Tuberculin ppd rt 23 ssi

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT TUBERCULIN PPD RT 23 SSI

Composition:

Active substance: tuberculin PPD RT 23

One dose (0.1 ml) contains: 0.04 mcg of tuberculin PPD RT 23 (2 TU)

One vial (1.5 ml) contains: 15 doses of Tuberculin PPD RT 23 SSI (2 TU/0.1 ml)

Excipients: disodium hydrogen phosphate dihydrate, sodium chloride, potassium dihydrogen phosphate, potassium hydroxyquinoline sulfate, polysorbate 80, water for injections.

Pharmaceutical form. Solution for injection.

Main physicochemical properties:

Tuberculin PPD RT 23 SSI is a clear, colorless to pale yellow solution free from foreign particles.

Pharmacotherapeutic group. Tuberculosis diagnostic agents. Tuberculin.

ATC Code V04CF01.

Pharmacological properties / immunological and biological properties.

Pharmacodynamics. The active ingredient of the preparation induces, when performing an intradermal diagnostic test, a specific delayed-type allergic reaction in an infected or vaccinated individual, manifested as a local reaction—hyperemia and infiltration (papule).

Pharmacokinetics.

Not applicable.

Clinical characteristics.

Indications.

The drug is intended for performing the intradermal tuberculin skin test (Mantoux test) with 2 TU PPD RT 23:

• for diagnosis of tuberculosis and identification of risk groups with latent tuberculosis infection;
• for selection of populations for BCG revaccination;
• for determining the prevalence of tuberculosis infection in the population (or the state of increased sensitivity to tuberculin, if post-vaccination allergy is present, which does not indicate actual infection).

Contraindications.

Skin diseases; acute illness or exacerbation of chronic disease,
including: allergic conditions, bronchial asthma, idiosyncrasy with pronounced skin manifestations, rheumatism in acute and subacute phases; epilepsy.

The Mantoux test should not be performed in child groups where quarantine is in place due to childhood infections.

Tuberculin PPD RT 23 SSI must not be administered:

• to individuals with known hypersensitivity (Type I) to the active substance or to excipients;

• to individuals with a history of severe local reaction (e.g., vesiculation, skin necrosis) following a previous Mantoux test. Necrosis at the injection site usually resolves within several days.

Special precautions.

When using a multidose vial, a new sterile, single-use autodisable syringe with a sterile needle must be used for each withdrawal of the product. The drug must be withdrawn from the vial under strict aseptic conditions.

Any unused medicinal product or waste material must be disposed of in accordance with current regulatory requirements in Ukraine.

Tuberculin PPD RT 23 SSI does not contain live microorganisms.

Interaction with other medicinal products and other forms of interaction.

Various medical and biological factors may lead to false-negative tuberculin reactions, for example, patient's age, nutritional status; or conditions such as renal failure, diabetes mellitus, presence of malignant tumors, HIV infection, sarcoidosis; or immunosuppressive influences (corticosteroid therapy). Viral infections (particularly measles, mumps, mononucleosis, varicella, and influenza) may reduce tuberculin reactivity for several months.

Reduced tuberculin reactivity may occur following vaccination with live vaccines (e.g., measles, mumps, and rubella vaccines). This reduced reactivity may lead to a false-negative result. Therefore, the interval between any prophylactic vaccination and the diagnostic Mantoux test should be at least 4–6 weeks.

Most patients co-infected with HIV and Mycobacterium tuberculosis do not exhibit tuberculin sensitivity. In patients with severe forms of tuberculosis (e.g., miliary tuberculosis), the tuberculin reaction may be diminished.

Prior BCG vaccination or recent infection with non-tuberculous mycobacteria may lead to cross-sensitization and result in a false-positive reaction to the Mantoux tuberculin test.

Special precautions for use.

Traceability

To improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly documented.

Although cases of anaphylaxis are very rare during administration of the Mantoux tuberculin test, standard emergency treatment measures for anaphylaxis must always be readily available. Medical supervision of the individual is required for 30 minutes after tuberculin injection due to the possibility of immediate-type allergic reactions.

The interval between any prophylactic vaccination, biological diagnostic test, and the Mantoux test should be at least 1 month. The Mantoux test must not be performed in child groups under quarantine due to childhood infections.

A medical examination prior to the Mantoux test is mandatory.

The Mantoux test is administered by a specially designated nurse, as appointed by a physician, who holds an official permit for performing tuberculin diagnostics using the intradermal method. The results of the tuberculin test may be evaluated by a physician or by a specially trained nurse who performed the test, under physician supervision. The results of the Mantoux test must be recorded in the established documentation forms, including the name of the manufacturer, batch number, control number, and expiry date of tuberculin; date and time of tuberculin test administration; and the injection site location.

Tuberculin PPD RT 23 SSI must not be administered subcutaneously or intramuscularly. If no papule forms, the needle was inserted too deeply. The test should then be repeated on the other arm or on the same arm at least 4 cm away from the first injection site, as directed by a physician.

