NOBILIS GUMBORO + ND COMBINED INACTIVATED VACCINE AGAINST GUMBORO AND NEWCASTLE DISEASE

País: Austrália

Língua: inglês

Origem: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Ingredientes ativos:

INACTIVATED GUMBORO VIRUS; INACTIVATED NEWCASTLE DISEASE VIRUS ANTIGEN

Disponível em:

INTERVET AUSTRALIA PTY LIMITED

DCI (Denominação Comum Internacional):

IBDV vaccine (D78)+Newcastle disease virus (I)

Forma farmacêutica:

MISC. VACCINES OR ANTI SERA

Composição:

INACTIVATED GUMBORO VIRUS BIOLOGICAL-VIRUS Active 0.0 VNU/dose; INACTIVATED NEWCASTLE DISEASE VIRUS ANTIGEN VACCINE-VIRAL Active 0.0 HI/dose

Unidades em pacote:

*(1000; *doses); 500mL

Classe:

VM - Veterinary Medicine

Fabricado por:

INTERVET AUSTRALIA

Grupo terapêutico:

POULTRY | BREEDERS | BROILER | CHICKENS | CHICKS | CHOOKS | DAY OLD CHICKS | HATCHLINGS | LAYERS

Área terapêutica:

IMMUNOTHERAPY

Indicações terapêuticas:

INFECTIOUS BURSAL DISEASE | NEWCASTLE DISEASE | BURSAL DISEASE

Resumo do produto:

Poison schedule: 0; Withholding period: WHP: As per the label Zero (0) days.; Host/pest details: POULTRY: [INFECTIOUS BURSAL DISEASE, NEWCASTLE DISEASE]; Poison schedule: 0; Withholding period: WHP: Nil; Host/pest details: POULTRY: [INFECTIOUS BURSAL DISEASE, NEWCASTLE DISEASE]; Poison schedule: 0; Withholding period: ; Host/pest details: POULTRY: [INFECTIOUS BURSAL DISEASE, NEWCASTLE DISEASE]; Inactivated vaccine for the protection of chickens against infectious bursal disease and poultry against Newcastle disease.

Status de autorização:

Registered

Data de autorização:

2023-07-01

Folheto informativo - Bula

NOBILIS GUMBORO + ND COMBINED INACTIVATED VACCINE AGAINST
GUMBORO AND NEWCASTLE DISEASE
58353/132518
Product Name:
APVMA Approval No:
Label Name:
NOBILIS GUMBORO + ND COMBINED INACTIVATED VACCINE AGAINST GUMBORO
AND NEWCASTLE DISEASE
Signal Headings:
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
ACTIVE CONSTITUENTS: NDV Clone 30 inducing ≥ 4 log2 HI units per
1/50th of a dose or
containing ≥ 50 PD50 units/dose; IBDV D78: inducing ≥ 14.5 log2 VN
units/dose in an oil
adjuvanted emulsion.
Nobilis® GUMBORO + ND contains one immunogenic strain of Newcastle
Disease virus
and one immunogenic strain of Infectious Bursal Disease virus.
The viruses have been grown on embryonated eggs or Vero Cell cultures
and are
inactivated with formalin. Subsequently they have been suspended in
the aqueous phase
of an oil adjuvant emulsion.
Claims:
Inactivated vaccine for the protection of chickens against Infectious
Bursal Disease and
poultry against Newcastle Disease.
Net Contents:
500 mL (1000 doses)
Directions for Use:
Restraints:
Do not mix with other vaccines.
Contraindications:
Precautions:
Vaccinate healthy birds only.
Side Effects:
Vaccination reactions: RLP APPROVED
In healthy birds no clinical reaction to vaccination will be observed.
For some weeks after
vaccination a slight swelling may be felt at the site of vaccination.
Local tissue reactions
may occur.
Dosage and
Administration:
Shake the bottle well before and during use.
Broached vials should be used within 3 hours.
Before using vaccine allow it to reach an ambient temperature (15°C
to 25°C).
Use sterile injection equipment. Each bird should be given 0.5 mL of
vaccine
intramuscularly (IM) in the thigh or chest muscle or subcutaneously
(SC) into the lower part
of the neck.
Recommended vaccination program:
Nobilis GUMBORO + ND should be given to birds around 14-18 weeks of
age but not less
than 4 weeks before the expected onset of lay. For an optimal booster
effect, the birds must
be previously primed with live vaccines against Newcastle Disease and
Infectiou

Características técnicas

PRODUCT NAME: NOBILIS® GUMBORO + ND COMBINED INACTIVATED
VACCINE AGAINST GUMBORO AND NEWCASTLE DISEASE
MATERIAL SAFETY DATA SHEET
THIS REVISION ISSUED: JULY, 2009
PAGE: 1 OF 6
MATERIAL SAFETY DATA SHEET
Issued by: Intervet Australia Pty Limited Phone: [phone]
(Business Hours)
Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800
764 766 in New Zealand)
SUBSTANCE:
Inactivated virus in an oil/water emulsion.
TRADE NAME:
NOBILIS
® GUMBORO + ND COMBINED INACTIVATED VACCINE AGAINST
GUMBORO AND NEWCASTLE DISEASE
PRODUCT CODE:
27692
RECOMMENDED USE:
Disease prevention by vaccination in laying and breeding poultry.
APVMA NO:
58353
CREATION DATE:
November, 2006
THIS VERSION ISSUED:
July, 2009
and is valid for 5 years from this date.
STATEMENT OF HAZARDOUS NATURE:
THIS PRODUCT IS CLASSIFIED AS:
Not classified as hazardous according to the criteria of SWA.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S25. Avoid contact with eyes.
SUSDP CLASSIFICATION:
None allocated.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
PHYSICAL DESCRIPTION & COLOUR:
White emulsion. Presented in 500mL bottle.
ODOUR:
No odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
The formaldehyde in this product is present at very low
concentrations. However, persons with known sensitisation to
formaldehyde should avoid contact with this product.
INHALATION:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. However
product may be mildly
irritating, although unlikely to cause anything more than mild
transient discomfort.
LONG TERM EXPOSURE:
No data for health effects associated with long term inhalation.
SKIN CONTACT:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. It should
present no hazards in
normal use. However product may be mildly irritating, but is unlikely
to cause anything m