 6 years 11 months and 29 days. In this case, the interval between the first and second, and second and third vaccine doses should not be less than 1 month, and the interval between the third and fourth doses should not be less than 6 months. For children aged 7 years and older, vaccination should be performed with ADP-M according to the instructions for use.

If a child has contraindications to the use of ACDP-Biolik vaccine, vaccination may be carried out with ADP-toxoid or with a vaccine containing acellular pertussis component, according to the instructions for use.

The ACDP-Biolik vaccine is intended for deep intramuscular injection.

The recommended injection site for infants and younger children is the anterolateral aspect of the thigh (middle third). For older children (>3 years of age), the vaccine should be administered into the densest part of the deltoid muscle (shoulder muscle prominence, upper third, lateral injection) at a dose of 0.5 ml (single dose). Before vaccination, the vial should be shaken to obtain a homogeneous suspension.

Children. To be used in children aged from 3 months to 6 years 11 months and 29 days.

Overdose.

No cases of overdose have been reported.

Adverse reactions.

The adverse reactions are based on post-marketing surveillance data.

The following criteria were used to assess the frequency of adverse reactions:

very common – more than 10 %;

common – 1–10 %;

uncommon – 0.1–1 %;

rare – 0.01–0.1 %;

very rare – less than 0.01 %.

General and local reactions may develop during the first two days after vaccination.

General disorders and administration site reactions

Uncommon: fever; erythema, swelling at the injection site.

Rare: pain, infiltration at the injection site.

Very rare: malaise.

Nervous system disorders

Very rare: seizures (usually associated with fever), episodes of high-pitched screaming.

Psychiatric disorders

Rare: irritability.

Immune system disorders

Very rare: exacerbation of allergic diseases, systemic reactions such as anaphylactic shock.

Skin and subcutaneous tissue disorders

Very rare: urticaria, polymorphic rash, angioedema (Quincke's edema).

When using other vaccines containing tetanus toxoid, cases of brachial neuritis and Guillain-Barré syndrome have been reported.

Additional information regarding specific populations.

The potential risk of apnea should be considered in preterm infants born at early gestational ages (< 28 weeks).

Shelf life.

18 months.

Storage conditions.

Store in a protected from light place at a temperature between 2 °C and 8 °C. Do not freeze! Keep out of reach of children.

Incompatibility.

The medicinal product should not be mixed with other medicinal products, as compatibility studies have not been conducted.

Packaging.

0.5 ml (1 dose) or 1 ml (2 doses) in an ampoule, 10 ampoules per pack.

Prescription status.

Prescription only.

Manufacturer.

JSC "Biolyk", Ukraine.

Manufacturer's address and location of its business activity.

Pomirky, Kharkiv, Kharkiv region.