BCG VACCINE AJV

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Mycobacterium bovis (bcg) stam 1331

Tillgänglig från:

AJ Vaccines A/S

ATC-kod:

J07AN; J07AN01

INN (International namn):

Mycobacterium bovis (bcg) stam 1331

Dos:

0 colony forming unit(s)/millilitre

Läkemedelsform:

Powder and solvent for suspension for injection

Receptbelagda typ:

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

Terapiområde:

Tuberculosis vaccines; tuberculosis, live attenuated

Bemyndigande status:

Not marketed

Tillstånd datum:

2001-12-14

Bipacksedel

1
_Version 4.2, 04/2021 _
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
BCG VACCINE AJV
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 OR YOUR CHILD 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 or your child only. Do not
pass it on to others.

If you or your child 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.
WHAT IS IN THIS LEAFLET
1.
What BCG VACCINE AJV is and what it is used for
2.
What you need to know before you or your child are vaccinated with BCG
VACCINE AJV
3.
How you or your child are vaccinated with BCG VACCINE AJV
4.
Possible side effects
5.
How to store BCG VACCINE AJV
6.
Contents of the pack and other information
1.
WHAT BCG VACCINE AJV IS AND WHAT IT IS USED FOR
BCG VACCINE AJV contains bacteria of the type _Mycobacterium bovis_
BCG and is used for
protection against tuberculosis (TB).
2.
WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD ARE VACCINATED WITH BCG
VACCINE
AJV
YOU OR YOUR CHILD SHOULD NOT BE VACCINATED WITH BCG VACCINE AJV

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 condit

Produktens egenskaper

Health Products Regulatory Authority
11 April 2022
CRN00CQYD
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
BCG VACCINE AJV
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 AJV.
Method of Administration:
BCG VACCINE AJV should be administered with a syringe fitted with a
short bevel needle (25G/ 0.50 mm or 26G/0.45mm).
BCG VACCINE AJV 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; Antiseptics should not be
used prior to administration. If alcohol is used to swab the
skin, it must be allowed to evaporate before the vaccine is injected.
The vaccine should be injected strictly intradermally in th