Norbrook Meloxicam 1.5mg/ml Oral Suspension for Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Meloxicam

Available from:

Norbrook Laboratories Limited

ATC code:

QM01AC06

INN (International Name):

Meloxicam

Pharmaceutical form:

Oral suspension

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Anti Inflammatory NSAID

Authorization status:

Authorized

Authorization date:

2016-02-11

Summary of Product characteristics

Revised: December 2022
AN: 02473/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Norbrook Meloxicam 1.5mg/ml Oral Suspension for Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Meloxicam
1.5 mg
EXCIPIENTS:
Sodium Benzoate
1.5 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Oral suspension
Pale yellow suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Alleviation of inflammation and pain in both acute and chronic
musculo-skeletal
disorders in dogs.
4.3
CONTRAINDICATIONS
Do not use in pregnant or lactating animals.
Do not use in animals suffering from gastrointestinal disorders such
as irritation and
haemorrhage, impaired hepatic, cardiac or renal function and
haemorrhagic
disorders.
Do not use in case of hypersensitivity to the active substance or to
any of the
excipients.
Do no use in dogs less than 6 weeks of age.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Revised: December 2022
AN: 02473/2022
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
If adverse reactions occur, treatment should be discontinued and the
advice of a
veterinarian should be sought.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as
there is a
potential risk of renal toxicity.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
People with known hypersensitivity to non-steroidal anti-inflammatory
drugs
(NSAIDs) should avoid contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and
show the
package leaflet or the label to the physician.
Wash any splashes from skin immediately with water.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Typical adverse reactions of NSAIDs such as loss of appetite,
vomiting, diarrhoea,
faecal occult blood, apathy and renal failure have been reported very
rarely in
spontane