Shhepionka pzhecivgruzhliha Bcg 10

Leaflet attached to the packaging: information for the user

BCG Tuberculosis Vaccine 10

Powder and solvent for the preparation of a suspension for intradermal injections
Vaccinum tuberculosis (BCG) cryodesiccatum
BCG tuberculosis vaccine lyophilized
10-dose vaccine

You should carefully read the contents of the leaflet before using the vaccine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This vaccine has been prescribed specifically for this person. It should not be given to others.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is BCG Tuberculosis Vaccine 10 and what is it used for
• 2. Important information before using BCG Tuberculosis Vaccine 10
• 3. How to use BCG Tuberculosis Vaccine 10
• 4. Possible side effects
• 5. How to store BCG Tuberculosis Vaccine 10
• 6. Contents of the packaging and other information
• 1.

What is BCG Tuberculosis Vaccine 10 and what is it used for

BCG Tuberculosis Vaccine 10 is available as a powder and solvent for the preparation of a suspension for intradermal injections. BCG Tuberculosis Vaccine 10 contains live, attenuated bacteria derived from the bovine tubercle bacillus BCG (Bacillus Calmette-Guerin), Moreau substrain.
The vaccine is used for protective vaccinations against tuberculosis.
Vaccinations in Poland are mandatory, performed in accordance with the Protective Vaccination Program approved annually by the Minister of Health.
If a child has not been vaccinated at birth, they should be vaccinated as soon as possible, but no later than the age of 15.
In the case of tuberculosis immunity, further doses of the vaccine are not recommended.

2. Important information before using BCG Tuberculosis Vaccine 10

When not to use BCG Tuberculosis Vaccine 10

• 1. BCG vaccinations should not be performed:
• in people with known hypersensitivity to any component of the vaccine;
• in newborns with a body weight below 2000 g;
• in newborns of HIV-infected mothers until HIV infection is ruled out in the child;
• in newborns with suspected congenital immune disorders;
• in newborns of mothers treated with drugs such as anti-TNF-alpha monoclonal antibodies in the third trimester of pregnancy;
• in people with HIV infection (confirmed or suspected, even if asymptomatic);
• in people with primary or secondary immune deficiencies (including interferon gamma deficiency or Di George's syndrome);
• in people undergoing radiotherapy;
• in people treated with corticosteroids, during immunosuppressive treatment (including treatment with anti-TNF-alpha monoclonal antibodies such as infliximab);
• in people with cancer (such as leukemia, lymphoma, or other reticuloendothelial system tumors);
• in patients after bone marrow or organ transplantation;
• in people with severe diseases (including severe malnutrition);
• during pregnancy; in people who have had tuberculosis or with a large (over 5 mm) tuberculin test reaction (RT23).
• 2. Vaccinations should be postponed in the case of:
• newborns in unstable clinical condition until their general health improves (they should be vaccinated before leaving the neonatal ward);
• during infection with fever;
• exacerbation of chronic disease;
• generalized skin infections.

Premature birth is not a contraindication to vaccination, and it is recommended to perform the vaccination in this group of patients after reaching a body weight of 2000 g.

Warnings and precautions

BCG vaccine should be administered intradermally only.
Consideration should be given to the risk of apnea and the need for monitoring of respiratory function for 48 to 72 hours in the case of administration of the vaccine to very premature infants (born ≤ 28 weeks of gestation), especially in children who have had symptoms of respiratory immaturity. Due to the significant benefits of vaccinating this group of infants, vaccination should not be waived or postponed.
Vaccination with BCG should be postponed in the case of newborns whose mothers received anti-TNF therapy or other potentially immunosuppressive IgG1 antibodies during pregnancy. The decision to vaccinate is made by the doctor.

BCG vaccine and other medicines

Intradermal BCG vaccination can be performed simultaneously with inactivated or attenuated vaccines.
If vaccines containing live microorganisms are not administered at the same time as the BCG vaccine, a minimum interval of 4 weeks should be maintained between vaccinations.
BCG vaccination should be postponed for 4 weeks if another live vaccine has been administered previously.
The interval between a vaccine containing live microorganisms and a vaccine not containing live microorganisms is arbitrary, with the necessary interval to avoid overlapping of any potential post-vaccination reaction with subsequent vaccination.
Vaccines administered at the same time should not be injected into the left arm reserved for the BCG vaccine.
Children should not be vaccinated in the left arm for at least 3 months after BCG administration due to the risk of developing regional lymphadenitis.

