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BCG VACCINE SSI POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION

Active substance(s): BCG

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Package leaflet: Information for the user

BCG Vaccine SSI
Powder and solvent for suspension for
injection.
Mycobacterium bovis BCG (Bacillus
Calmette-Guerin), Danish strain 1331,
live attenuated.
Read all of this leaflet carefully
before you are vaccinated 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.
- This medicine has been prescribed
for you only. Do not pass it on to
others.
- If you get any side effects talk to
your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See
section 4.

S T A T E N S
S E R U M
I N S T I T U T










If you have been exposed to immunosuppressive
treatment in utero or via breast-feeding (e.g. treatment
with TNF-α antagonists)
If you are suffering from any malignant conditions
(e.g. lymphoma, leukaemia or Hodgkin’s disease)
If your immune status is in question
If you are infected with HIV
If you are receiving medical treatment against TB

The doctor or nurse will be extra cautious about
vaccinating you with BCG Vaccine SSI
• If you have eczema. The vaccination can be given in an
eczema-free area
• If you have been skin tested for TB infection and the test
was found positive vaccination is not required.
Vaccination may cause a severe local reaction in that
case

5, Artillerivej
DK-2300 Copenhagen S
Denmark

What is in this leaflet
1. What BCG Vaccine SSI is and what it is used for
2. What you need to know before you are vaccinated with
BCG Vaccine SSI
3. How you are vaccinated with BCG Vaccine SSI
4. Possible side effects
5. How to store BCG Vaccine SSI
6. Contents of the pack and other information

Other medicines and BCG Vaccine SSI
• Tell your doctor or pharmacist if you are taking, have
recently taken or might take any others medicines
• Other vaccines can be given at the same time as BCG
Vaccine SSI at different injection sites
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before being vaccinated with BCG
Vaccine SSI.
Vaccination is not recommended during pregnancy or
breast-feeding, although no harmful effects to the unborn
or breastfed child have been associated with BCG Vaccine
SSI.
Driving and using machines
BCG Vaccine SSI has no influence on the ability to drive
and use machines.

1. What BCG Vaccine SSI is and what it is used for

3. How you are vaccinated with BCG Vaccine SSI

BCG Vaccine SSI contains bacteria of the type
Mycobacterium bovis BCG and is used for protection
against tuberculosis (TB).

The doctor or nurse will give the vaccination by injection
into the upper layer of the skin.
The dose is 0.05 ml for children under 12 months of age and
0.1 ml for adults and children aged 12 months or more.
The injection site is best left uncovered to facilitate healing.

2. What you need to know before you are
vaccinated with BCG Vaccine SSI
You should not be vaccinated with BCG Vaccine SSI
• If you have known allergies to any of the excipients in
the vaccine (listed in section 6)
• If you are suffering from an acute severe febrile illness or
generalised skin infection. In these cases vaccination
should be postponed
• If you have a weakened resistance toward infections due
to a disease in/of your immune system
• If you are receiving medical treatment that affects the
immune response e.g. corticosteroids or radiotherapy

The following information is intended for medical and
healthcare professionals only
Special warnings and precautions for use
The vaccine should be administered strictly by the
intradermal route.
The vaccine should preferably be administered by personnel
trained in the intradermal vaccination technique.
Inadequate administered injections e.g. subcutaneously
or intramuscularly increase the risk of lymphadenitis and
abscess formation.
Tuberculin skin test positive persons should not be
vaccinated as this may result in an aggravated loco-regional
reaction.
Although anaphylactic reactions are rare, facilities for its
management should always be available during vaccination.
Whenever possible, persons should be kept under
observation for 15-20 minutes after vaccination, in case an
allergic reaction should occur.
BCG vaccination may be given concurrently with
inactivated or live vaccines, including combined measles,
mumps and rubella vaccines. If not given concurrently a
period of not less than 4 weeks must pass before giving
another live vaccine.
There must be an interval of at least 3 months before a
vaccination in the same arm can take place.

The expected reactions to the vaccination include:
• a slight swelling, redness and tenderness at the injection
site followed by a local lesion
• some weeks later this lesion evolves into a small ulcer
• after some months this ulcer will heal leaving a small,
flat scar
• a slight swelling of the lymph nodes in the armpit may be
experienced
These are common reactions to the vaccination.

Handling
The rubber stopper must not be wiped with any antiseptic
or detergent. If alcohol is used to swab the rubber stopper, it
must be allowed to evaporate before the stopper is
penetrated with the syringe needle.
Using a syringe fitted with a long needle, transfer to the vial
the volume of solvent stated on the label. Do not use other
diluents, as these may damage the vaccine.
Carefully invert the vial a few times to the resuspend the
lyophilised BCG completely.
Do not shake the vial. Gently swirl the vial with the
reconstituted vaccine before drawing up each subsequent
dose.
When drawn up into the syringe the reconstituted vaccine
should appear homogeneous, slightly opaque and colourless.
When reconstituted the vaccine should be used within 4
hours.
Method of administration
The vaccine should be administered by personnel trained in
the intradermal technique.
The injection site should be clean and dry.
If antiseptics (such as alcohol) are applied to swab the skin,
it must be allowed to evaporate before injection.
The vaccine must be given strictly intradermally,
approximately one third down the upper arm corresponding
to the area of the distal insertion of the deltoid muscle, as
follows:

4. Possible side effects

6. Contents of the pack and other information

Like all medicines, BCG Vaccine SSI can cause side
effects, although not everybody gets them.
Severe allergic reactions (such as redness of the face and
neck, swelling of the face, throat or neck, skin rash,
breathing difficulties and collapse) may occur in rare cases
(less than 1 in 1,000).
If you observe any of the above reactions contact your
doctor immediately.

