PROTECH BRONCHI-SHIELD III BORDETELLA BRONCHISEPTICA, CANINE ADENOVIRUS TYPE 2 AND PARAINFLUENZA VACCINE

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

CANINE PARAINFLUENZA; BORDETELLA BRONCHISEPTICA; CANINE ADENO VIRUS TYPE 2

Available from:

Boehringer Ingelheim Animal Health Australia Pty. Ltd.

INN (International Name):

vaccine - canine Bordetella+canine adenovirus + others

Pharmaceutical form:

MISC. VACCINES OR ANTI SERA

Composition:

CANINE PARAINFLUENZA VACCINE Active 0.0 P; BORDETELLA BRONCHISEPTICA VACCINE-MICROBIAL Active 0.0 P; CANINE ADENO VIRUS TYPE 2 VACCINE-VIRAL Active 0.0 P

Units in package:

!10 x 1mL; !diluent; !dose vial; !sterile; #25 x 1mL; #diluent; #dose vial; #sterile; *10 intra-; *nasal app; @25 intra-; @nasal

Class:

VM - Veterinary Medicine

Therapeutic group:

DOG - OVER 8 WEEKS

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

BORDETELLA BRONCHISEPTICA | CANINE ADENOVIRUS - TYPE 2 | CANINE PARAINFLUENZA | CANINE COUGH SYNDROME | INFECTIOUS TRACHEOBRONCHITIS

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG - OVER 8 WEEKS: [BORDETELLA BRONCHISEPTICA, CANINE ADENOVIRUS - TYPE 2, CANINE PARAINFLUENZA]; For the active immunisation by intranasal inoculation of healthy dogs over 8 weeks of age as an aid in preventing canine cough caused by Bordetella bronchiseptica, canine adenovirus type 2 and canine parainfluenza virus.Vaccinate only healthy dogs, with normal temperatures. Dogs under treatment with immunosuppressive drugs should be vaccinated with caution.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Protech® Bronchi-Shield® Ill
VIAL
LABEL
Bordetella bronchiseptica, Canine Adenovirus type 2 and Parainfluenza
Vaccine
Contents: 1 dose
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
..
Store between
2•c
-
8•c.
Do not freeze.
Protect from light.
Batch No.:
Expiry Date:
APVMA 51824/52588
Boehringer
lngelheim
+
RLP
Approved
Infopest
Verified
DILUENT
LABEL
FOR ANIMAL TREATMENT
ONLY
Sterile
diluent
Contents: 1
dose
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.
Store between
2'C
-
8'C.
·Do
not freeze.
Protect from light.
Batch No.:
Expiry Date:
Boehringer
lngelheim
TRAY
LABEL-
25
dose
!>RESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Protech® Bronchi-Shield® Ill
Bordetella
bronchiseptica, Canine
Adenovirus
type
2 and Parainfluenza Vaccine
For the active immunisation by intranasal inoculation of healthy dogs
over 8 weeks
of
age as
an
aid
in
preventing canine cough caused by
Bordetella
bronchiseptica,
canine adenovirus type 2
and canine parainfluenza virus
Active
Constituent
Each dose contains live avirulent
Bordetella
bronchiseptica
(2x 10
6
CFU
per dose), modified live canine adenovirus type 2 (10
3
·
4
TCID
50
)
and modified live
canine parainfluenza virus (10
4
"
3
TCID
50
).
•
CONTENTS:
10 x 1 dose vials
10 x 1 mL diluent
1 0 x intransal applicators
(25 x 1 dose vials
25 x 1 mL diluent
25 x
intraQs~l
ap~licators)
READ ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
Directions
for
Use
Use entire contents reconstituted with sterile water for injection
(1
mL)
and
use by intranasal
administration with syringe and intranasal applicator.
APVMA No 51824/52588
Store between 2-8·.
Do
not freeze.
Protect from light.
Batch
No.
Expiry Date:
Boehringer lngelheim Ply Limited
Animal Health Division
78 Waterloo Road
North Ryde NSW 2113
PACKAGING INSERT
PRESCRIPTION
ANIMAL
REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Protech® Bronchi-Shield'"
III
Bordetella
bronchiseptica,
Canine

Summary of Product characteristics

CS: 1.7.2
Page:
1
MATERIAL SAFETY DATA SHEET
4
of
Infosafe No™
LQ081
August 2011
ISSUED by BOEHRING
Issue Date :
BRONCHI-SHIELD III
Product Name :
Not classified as hazardous
1. IDENTIFICATION OF THE MATERIAL AND SUPPLIER
BRONCHI-SHIELD III
PRODUCT NAME
Boehringer Ingelheim Pty. Limited
COMPANY NAME
78 Waterloo Rd North Ryde
NSW 2113 Australia
ADDRESS
1800 038 037
EMERGENCY TEL.
Tel: [phone]
Fax: [phone]
TELEPHONE/FAX
NUMBER
[e-mail]
EMAIL
Canine Adenovirus Type 2-Parainfiuenza-Bordetella bronchiseptica
Vaccine
(modified live virus)
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
NAME
CAS
PROPORTION
INGREDIENTS
Ingredients determined
not to be hazardous
-
Balance
Modified Live Virus
Unknown
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 in eyes, hold eyelids apart and flush the eyes continuously with
running
water. Continue flushing for s