INGELVAC CIRCOFLEX SUSPENSION FOR INJECTION IN PIGS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

PORCINE CIRCOVIRUS TYPE 2 ORF2 PROTEIN; CARBOMER

Available from:

Boehringer Ingelheim Animal Health Australia Pty. Ltd.

INN (International Name):

porcine circovirus type 2

Pharmaceutical form:

MISC. VACCINES OR ANTI SERA

Composition:

PORCINE CIRCOVIRUS TYPE 2 ORF2 PROTEIN VACCINE-VIRAL Active 1.0 ml/do; CARBOMER UNGROUPED Other 1.0 mg

Units in package:

100mL; 10mL; 250mL; 50mL

Class:

VM - Veterinary Medicine

Therapeutic group:

PIGS - SEE LABEL FOR TYPE

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

DISEASE CONTROL

Product summary:

Poison schedule: 0; Withholding period: WHP: MEAT: NIL Zero (0) days; Host/pest details: PIGS - SEE LABEL FOR TYPE: [DISEASE CONTROL]; Poison schedule: 0; Withholding period: WHP: MEAT: NIL; Host/pest details: PIGS - SEE LABEL FOR TYPE: [DISEASE CONTROL]; For active immunisation of pigs from two weeks of age and older as an aid in the prevention & control of diseases associated with porcine circovirus type 2.DO NOT mix with other vaccine/immunological products. A mild & transient hyperthermia very commonly occurs on the day of vaccination. No safety/efficacy data has been generated in breeding animals

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

INGELVAC CIRCOFLEX SUSPENSION FOR INJECTION IN PIGS
63448/135400
Product Name:
APVMA Approval No:
Label Name:
INGELVAC CIRCOFLEX SUSPENSION FOR INJECTION IN PIGS
Signal Headings:
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
Each 1 mL dose contains:
PORCINE CIRCOVIRUS TYPE 2 ORF2 PROTEIN ≥ 1.0 RP
Also contains:
1mg Carbomer (Adjuvant)
Claims:
For active immunisation of pigs from two weeks of age and older as an
aid in the prevention
and control of diseases associated with porcine circovirus type 2.
This vaccine has been
demonstrated safe in pregnant and lactating sows.
Net Contents:
100mL
10mL
250mL
50mL
Directions for Use:
Restraints:
Contraindications:
Precautions:
Interaction: No information is available on the safety and efficacy of
the concurrent use
of this vaccine with any other products except with Boehringer
lngelheim's lngelvac
MycoFLEX
Side Effects:
A mild and transient hyperthermia very commonly occurs on the day of
vaccination. RLP APPROVED
Dosage and
Administration:
SHAKE WELL BEFORE USE and use immediately.
Use the entire contents after broaching the container.
Administer a single 1 mL dose intramuscularly, irrespective of
bodyweight.
When mixed with Ingelvac MycoFLEX: Vaccinate only pigs from 3 weeks of
age.
Use the same volumes of Ingelvac CircoFLEX and Ingelvac MycoFLEX.
When mixing using conventional bottles:
Use a pre-sterilised transfer needle. Pre-sterilised transfer needles
are commonly available
via medical equipment suppliers.
To ensure correct mixing follow the steps as described below:
Connect one end of the transfer needle to the vaccine bottle of
Ingelvac MycoFLEX.
Connect the opposite end of the transfer needle to the vaccine bottle
of Ingelvac
CircoFLEX. Transfer the Ingelvac CircoFLEX vaccine into the vaccine
bottle of Ingelvac
MycoFLEX. If needed, gently press the vaccine bottle of Ingelvac
CircoFLEX to facilitate
the transfer. After the transfer of the full content of Ingelvac
CircoFLEX, disconnect
the transfer needle. Discard the empty vaccine

Summary of Product characteristics

CS: 1.7.2
Page:
1
MATERIAL SAFETY DATA SHEET
4
of
Infosafe No™
LPYSN
May 2010
ISSUED by BOEHRING
Issue Date :
INGELVAC CIRCOFLEX
Product Name :
Not classified as hazardous
1. IDENTIFICATION OF THE MATERIAL AND SUPPLIER
INGELVAC CIRCOFLEX
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 active immunisation of pigs from two weeks of age and older as an
aid in
the prevention and control of diseases associated with porcine
circovirus type
2.
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
S1/2 Keep locked up and out of reach of children.
S13 Keep away from food, drink and animal feeding stuffs.
SAFETY PHRASE(S)
FOR SWINE INJECTION ONLY.
Not for human use.
This is an inactivated vaccine and there should be no danger of
reversion to
virulence or potential for it to combine with field strains.
OTHER INFORMATION
3. COMPOSITION/INFORMATION ON INGREDIENTS
NAME
CAS
PROPORTION
INGREDIENTS
Additives
Proprietary
0-100 %
inactivated
baculo-expressed PCV2
ORf2
0-100 %
Do not administer with other vaccines/immunological products. Do not
administer during pregnancy and lactation as no safety data has been
generated
in breeding animals.
OTHER INFORMATION
4. FIRST AID MEASURES
General: Animals or persons developing anaphylactic (life-threatening)
reactions, such as difficulty in breathing or unconsciousness, must
recieve
immediate medical attention.
FIRST AID MEASURES
Not a likely source of exposure. However if inhaled, remove affected
person to
fresh air. If symptoms develop seek medical attention.
INHALATION
Do not induce vomiting. Wash out mouth thoroughly with water. Seek
immediate
medical attention.
ING