ONCEPT® CANINE MELANOMA VACCINE, DNA

国: オーストラリア

言語: 英語

ソース: APVMA (Australian Pesticides and Veterinary Medicines Authority)

有効成分:

PLASMID DNA, RE.COLI DH5A PINGHT

から入手可能:

Boehringer Ingelheim Animal Health Australia Pty. Ltd.

医薬品形態:

MISC. VACCINES OR ANTI SERA

構図:

PLASMID DNA, RE.COLI DH5A PINGHT Active 92.7 ug

パッケージ内のユニット:

4 x 1 dose (0.4 mL) vials

クラス:

VM - Veterinary Medicine

治療領域:

IMMUNOTHERAPY

製品概要:

Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [STAGE II OR STAGE III ORAL MELANOMA - SEE LABEL]

認証ステータス:

Registered

承認日:

2023-07-01

情報リーフレット

Product name:
APVMA Approval No:
ONCEPT
Canine Melanoma Vaccine, DNA
67247 / 55587
Label
name:
ONCEPT Canine Melanoma Vaccine, DNA
Si
gnal Headings:
PRESCRIPTION ANIMAL REMEDY
FOR ANIMAL TREATMENT ONLY
KEEP OUT OF REACH OF CHILDREN
Co
nstituent
Statements:
Each dose (0.4 mL) contains ≥ 92.7 μg supercoiled plasmid DNA
expressing the gene coding for human tyrosinase.
Claims:
Aids in extending survival times of dogs with stage II or stage III
oral
melanoma for which local disease control has been achieved (negative
local lymph nodes or positive lymph nodes that were surgically removed
or irradiated).
For use only by a registered veterinarian.
Net Cont
ents:
4 x 1 dose (0.4 mL) vials
Dire
ctions for Use:
Rest
raints:
Con
traindications:
Pre
cautions:
Safety of the product has not been established during pregnancy and
lactation.
Sid
e effects:
A transient, low-grade fever may be observed in some dogs.
Transdermal injection has been associated with injection site pain,
swelling, and bruising.
In rare instances, administration of vaccines may cause lethargy,
fever,
and inflammatory or hypersensitivity types of reactions. Treatment may
include antihistamines, anti-inflammatories, and/or epinephrine. RLP APPROVED
Dosage and
Administration:
Use entire contents of vial when first opened.
The vaccine is packaged in a box containing four single-dose (0.4 mL)
vials.
This package of four vials is sufficient for the initial series of
vaccinations administered as an adjunct to surgery and radiotherapy.
The vaccine is administered in a 0.4 mL dose volume using the VET
JET transdermal vaccination system. Refer to the device package
insert for instructions on vaccinating with the device (see diagram).
The site of injection for all dogs is into the muscle of the medial
thigh
just caudal to the femur.
Initial treatment requires administration of four doses of vaccine at
two
week intervals.
A booster dose (1 x 0.4 mL) should be administered at six month
intervals.
< VET JET Diagram >
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