What BCG Vaccine SSI contains
The active substance is:
Freeze-dried powder containing live attenuated bacteria of
the type Mycobacterium bovis BCG (Bacillus
Calmette-Guerin), Danish strain 1331.
1 ml vaccine contains between 2-8 million bacteria.

Other side effects include:
Uncommon side effects (may occur in less than 1 in 100
people)
• Fever
• Swelling of lymph nodes in the armpit larger than 1 cm
across
• An oozing ulcer at the injection site
• Headache
Rare side effects (may occur in less than 1 in 1,000
people)
• Inflammation of lymph nodes, sometimes with oozing
ulcers, possibly abscess
• Infection with the bacteria from the vaccine can occur.
The infection can spread throughout the body, including
the bones
Fainting, seizures and convulsions among patients receiving
injections have been observed.
In babies born very prematurely (at or before 28 weeks of
gestation) longer gaps than normal between breaths may
occur for 2-3 days after vaccination.

The excipients are:
Sodium glutamate, magnesium sulphate heptahydrate,
dipotassium phosphate, L-asparagine monohydrate, ferric
ammonium citrate, glycerol 85%, citric acid, monohydrate
and water for injections.
What BCG Vaccine SSI looks like and contents of the
pack
BCG Vaccine SSI consists of a powder and solvent for
suspension for injection (2-8 x 105 bacteria/0.1 ml dose or
1-4 x 105 bacteria/0.05 ml dose). Pack sizes of 1, 5, or 10
vials and pack size of 1 vial with one syringe and two
injection needles (one long for adding solvent and one short
for intradermal injection).
The powder in the amber vial is white and crystalline, the
powder might be difficult to see due to the small amount of
powder in the vial.
The solvent in the clear vial is a colourless solution without
visible particles.
The mixed vaccine should appear as a homogenous, slightly
opalescent, colourless suspension.
Pack sizes: 1, 5, 10-vial packages and 1 vial enclosed in a
1-dose injection kit.
Not all pack sizes may be marketed.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed in
this leaflet. You can also report side effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

Marketing Authorisation Holder and Manufacturer
Statens Serum Institut,
5 Artillerivej,
DK-2300 Copenhagen S,
Denmark
tel.: +45 3268 3268
fax: +45 3268 3973
e-mail: serum@ssi.dk

5. How to store BCG Vaccine SSI

This medicinal product is authorised in the Member
States of the EEA under the following names:
DK, EL, FI, SK, UK: BCG Vaccine SSI
FR: VACCIN BCG SSI
NO: BCG-vaksine SSI
PL: BCG Szczepionka SSI
SE: BCG-vaccin SSI

• Keep this medicine out of sight and reach of children
• Store in a refrigerator (2ºC - 8ºC)
• Store in the original package in order to protect from
light
• Do not freeze
• Do not use the vaccine after the expiry date which is
stated on the carton as “EXP”
• The expiry date refers to the last day of that month

This leaflet was last revised in 06/2015

Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.

10-630-01 en 06-2015

• The skin is stretched between thumb and forefinger
• The needle should be almost parallel with the skin
surface and slowly inserted (bevel upwards),
approximately 2 mm into the superficial layers of the
dermis. The needle should be visible through the
epidermis during insertion
• The vaccine should be given slowly
• A raised, blanched papule at the needle point is a sign of
correct injection
• The injection site is best left uncovered to facilitate
healing
0.1 ml
(Adults and children aged 12 month or more)
0.05 ml
(Children under 12 month of age)

Epidermis
Dermis
Subcutis

The mixed vaccine should be administered with a syringe
of 1 ml graduated into hundredths of millilitre (1/100) fitted
with a short bevel syringe needle (25G or 26G).
Jet injectors or multiple puncture devices should not be used
to administer the vaccine.
Over dosage or incorrect administration
Overdose increases the risk of suppurative lymphadenitis
and may lead to excessive scar formation.
Gross over dosage increases the risk of undesirable BCG
complications.

Administering the vaccine too deep increases the risk of
discharging ulcer, lymphadenitis and abscess formation.
Treatment of complications after vaccination with BCG
Vaccine SSI
Expert advice should be sought regarding the appropriate
treatment regimen for the management of systemic
infections or persistent local infections following
vaccination with BCG Vaccine SSI.
Antibiotic sensitivity of the BCG strain:
The table below indicates the minimum inhibitory
concentrations (MIC) for selected anti-tuberculous drugs
towards the BCG Danish strain 1331 [as determined by
Bactec 460].
The MIC for isoniazid is 0.4 mg/l. There is no consensus as
to whether Mycobacterium bovis BCG should be classified as
susceptible, intermediately susceptible or resistant to isoniazid
when the MIC is 0.4 mg/l. However, based on criteria set for
Mycobacterium tuberculosis, the strain could be considered to
be of intermediate susceptibility.
Drug
Isoniazid

Minimum Inhibitory Concentration (MIC)
0.4 mg/l

Streptomycin 2.0 mg/l
Rifampicin

2.0 mg/l

Ethambutol

2.5 mg/l

BCG Danish strain 1331 is resistant to pyrazinamide.
10-630-01 en 06-2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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