Meloxyl 0.5 mg/ml oral suspension for cats

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Meloxicam

Available from:

C&H Generics Limited

ATC code:

QM01AC06

INN (International Name):

Meloxicam

Pharmaceutical form:

Oral suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

meloxicam

Authorization date:

2022-07-15

Summary of Product characteristics

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Meloxyl 0.5 mg/ml oral suspension for cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE
Meloxicam
0.5 mg
EXCIPIENT
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS_ _
QUANTITATIVE
COMPOSITION
IF THAT INFORMATION IS
ESSENTIAL
FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
_ _
Sodium benzoate
_ _
1.5 mg
Glycerol
_ _
_- _
Citric acid monohydrate
_ _
_- _
Povidone
_ _
_-_
Xanthan gum
_-_
Sodium dihydrogen phosphate monohydrate
_-_
Simethicone emulsion
_-_
Honey flavour
_-_
Silica, colloidal anhydrous
_-_
Water, purified
_-_
A smooth light yellow oral suspension.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cats
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Alleviation of mild to moderate post-operative pain and inflammation
following surgical procedures in
cats, e.g. orthopaedic and soft tissue surgery.
Alleviation of pain and inflammation in acute and chronic
musculo-skeletal disorders in cats.
3.3
CONTRAINDICATIONS
Do not use in pregnant or lactating animals.
Do not use in cats suffering from gastrointestinal disorders such as
irritation and haemorrhage,
impaired hepatic, cardiac or renal function and haemorrhagic
disorders.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
Do not use in cats less than 6 weeks of age.
3.4
SPECIAL WARNINGS
None.
2
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as
there is a potential risk of renal
toxicity.
Post-operative pain and inflammation following surgical procedures:
In case additional pain relief is required, multimodal pain therapy
should be considered.
Chronic musculoskeletal disorders:
Response to long-term therapy should be monitored at regular intervals
by a veterinary surgeon.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals:
People with known hypersensitivity to