PROTECH C3

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

CANINE ADENO VIRUS TYPE 2; CANINE DISTEMPER VIRUS; CANINE PARVO VIRUS

Available from:

Boehringer Ingelheim Animal Health Australia Pty. Ltd.

INN (International Name):

canine distemper virus+canine adenovirus+canine parvovirus

Pharmaceutical form:

MISC. VACCINES OR ANTI SERA

Composition:

CANINE ADENO VIRUS TYPE 2 VACCINE-VIRAL Active 0.0 Undefined; CANINE DISTEMPER VIRUS VACCINE-VIRAL Active 0.0 Undefined; CANINE PARVO VIRUS VACCINE-VIRAL Active 0.0 Undefined

Units in package:

10 x 1mL; 1mL; 25 x 1mL

Class:

VM - Veterinary Medicine

Therapeutic group:

DOG - OVER 6 WEEKS OLD

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

CANINE DISTEMPER | CANINE PARVOVIRUS | HEPATITIS :- INFECTIOUS | CANINE ADENOVIRUS TYPE 1 | CANINE ADENOVIRUS TYPE 2 | INFECTIOUS CANINE HEPATITIS | PARVOVIRUS

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG - OVER 6 WEEKS OLD: [CANINE DISTEMPER, CANINE PARVOVIRUS, HEPATITIS :- INFECTIOUS]; Live vaccine for the immunisation of healthy dogs, 6 weeks of age or older to protect against disease caused by canine distemper virus, canine adenovirus types 1&2 & canine parvovirus. Prevents viral shedding caused by CPV infectionDogs under treatment with immunosuppressive drugs should not be vaccinated. The use of these vaccines in pregnant bitches is not recommended. See also 'Precautions and side effects' on label.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

BOEHRINGER INGELHEIM PTY LIMITED, VETMEDICA DIVISION
PROTECH C3
51487/101270
COMPANY NAME:
PRODUCT NAME:
APVMA APPROVAL NO:
LABEL NAME:
PROTECH C3
SIGNAL HEADINGS:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
canine distemper virus (10^2.9 TCID50)
canine adenovirus type 2 (10^3.62 TCID50)
canine parvovirus (CPV-2b strain, 10^5.5 TCID50)
CLAIMS:
Live vaccine for the immunisation of healthy dogs, 6 weeks of age or
older to protect
against disease caused by canine distemper virus, canine adenovirus
type 1, canine
adenovirus type 2 and canine parvovirus. This vaccine prevents viral
shedding caused by
canine parvovirus infection. Early protection of puppies with final
vaccination at 10 weeks.
NET CONTENTS:
10 x 1mL
1mL
25 x 1mL
DIRECTIONS FOR USE:
A new sterile syringe and needle should always be used to administer
this vaccine.
Reconstitute the freeze-dried Protech® vaccines with sterile water
for injection (1mL) or
Protech® C2i vaccine.
Inject subcutaneously within 20 minutes of reconstitution. Do not use
chemicals or
disinfectants to sterilise the skin, needles or syringes.
RESTRAINTS:
CONTRAINDICATIONS:
PRECAUTIONS:
Vaccinate only healthy dogs with normal temperatures.
Dogs under treatment with immunosuppressive drugs should not be
vaccinated.
The use of these vaccines in pregnant bitches is not recommended. RLP APPROVED
SIDE EFFECTS:
Some animals may show transient post-vaccination pain, malaise and
depression.
Allergic reactions such as anaphylaxis occur rarely and may require
parenteral treatment
with
an antihistamine, a corticosteroid or adrenalin as appropriate.
Local site reactions after vaccination are rare but transient
swelling, pain and subcutaneous
thickening have been reported.
DOSAGE AND
ADMINISTRATION:
This section contains file attachment.
FILE NAME: Protech C3 and C4 dosage and administration.docx
FILE SIZE: 20094 bytes
GENERAL DIRECTIONS:
WITHHOLDING
PERIODS:
TRADE ADVICE:
SAFETY DIRECTIONS:
FIRST AID
INSTRUCTIONS:
If poisoning occurs

Summary of Product characteristics

CS: 1.7.2
Page:
1
MATERIAL SAFETY DATA SHEET
4
of
Infosafe No™
LQ08E
August 2011
ISSUED by BOEHRING
Issue Date :
PROTECH C3
Product Name :
Not classified as hazardous
1. IDENTIFICATION OF THE MATERIAL AND SUPPLIER
PROTECH C3
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
For the immunisation of healthy dogs, 6 weeks of age or older, to
protect
against disease caused by canine distemper virus, canine adenovirus
type 1,
canine adenovirus type 2 and canine parvovirus.
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
Protech C3 contains live attenuated canine distemper virus, canine
adenovirus
type 2 and canine parvovirus. A lyophilised vaccine for reconstitution
with
sterile water.
INFORMATION ON
COMPOSITION
NAME
CAS
PROPORTION
INGREDIENTS
Ingredients determined
not to be hazardous
-
Balance
Live virus vaccine
-
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 si