PROSPECTO: INFORMATION FOR THE USER

Vaccine BCG 0.75 mg/ml powder and solvent for injectable suspension

Mycobacterium bovis

Read this prospect carefully beforeyou or your child are vaccinated, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you or your child and must not be given to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

The BCG vaccine powder and diluent for injectable suspension belongs to a group of medicines called antitubercular vaccines.

The BCG vaccine is indicated for the prevention of tuberculosis. Although it does not guarantee complete immunity, it increases resistance to tuberculosis infection.

The BCG vaccine should be used based on official recommendations.

No use la Vacuna BCG

• Si es alérgico (hipersensible) a Mycobacterium bovis o a alguno de los demás componentes de la vacuna BCG (incluidos en la sección 6).
• Si padece tuberculosis o cualquier otra enfermedad infecciosa (activa o durante su convalecencia) o si está en tratamiento antituberculosis.
• Si padece algún trastornos de inmunidad, fundamentalmente en pacientes con infección por VIH, en niños nacidos de madres seropositivas, en casos de inmunodeficiencia congénita, o casos con la respuesta inmune disminuida por la acción de ciertos medicamentos (corticoides, agentes alquilantes, antimetabolitos) o la radiación.
• Si ha sido expuesto a un tratamiento inmunosupresor en el útero o durante la lactancia (por ejemplo tratamiento con un antagonista α-FNT).
• Si su estado inmunitario es cuestionable.
• En niños con malnutrición Kwashiorkor (que cursa con una deficiencia de proteínas y calorías).
• Si padece síndrome febril agudo severo o alguna enfermedad generalizada en la piel (se debe posponer la vacunación).
• Si padece angiopatías (enfermedades de los vasos sanguíneos) o hemopatías (enfermedades de la sangre) graves.
• Si padece procesos oncológicos.

Advertencias y precauciones

Consulte a su médico o farmacéutico antes de que usted o su hijo sean vacunados con la vacuna BCG.

Antes de iniciar el tratamiento con la Vacuna BCG, deberán realizarle la prueba de la tuberculina.Hasta los ocho años de edad se pueden utilizar las pruebas en la piel, pero en niños mayores o adultos, debe emplearse la prueba intracutánea de Mantoux con Tuberculina.

Aunque las reacciones alérgicas son raras, se debe contar con medidas necesarias para su tratamiento y, si es posible, se recomienda observar al paciente hasta 15-20 minutos posteriores tras la inyección en busca de síntomas de reacción alérgica.

En caso de que el paciente padezca eccema, la inyección de la vacuna BCG no está contraindicada, pero debe realizarse la inyección en una zona libre de lesiones.

Uso de la Vacuna BCG con otros medicamentos

Informe a su médico o farmacéutico si usted o su hijo está utilizando, ha utilizado recientemente o pudiera tener que utilizar cualquier otro medicamento.

No se debe administrar la vacuna a pacientes que hayan sido tratados con medicamentos antituberculosos.

La vacuna BCG puede ser administrada al mismo tiempo que vacunas vivas, incluyendo las combinadas (sarampión, paperas y rubéola), teniendo especial precaución para no administrarlas en el mismo brazo. En caso de que la administración no sea simultánea, debe dejarse un intervalo de 4 semanas entre la administración de las dos vacunas vivas.

Para evitar el riesgo de hinchazón y dolor en los ganglios linfáticos de la zona, se recomienda no usar el mismo brazo en el que se ha aplicado la vacuna BCG para la administración de otras vacunas durante un período de tres meses.

Embarazo, lactancia y fertilidad

Si está embarazada o en periodo de lactancia, cree que podría estar embarazada o tiene intención de quedarse embarazada, consulte a su médico o farmacéutico antes de ser vacunada con la Vacuna BCG.

Aunque no se han asociado daños al feto con el uso de la Vacuna BCG, no se recomienda su administración durante el embarazo o lactancia, a menos que exista un riesgo excesivo o inevitable de exposición al contagio de la tuberculosis.

Consulte a su médico o farmacéutico antes de utilizar un medicamento.

