BCG VACCINE AJV POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION

Negara: Singapura

Bahasa: Inggris

Sumber: HSA (Health Sciences Authority)

Bahan aktif:

LIVE ATTENUATED MYCOBACTERIUM BOVIS (BCG) DANISH 1331

Tersedia dari:

DKSH SINGAPORE PTE. LTD.

Kode ATC:

J07AN01

Dosis:

0.75 mg/ml

Bentuk farmasi:

INJECTION, POWDER, FOR SOLUTION

Komposisi:

LIVE ATTENUATED MYCOBACTERIUM BOVIS (BCG) DANISH 1331 0.75 mg/ml

Rute administrasi :

INTRADERMAL

Jenis Resep:

Prescription Only

Diproduksi oleh:

AJ VACCINES A/S (Drug Product & Solvent Manufacturer)

Status otorisasi:

ACTIVE

Tanggal Otorisasi:

1999-08-31

Selebaran informasi

CONFIDENTIAL
Page 1 of 4
12-Mar-2018
Final
BCG Vaccine AJV
DIR 28534-04
Package Leaflet
INSTRUCTIONS FOR USE OF BCG VACCINE SSI
(FOR INTRADERMAL USE ONLY)
DESCRIPTION
BCG Vaccine is a live freeze-dried vaccine, made from an attenuated
strain of
_Mycobacterium _
_bovis_
(BCG), Danish strain 1331. It is used for the prevention of
tuberculosis, but does not ensure
complete immunity.
The vaccine fulfils the requirements for dried BCG vaccine
(Requirements for Biological
Substances No. 11), formulated by the WHO Expert Committee on
Biological Standardization.
DECLARATION
1 ml of the reconstituted vaccine contains:
PRODUCED IN DENMARK BY
AJ Vaccines A/S, 5 Artillerivej, 2300 Copenhagen S, Denmark
ADMINISTRATION
FOR INTRADERMAL USE ONLY.
_Reconstitution: _
Only Diluted Sauton SSI should be used for reconstitution.
The rubber stopper must not be wiped with any antiseptic or detergent.
If alcohol is used to swab
the rubber stopper of the vial, it must be allowed to evaporate before
the stopper is penetrated with
the syringe needle.
The vaccine should be visually inspected both before and after
reconstitution for any foreign
particulate matter prior to the administration.
Using a syringe fitted with a long needle, transfer to the vial the
volume of Diluted Sauton given on
the label. Carefully invert the vial a few times to resuspend the
lyophilised BCG completely. DO
_Mycobacterium bovis_
(BCG), Danish strain 1331
2.0 x 10
6
– 8.0 x 10
6
CFU (Colony Forming Units)
0.75 mg
Sodium glutamate
3.75 mg
Magnesium sulphate
125 microg.
Dipotassium phosphate
125 microg.
L-asparagine monohydrate
1 mg
Ferric ammonium citrate
12.5 microg.
Glycerol (85%)
18.4 mg
Citric acid monohydrate
0.5 mg
Water for injections
to 1 ml
CONFIDENTIAL
Page 2 of 4
12-Mar-2018
Final
BCG Vaccine AJV
DIR 28534-04
Package Leaflet
NOT SHAKE. Gently swirl the vial of resuspended vaccine before drawing
up each subsequent
dose. When drawn up into the syringe the vaccine suspension should
appear homogeneous, slightly
opaque and colourless.
_Dose for children bel

Karakteristik produk

PACKAGE LEAFLET: INFORMATION FOR THE USER
BCG VACCINE AJV POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
(FOR INTRADERMAL USE ONLY)
DESCRIPTION
BCG Vaccine AJV is a live freeze-dried vaccine, made from an
attenuated strain of
_Mycobacterium bovis_
(BCG), Danish strain 1331. It is used for the prevention of
tuberculosis but
does not ensure complete immunity.
The vaccine fulfils the requirements for dried BCG vaccine
(Requirements for Biological
Substances No. 11), formulated by the WHO Expert Committee on
Biological Standardization.
DECLARATION
1 ml of the reconstituted vaccine contains:
_Mycobacterium bovis _
(BCG), Danish strain 1331
2.0 x 10
6
– 8.0 x 10
6
CFU (Colony Forming Units)
0.75 mg
Sodium glutamate
3.75 mg
Magnesium sulphate
125 microg.
Dipotassium phosphate
125 microg.
L-asparagine monohydrate
1 mg
Ferric ammonium citrate
12.5 microg.
Glycerol (85%)
18.4 mg
Citric acid monohydrate
0.5 mg
Water for injections
to 1 ml
PRODUCED IN DENMARK BY
AJ Vaccines A/S, 5, Artillerivej, 2300 Copenhagen S, Denmark
ADMINISTRATION
FOR INTRADERMAL USE ONLY.
_Reconstitution: _
Only the solvent provided with BCG Vaccine AJV should be used for
reconstitution.
The rubber stopper must not be wiped with any antiseptic or detergent.
If alcohol is used to swab
the rubber stopper of the vial, it must be allowed to evaporate before
the stopper is penetrated with
the syringe needle.
The vaccine should be visually inspected both before and after
reconstitution for any foreign
particulate matter prior to the administration.
Using a syringe fitted with a long needle, transfer to the vial the
volume of solvent given on the
label. Carefully invert the vial a few times to resuspend the
lyophilised BCG completely.
DO NOT SHAKE. Gently swirl the vial of resuspended vaccine before
drawing up each subsequent
dose. When drawn up into the syringe the vaccine suspension should
appear homogeneous, slightly
opaque and colourless.
_Dose for children below one year_
: 0.05 ml of the reconstituted vaccine and for others 0.1 ml. Use a
sterile syr