SOLENSIA Solution

Pajjiż: Kanada

Lingwa: Franċiż

Sors: Health Canada

Ingredjent attiv:

Frunévetmab

Disponibbli minn:

ZOETIS CANADA INC

Dożaġġ:

7MG

Għamla farmaċewtika:

Solution

Kompożizzjoni:

Frunévetmab 7MG

Rotta amministrattiva:

Sous-cutanée

Unitajiet fil-pakkett:

15G/50G

Tip ta 'preskrizzjoni:

Prescription

Grupp terapewtiku:

Chats

Sommarju tal-prodott:

Numéro de groupe d'ingrédients actifs (GIA) :0163073001

L-istatus ta 'awtorizzazzjoni:

APPROUVÉ

Data ta 'l-awtorizzazzjoni:

2021-07-27

Fuljett ta 'informazzjoni

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