Conducción y uso de máquinas

La Vacuna BCG no afecta a su capacidad de conducir o manejar maquinaria

La Vacuna BCG contiene sodio

Este medicamento contiene menos de 23 mg de sodio por dosis; esto es esencialmente “exento de sodio”.

Follow exactly the administration instructions for the BCG Vaccine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and children over 1 year:a single dose of 0.1 ml.

Children under 1 year:a single dose of 0.05 ml.

Method of use and route of administration

The BCG Vaccine is administered strictly by INTRADERMAL ROUTE on the outer surface of the upper arm and on the outer surface of the thigh. The injection must be made slowly in the upper layer of the skin by trained personnel, as if the injection is made deeper, the risk of abscess formation (localized accumulations of pus in the skin) increases.

If you use moreBCG Vaccinethan you should

In cases of overdose, especially in young children, suppurative benign lymphadenitis (inflammation of lymph nodes) may occur, which heals slowly and spontaneously.

In exceptional cases, a generalized infection by the BCG Vaccine may develop. Consult regarding the treatment regimen for the management of systemic infections or persistent local infections after vaccination with the BCG Vaccine.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service (Phone: 91 562 04 20) indicating the medication and the amount ingested.

If you missed the administration of the BCG Vaccine

As a single dose, it is unlikely that you will forget your dose. However, inform your doctor or pharmacist if you have missed your dose.

Like all medications, the BCG Vaccine can produce adverse effects, although not all people will experience them.

Generally, this vaccination does not usually cause fever or discomfort. A few days after the vaccination, a hardened nodule (an area of hardened tissue that forms on the skin) develops at the injection site. This nodule decreases gradually and is replaced by a local lesion that may ulcerate a few weeks later. The local lesion does not require treatment and should not be covered with a bandage. This lesion heals spontaneously with the formation of a small black scab.

Occasionally, an enlargement of the lymph nodes, cervical or axillary, may be observed, which also does not require treatment.

The following adverse reactions have been observed, classified by organs and systems, in decreasing order of frequency of appearance:

Less common adverse effects (at least 1 in every 1,000 patients):

Enlargement of lymph nodes (> 1 cm), headache, fever, ulceration at the injection site, inflammation with pus of the lymph nodes.

Rare adverse effects (at least 1 in every 10,000 patients):

Disseminated infection, such as acute or chronic inflammation of the bones, originating or not from an infection, abscess at the injection site, allergic reaction, hypersensitivity reaction.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Store in the refrigerator (between 2°C and 8°C) protected from light.

Use only within 4 hours after reconstitution. Once this time has passed, discard the suspension.

Keep this medication out of the sight and reach of children.

Do not use the BCG Vaccine after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Deposit empty containers and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of empty containers and unused medicines. By doing so, you will help protect the environment.

Composition of the BCG Vaccine

• The active principle of the BCG vaccine isMycobacterium bovis(BCG)Danish Strain 1331.Each 1 ml of reconstituted vaccine contains 0.75 mg ofMycobacterium bovis(BCG)Danish Strain 1331, with 2-8 x106CFU/ml.
• The other components are: sodium glutamate, magnesium sulfate, dibasic potassium phosphate, L-asparagine monohydrate, ferric-ammonium citrate, 85% glycerol, monohydrated citric acid, and water for injection, etc.

Appearance of the product and contents of the package

The BCG vaccine is presented in the form of a powder and a solvent for injectable suspension.

The powder is a white crystalline lyophilisate, barely perceptible to the eye due to the small amount it contains in the vial. The powder is packaged in a type I glass vial with a bromobutyl stopper and an aluminum capsule.

The solvent is an colorless solution without visible particles. The solvent is packaged in a type I glass vial with a chlorobutyl stopper and an aluminum capsule.

A vial of the reconstituted BCG vaccine contains 1 ml, corresponding to 10 doses for adults and children over 1 year (0.1 ml) or 20 doses for children under 1 year (0.05 ml).

