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VIETNAM Pestikal B1
SPF
95 x 245
mm 4/0
CMYK


GENERA
PESTIKAL B1 SPF
lyophlllsed vaccine against
Newcastle disease strain
Hltchner B1, lyophlllsate for
suspension, ^lO^EID^, for
chickens and turkeys
NAME

AND

ADDRESS

MARKETING
HOLDER

OF

THE

AUTHORISATION
AND

OF

THE

MANUFACTURING AUTHORISATION
HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
GENERA Inc.
Svetonedeljska 2, Kalinovica,
10436 Rakov Potok, Croatia
NAME

OF

THE

VETERINARY

MEDICINAL PRODUCT
PESTIKAL B1 SPF, lyophilised vaccine
against Newcastle disease strain Hitchner
B1,

lyophlllsate

for


suspension,

alOMEIDso, for chickens and turkeys
STATEMENT

OF

SUBSTANCE(S)

THE

ACTIVE

AND

OTHER

INGREDIENT(S)
Each dose contains:
Live , I entogen ic vi rus of N ewcastle
disease, strai nHitchnerBI
10“EIDw

&


INDICATION(S)
Immunization of chickens and turkeys
against Newcastle disease.
Immunity begins to develop 5-6 days after

vaccination and is antibody immunity is
proved on 21“ day. Chickens are protected
until the end of the fattening period, if
prolonged immunity is required, the
chickens can be revaccinated.
CONTR
AINDIC
ATIONS
Not
known.
ADVERSE REACTIONS
Not known.
If you notice any serious effects or other
effects not mentioned in this package
leaflet, please inform your veterinary
surgeon.
TARGE
T
SPECIE
S
Chicken
s and
turkeys.
DOSAGE
ROUTE(S)

FOR
AND

EACH


SPECIES,

METHOD

OF

ADMINISTRATION
The vaccine can be used in three ways oculonasally, in drinking water and spray.


Method of application depends on the
epizootiological situation, age category
and number of animals. Vaccine can be
administered to 1-day old chicks and older
chickens by coarse spray or by the
oculonasal route of administration.
Chickens can be vaccinated by the inwater route once birds are shown to be
drinking well from the drinker system in
use.
Turkeys can be vaccinated from 14 days of
age by coarse spray, by the oculonasal
route of administration or by the drinking
water route.
1. Oculonasal administration
Suspend 1000 doses of the vaccine in 100
ml distillate water. A dose of reconstituted
vaccine is 0.1 ml, i.e. two drops,
irrespective of poultry age, weight and
type. Instil one drop into the eye and one

drop into the nose opening.
2. Administration

In

the

drinking

water
Suspend the vaccine in cool and clean
water without traces of chlorine or other
disinfectants in a number of doses
corresponding to the number of birds to be
vaccinated.
Vaccine should be suspended immediately
before use.
In order to determine the quantity of water
in which will be vaccine suspended, it is


necessary to multiply the number of birds
in the thousands with the day of life (e.g. 1
thousand of chickens in the 7th day of life
= 1 x 7 = 71) or in the amount that the
chickens can drink for 1.5 to 2.5 hours.
In order to make the birds thirsty,
withdraw the supply of drinking water for
2 - 3 hours prior to immunisation
(depending on the air temperature).

Provide sufficient drinking area to secure
the intake of the water containing the
vaccine by all birds within 1.5 - 2.5 hours.
The drinking system should be dean,
without

traces

of

chlorine,

other

disinfectants or impurities.
3. By spraying
It is recommended to resuspend 1000
doses of the vaccine in 150 - 300 ml of
distilled water. The number of doses
diluted corresponds to the number of birds
in a flock.
The vaccine is sprayed by means of a
dispensing system creating coarse spray.
Use the larger particle size for younger
and the smaller particle size for older
birds.
Administration

by


spraying

is

recommended for a rapid onset of solid
immunity or in case of direct flock
exposure to the disease.
In case of vacdnation by spraying, day-old
chickens are best vaccinated in hatchery or


during moving in poultry house. Oder
categories are recommended vaccinated in
a smaller space (floor breeding), or the
vaccine is sprayed directly on birds kept in
cages. Prior to vaccination, it is necessary
to switch off the aeration system.
ADVICE ON CORRECT
ADMINISTRATION All the birds in the
flock should be vaccinated at the same
time.
WITHD
RAWAL
PERIOD
Zero
days.
SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of
children.
Store in a refrigerator (2 “C - 8 °C).

Protect from light.
Do not use this veterinary medicinal
product after the expiry date which is
stated on the label and carton. Shelf life
after reconstitution: 3 hours.
SPECIAL WARNING(S)
Special warnings for each target species:
In any population of animals there are
individuals

who

respond

poorly

to

vaccination. Success of vaccination, in
addition to proper storage and the use of
vaccines, is affected by hereditary factors,
age, presence of diseases, the titer of


maternal

antibodies,

nutrition,


stress

effect, concomitant use of other veterinary
medicinal products (VMP), etc.
Prior to vaccination of the whole flock it is
advisable to consult with doctors of
veterinary medicine - experts in poultry,
because immunization programs vary from
area to area.
Special precautions for use in animals:
Only healthy birds may be vaccinated.
Clean equipment must be used for
preparation and application of the vaccine,
with

no

traces

of

antiseptics

or

disinfectants.
Special precautions to be taken by the
person administering the veterinary
medicinal product to animals: Care should
be taken when handling and administering

the vaccine. Since live vaccines against
Newcastle disease may in rare cases cause
conjunctivitis in humans, it is
recommended that person applying the
vaccine by spraying wears a protective
mask. Hands should be washed and
disinfected after vaccinating.
Lav:
The vaccine is not intended for use in
laying period, but can be applied in case of
need and immediate threat of infection.
Interaction with other medicinal products
and other forms of interaction:


No information is available on the safety
and efficacy of this vaccine with any other
veterinary medicinal product. A decision
to use this vaccine before or after any
other

veterinary

medicinal

product

therefore needs to be made on a case by
case basis.
Overdose


(symptoms,

emergency

procedures, antidotes):
A tenfold dose does not cause any negative
symptoms.
SPECIAL PRECAUTIONS FOR THE
DISPOSAL OF UNUSED PRODUCT OR
WASTE MATERIALS, IF ANY
Any unused veterinary medicinal product
or waste materials derived from such
veterinary medicinal product should be
disposed of in accordance with local
requirements.
OTHER INFORMATION
In

immunized

healthy

chickens

and

turkeys, PESTIKAL B1 SPF vaccine
induces


the

production

of

specific

antibodies against the Newcastle disease.
For animal treatment only.
Carton or plastic box with 10 vials of 1000
doses of vaccine.
Carton or plastic box with 10 vials of 2500
doses of vaccine.
Carton or plastic box with 10 vials of 5000
doses of vaccine.
Not all pack sizes may be marketed.


A

For
any information about this veterinary
O GENERA
GENERA Inc.

Svetonedeljska
2,
Kalinovica 10436 Rakov
Potok, CROATIA


Distributw in Vietnam:
Central Veter nary Med
idne JSC No. 5 Ha Blnh
Phuong Industrial Zone
Hanoi, Vietnam Tel;
043376.5858 Website;
www.ffvewi.vn Email;
infb@fivevetvn

medicinal product, please contact
fiveve the local
representative

—GMP-WHO—

of

t

the

marketing

authorisation holder.
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