LIBRELA Solution

Țară: Canada

Limbă: franceză

Sursă: Health Canada

Ingredient activ:

Bédinvetmab

Disponibil de la:

ZOETIS CANADA INC

Dozare:

30MG

Forma farmaceutică:

Solution

Compoziție:

Bédinvetmab 30MG

Calea de administrare:

Sous-cutanée

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Prescription

Grupul Terapeutică:

Chiens

Rezumat produs:

Numéro de groupe d'ingrédients actifs (GIA) :0162744005

Statutul autorizaţiei:

APPROUVÉ

Data de autorizare:

2021-02-01

Prospect

LIBRELA
Zoetis Version – October 17, 2022
PACKAGE INSERT
DIN 02511797, DIN 02511800
DIN 02511819, DIN 02511827
DIN 02511835
LIBRELA
®
BEDINVETMAB INJECTION
_VETERINARY USE ONLY _
CANINE ANTI-NERVE GROWTH FACTOR MONOCLONAL ANTIBODY FOR DOGS
STERILE
DESCRIPTION:
LIBRELA
®
is an injectable solution containing bedinvetmab (5 mg, 10 mg, 15 mg,
20 mg or
30 mg per mL) as the active ingredient. The product does not contain a
preservative.
Bedinvetmab is a canine therapeutic monoclonal antibody that
neutralizes Nerve Growth Factor
(NGF).
INDICATIONS:
LIBRELA is indicated for the alleviation of pain associated with
osteoarthritis in dogs.
DOSAGE AND ADMINISTRATION:
The recommended dosage of LIBRELA is 0.5-1.0 mg/kg body weight,
administered
subcutaneously once monthly as needed.
DOSING INFORMATION
DOGS WEIGHING <5.0 KG:
Aseptically withdraw 0.1 mL/kg from a single 5 mg vial and administer
subcutaneously.
DOGS WEIGHING ≥5.0 KG:
For dogs weighing 5.0-60.0 kg, aseptically withdraw 1 mL from the
appropriate strength vial
according to the dosing table below and administer subcutaneously.
For dogs weighing >60.0 kg, the contents of more than one strength or
vial are required to be
administered as a single dose. In those cases, withdraw the content
from each required vial into
the same syringe and administer as a single subcutaneous injection.
LIBRELA
Zoetis Version – October 17, 2022
DOSING TABLE
NUMBER AND STRENGTH (MG) OF LIBRELA VIALS TO BE ADMINISTERED
DOG’S
WEIGHT IN
KG
5
MG/ML
10
MG/ML
15
MG/ML
20
MG/ML
30
MG/ML
5.0 to 10.0
1 vial
10.1 to
20.0
1 vial
20.1 to
30.0
1 vial
30.1 to
40.0
1 vial
40.1 to
60.0
1 vial
60.1 to
80.0
2 vials
80.1 to
100.0
1 vial
+
1 vial
100.1 to
120
2 vials
CONTRAINDICATIONS:
Do not administer to dogs with known hypersensitivity to bedinvetmab.
Do not use in breeding, pregnant, or lactating dogs.
Do not use in dogs less than 12 months of age.
CAUTIONS:

Discontinue use if signs of intolerance or anaphylaxis are observed
(see
IMMUNOGENICITY section).

Since it may take two (2) monthly