Robexera 20 mg chewable tablets for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Robenacoxib

Available from:

Krka, d.d., Novo mesto

ATC code:

QM01AH91

INN (International Name):

Robenacoxib

Pharmaceutical form:

Chewable tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

robenacoxib

Authorization date:

2023-08-21

Summary of Product characteristics

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Robexera 20 mg chewable tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains:
ACTIVE SUBSTANCE:
Robenacoxib
20 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS_ _
Cellulose, microcrystalline
_ _
Povidone
_ _
Crospovidone
_ _
Yeast powder
_ _
Meat flavour
Silica, colloidal anhydrous
Magnesium stearate
Light brown, round, biconvex tablets with lighter and darker dots and
marked with T3 on one side of
the tablet.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For the treatment of pain and inflammation associated with chronic
osteoarthritis.
For the treatment of pain and inflammation associated with soft tissue
surgery.
3.3
CONTRAINDICATIONS
Do not use in dogs suffering from gastrointestinal ulceration or with
hepatic disease.
Do not use concomitantly with corticosteroids or other non-steroidal
anti-inflammatory drugs
(NSAIDs).
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
Do not use in pregnant and lactating animals (see section 3.7).
3.4
SPECIAL WARNINGS
In clinical studies in dogs with osteoarthritis, inadequate response
to treatment was seen in 10-15% of
the dogs.
2
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
The safety of the veterinary medicinal product has not been
established in dogs weighing less than 2.5
kg or under 3 months of age.
For long term therapy, liver enzymes should be monitored at the start
of therapy, e.g. after 2, 4 and 8
weeks. Thereafter it is recommended to continue regular monitoring,
e.g. every 3-6 months. Therapy
should be discontinued if liver enzyme activities increase markedly or
the dog shows clinical signs
such as anorexia, apathy or vomiting in combination with elevated
liver enzymes.
Use in dogs with impaired cardiac or renal function or dogs that are
dehydrated, hypovolaemic or
hypotensive may involve additional risks. If use cannot