PROTECH BB BORDETELLA BRONCHISEPTICA KILLED VACCINE

Land: Australia

Språk: engelsk

Kilde: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Preparatomtale Preparatomtale (SPC)
20-06-2017
Sikkerhetsdatablad Sikkerhetsdatablad (SDS)
04-09-2002

Aktiv ingrediens:

BORDETELLA BRONCHISEPTICA KILLED VACCINE

Tilgjengelig fra:

Boehringer Ingelheim Animal Health Australia Pty. Ltd.

INN (International Name):

vaccine - canine Bordetella(20ug/mL)

Legemiddelform:

MISC. VACCINES OR ANTI SERA

Sammensetning:

BORDETELLA BRONCHISEPTICA KILLED VACCINE VACCINE-MICROBIAL Active 0.0 P

Enheter i pakken:

25 x 1mL; Syringe

Klasse:

VM - Veterinary Medicine

Terapeutisk gruppe:

DOG | BITCH | CASTRATE | PUPPY

Terapeutisk område:

IMMUNOTHERAPY

Indikasjoner:

BORDETELLA BRONCHISEPTICA | CANINE COUGH SYNDROME | INFECTIOUS TRACHEOBRONCHITIS

Produkt oppsummering:

Poison schedule: 0; Withholding period: WHP:N/A; Host/pest details: DOG: [BORDETELLA BRONCHISEPTICA]; Poison schedule: 0; Withholding period: ; Host/pest details: DOG: [BORDETELLA BRONCHISEPTICA]; For the immunisation of dogs against Bordetella bronchiseptica infection, a contributing factor to the canine cough syndrome.For use only by or under the direction of a registered veterinary surgeon. This product should not be used in dogs when they are incubating an infectious disease, seriously debilitated by another infectious disease, parasitic infestation, malnutrition...

Autorisasjon status:

Registered

Autorisasjon dato:

2023-07-01

Informasjon til brukeren

                                Protech BB Bordetella bronchiseptica Killed Vaccine
APVMA54951
Page 1 of 5
20
June 2014
FOR ANIMAL TREATMENT ONLY
PROTECH®BB
Syringe label
BORDETELLA BRONCHISEPTICA
KILLED VACCINE
Contents:
1 dose
(1
mL)
To be used
by,
or
under the direction of a registered veterinary surgeon.
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.
Contents must be left
in
outer package until immediately before use.
SHAKE GENTLY BEFORE USE.
Store between 2-S"C.
Do not freeze.
Protect from light.
APVMA 54951/62963
Batch No.:
Expiry:
Boehringer
lngelheim
+
RLP
Approved
Protech BB Bordetella bronchiseptica Killed Vaccine
APVMA54951
Page 2
of
5
20 June 2014
Tray label -
25
FOR ANIMAL
TREATMENT
ONLY
PROTECH® BB
BORDETEL/A BRONCHISEPTICA
KILLED VACCINE
ACTIVE CONSTITUENT:
An inactivated vaccine prepared from a cell-free extract of
Bordetella bronchiseptica
(20
~glmL)
For the immunisation of dogs against
Bordetella bronchiseptica
infection, a contributing factor
to
the canine cough syndrome.
Contents:
25 single dose syringes
READ ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
TO
BE USED BY,
OR
UNDER THE DIRECTION
OF
A REGISTERED VETERINARY SURGEON.
Contents must be left
in
outer package until immediately before use.
SHAKE GENTLY BEFORE USE.
Dose: A 1 mL dose (one syringe) is recommended for dogs of all ages.
The vaccine is injected
subcutaneously.
Store between 2-B'C.
Do not freeze.
Protect from light.
APVMA
No.
54951/62963
Batch No.:
Expiry:
Protech®
BB
is a registered trademark of Boehringer lngelheim Vetmedica
Inc.-
used under
license.
Please recycle leaflet, label and tray only.
Boehringer
lngelheim
FOR ANIMAL TREATMENT ONLY
PROTECH®BB
Protech
BB
Bordetella bronchiseptica Killed Vaccine
APVMA
54951
Page 3 of 5
20
June 2014
Carton label -
25
BORDETELLA BRONCHISEPTICA
KILLED VACCINE
ACTIVE CONSTITUENT:
An
inactivated vaccine prepared from a cell-free extract of
Bordeteffa bronchiseptica
(20
~g/mL)
For the immunisation
of
dogs against
Bordeteffa bronchiseptica
infection, a contributing factor
to
the canine cough syndrome.
Contents:
25 sin
                                
