SOLENSIA SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FRUNEVETMAB

Available from:

ZOETIS CANADA INC

Dosage:

7MG

Pharmaceutical form:

SOLUTION

Composition:

FRUNEVETMAB 7MG

Administration route:

SUBCUTANEOUS

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic group:

CATS

Product summary:

Active ingredient group (AIG) number: 0163073001

Authorization status:

APPROVED

Authorization date:

2021-07-27

Patient Information leaflet

Zoetis version July 8, 2021– Mock-Up
PACKAGE INSERT (ENGLISH)
DIN XXXXXXXX
SOLENSIA ®
FRUNEVETMAB INJECTION
VETERINARY USE ONLY
FELINE ANTI-NERVE GROWTH FACTOR MONOCLONAL ANTIBODY FOR CATS
STERILE
DESCRIPTION:
SOLENSIA is an injectable solution containing 7 mg/mL of frunevetmab
in histidine buffer
(sorbitol, L-histidine, polysorbate, sodium hydroxide, hydrochloric
acid and water). Frunevetmab
is a feline therapeutic monoclonal antibody that neutralizes Nerve
Growth Factor (NGF). The
product does not contain a preservative.
INDICATIONS:
SOLENSIA is indicated for the alleviation of pain associated with
osteoarthritis in cats.
DOSAGE AND ADMINISTRATION
The nominal dose of SOLENSIA (frunevetmab injection) is 1.0 mg/kg body
weight,
administered subcutaneously once a month. The full content of each
vial is for single use only
and vial should be properly discarded after puncture.
DOSING INFORMATION: Cats should be dosed by weight range according to
the Dosing Chart
below. Cats are given the full content of 1 or 2 vials based on body
weight. Aseptically withdraw
the total dose into a single syringe and administer immediately.
TABLE 1. Dosing Chart
WEIGHT OF CAT
(KG)
VOLUME
NUMBER OF VIALS*
2.5-7 kg
1 mL
1
7.1-14 kg
2 mL
2
*1 mL frunevetmab injection per vial
For cats greater than 7 kg, the contents of more than one vial are
required to administer a single
dose. In those cases, withdraw the appropriate content from each
required vial into the same
syringe.
CONTRAINDICATIONS
:
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
Do not use in breeding, pregnant or lactating cats.
Do not use in cats less than 12 months or under 2.5 kg body weight.
Zoetis version July 8, 2021– Mock-Up
CAUTIONS:
SOLENSIA contains a felinized monoclonal antibody. Discontinue use if
signs of intolerance or
anaphylaxis are observed.
The safe use of anti-NGF monoclonal antibodies (mAbs) with concurrent
NSAIDs has not been
studied in cats. The safe use of this product with other concurrent
mAbs is not kn