Each 1 ml vial contains:
bedinvetmab*:

5 mg
10 mg
15 mg
20 mg
30 mg
* canine monoclonal antibodies expressed recombinantly in Chinese hamster ovary.
PHARMACEUTICAL FORM
Solution for injection.
From clear to slightly opalescent solution.

CLINICAL FEATURES
Target species - dogs.
Indications for use with indication of target species - for the relief of pain associated with osteoarthritis in dogs.
Contraindications - Do not use in case of hypersensitivity to the active substance or any of the excipients.
Do not use in dogs under 12 months of age.
Do not use in animals intended for breeding.
Do not use in pregnant or lactating animals.

Special precautions for use:
-The person administering the veterinary medicinal product must take special precautions.
-Hypersensitivity reactions, including anaphylaxis, may potentially occur in the event of accidental injection. Repeated self-administration may increase the risk of hypersensitivity reactions.
-The importance of nerve growth factor in ensuring normal development of the fetal nervous system is very high. -In case of accidental self-injection, contact a doctor immediately and show the package insert or label.

Adverse reactions (frequency and severity):
In rare cases, mild reactions at the injection site (e.g. swelling and increased local temperature) may occur.
The frequency of adverse reactions is defined by the following condition:
- very common (more than 1 in 10 treated animals shows adverse reactions)
- common (more than 1, but less than 10 animals per 100 treated animals)
- uncommon (more than 1, but less than 10 animals per 1000 treated animals)
- rare (more than 1, but less than 10 animals per 10,000 treated animals)
- very rare (less than 1 animal per 10,000 treated animals, including isolated reports).

Use during pregnancy, lactation or ovulation:
- Do not administer to pregnant or lactating animals.

Interaction with other medicinal products and other forms of interaction:
- In laboratory studies over a 2-week period in young healthy dogs without osteoarthritis, the drug did not cause adverse effects when used simultaneously with a non-steroidal anti-inflammatory drug (carprofen).
-There is no safety data on the concomitant long-term use of NSAIDs and bedinvetmab in dogs.
-No interactions were observed in field studies where this veterinary medicinal product was administered concomitantly with parasiticides, antimicrobials, topical antiseptics, antihistamines and vaccines.

Amount and route of administration:
-Subcutaneous use.
Dosage and treatment regimen:
-The recommended dose is 0.5-1.0 mg / kg body weight once a month.

LIBRELA quantity (mg) to be administered

Body weight (kg) of dog

5

10

15

20

30

5.0-10.0

1 vial

10.1-20.0

1 vial

20.1-30.0

1 vial

30.1-40.0

1 vial

40.1-60.0

1 vial

60.1-80.0

2 vials

80.1-100.0

1 vial

1 vial

100.1-120.00

2 vials

Overdose (symptoms, emergency procedures, antidotes if necessary):
-No adverse reactions, except for mild reactions at the injection site, have been observed in the laboratory.
-In case of adverse clinical manifestations after overdose, symptomatic treatment of the dog is necessary.

IMMUNOLOGICAL PROPERTIES.
Pharmacotherapeutic group – other analgesics and antipyretics.

Mechanism of action:
Bedinvetmab is a canine monoclonal antibody (mAb) targeting nerve growth factor (NGF). Inhibition of NGF-mediated cell signaling has been shown to alleviate osteoarthritis-related pain.

PHARMACEUTICAL DATA
List of excipients:
-L-histidine
-Histidine hydrochloride monohydrate
-Trehalose dihydrate
-Disodium edetate
-Methionine
-Poloxamer 188
-Water for injection

Major incompatibilities:
-Do not mix with other veterinary drugs.

Shelf life:
-Shelf life of the veterinary medicinal product in the package: 2 years.

Shelf life after first opening of the package - use immediately.

Special precautions for storage:
-Store and transport in the refrigerator (2-8 ° C).
-Do not freeze.
-Store in the original packaging.
-Protect from light.

Type and composition of the immediate packaging:
-Vials of transparent glass type I with a fluorobutyl rubber stopper.