SOLENSIA Solution for Injection for Cats

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:

FRUNEVETMAB

から入手可能:

ZOETIS AUSTRALIA PTY LTD

医薬品形態:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

構図:

FRUNEVETMAB Active 7.0 mg

パッケージ内のユニット:

1 x 1 mL vial; 2 x 1 mL vials; 6 x 1 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: CAT: [FOR THE CONTROL OF PAIN AND INFLAMMATION ASSOCIATED WITH OSTEOARTHRITIS, PAIN/INFLAMMATION ASSOCIATED WITH NONINF]

認証ステータス:

Registered

承認日:

2023-07-01

情報リーフレット

SOLENSIA Solution for Injection for Cats
89387/124578
Product Name:
APVMA Approval No:
Label Name:
SOLENSIA Solution for Injection for Cats
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS
Constituent
Statements:
Each 1 mL vial contains 7 mg frunevetmab.
Claims:
For use by or under direction of a registered veterinarian.
For the alleviation of pain associated with osteoarthritis in cats.
Net Contents:
1 x 1 mL vial
2 x 1 mL vials
6 x 1 mL vials
Directions for Use:
Restraints:
Contraindications:
This product must not be used in cats intended for breeding.
This product must not be used in pregnant or lactating cats as Nerve
Growth Factor (NGF)
plays a key role in foetal nervous system development.
This product must not be used in cats under 12 months of age, weighing
less than 2.5 kg.
This product must not be used in cats with hypersensitivity to
frunevetmab.
Precautions:
There are no safety data on the concurrent use of non-steroidal
anti-inflammatory drugs
(NSAIDs) and frunevetmab in the cat.
The safety and efficacy of this product has not been investigated in
cats with kidney
disease IRIS stages 3 and 4. Use of the product in such cases should
be based on a
benefit-risk assessment performed by the responsible veterinarian. RLP APPROVED
This veterinary medicinal product may induce transient or persistent
anti-drug antibodies.
The induction of such antibodies may reduce the efficacy of the
product although this was
not observed during the 84 days of the pivotal clinical trial. No
information is available for
longer duration treatment.
Side Effects:
Focal skin reactions (e.g. pruritis, dermatitis and alopecia) occurred
commonly in studies
(i.e. between 1 and 10 animals in every 100 animals treated).
Dosage and
Administration:
Avoid excessive shaking or foaming of the solution.
Use the contents immediately after broaching the vial. Discard any
unused portion.
Remove the vial(s) from the carton at the time of monthly treatment,
withdraw all liq