INGELVAC MYCOFLEX MYCOPLASMA HYOPNEUMONIAE INACTIVATED VACCINE FOR PIGS

Country: Ástralía

Tungumál: enska

Heimild: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Virkt innihaldsefni:

CARBOMER; MYCOPLASMA HYOPNEUMONIAE - INACTIVATED ANTIGEN

Fáanlegur frá:

Boehringer Ingelheim Animal Health Australia Pty. Ltd.

INN (Alþjóðlegt nafn):

vaccine - Mycoplasma hyopneum.

Lyfjaform:

MISC. VACCINES OR ANTI SERA

Samsetning:

CARBOMER UNGROUPED Active 1.0 mg; MYCOPLASMA HYOPNEUMONIAE - INACTIVATED ANTIGEN VACCINE-GENERAL Active 1.0 RP

Einingar í pakka:

10 doses - 15mL (30mL head space bottle); 10 doses - 15mL (30mL HSB); 100 doses - 120mL (250mL head space bottle); 100 doses - 120mL (250mL HSB); 20 doses - 30mL (60mL head space bottle); 20 doses - 30mL (60mL HSB); 250 doses - 250mL (500mL head space bottle); 250 doses - 250mL (500mL HSB); 50 doses - 60mL (120mL head space bottle); 50 doses - 60mL (120mL HSB)

Tegund:

VM - Veterinary Medicine

Lækningarsvæði:

IMMUNOTHERAPY

Vörulýsing:

Poison schedule: 0; Withholding period: Zero (0) days ESI: Zero (0) days. Befor e using this product, confirm the curren t ESI from the Boehringer Ingelheim Anim al Health Australia Pty. Ltd. on 1800 80 8 691 or the APVMA website (www.apvma.go v.au/residues); Host/pest details: PIG - 3 WEEKS AND OLDER: [MYCOPLASMA HYOPNEUMONIAE]; PIG SOW LACTATING: [MYCOPLASMA HYOPNEUMONIAE]; PIG SOW PREGNANT: [MYCOPLASMA HYOPNEUMONIAE]; Poison schedule: 0; Withholding period: WHP: Zero (0) days ESI: Zero (0) days. Before using this product, confirm the current ESI from the Boehringer Ingelhei m Animal Health Australia Pty. Ltd. on 1 800 808 691 or the APVMA website (www.ap vma.gov.au/residues); Host/pest details: PIG - 3 WEEKS AND OLDER: [MYCOPLASMA HYOPNEUMONIAE]; PIG SOW LACTATING: [MYCOPLASMA HYOPNEUMONIAE]; PIG SOW PREGNANT: [MYCOPLASMA HYOPNEUMONIAE]; Poison schedule: 0; Withholding period: WHP: N/A; Host/pest details: PIG - 3 WEEKS AND OLDER: [MYCOPLASMA HYOPNEUMONIAE]; PIG SOW LACTATING: [MYCOPLASMA HYOPNEUMONIAE]; PIG SOW PREGNANT: [MYCOPLASMA HYOPNEUMONIAE]; For the vaccination of healthy, susceptible swine at weaning (3 weeks of age) or older as an aid in the prevention of enzootic pneumonia of swine caused by Mycoplasma hyopneumoniae.See RESTRAINTS etc. on label.

Leyfisstaða:

Registered

Leyfisdagur:

2023-07-01

Upplýsingar fylgiseðill

INGELVAC MYCOFLEX MYCOPLASMA HYOPNEUMONIAE INACTIVATED VACCINE
FOR PIGS
69810/135403
Product Name:
APVMA Approval No:
Label Name:
INGELVAC MYCOFLEX MYCOPLASMA HYOPNEUMONIAE INACTIVATED VACCINE
FOR PIGS
Signal Headings:
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
Each 1 mL dose contains:
INACTIVATED MYCOPLASMA HYOPNEUMONIAE ≥ 1.0 RP
Also contains:
1mg Carbomer (Adjuvant)
Claims:
For the vaccination of healthy, susceptible swine at weaning (3 weeks
of age) or older
as an aid in the prevention of enzootic pneumonia of swine caused by
Mycoplasma
hyopneumoniae.
This vaccine has been demonstrated to be safe in pregnant and
lactating sows.
Net Contents:
10 doses - 15 mL (30 mL HSB*)
20 doses - 30 mL (60 mL HSB*)
50 doses - 60 mL (120 mL HSB*)
100 doses - 120 mL (250 mL HSB*)
250 doses - 250 mL (500 mL HSB*)
*HSB = head space bottle - includes larger headspace
Directions for Use:
Restraints:
Contraindications:
Precautions:
No information is available on the safety and efficacy of the
concurrent use of this vaccine
with any other vaccine/immunological products except with Boehringer
lngelheim's lngelvac
CircoFLEX. RLP APPROVED
Side Effects:
A mild and transient hyperthermia very commonly occurs on the day of
vaccination.
Dosage and
Administration:
SHAKE WELL BEFORE USE and use immediately.
During use, hold vaccine at or below 25°C.
Use entire contents after broaching the container.
Administer a single 1 mL dose per pig intramuscularly.
When mixed with Ingelvac CircoFLEX:
•Vaccinate only pigs from 3 weeks of age.
•Use the same volumes of Ingelvac CircoFLEX and Ingelvac MycoFLEX.'
(Conventional Bottle mixing instructions):
•Aseptically transfer the full content of each vaccine bottle into a
pre-sterilised plastic or
glass container of at least double the capacity of the vaccine bottle
by using pre-sterilised
transfer needles. Pre-sterilised transfer needles are commonly
available via medical
equipment suppliers.
(Head Space Bottle mixing instructions):
•Use a pre-sterilised tra