BCG Vaccine AJV

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Bacillus Calmette-Guerin 0.75 mg/mL (when reconstituted with Diluted Sauton AJV (Danish strain 1331) (vaccine))

Available from:

Seqirus (NZ) Ltd

INN (International Name):

BCG vaccine 0.75 mg/mL (when reconstituted (Danish strain 1331))

Dosage:

0.75 mg/mL

Pharmaceutical form:

Suspension for injection

Composition:

Active: Bacillus Calmette-Guerin 0.75 mg/mL (when reconstituted with Diluted Sauton AJV (Danish strain 1331) (vaccine)) Excipient: Monosodium glutamate Asparagine Citric acid monohydrate Dibasic potassium phosphate Ferric ammonium citrate Glycerol Magnesium sulfate Water for injection

Units in package:

Combination pack, 10 x (10 doses + 1 mL diluent), 10 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

AJ Vaccines A/S

Therapeutic indications:

Active immunisation against tuberculosis

Product summary:

Package - Contents - Shelf Life: Combination pack, 10 x (10 doses + 1 mL diluent) - 10 dose units - 0 months stored at 2° to 8°C (Refrigerate, do not freeze). 12 to 24 months, with shelf life assigned based on the test for 'Count of viable units/Viability' 4 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Combination pack, 10 x (20 doses + 2mL diluent) - 20 dose units - 0 months stored at 2° to 8°C (Refrigerate, do not freeze). 12 to 24 months, with shelf life assigned based on the test for 'Count of viable units/Viability' 4 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, 1 x 1mL - 1 mL -   - Vial, glass, 1 x 2mL - 2 mL -   - Vial, glass, multi-dose, 1 x 10 dose units - 10 dose units -   - Vial, glass, multi-dose, 1 x 20 dose units - 20 dose units -  

Authorization date:

1996-04-10

Patient Information leaflet

NEW ZEALAND CONSUMER MEDICINE INFORMATION
BCG VACCINE AJV
_Mycobacterium bovis _BCG (Bacillus Calmette-Guerin), Danish strain
1331, live
attenuated, 2-8 x 10
5
cfu powder and solvent for suspension for injection.
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about BCG Vaccine AJV.
It does not contain all the available information.
It does not take the place of talking to your doctor or nurse.
All medicines have risks and benefits. Your doctor has weighed the
risks of you
taking BCG Vaccine AJV against the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR NURSE.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT BCG VACCINE AJV IS USED FOR
BCG Vaccine AJV is a vaccine which provides active immunisation
against
tuberculosis. Tuberculosis (TB) is a disease caused by infection with
the bacteria
(germ) _Mycobacterium Tuberculosis_. TB can damage a person’s lungs
or other parts
of the body and cause serious illness.
BCG Vaccine AJV is a dried powder containing bacteria which are very
similar to the
organisms which cause tuberculosis. The bacteria in the medicine has
been altered
so that they produce only a mild localised infection but at the same
time cause your
body to build up resistance to tuberculosis.
Your doctor may have prescribed BCG Vaccine AJV for another reason.
Ask your
doctor or nurse if you have any questions about why BCG VACCINE AJV
has been
prescribed for you.
BEFORE YOU ARE GIVEN BCG VACCINE AJV
_WHEN YOU MUST NOT USE IT_
_ _
Do not take BCG Vaccine AJV if:
•
you are sensitive (allergic) to any of the ingredients listed at the
end of this
leaflet
•
you are receiving anti-tuberculosis drug
•
you had an allergic reaction to a previous dose of BCG Vaccine
•
you have fever
•
you have a general skin infection
•
you have a HIV infection or are in a high risk group but have not been
tested
for HIV
•
you have an impaired immune system
•
you are receiving immunosuppressive treatment (a

Summary of Product characteristics

BCG Vaccine AJV
1
NEW ZEALAND DATA SHEET
BCG VACCINE AJV
1. PRODUCT NAME
BCG Vaccine AJV - _Mycobacterium bovis_ BCG (Bacillus
Calmette-Guerin), Danish strain
1331, live attenuated, 2-8 x 10
5
cfu powder and solvent for suspension for injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
BCG vaccine is reconstituted with Diluted Sauton AJV.
After reconstitution, 1 dose (0.1 ml) for adults and children aged 12
months and over
contains:
_Mycobacterium bovis_ BCG (Bacillus Calmette-Guerin), 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-Guerin), Danish strain
1331, live attenuated, 1-
4 x 10
5
cfu.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
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.
This is a multidose container. See SECTION 6.5 NATURE AND CONTENTS OF
CONTAINER for the
number of doses per vial.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Active immunisation against tuberculosis.
BCG Vaccine AJV is to be used on the basis of national official
recommendations.
4.2 DOSE AND METHOD OF ADMINISTRATION
Adults and children aged 12 months and over
A dose of 0.1 ml of the reconstituted vaccine is injected strictly by
the intradermal route.
Infants under 12 months of age
A dose of 0.05 ml of the reconstituted vaccine is injected strictly by
the intradermal route.
National recommendations should be consulted regarding the need for
tuberculin testing prior
to administration of BCG Vaccine AJV.
BCG Vaccine AJV should be administered with a syringe of 1 ml
subgraduated into
hundredths of ml (1/100 ml) fitted with a short bevel needle (25G/0.50
mm or 26G/0.45 mm).
Jet injectors or multiple puncture devices should not be used to
administer the vaccine.
The injection si