Siiltibcy

Package leaflet: Information for the user

SIILTIBCY (0.5 micrograms + 0.5 micrograms)/mL solution for injection

Derived Mycobacterium tuberculosis antigens (rdESAT-6 and rCFP-10)
This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Before undergoing the skin test, please read this leaflet carefully as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What SIILTIBCY is and what it is used for
2. What you need to know before using SIILTIBCY
3. How to use SIILTIBCY
4. Possible side effects
5. How to store SIILTIBCY
6. Contents of the pack and other information

1. What SIILTIBCY is and what it is used for

SIILTIBCY is for diagnostic use and contains as active substances two specific tubercular proteins (antigens) named rdESAT-6 and rCFP-10.
SIILTIBCY is injected into the skin (intradermally) to detect infection (including disease) caused by Mycobacterium tuberculosis in adults and children aged 28 days and older.
The test results are interpreted in conjunction with other medical procedures.
If a person has been infected with Mycobacterium tuberculosis, their immune system responds by producing cytokines (inflammatory proteins), which cause induration at the injection site of SIILTIBCY, typically occurring between 48 and 72 hours after injection.

2. What you need to know before using SIILTIBCY

Do not take SIILTIBCY

• if you are allergic to the active substances in SIILTIBCY, rdESAT-6, rCFP-10, or to any other component of this medicine (listed in section 6).
• if you are allergic to Lactococcus lactis, a bacterium used to produce SIILTIBCY.
• if you have previously had a severe local (skin) or general (affecting any part of the body) reaction to other skin tests for tuberculosis.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using the SIILTIBCY test if:

• you have had a SIILTIBCY test within the last 6 weeks.
• you have been vaccinated in the last 4 weeks with live vaccines (such as vaccines against measles, mumps, and rubella).
• you are taking any medicines (e.g., corticosteroids) or suffer from conditions that may suppress the immune system, such as human immunodeficiency virus (HIV). Although not known to occur with SIILTIBCY, severe allergic reactions (anaphylaxis), such as swelling of lips, face, and throat, difficulty breathing, and hives, have occurred very rarely with other skin tests for tuberculosis. Inform your doctor or nurse who performed this skin test immediately, or contact your doctor or nearest emergency department 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 SIILTIBCY test is not suitable for identifying prior exposure to types of mycobacteria that do not cause tuberculosis or prior vaccination with Bacille Calmette-Guérin (BCG).
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before undergoing the skin test.
The use of the SIILTIBCY test during pregnancy and breastfeeding is not expected to have harmful effects.
Driving and using machines
SIILTIBCY does not affect, or has a negligible effect on, the ability to drive or operate machinery.
SIILTIBCY contains potassium, sodium and polysorbate 20
This medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium-free’.
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.
This medicine contains 0.011 mg of polysorbate 20 per dose, equivalent to 0.11 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergy.

3. How to use SIILTIBCY

The doctor or nurse will inject SIILTIBCY into the upper layer of the skin of the forearm.
The recommended dose is 0.1 mL. This dose is the same for all age groups.
After the injection, a papule (a raised area on the skin) of 8–10 millimeters in diameter will appear and
will remain for about 10 minutes. Redness and induration (hardening of the skin) may occur at the
injection site. After the injection, the doctor or nurse may observe you for at least 15 minutes to monitor
for signs of an allergic reaction.
It is important to keep the injection site clean, avoid rubbing it, and, if itching occurs, apply a cold compress.
For test interpretation, you must return to the doctor or nurse 48–72 hours after the injection to
check the result. Any redness or induration that appeared should decrease after this period.
Detailed information on the administration method of SIILTIBCY and on result evaluation is included
in the section “The following information is intended exclusively for healthcare professionals:”.
The SIILTIBCY test is not affected by previous vaccination with Bacille Calmette-Guérin (BCG) vaccine.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

Serious side effects

Although it is not known to occur with SIILTIBCY, severe allergic reactions (anaphylaxis), such as swelling of the lips, face and throat, difficulty breathing and urticaria, have been reported very rarely with other tuberculin skin tests. If you experience any of these reactions, inform immediately the doctor or nurse who performed this skin test, or contact your doctor or the nearest emergency department.

