Norbrook Meloxicam 5 mg/ml Solution for Injection for Dogs and Cats

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:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats, Dogs

Therapeutic area:

Anti Inflammatory NSAID

Authorization status:

Authorized

Authorization date:

2016-02-11

Summary of Product characteristics

Revised: June 2023
AN: 00379/2023
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Norbrook Meloxicam 5 mg/ml Solution for Injection for Dogs and Cats
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Meloxicam 5 mg
EXCIPIENTS:
Ethanol, anhydrous 150 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
Pale yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Dogs:
Alleviation of inflammation and pain in both acute and chronic
musculo-skeletal
disorders. Reduction of post-operative pain and inflammation following
orthopaedic
and soft tissue surgery.
Cats:
Reduction of post-operative pain after ovariohysterectomy and minor
soft tissue
surgery.
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 not use in animals less than 6 weeks of age nor in cats of less
than 2 kg.
Revised: June 2023
AN: 00379/2023
Page 2 of 6
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
For post-operative pain relief in cats, safety has only been
documented after
thiopental/halothane anaesthesia.
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.
During anaesthesia, monitoring and fluid therapy should be considered
as standard
practice.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
Accidental self-injection may give rise to pain. People with known
hypersensitivity to
NSAIDs shou