SIILTIBCY (0.5 micrograms + 0.5 micrograms)/mL Injectable Solution

Introduction

Package Leaflet: Information for thepatient

SIILTIBCY (0.5 micrograms + 0.5 micrograms)/ml injectable solution

antigens derived from Mycobacterium tuberculosis(rdESAT-6 and rCFP-10)

This medicinal product is subject to additional monitoring, which will allow for the quick detection of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

Read all of this leaflet carefully before receiving this skin test because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is SIILTIBCY and what is it used for
2. What you need to know before receiving SIILTIBCY
3. How SIILTIBCY is administered
4. Possible side effects
5. Storage of SIILTIBCY
6. Package contents and further information

1. What is SIILTIBCY and what is it used for

SIILTIBCY is for diagnostic use and contains two specific tubercular proteins (antigens) called rdESAT-6 and rCFP-10 as active substances.

SIILTIBCY is injected into the skin (by intradermal route) to detect infection (including disease) caused by Mycobacterium tuberculosisin adults and children over 28 days.

For the interpretation of the test results, it is used together with other medical procedures.

If a person has been infected with Mycobacterium tuberculosis, their immune system will respond by producing cytokines (inflammatory proteins) that cause an induration (hardening) at the site where SIILTIBCY was injected, which usually occurs between 48 and 72 hours after injection.

2. What you need to know before receiving SIILTIBCY

You should not receive SIILTIBCY

• if you are allergic to the active substances of SIILTIBCY, rdESAT-6, rCFP-10, or to any of the other components of this medicinal product (listed in section 6).
• if you are allergic to Lactococcus lactis, a bacterium used to manufacture SIILTIBCY.
• if you have experienced a severe local (skin) or general (affecting any part of the body) reaction to other tuberculosis skin tests.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before undergoing a SIILTIBCY test if:

• you have undergone a SIILTIBCY test in the last 6 weeks.
• you have been vaccinated in the last 4 weeks with live vaccines (such as measles, mumps, and rubella vaccines).
• you are taking any medication (such as corticosteroids) or have a disease that may suppress the immune system, such as the human immunodeficiency virus (HIV).

Although it is not known to occur with SIILTIBCY, very rare severe allergic reactions (anaphylaxis) such as lip, face, and throat swelling, difficulty breathing, and urticarial rash have occurred with other tuberculosis skin tests. Inform your doctor or nurse immediately or contact the nearest doctor or emergency service if you experience one or more of these symptoms after undergoing the SIILTIBCY test.

Children and adolescents

There are no additional warnings or precautions applicable to children or adolescents.

Other types of mycobacteria (non-tuberculous mycobacteria) and SIILTIBCY

The use of SIILTIBCY is not suitable for identifying prior contact with non-tuberculous mycobacteria types or prior vaccination with Bacillus Calmette-Guérin.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before undergoing a skin test.

It is not expected that undergoing the SIILTIBCY test during pregnancy and breastfeeding will have a harmful effect.

Driving and using machines

SIILTIBCY has no or negligible influence on the ability to drive and use machines.

SIILTIBCY contains potassium, sodium, and polysorbate 20

This medicinal product contains potassium, less than 1 mmol (39 mg) per dose; this is, essentially 'potassium-free'.

This medicinal product contains less than 1 mmol of sodium (23 mg) per dose; this is, essentially 'sodium-free'.

This medicinal product contains 0.011 mg of polysorbate 20 in each dose, which is equivalent to 0.11 mg/ml.

Polysorbates may cause allergic reactions. Consult your doctor if you have any known allergy.

3. How SIILTIBCY is administered

Your doctor or nurse will inject SIILTIBCY into the upper layer of the skin of your forearm.

The recommended dose is 0.1 ml. The dose is the same for all age groups.

After injection, a papule (elevated bump on the skin) of 8-10 millimeters in diameter will appear, which will last for about 10 minutes. Redness and induration (skin hardening) may appear in the injection area. After injection, your doctor or nurse may monitor you for at least 15 minutes to detect signs of an allergic reaction.

You should keep the injection area clean; do not scratch the injection area, and if itching occurs, a cold compress can be applied.

You should return to your doctor or nurse 48 to 72 hours after the test to check the result. If redness or induration has appeared, it should decrease after this time.

Detailed information on the method of administration of SIILTIBCY and evaluation of the result is included in the section 'The following information is intended exclusively for healthcare professionals'.

The SIILTIBCY test is not affected by prior vaccination with the Bacillus Calmette-Guérin (BCG) vaccine.

If you have any further questions on the use of this medicinal product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Although it is not known to occur with SIILTIBCY, very rare severe allergic reactions (anaphylaxis) such as lip, face, and throat swelling, difficulty breathing, and urticarial rash have occurred with other tuberculosis skin tests. If you experience any of these reactions, inform your doctor or nurse immediately or contact the nearest doctor or emergency service.

