Adp-m-biolik

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ADP-M-BIOLIK

Composition:

Active substances: diphtheria anatoxin, tetanus anatoxin;

0.5 mL (1 dose) of the preparation contains:

diphtheria anatoxin – 5 flocculating units (Lf);

tetanus anatoxin – 5 binding units (BU);

Excipients: aluminium hydroxide gel (calculated as aluminium) – 0.5 mg; thiomersal (preservative) – 0.05 mg; sodium chloride – 4.5 mg; water for injections – up to 0.5 mL.

Pharmaceutical form. Suspension for injection.

Main physicochemical properties: the preparation consists of a mixture of purified diphtheria and tetanus anatoxins adsorbed onto aluminium hydroxide gel and is a yellowish-white suspension which, upon standing, separates into a clear supernatant liquid and a loose sediment that fully disperses upon shaking.

Pharmacotherapeutic group.

Bacterial vaccines. Tetanus anatoxin, combined with diphtheria anatoxin.

ATC code J07AM51.

Pharmacological properties.

Pharmacodynamics.

Administration of the vaccine according to the approved schedule leads to the development of specific immunity against diphtheria and tetanus.

Pharmacokinetics.

Assessment of pharmacokinetic data is not applicable.

Clinical characteristics.

Indications.

Prevention of diphtheria and tetanus in children from 7 years of age and adults.

Contraindications.

Severe complications after previous administration in the form of anaphylactic reaction or toxic erythema.

Allergic reaction to any component of the toxoid or to a previous administration of vaccines containing diphtheria and/or tetanus toxoid (see section "Special precautions").

Organic progressive disorders of the nervous system, epilepsy, epileptic syndrome with seizures occurring at least twice per month.

Acute illnesses or exacerbation of chronic diseases (see section "Special precautions").

Congenital combined immunodeficiencies, primary hypogammaglobulinemia.

Immunosuppressive therapy (see section "Special precautions").

Special safety measures.

The product must not be used if it is contained in vials with damaged integrity, missing labeling, altered physical properties (change in color, presence of insoluble precipitate upon shaking), expired shelf life, 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 product in an opened vial must not be stored.

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

Interaction with other medicinal products and other forms of interaction.

Simultaneous administration of ADP-M-Biolik with other inactivated vaccines and/or toxoids, as well as with live vaccines (except BCG), is permitted, provided they are administered at different body sites and this does not contradict the instructions for use of the specific vaccine/toxoid.

Vaccination with ADP-M-Biolik may be performed with an interval of at least 1 month before or after BCG vaccination.

Special precautions for use

Due to the possibility of immediate-type allergic reactions, vaccinated individuals must be under medical supervision for 30 minutes after vaccination. Vaccination sites must be equipped with emergency anti-shock therapy supplies.

Individuals who have experienced severe allergic reactions to ADP-M-Biolik administration should discontinue further scheduled vaccinations with this vaccine (see section "Contraindications").

Syncope (fainting) may occur during or prior to vaccination as a psychogenic response to needle injection. In view of the above, to prevent patient injury, vaccination should be performed with the patient in a sitting or lying position, and the patient should remain in this position for 15 minutes after vaccination.

HIV infection is not considered a contraindication; HIV-infected individuals should be vaccinated according to the standard schedule.

Scheduled vaccinations with ADP-M-Biolik should be postponed until acute illness symptoms have resolved or until chronic disease exacerbations have subsided, and should be administered after recovery or during remission (see section "Contraindications"). Individuals with chronic diseases in remission may be vaccinated in a hospital setting based on the decision of a vaccination committee.

Immunosuppressive therapy – defined as treatment with cytostatic agents, including monotherapy with cyclosporine A and other corticosteroids at immunosuppressive doses (more than 2 mg/kg/day calculated as prednisolone), lasting more than 14 days when administered systemically, or radiation therapy. Scheduled vaccinations with ADP-M-Biolik should be performed after completion of such therapy (see section "Contraindications"). If corticosteroid therapy lasts less than 14 days regardless of dose, or more than 14 days at a prednisolone dose of less than 2 mg/kg/day, or is used as replacement therapy, or is administered locally, such therapy is not considered immunosuppressive and is not a contraindication for scheduled vaccination.

Subcutaneous administration is recommended for patients with thrombocytopenia or coagulation disorders.