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)

• Haematoma (bruising) at the injection site
• Blisters (spots) at the injection site
• Headache
• Induration (hardening of the skin) at the injection site
• Swelling at the injection site
• Pain at the injection site
• Skin rash at the injection site
• Erythema (redness) at the injection site

Uncommon (may affect up to 1 in 100 people)

• Lymphadenopathy (swollen lymph nodes)
• Fever
• Ulcers at the injection site
• Haemorrhage (bleeding) at the injection site
• Malaise (general feeling of discomfort, illness or uneasiness)
• Dizziness
• Skin rash
• Itching
• Myalgia (muscle pain)
• Fatigue (tiredness)
• Change in skin colour at the injection site
• Limb pain (hands, arms, feet or legs)
• Pain
• Gastroenteritis (inflammation of the stomach and intestines)
• Diarrhoea
• Influenza-like illness
• Nausea (feeling unwell)

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

• Lymphadenitis (infection of the lymph nodes)
• Hepatitis (inflammation of the liver)
• Urticaria (itching and raised red areas of skin) anywhere on the body
• Armpit pain
• Head discomfort
• Chills
• Hypoaesthesia (numbness at the injection site)
• Papule (swelling) at the injection site
• Urticaria (itching and raised red areas of skin) at the injection site
• Nodule (swollen lump) at the injection site
• Inflammation at the injection site
• Eosinophilia (increase in white blood cells)
• Night sweats
• Arthritis (joint pain and swelling)
• Vomiting
• Increased transaminases (elevated blood levels of liver enzymes)
• Paresthesia (numbness, tingling or prickling) anywhere on the body
• Jaundice (yellowing of the skin and eyes)

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SIILTIBCY

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the label of the
vial after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep in the original packaging to protect from light.
After first opening, the vial may be used for up to 28 days if stored in the refrigerator (2 °C – 8 °C).
Do not dispose of medicines via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What SIILTIBCY contains

• The active substances are 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 dibasic dihydrate (E339), potassium dihydrogen phosphate, potassium chloride (E340), sodium chloride (E508), polysorbate 20 (E432), phenol, and water for injections. See section 2 “SIILTIBCY contains potassium, sodium and polysorbate 20”.

Description of the appearance of SIILTIBCY and contents of the pack
SIILTIBCY injectable solution (injection) is a clear, colourless or pale yellow solution.
This medicinal product must not be used if visible particles are observed.
SIILTIBCY is available in packs containing 1 multidose glass vial or in multiple packs
containing 10 (10 packs of 1) multidose glass vials, each containing 1 mL.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Serum Life Science Europe GmbH
Ahrensburger Strasse 1
30659 Hannover
Germany
Manufacturer
Bilthoven Biologicals B.V.
Antonie Van Leeuwenhoeklaan 9-13
3712 MA Bilthoven
The Netherlands
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: https://www.ema.europa.eu .
The following information is intended exclusively for healthcare professionals
SIILTIBCY must be prepared and administered via intradermal injection by healthcare professionals
trained in the Mantoux technique. The medicinal product must be administered with proper
hand hygiene and using an aseptic technique, as follows:

• Draw up 0.1 mL of SIILTIBCY using a 1 mL syringe with a short, bevelled needle. Before aspirating SIILTIBCY from the multidose vial, expel air from the syringe. If the vial has already been opened, wipe it with an alcohol swab and allow it to dry before use.
• Administer 0.1 mL of SIILTIBCY intradermally into the middle third of the forearm using the Mantoux technique. Stretch the skin slightly and hold the needle almost parallel to the skin surface with the bevel facing upward. Insert the needle tip into the superficial layer of the dermis. Ensure that the needle tip is visible through the epidermis during injection. Do not administer the test at sites with scars, skin eruptions, burns, or tattoos.
• Slowly inject the 0.1 mL of solution drawn up. A small, pale wheal of 8–10 millimetres (mm) in diameter should appear, which should disappear within approximately 10 minutes. If no wheal appears, repeat a new 0.1 mL injection of SIILTIBCY on the other arm or on the same arm at least 4 cm away from the initial injection site.

It is recommended to observe the subject carefully for at least 15 minutes after administration.
Evaluation of the reaction
Intradermally injected SIILTIBCY may induce induration at the injection site.
Induration may be observed as a raised area with a clearly defined margin at and around the
injection site. Although erythema may accompany induration, only induration should be measured.
Induration should be measured 48 to 72 hours after injection by a qualified healthcare professional.
Measure the diameter of the induration perpendicular to the long axis of the forearm using a ruler.
For ease of measurement, a flexible (or easily bendable) ruler is recommended.
Typically, induration and erythema decrease after 4 days and disappear within 28 days
after injection.
Interpretation
An induration ≥ 5 mm is considered a positive test result, indicating infection with Mycobacterium tuberculosis.