This medicinal product contains less than 1 mmol (39 mg)/dose of potassium, i.e., essentially "potassium-free".

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

Use during pregnancy or breastfeeding

Reproductive studies on Tuberculin PPD RT 23 SSI have not been conducted in animals.

The Mantoux tuberculin skin test using Tuberculin PPD RT 23 SSI is safe during pregnancy and lactation.

Fertility. There are no clinical or preclinical data on the potential effect of Tuberculin PPD RT 23 SSI on male or female fertility.

Ability to affect reaction rate while driving or operating machinery

Studies on the ability to affect reaction rate while driving or operating machinery have not been conducted.

Tuberculin PPD RT 23 SSI does not affect reaction rate while driving or operating machinery.

Method of administration and dosage.

Method of administration

Tuberculin PPD RT 23 SSI is administered intradermally.

Prior to performing tuberculin testing (Mantoux test), the vial should be carefully inspected. Remove the plastic cap from the aluminum crimped cap of the vial. Disinfect the rubber stopper with a cotton swab moistened with 70% ethyl alcohol. Draw up the required amount of tuberculin (0.1 mL – one dose) using a self-locking single-use 0.1 mL syringe with a sterile needle and administer strictly intradermally 0.1 mL of the preparation (one dose) into the inner surface of the forearm. A separate self-locking 0.1 mL syringe with a sterile needle must be used for each individual being tested.

The Mantoux test is performed under strict aseptic conditions as follows: the skin of the middle third of the inner surface of the forearm is disinfected with 70% ethyl alcohol and dried with a sterile cotton swab. The injection should be administered into the middle third of the forearm (the reaction may be weaker near the wrist or elbow crease). The skin is slightly stretched and the needle is inserted into the superficial layer of the skin almost parallel to its surface with the bevel facing upward. The needle should be visible through the epidermis. The preparation is injected slowly, forming a papule 8–10 mm in diameter, which should remain visible for approximately 10 minutes. If no papule forms, the needle was inserted too deeply; the test should be repeated on the other arm as directed by a physician.

The reaction to the injection is evaluated 48–72 hours after administration. The final assessment is performed at 72 hours. A positive reaction is defined by the presence of an induration (papule) with a diameter of 5 mm or greater, surrounded by erythema. Only the skin induration is evaluated. Its diameter is measured perpendicular to the long axis of the forearm using a flexible, transparent plastic ruler.

Recommendations for evaluating Mantoux test results in Ukraine

Reactions of 15–16 mm are considered pronounced; hyperergic reactions are defined as the presence of a papule of 17 mm or more in children and adolescents and of 21 mm or more in adults, as well as the presence of vesiculonecrotic reaction, lymphangitis, and regional lymphadenitis, regardless of the papule size.

Dosage

For performing the Mantoux test with 2 TU, a single dose of Tuberculin PPD RT 23 SSI, amounting to 0.1 mL, is used.

Children. Administered to children aged 2 months and older (see section "Indications").

Overdose.

Adverse reactions associated with overdose of the drug are unknown.

Adverse reactions

The most commonly reported adverse reactions following administration of Tuberculin PPD RT 23 SSI are pain, itching, and irritation at the injection site.

There is extensive clinical experience with Tuberculin PPD RT 23 SSI, and its safety profile is well established (see table below).

Adverse reactions are classified according to their frequency of occurrence:

Very common: ≥ 1/10
Common: ≥ 1/100 to < 1/10
Uncommon: ≥ 1/1000 to < 1/100
Rare: ≥ 1/10000 to < 1/1000
Very rare: < 1/10000
Not known: cannot be estimated from the available data.

Table of adverse reactions

Reporting of Adverse Reactions

Reporting suspected adverse reactions after medicinal product authorization is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at https://aisf.dec.gov.ua.

Shelf life

3 years (from the date of manufacture of the bulk form).

From a microbiological standpoint, after the first opening of the multidose vial, the medicinal product should be used immediately.

If the medicinal product is not used immediately, storage time and conditions must not exceed 24 hours at a temperature of 2 to 8 °C.

Storage conditions

Store in a refrigerator at a temperature of 2 to 8 °C.

Store in the original packaging, protected from light.

Keep out of reach of children.

Storage conditions after first opening of the vial (see section “Shelf life”).

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Packaging

1.5 ml of injectable solution containing 2 TU/0.1 ml (15 doses) of Tuberculin PPD RT 23 SSI, in clear Type I glass vials according to Eur.Ph., with a chlorobutyl rubber stopper and an aluminum seal with a polypropylene “flip-off” cap.

One vial, together with 15 self-locking syringes, in a blister pack or without a blister pack, in a cardboard box with the instructions for medical use.

Prescription status

Prescription only.

Manufacturer/Applicant

LLC “LYUM’ER PHARMA”, Ukraine (manufacturing and packaging of bulk product by AJ Vaccines A/S, Denmark).

Manufacturer’s location and address of the place of business

13 Stepan Bandera Avenue, Kyiv, 04073, Ukraine