Pregnancy and breastfeeding

Vaccines should not be used during pregnancy.
Breastfeeding is not a contraindication to the administration of the BCG vaccine.

Driving and using machines

BCG vaccine does not affect or has a negligible effect on the ability to drive and use machines.

3. How to use BCG Tuberculosis Vaccine 10

Vaccination should be performed by personnel specially trained in intradermal injections.
BCG Tuberculosis Vaccine 10 should be administered intradermally only!
The instructions for preparing the BCG Tuberculosis Vaccine 10 suspension and performing the vaccination are included in the section: Information intended exclusively for medical personnel, at the end of the leaflet.
In accordance with the recommendations of the World Health Organization, the BCG vaccine should be administered in the middle of the upper left arm (in the deltoid region).
Injecting the vaccine too high, into the upper part of the arm, may contribute to the development of a keloid.
After 2-4 weeks, a nodule forms at the vaccination site in 90-95% of vaccinated individuals, which persists for several weeks. Usually, a pustule forms on the surface of the nodule, and then an ulcer, usually with a diameter of 2-5 mm, not exceeding 10 mm. The lesion heals spontaneously within 2-3 months of vaccination, leaving a white scar with a diameter of several millimeters.
In some individuals, a serous fluid may drain from the pustule for a longer period, which is not a complication and does not require treatment, but rather keeping the area clean.

Use of a higher dose of BCG Tuberculosis Vaccine 10

An increase in the vaccine dose causes a significant increase in the number of post-vaccination complications from the lymph nodes.

4. Possible side effects

Like any medicine, this vaccine can cause side effects, although they may not occur in everyone. Changes at the injection site: nodule, pustule, ulcer, sometimes with serous fluid drainage, usually resolve spontaneously within 3 months of vaccination and do not require treatment.
Enlargement of regional lymph nodes, usually axillary, up to 15 mm in the vaccinated person, is considered an expected, normal post-vaccination reaction.
Severe local reactions such as:

• large ulcers (with a diameter greater than 1 cm),
• abscess or keloid (scar), are most often associated with an error in vaccine administration technique, incorrect dose, or individual reaction (e.g., positive tuberculin test result - RT23).

If a local reaction occurs after BCG vaccination within 24-48 hours and an abscess (within 5-7 days), it can be suspected that there was a previous tuberculosis infection.
Injecting the vaccine too high, into the upper part of the arm, increases the risk of developing a keloid (scar).
In the case of severe local reactions or regional lymphadenitis, medical consultation is required, followed by an individual decision on further proceedings, but usually, no treatment is given, as they resolve spontaneously.
Severe generalized reactions after BCG vaccination are very rare (about 2/1000000) and usually occur in people with immune disorders.
Disseminated BCG infection requires specialized advice, bacteriological diagnosis, and immunological assessment, as well as anti-tuberculosis treatment in a hospital setting.
In the case of post-vaccination changes that the pediatrician considers a post-vaccination complication, the child should be referred to a consultant who will make a final diagnosis and recommend further proceedings.
In premature infants (born at 28 weeks of gestation or earlier), within 2-3 days after vaccination, longer pauses between breaths may occur.
Tabular list of side effects
The table below has been prepared in accordance with the MedDRA system organ classification (system organ classification and recommended terms).
The frequency of occurrence was assessed according to the following criteria: very common (>1/10), common (>1/100 to <1>1/1,000 to <1>1/10,000 to <1>

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store BCG Tuberculosis Vaccine 10

Store in a place invisible and inaccessible to children.
Do not use this vaccine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Store the vaccine in a refrigerator (2°C - 8°C). To protect from light, store the ampoules or vials in the outer packaging.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
Batch number (Lot)
Expiry date (EXP)

6. Contents of the packaging and other information

What does BCG Tuberculosis Vaccine 10 contain

• The active substance is live BCG bacteria (Bacillus Calmette-Guerin), Moreau substrain. One vaccine dose (0.1 ml) contains: 50 micrograms (from 150,000 to 600,000) of dry BCG bacteria mass.