Other side effects

Very common(may affect more than 1 in 10 people)

• Itching at the injection site

Common(may affect up to 1 in 10 people)

• Bruising at the injection site
• Vesicles at the injection site
• Headache
• Induration at the injection site
• Swelling at the injection site
• Pain at the injection site
• Rash at the injection site
• Redness at the injection site

Uncommon(may affect up to 1 in 100 people)

• Lymphadenopathy
• Fever
• Ulcers at the injection site
• Bleeding at the injection site
• Malaise
• Dizziness
• Rash
• Itching
• Myalgia
• Fatigue
• Discoloration at the injection site
• Pain in the limbs
• Pain
• Gastroenteritis
• Diarrhea
• Flu-like illness
• Nausea

Rare(may affect up to 1 in 1,000 people)

• Lymphadenitis
• Hepatitis
• Urticaria on any part of the body
• Pain in the armpit
• Head discomfort
• Chills
• Hypoesthesia at the injection site
• Papule at the injection site
• Urticaria at the injection site
• Nodule at the injection site
• Inflammation at the injection site
• Eosinophilia
• Nocturnal sweats
• Arthritis
• Vomiting
• Increased transaminases (increased blood concentrations of liver enzymes)
• Paresthesia on any part of the body
• Jaundice

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. Storage of SIILTIBCY

Keep this medicinal product out of the sight and reach of children.

Do not use this medicinal product after the expiry date which is stated on the carton and on the label of the vial after EXP. The expiry date is the last day of the month stated.

Store in a refrigerator (between 2°C and 8°C). Do not freeze.

Store in the original package to protect from light.

Once opened, the vial can be used for 28 days, provided it is stored in a refrigerator (between 2°C and 8°C).

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and further information

Composition of SIILTIBCY

• The active substances are the antigens derived from Mycobacterium tuberculosis rdESAT-6 and rCFP-10.
• One dose (0.1 ml) of SIILTIBCY contains 0.05 micrograms of rdESAT-6 and 0.05 micrograms of rCFP-10.
• The other ingredients are disodium phosphate dihydrate (E339), potassium dihydrogen phosphate (E340), potassium chloride (E508), sodium chloride, polysorbate 20 (E432), phenol, and water for injections (see section 2 'SIILTIBCY contains potassium, sodium, and polysorbate 20').

Appearance of the product and package contents

SIILTIBCY injectable solution (injectable) is a clear, colorless to pale yellow solution. This medicinal product should not be used if visible particles are observed.

SIILTIBCY is presented in a pack of 1 multidose glass vial or in multiple packs containing 10 (10 packs of 1) multidose glass vials, each with 1 ml.

Not all pack sizes may be marketed.

Marketing authorization holder

Serum Life Science Europe GmbH

Ahrensburger Strasse 1

30659 Hannover

Germany

Manufacturer

Bilthoven Biologicals B.V.

Antonie Van Leeuwenhoeklaan 9

3712 MA Bilthoven

Netherlands

Date of last revision of this leaflet:

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.

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This information is intended exclusively for healthcare professionals

SIILTIBCY should be prepared and administered by intradermal injection by trained healthcare professionals using the Mantoux technique. The medicinal product should be administered with adequate hand hygiene and using an aseptic technique, as follows:

• Draw up 0.1 ml of SIILTIBCY using a 1 ml syringe with a short-bevel needle. Before drawing up SIILTIBCY from the multidose vial, expel the air from the syringe. If the vial is already open, clean with an alcohol swab and let it dry before use.
• Administer the 0.1 ml of SIILTIBCY by intradermal route in the middle third of the forearm using the Mantoux technique. To do this, stretch the skin slightly and hold the needle almost parallel to the skin surface with the bevel upwards. Insert the tip of the needle into the superficial layer of the dermis. Check that the needle is visible through the epidermis during injection. Do not apply the test to areas of scars, rashes, burns, or tattoos.
• Inject the 0.1 ml of solution slowly. A small white papule of 8-10 millimeters in diameter will appear, which should disappear after about 10 minutes. If the papule does not appear, repeat a new injection of 0.1 ml of SIILTIBCY in the other arm or in the same arm at a minimum distance of 4 cm from the first injection site.

It is recommended to closely monitor the subject for at least 15 minutes after the test.

Evaluation of the reaction

Intradermal injection of SIILTIBCY may induce an induration at the injection site. The induration can be seen as a raised area with a clearly defined margin in the injection area and around it. Although erythema may accompany the induration, only the induration should be measured.

The induration should be measured between 48 and 72 hours after injection by a trained healthcare professional. Measure the diameter of the induration transversely to the long axis of the forearm with a ruler. To facilitate measurement, it is suggested to use a flexible ruler (or one that can be easily bent).

Normally, the induration and erythema will decrease after 4 days and disappear within 28 days after injection.

Interpretation

An induration of ≥ 5 mm is considered a positive result, indicating an infection with Mycobacterium tuberculosis.