Due to the use of formaldehyde in the manufacturing process of ADP-M-Biolik, residual amounts of this substance may be present in the final product; therefore, ADP-M-Biolik should be used with caution in individuals hypersensitive to formaldehyde.

This medicinal product contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially sodium-free.

Administration of the product must be recorded in the designated documentation forms, specifying the dose, product number, batch number, expiry date, manufacturer, and date of administration.

Use during pregnancy or breastfeeding

Data are lacking. The use of this vaccine during pregnancy or breastfeeding is not recommended.

Ability to affect reaction speed when driving or operating machinery

Data are lacking.

Method of Administration and Dosage

ADP-M-Biolik should be administered deep intramuscularly in the deltoid muscle area at a dose of 0.5 ml (single dose). Before administration, the ampoule should be shaken thoroughly until a homogeneous suspension is obtained.

When conducting immunization in Ukraine, current regulatory documents of the Ministry of Health of Ukraine must be followed.

Under no circumstances should the vaccine be administered intravenously or intradermally.

ADP-M-Biolik should be used in the following cases:

• for routine booster vaccination against diphtheria and tetanus at the age of 16 years;
• for the first routine booster vaccination in adults according to age and epidemiological indications who were previously vaccinated, to be administered at the age of 26 years, followed by subsequent routine booster vaccinations with ADP-M at a minimum interval of 10 years from the previous ADP-M vaccination.

Emergency tetanus prophylaxis does not interfere with routine immunization.

• For immunization against diphtheria and tetanus in children aged 7 years and older who have not been vaccinated according to schedule, and in adults who have never been vaccinated or whose vaccination history is unknown, a three-dose vaccination course with ADP-M is recommended. Booster vaccination in children aged 15–18 years who receive vaccinations outside the Ukrainian Vaccination Schedule should be performed at a minimum interval of 3 years after the last dose for diphtheria and tetanus prevention.
• For diphtheria prophylaxis in contacts aged 7 years and older within outbreak foci: unvaccinated individuals should receive the primary vaccination series with ADP-M-Biolik (vaccination and first booster); individuals due for a booster with ADP-M in the current year should receive the scheduled booster with ADP-M-Biolik. For vaccination within diphtheria outbreak foci in contacts who have been immunized according to the Vaccination Schedule, if at least one year has passed since the last diphtheria vaccination, an additional dose of AD or AD-M toxoid should be administered depending on age.
• For emergency tetanus immunoprophylaxis, if routine booster vaccination against diphtheria with ADP-M is also indicated, according to the "Guidelines for Specific Prophylaxis of Tetanus" approved by the order of the Ministry of Health of Ukraine.

Children. Administer to children aged 7 years and older.

Overdose.

No cases of overdose have been reported.

Adverse Reactions

Adverse reactions are listed based on post-marketing surveillance data.

The following criteria have been 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%.

Blood and lymphatic system disorders:

Very rare: Lymphadenopathy.

Immune system disorders:

Very rare: Allergic reactions, including anaphylactic shock, anaphylactoid reactions, and mild exacerbation of allergic diseases.

Psychiatric disorders:

Very rare: Sleep disturbances.

Nervous system disorders:

Very rare: Headache.

Vascular disorders:

Very rare: Arterial hypotension.

Respiratory, thoracic and mediastinal disorders:

Very rare: Dyspnea.

Gastrointestinal disorders:

Very rare: Nausea, diarrhea.

Skin and subcutaneous tissue disorders:

Very rare: Polymorphic rash, urticaria, pruritus, burning sensation of the skin, angioedema (Quincke's edema).

General disorders and administration site conditions:

Uncommon: Fever < 39 °C; pain at injection site, erythema, swelling at injection site.

Very rare: Fever ≥ 39 °C, weakness, irritability; infiltration at injection site.

Shoulder neuritis has been reported with other vaccines containing antigenic components similar to those in ACD-M-Biolik.

Shelf life. 2 years.

Storage conditions.

Store protected from light at a temperature between 2 and 8 °C. Do not freeze!

Keep out of reach of children.

Incompatibilities.

The medicinal product must not be mixed with other medicinal products.

Packaging.

0.5 mL (1 dose) or 1 mL (2 doses) in ampoules; 10 ampoules per pack.

Prescription category. Prescription only.

Manufacturer.

JSC "BIOLIK", Ukraine.

Manufacturer's address and place of business.

Pomirky, Kharkiv region, Ukraine.