One ampoule or vial with powder ( 10 doses) contains:
0.5 mg (from 1.5 million to 6 million) live BCG bacteria.

• The excipient is sodium glutamate. One ampoule with solvent contains: isotonic sodium chloride solution 1.0 ml.

What does BCG Tuberculosis Vaccine 10 look like and what does the packaging contain

Before reconstitution, the powder in the ampoule or vial is a white or light cream-colored, amorphous powder.
After reconstitution, a uniform, slightly opalescent suspension is formed without any visible clumps or precipitates.
The vaccine should be used immediately after reconstitution.

Packaging

5 ampoules with powder and 5 ampoules with solvent of 1 ml each
1 ampoule with powder and 1 ampoule with solvent of 1 ml each
5 vials with powder and 5 ampoules with solvent of 1 ml each
1 vial with powder and 1 ampoule with solvent of 1 ml each

Marketing authorization holder and manufacturer

Synthavesre S.A.
20-029 Lublin, ul. Uniwersytecka 10
Phone: 81 533 82 21
Fax: 81 533 80 60
Email: [email protected]

Date of the last update of the leaflet:

Information intended exclusively for medical personnel

Before using the vaccine, check the label for the type of vaccine, the number of doses in the ampoule or vial, and the expiry date. Also, check and ensure that the vaccine in the form of dry powder is entirely at the bottom of the ampoule or vial.
The neck of the ampoule with the solvent and the ampoule with the powder, as well as the vial before and after removing the plastic cap, should be thoroughly disinfected with a swab moistened with 70% ethyl alcohol and allowed to dry.
After opening the ampoule or puncturing the rubber stopper of the vial with the powder, introduce exactly 1 ml of isotonic sodium chloride solution using a syringe.
The solvent should be introduced in a gentle stream along the wall of the ampoule or vial. Then, withdraw the entire contents into the syringe and gently reintroduce it into the ampoule or vial, avoiding foaming. Repeat this process until a uniform suspension is obtained.
The suspension withdrawn into the syringe should be uniform and slightly opalescent.
It is recommended to perform a visual assessment of the vaccine both before and after reconstitution to exclude the risk of potential clumps or precipitates.
The vaccine should be used immediately after reconstitution.
Only 1 dose of the vaccine should be drawn into the syringe in a volume of 0.1 ml for one child.
The vaccine must be administered using a special tuberculin syringe with a well-fitting needle.
Before vaccination, the skin at the injection site should be disinfected with alcohol and allowed to dry.
Hold the skin with your thumb and index finger of one hand, and insert the needle at an angle of about 2 mm under the top layer of skin, almost parallel to its surface.
The vaccine should be administered intradermally in the outer 1/3 of the upper left arm.
After administering 0.1 ml of the BCG vaccine and using the correct vaccination technique, a subcutaneous bubble with a diameter of about 7 mm should form on the arm.

Warnings

• 1. All activities related to opening ampoules or puncturing vial caps, introducing the solvent, and reconstituting the vaccine should be performed to avoid contamination.
• 2. Only single-use needles and syringes should be used for BCG vaccinations.
• 3. Any unused vaccine or waste should be disposed of in accordance with local regulations.

Instructions for preparing the BCG Tuberculosis Vaccine 10 suspension

Proper preparation of the BCG Tuberculosis Vaccine 10 suspension:

• 1. After opening the ampoule, introduce the solvent in a gentle stream along the upper wall of the ampoule, gently rotating it.
• 2. Withdraw the entire contents into the syringe, avoiding foaming and shaking.

• 3. Introduce the contents back into the ampoule in a gentle stream along the upper wall, gently rotating the ampoule. Avoid shaking and foaming.

• 4. Gently mix the suspension in the ampoule with a circular motion.

• 5. Repeat the process from point 2 to 4 until a uniform suspension is obtained.

Incorrect preparation of the BCG Tuberculosis Vaccine 10 suspension:

Do not introduce the solvent into the ampoule in a strong stream!
Do not shake!
Avoid foaming the suspension in the ampoule.
Shaking and foaming can cause clumps and precipitates to form.

Proper procedure allows for the preparation of a uniform BCG Tuberculosis Vaccine 10 suspension.

In the case of clumps or precipitates, the ampoule/vial should be discarded.