| BCG VACCINE, FREEZE-DRIED (Live) |
| VACCINUM TUBERCULOSIS (BCG) CRYODESSICATUM |
| |
| Composition: |
Each single 0.1 ml human dose contains: |
Approximately 0,05 mg moist weight of BCG and between 1,5-6,0 x 105
viable units.
Each ampoule contains 3 mg Sodium L-glutamate monohydrate. |
Description: |
| Freeze-Dried BCG Vaccine is a dried preparation containing live bacteria
derived from a culture of the Bacillus of Calmette and Guerin,
known as BCG, intended for intradermal injection,
1, 2, 3. The vaccine meets the requirements of WHO
for dried BCG vaccine (Requirements for Biological Substances
No 11, formulated by WHO Expert Committee of Biological
Standardization Technical Report Series, No 745, 1987; 771,
1988). |
|
Indications:
|
| For
the primary immunization of infants and immunization or
reimmunization of children and adults who have reacted negatively
to the usual tuberculin tests. It may be given at the same
time with DPT, DT, TT, Measles, Polio vaccines (OPV and
IPV), Hepatitis B and Yellow fever. |
Administration: |
|
For infants under one year of age, 0,05
ml of the reconstituted vaccine should be given intradermally.
For others, the dose is 0,1 ml, again given intradermally.
The use of a special tuberculin syringe and a sterile 26-gauge
needle is recommended for each injection, so that exact
dose can be administrated. The skin may not be cleaned with
antiseptic. Jet injections do not generally provide a reliable
dose and should not be used. Prior to use, the bacterial
mass should be shaken so that it falls to the bottom of
the ampoule. Special care is needed in opening the ampoule
and reconstituting the vaccine gently with the sterile diluent
provided, so that the vaccine is not blown out of the ampoule.
A site frequently used for vaccination is the region over
the distal insertion of the deltoid muscle, about one third
down the left upper arm. The needle should be introduces
with its aperture upwards.
Because of sensitivity to daylight,
the vaccine must be kept in the dark. When withdrawals are
made from the ampoule, the vaccine may only be exposed to
the light for the minimum period of time. If not used immediately
after reconstitution, the vaccine should be kept on ice
and protected from light. Any opened ampoule should be kept
on ice and protected from light, any opened ampoule remaining
at the end of the immunizing session (maximum 6 hours) MUST
BE DISCARDED.
Skin testing with tuberculin is not generally carried out before
giving BCG, but when performed, those who are found to be
positive reactors need not be immunized.
|
Reactions and side effects: |
| The
papule caused by the intradermal injection persist 15-30
minutes. Two or three weeks later a red nodule is observed
and its dimensions increase for a further one or two weeks.
In some cases a small abscess is formed which later develops
into a small ulcer. The latter heals spontaneously without
treatment in a few weeks. Three to six months after vaccination
the ulcer heals completely and a small scar is formed. Enlargement
of the axillary lymph-nodes may occasionally develop after
vaccination but spontaneous regression usually occurs after
a few months. In rare cases perforation and persistent suppuration
can accompany the lymph-node enlargement and anti- tuberculous
chemoprophylaxis may be indicated. Surgical excision is
not recommended. Inadvertent subcutaneous injection produces
abscess formation and may lead to ugly retracted scars. |
Contraindications and warnings: |
| The
vaccine is contraindicated in those individuals with cell-mediated
immune deficiency including treatment with immuno-suppressive
drugs. Keloid and lupoid reactions may occur at the site
of injection and such infants or children should not be
re-vaccinated. HIV infected, non symptomatic persons should
be immunized with BCG vaccine according to standard schedules.
Persons with clinical AIDS should not receive BCG vaccine
(but should receive other EPI vaccines). |
Storage of the vaccine: |
| The
vaccine should be stored in a dry, dark place at a temperature
between 2°C and 8°C. Transportation should also be at 2°C-8°C.
The vaccine should be protected from the light. Once an
ampoule has been opened, its contents should be used immediately.
The diluent should not be frozen. During storage in refrigerator
(2°C-8°C) the product is stable until indicated date of
expiration. |
|
Shelf – life:
|
| Not
more than 24 months after the date of issue, provided that
this is not more than 36 months from date of last satisfactory
test for culturable particles, if stored in the dark at
2°C-8°C. |
|
Presentation:
10-doses Ampoule plus diluent.
20-doses Ampoule plus diluent.
|
|
Bibliography:
1. Las Souches BCG. Lyophisation
et activine biologique. (1970) Rodopska, S. Int. Symp. on
BCG Vaccine. Symp. Series lmmunobiol. Stand. 17, pp. 169-174.
2. Studies on the quality control of BCG: Laboratory examinations
and postvaccination control in the field. (1983) Engibarov,
A. Chouchkova, M. and Koychev C. Int, Symp. on BCG Vaccines
and Tuberculins. Develop. biol. Stand. 58, pp. 163-171.
3. A quarter of a century in the field of BCG. (1983) Rodopska,
S. let, Symp. on BCG Vaccines and Tuberculins. Develop.
biol. Stand. 58, pp. 257-272.
|
|
Name and address of manufacturer:
|
BB-
NCIPD Ltd. BULGARIA
1504 Sofia, 26 Yanko Sakazov Blvd.,
Tel.: **359 2 944 69 99 / 281
Fax: **359 2 943 30 75
E-mail: bulbio@bulbio.com |
| Last Revision: October 2001 |