Ad-m-biolic

INSTRUCTION for medical use of the medicinal product AD-M-BIOLIK

Composition:

Active substance: diphtheria anatoxin;

0.5 mL (1 dose) of the preparation contains diphtheria anatoxin – 5 flocculating units (Lf);

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. Injection suspension.

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

Pharmacotherapeutic group.

Bacterial vaccines. Diphtheria anatoxin.

ATC code J07A F01.

Immunological and biological properties.

Pharmacodynamics.

Administration of the preparation according to the approved schedule induces the formation of specific immunity against diphtheria.

Pharmacokinetics.

Assessment of pharmacokinetic data is not applicable for immunobiological medicinal products.

Clinical characteristics.

Indications.

Prevention of diphtheria in children aged 6 years and older, and adults.

Contraindications.

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

Allergic reaction to any component of the toxoid.

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

Acute illness or exacerbation of a chronic disease.

Congenital combined immunodeficiencies, primary hypogammaglobulinemia.

Immunosuppressive therapy.

Special precautions.

The product must not be used if the vial is damaged, unlabelled, beyond its expiry date, or if storage temperature requirements have been violated, or if there is a change in physical properties (change in color, presence of insoluble flakes).

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 medicines or waste must be carried out in accordance with national requirements.

Interaction with other medicinal products and other types of interactions.

Vaccination with AD-M-Biolik may be administered simultaneously with poliomyelitis vaccination. For co-administration with other vaccines according to the vaccination schedule, current orders of the Ministry of Health of Ukraine must be followed.

Special precautions.

A syncopal state (fainting) may occur before or during vaccination as a psychogenic reaction to needle injection. To prevent patient injury, vaccination should be administered while the patient is seated or lying down, and the patient should remain in this position for 15 minutes after vaccination.

Due to the possibility of immediate-type allergic reactions in particularly sensitive individuals, medical supervision is required for 30 minutes after vaccination. Vaccination rooms must be equipped with emergency anti-shock therapy supplies.

Further vaccinations with this vaccine should not be administered to individuals who have experienced severe allergic reactions after receiving AD-M-Biolik.

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

The use of the vaccine must be recorded in the established documentation forms, including the batch number, expiry date, manufacturing company, and date of administration.

Use during pregnancy or breastfeeding.

Data are lacking.

Ability to influence the speed of reactions when driving or operating machinery.

Data are lacking.

Method of Administration and Dosage.

AD-M-Biolik should be administered intramuscularly into the upper outer quadrant of the buttock, or into the anterolateral part of the thigh, or subcutaneously into the subscapular region, 0.5 mL of suspension (single dose). Before administration, the ampoule must be thoroughly shaken until a homogeneous suspension is obtained.

When carrying out immunization in Ukraine, current orders of the Ministry of Health must be followed.

AD-M-Biolik should be used in diphtheria outbreak areas for immunization of individuals previously vaccinated according to the Calendar of Preventive Vaccinations, provided that at least one year has passed since the last diphtheria vaccination. In cases where individuals are due for booster vaccination in the current year, or for immunization of unvaccinated individuals, vaccines containing diphtheria component should be used according to the patient's age.

Children. Indicated for use in children aged 6 years and older.

Overdose.

No cases of overdose have been reported.

Side effects.

The side effects listed below 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 disorders and administration site reactions

Rare: fever, malaise; pain, erythema, swelling at the injection site.

Immune system disorders

Very rare: mild exacerbation of allergic diseases.

Nervous system disorders

Very rare: headache.

Skin and subcutaneous tissue disorders

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

Shelf life. 3 years.

Storage conditions.

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

Keep out of reach of children.

Incompatibilities.

The medicine 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 ampoules; 10 ampoules per pack.

Prescription status. Prescription only.

Manufacturer.

JSC "BIOLIK", Ukraine.

Manufacturer's address and location of its business activity.

Pomirky, Kharkiv region, Ukraine.