BCG VACCINE AJV INJECTION

Država: Južnoafriška republika

Jezik: angleščina

Source: South African Health Products Regulatory Authority (SAHPRA)

Dostopno od:

The Biovac Institute

Odmerek:

See ingredients

Farmacevtska oblika:

INJECTION

Sestava:

EACH 1 ML SOLUTION CONTAINS MYCOBACTERIUM BOVIS 0,75 MG (DANISH 1331)

Status dovoljenje:

Registered

Datum dovoljenje:

1998-02-11

Navodilo za uporabo

Version No.: 00
Date submitted: 07 December 2020
Page 1 of 8
Signed:
Module 1.5.5.2: Proposed Clean Copy of Patient Information Leaflet
Proprietary Name Changed BCG Vaccine SSI to BCG Vaccine AJV
MODULE 1.5.5.2
PATIENT INFORMATION LEAFLET (CLEAN COPY)
Read all of this leaflet carefully before you start using BCG VACCINE
AJV freeze-dried powder for
reconstitution for intradermal injection:
•
keep this leaflet. You may need to read it again, and
•
if you have further questions, please ask your doctor or your
pharmacist.
BCG VACCINE AJV
SCHEDULING STATUS
PROPRIETARY NAME AND DOSAGE FORM
BCG VACCINE AJV freeze-dried powder for reconstitution for intradermal
injection.
WHAT BCG VACCINE AJV CONTAINS_ _
•
The active substance is: 0,75 mg Mycobacterium bovis (BCG), Danish
1331 and sodium
glutamate as stabiliser per 1 ml of the reconstituted vaccine.
•
The other ingredients are: The Reconstituting fluid for BCG VACCINE
AJV contains: magnesium
sulphate, dipotassium phosphate, citric acid monohydrate, L-asparagine
monohydrate, ferric
ammonium citrate, glycerol 85 %, ammonia solution 25 % and water for
injection.
WHAT BCG VACCINE AJV IS USED FOR
This medicinal product is a vaccine and is used for the prevention of
tuberculosis in infants, children
and adults but does not ensure complete immunity. Babies should be
immunised as soon as possible
after birth.
S2
Version No.: 00
Date submitted: 07 December 2020
Page 2 of 8
Signed:
Module 1.5.5.2: Proposed Clean Copy of Patient Information Leaflet
Proprietary Name Changed BCG Vaccine SSI to BCG Vaccine AJV
BEFORE YOU ARE IMMUNISED WITH BCG VACCINE AJV
DO NOT USE BCG VACCINE AJV:
•
if you are hypersensitive (allergic) to any of the ingredients of BCG
VACCINE AJV,
•
if you have a weakened resistance towards infections due to a disease
in/of your immune
system,
•
if
you
are
receiving
medical
treatment
that
affects
the
immune
response
e.g.
corticosteroids, radiotherapy or other immunosuppressive treatment;
infants who are
exposed to immunosuppressive therapy while in ute

Lastnosti izdelka

Module 1.5.5.1: Proposed Clean Copy of Professional Information
Proprietary Name Changed BCG Vaccine SSI to BCG Vaccine AJV
Version No.: 00
Date submitted: 07 December 2020
Page 1 of 10
Signed:
MODULE 1.5.5.1
PROFESSIONAL INFORMATION (CLEAN COPY)
BCG VACCINE AJV
SCHEDULING STATUS
PROPRIETARY NAME AND DOSAGE FORM
BCG VACCINE AJV freeze-dried powder for reconstitution for intradermal
injection.
COMPOSITION
1 ml of the reconstituted vaccine contains 0,75 mg Mycobacterium bovis
(BCG), Danish 1331 and
sodium glutamate as stabiliser. The Reconstituting fluid for BCG
vaccine AJV contains: magnesium
sulphate,
dipotassium
phosphate,
citric
acid
monohydrate,
L-asparagine
monohydrate,
ferric
ammonium citrate, glycerol 85 %, ammonia solution 25 % and water for
injection.
PHARMACOLOGICAL CLASSIFICATION
A 30.2 Biological antigens.
PHARMACOLOGICAL ACTION
This vaccine is used for the prevention of tuberculosis in infants,
children and adults but does not
ensure complete immunity.
INDICATIONS
Active immunisation against tuberculosis.
Babies should be immunised as soon as possible after birth.
S2
Module 1.5.5.1: Proposed Clean Copy of Professional Information
Proprietary Name Changed BCG Vaccine SSI to BCG Vaccine AJV
Version No.: 00
Date submitted: 07 December 2020
Page 2 of 10
Signed:
CONTRA-INDICATIONS
BCG VACCINE AJV must not be administered to persons known to be
hypersensitive to any
component of the vaccine.
BCG VACCINE AJV SHOULD NOT BE GIVEN in individuals:
•
with congenital or acquired immunodeficiency, including symptomatic
HIV disease (clinical
symptomatic AIDS),
•
known to be HIV-infected, even if they show no symptoms of
HIV-infection,
•
on
concurrent
treatment
with
immunosuppressive
medicines
or
radiotherapy;
this
also
includes infants exposed to immunosuppressive treatment in utero or
via breastfeeding for as
long as postnatal influence of the immune status of the infant remains
possible (e.g. maternal
treatment with TNF α-antagonists),
•
whose immune status is in question, and
•
with malignant condition