BCG VACCINE SSI %v/v Pdr+Solv for Susp for Inj

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MYCOBACTERIUM BOVIS (BCG) STAM 1331

Available from:

Statens Serum Institute

ATC code:

J07AN01

INN (International Name):

MYCOBACTERIUM BOVIS (BCG) STAM 1331

Dosage:

%v/v

Pharmaceutical form:

Pdr+Solv for Susp for Inj

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Tuberculosis vaccines

Authorization status:

Authorised

Authorization date:

2001-12-14

Patient Information leaflet

BCG VACCINE SSI
Powder and solvent for suspension for 
injection.
_Mycobacterium bovis_ BCG (Bacillus 
Calmette-Guérin), 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. 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
WHAT IS IN THIS LEAFLET
1.  What BCG VACCINE SSI is and what it is used for
2.  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
1  WHAT BCG VACCINE SSI IS AND WHAT IT IS USED FOR
BCG VACCINE SSI contains bacteria of the type Mycobacterium
bovis BCG and is used for protection against tuberculosis (TB).
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.
•  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 dise

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
BCG VACCINE SSI
Powder and solvent for suspension for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 dose (0.1 ml) for adults and children aged 12 months and over contains:
_Mycobacterium bovis _BCG (Bacillus Calmette-Guérin), Danish strain 1331, live attenuated, 2-8 x 10
5
cfu.
After reconstitution, 1 dose (0.05 ml) for infants under 12 months of age contains:
_Mycobacterium bovis _BCG (Bacillus Calmette-Guérin), Danish strain 1331, live attenuated, 1-4 x 10
5
cfu.
This is a multidose container. See section 6.5 for the number of doses per vial.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Powder and solvent for suspension for injection.
White crystalline powder (might be difficult to see due to the small amount of powder in the vial). The solvent is a
colourless solution without any visible particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Active immunization against tuberculosis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
_Children at least 12 months of age and adults:_
0.1 ml of the reconstituted vaccine strictly by intradermal injection.
_Infants under 12 months of age:_
0.05 ml of the reconstituted vaccine strictly by intradermal injection.
National recommendations should be consulted regarding the need for tuberculin testing prior to administration of BCG
VACCINE SSI.
Method of Administration:
BCG VACCINE SSI should be administered with a syringe fitted with a short bevel needle (25G/ 0.50 mm or
26G/0.45mm).
BCG VACCINE SSI should be administered by personnel trained in the intradermal technique.
Jet injectors or multiple puncture devices should not be used to administer the vaccine.
The injection site should be clean and dry; A