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Preparatomtale

                                CS: 1.7.2
Page:
1
MATERIAL SAFETY DATA SHEET
4
of
Infosafe No™
LQ08B
August 2011
ISSUED by BOEHRING
Issue Date :
PROTECH® BB BORDETELLA BRONCHISEPTICA KILLED VACCINE
Product Name :
Not classified as hazardous
1. IDENTIFICATION OF THE MATERIAL AND SUPPLIER
PROTECH® BB BORDETELLA BRONCHISEPTICA KILLED VACCINE
PRODUCT NAME
Boehringer Ingelheim Pty. Limited
COMPANY NAME
78 Waterloo Rd North Ryde
NSW 2113 Australia
ADDRESS
1800 038 037
EMERGENCY TEL.
Tel: 1800 038 037
Fax: +61 2 8875 8715
TELEPHONE/FAX
NUMBER
animalhealth.au@boehringer-ingelheim.com
EMAIL
For the immunisation of dogs against Bordetella bronchiseptica (canine
cough).
RECOMMENDED USE
2. HAZARDS IDENTIFICATION
Not classified as hazardous
NON-HAZARDOUS SUBSTANCE.
NON-DANGEROUS GOODS.
Hazard classification according to the criteria of NOHSC.
Dangerous goods classification according to the Australia Dangerous
Goods
Code.
HAZARD
CLASSIFICATION
3. COMPOSITION/INFORMATION ON INGREDIENTS
Water suspension of killed Bordetella bronchiseptica
INFORMATION ON
COMPOSITION
NAME
CAS
PROPORTION
INGREDIENTS
Ingredients determined
not to be hazardous
-
100 %
4. FIRST AID MEASURES
No special precautions required. However, if inhaled, remove affected
person
from contaminated area. Keep at rest until recovered. If symptoms
persist seek
medical attention.
INHALATION
Do not induce vomiting. Wash out mouth thoroughly with water. If
symptoms
develop seek medical attention.
INGESTION
Wash affected area thoroughly with soap and water. If symptoms develop
seek
medical attention.
Self-Injection: Accidental self injection may lead to an inflammatory
response
and medical advice should be sought on the management of deep
injections,
particularly those near a joint or associated with bruising. If
possible the
application of gentle squeezing pressure with absorbent material (e.g.
facial
tissues) at the injection site will swab up unabsorbed vaccine. Strong
squeezing of the site should be avoided. The damaged area should be
thoroughly
cleansed and a topical antiseptic applied.
SKIN
If
                                
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Sikkerhetsdatablad

                                Protech® BB
ABCD
Composition
An inactivated vaccine prepared from a cell-free
extract of Bordetella bronchiseptica (20 mg/mL). An
aluminium salt is included to enhance the response
to vaccination and to increase the duration of
immunity. Thiomersal 0.1 mg/mL is added as a
preservative.
Indication
The vaccine is used for the immunisation of dogs
against colonisation of the upper and lower
respiratory tract, nose and throat with Bordetella
bronchiseptica.
Directions for Use
To be used by, or under the direction of a registered
veterinary surgeon.
Contents must be left in outer package until
immediately before use.
Shake gently before use.
Precautions
Protech® BB should not be used in dogs when they
are:
1.
Incubating an infectious disease
2.
Seriously debilitated by another infectious
disease, parasitic infestation or malnutrition; or
3.
Under treatment with immunosuppressive drugs.
Side Effects
As Protech® BB is an inactivated vaccine, untoward
systemic effects are uncommon and the vaccine may
be used in pregnant bitches. Careful palpation of the
site of injection may reveal a small fibrous nodule in
some dogs about a week after vaccination. This
nodule will regress, becoming impalpable within two
to six weeks. In a very few small, smooth-coated
dogs a nodule may be visible for a limited period.
Some animals may show transient post-vaccination
reactions including injection site pain, lethargy
and/or vomiting.
Systemic allergic reactions such as anaphylaxis are
thought to occur rarely with all vaccines and may
require appropriate treatment. Systemic
hypersensitivity reactions, mainly characterised by
urticaria and facial oedema, have also been
reported, particularly in animals receiving a second
injection of Protech® BB 4 to 8 weeks after the first
injection. Premedication with antihistamine may be
indicated in animals at risk.
Dosage and Administration
The vaccine is injected subcutaneously. A 1 mL dose
(one syringe) is recommended for dogs of all ages.
Gentle massage at the site of injection will help to
di
                                
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