Holder of the Marketing Authorization and Responsible for Manufacturing

AJ Vaccines A/S,Artillerivej 5.DK-2300 Copenhagen S, Denmark.

For further information about this medication, please contact the local representative of the marketing authorization holder:

MEDICARE PHARMA, S.L.

Paseo de la Castellana, 177 3ºB

28046 Madrid, Spain

This leaflet was approved in 06/2020

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

_____________________________________________________________________________________

This information is intended solely for healthcare professionals:

Special warnings and precautions for use

The vaccine should only be administered intradermally.

Preferably, the vaccine should be administered by trained personnel in the intradermal vaccination technique.

Injecting the vaccine inappropriately, for example, subcutaneously or intramuscularly, increases the risk of lymphadenitis and the formation of abscesses

Do not vaccinate individuals who test positive for the tuberculin test, as this may worsen the local reaction.

Although anaphylactic reactions are rare, facilities for treatment should be available during vaccination.

Whenever possible, individuals should be kept under observation for 15-20 minutes after vaccination in case of an allergic reaction.

The BCG vaccine can be administered at the same time as inactivated or live vaccines, including combined vaccines against measles, mumps, and rubella. If not administered simultaneously, a minimum interval of 4 weeks should be left before administering another live vaccine.

A minimum interval of 3 months should be left before administering another vaccine in the same arm.

Handling

The rubber stopper should not be cleaned with any antiseptic or soap. If alcohol is used to clean the stopper of the vial, it should be allowed to evaporate before the needle of the syringe passes through it.

Using a syringe equipped with a long needle, transfer the specified volume of solvent to the vial.

Do not use other solvents as they may damage the vaccine.

Invert the vial carefully several times to resuspend the lyophilisate completely.

DO NOT SHAKE. Before extracting each dose of the reconstituted vaccine, gently agitate the vial.

When extracted in the syringe, the vaccine suspension should appear homogeneous, slightly opaque, and colorless.

The reconstituted vaccine should be used within the next 4 hours.

Method of administration

The BCG vaccine should be administered by trained personnel in the intradermal technique.

The area where the injection will be administered should be clean and dry.

If an antiseptic (e.g., alcohol) is used to clean the skin, it should be allowed to evaporate completely before the injection.

The BCG vaccine is administered strictly by INTRADERMAL ROUTE in the upper third of the corresponding arm, corresponding to the distal insertion area of the deltoid muscle, as follows:

• The skin should be stretched between the index finger and thumb.
• The needle should be almost parallel to the skin surface and inserted slowly (with the bevel upwards), approximately 2 mm in the superficial layer of the dermis. The needle should be visible through the epidermis during insertion.
• The injection should be administered slowly.
• If the administration is correct, a white papule will appear at the injection site.
• It is recommended not to protect the injection site to facilitate healing.

The BCG vaccine should be administered with a 1 ml syringe graduated in hundredths of ml (1/100 ml) equipped with a short bevel needle of caliber 25G or 26G. Injectors with pressure or multiple puncture devices should not be used for the administration of this vaccine.

Overdose or incorrect administration

An overdose increases the risk of suppurative lymphadenitis and may cause excessive scarring.

A massive overdose increases the risk of adverse effects of the BCG vaccine.

Deep injection of the vaccine increases the risk of suppurative ulcer, lymphadenitis, and abscess formation

Treatment of complications after vaccination with the BCG vaccine

Consultation should be sought regarding the appropriate treatment regimen for the management of systemic or persistent local infections after vaccination with the BCG vaccine.

Sensitivity of the BCG strain to antibiotics:

The table below indicates the minimum inhibitory concentrations (MICs) for the selected antitubercular drugs against the Danish Strain 1331 [determined by the Bactec 460 method].

The MIC for isoniazid is 0.4 mg/l. There is no consensus on whether Mycobacterium bovis should be classified as susceptible, intermediate, or resistant to isoniazid when the MIC is 0.4 mg/l. However, based on the criterion established for Mycobacterium tuberculosis, the strain is considered to be of intermediate susceptibility.

The Danish Strain 1331 is resistant to pyrazinamide.