PROTECH C4 + 2I

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

CANINE PARAINFLUENZA; LEPTOSPIRA ICTEROHAEMORRHAGIAE ANTIGEN; CANINE ADENO VIRUS TYPE 2; CANINE CORONAVIRUS VACCINE - ANTIGEN; CANINE DISTEMPER VIRUS; CANINE PARVO VIRUS

Available from:

Boehringer Ingelheim Animal Health Australia Pty. Ltd.

INN (International Name):

canine distemper virus+canine adenovirus+vaccine - canine parainfluen + others

Pharmaceutical form:

MISC. VACCINES OR ANTI SERA

Composition:

CANINE PARAINFLUENZA VACCINE Active 0.0 Undefined; LEPTOSPIRA ICTEROHAEMORRHAGIAE ANTIGEN VACCINE-ANTIGEN Active 0.0 Undefined; CANINE ADENO VIRUS TYPE 2 VACCINE-VIRAL Active 0.0 Undefined; CANINE CORONAVIRUS VACCINE - ANTIGEN 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:

25 x 1 dose Protech C4 and 25 x 1 dose C2i

Class:

VM - Veterinary Medicine

Therapeutic group:

DOG - OVER 6 WEEKS OLD

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

CANINE ADENOVIRUS - TYPE 1 | CANINE ADENOVIRUS - TYPE 2 | CANINE CORONAVIRUS | CANINE DISTEMPER | CANINE PARAINFLUENZA | CANINE PARVOVIRUS | LEPTOSPIRA ICTEROHAEMORRHAGIAE | PARVOVIRUS

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG - OVER 6 WEEKS OLD: [CANINE ADENOVIRUS - TYPE 1, CANINE ADENOVIRUS - TYPE 2, CANINE CORONAVIRUS, CANINE DISTEMPER, CANINE PARAINFLUENZA, CANINE PARVOVIRUS, LEPTOSPIRA ICTEROHAEMORRHAGIAE]; 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 parainfluenza virus, canine parvovirus & L. interrogans sv. Copenhageni & aid in .See DIRECTIONS FOR USE, PRECAUTIONS and SIDE EFFECTS on label.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

BOEHRINGER INGELHEIM PTY LIMITED, VETMEDICA DIVISION
PROTECH C4 + 2I
51489/101279
COMPANY NAME:
PRODUCT NAME:
APVMA APPROVAL NO:
LABEL NAME:
PROTECH C4 + 2I
SIGNAL HEADINGS:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
Attenuated canine distemper virus (10^2.9 TCID50)
Attenuated canine adenovirus type 2 (10^3.62 TCID50)
Attenuated canine parvovirus (CPV-2b strain 10^5.5 TCID50)
Attenuated canine parainfluenza virus type 2 (10^4.55 TCID50)
Inactivated canine coronavirus (RP
≥
1.62)
Inactivated bacterins of Leptospira interrogans serovar Copenhageni
(RP
≥
1.0)
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, canine parainfluenza virus, canine parvovirus and
Leptospira
interrogans serovar Copenhageni and aid in protection against disease
caused by canine
coronavirus. This vaccine prevents viral shedding caused by canine
parvovirus infection.
Early protection of puppies with final vaccination at 10 weeks.
NET CONTENTS:
25 x 1 dose Protech C4
25 x 1 dose Protech C2i
DIRECTIONS FOR USE:
A new sterile syringe and needle should always be used to administer
this vaccine.
Reconstitute the freeze-dried Protech® C4 vaccine with sterile water
for injection (1 mL) 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. RLP APPROVED
The use of these vaccines in pregnant bitches is not recommended.
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 appropr

Summary of Product characteristics

CS: 1.7.2
Page:
1
MATERIAL SAFETY DATA SHEET
4
of
Infosafe No™
LQ08H
August 2011
ISSUED by BOEHRING
Issue Date :
PROTECH® C4 +2I
Product Name :
Not classified as hazardous
1. IDENTIFICATION OF THE MATERIAL AND SUPPLIER
PROTECH® C4 +2I
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 against diseases caused by Canine
Distemper, Canine Adenovirus types 1 and 2, Canine Parainfluenza,
Canine
Parvovirus, Canine Coronavirus and Leptospira interrogans serovar
Copenhageni.
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
Product contains Canine distemper virus, Canine adenovirus, Canine
parvovirus,
Canine parainfluenza virus, Canine coronavirus and Leptospira
interrogans
serovar Copenhageni.
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

Safety Data Sheet

TOP
(B)
Exp.:
PROTECH® C4+2I
176501-00
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, canine parainfluenza virus, canine parvovirus and
Leptospira interrogans
serovar Copenhageni and aid in
protection against disease caused by canine coronavirus.
Early protection of puppies with final vaccination at 10 weeks.
READ ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
DOSE: Contents of one vial of PROTECH C4 to be reconstituted with
one vial of PROTECH C2I injected subcutaneously.
Store between 2-8°C. Do not freeze. Protect from light.
abcd
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
PROTECH® C4+2I
ACTIVE CONSTITUENTS: attenuated canine
distemper virus (10
2.9
TCID
50
), canine adenovirus
type 2 (10
3.62
TCID
50
), canine parvovirus
(CPV-2b strain, 10
5.5
TCID
50
) and canine
parainfluenza Type 2 (10
4.55
TCID
50
), inactivated
canine coronavirus (RP≥ 1.62) and bacterins of
Leptospira interrogans
serovar Copenhageni
(RP≥ 1.0).
CONTENTS:
25 single dose vials of PROTECH C4
25 single dose vials of PROTECH C2I
PROTECH® C4+2I
Please note leaflet, label and tray only are recyclable.
Protech® C4+2i is a registered trademark of Boehringer Ingelheim
Vetmedica, Inc.
BOEHRINGER INGELHEIM PTY LIMITED
ANIMAL HEALTH DIVISION
78 WATERLOO ROAD
NORTH RYDE NSW 2113
APVMA Approval No. 51489/56234
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BOEHRINGER
INGELHEIM
7
lsh
22May12
176501-00
REQUESTED
Protech C4+2i
Tray / 25 x 1 mL
306
3” x 8-1/2”
.312”
22May12 lsh
00
BLACK
PMS 107
PMS 285
PMS 499
DIMENSIONS: 76.2 MM X 215.9 MM
THIS FILE IS 100% WHEN PRINTED ON A4 (OR A3, AS APPLICABLE)
FONT SIZES:
MAIN PANEL: 6.5 pt
TRADENAME: 13 pt
SIDE PANEL:
6.5 pt