Emdocam 15 mg/ml Oral Suspension for Horses

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Meloxicam

Available from:

Emdoka bvba

ATC code:

QM01AC06

INN (International Name):

Meloxicam

Pharmaceutical form:

Oral suspension

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Horses

Therapeutic area:

Anti Inflammatory NSAID

Authorization status:

Authorized

Authorization date:

2022-02-08

Summary of Product characteristics

Issued: June 2021
AN: 01452/2019
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Emdocam 15 mg/ml oral suspension for horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Meloxicam
15.0 mg
EXCIPIENTS:
Sodium benzoate
1.5 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension
Yellow suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Alleviation of inflammation and relief of pain in both acute and
chronic musculo-skeletal
disorders in horses.
4.3
CONTRAINDICATIONS
Do not use in pregnant or lactating mares.
Do not use in horses 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 horses less than 6 weeks of age.
4.4
SPECIAL WARNINGS
None.
Issued: June 2021
AN: 01452/2019
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animals 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.
This product can cause eye irritation. In case of contact with the
eyes, immediately
rinse thoroughly with water.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Isolated cases of adverse reactions typically associated with NSAIDs
were observed in
clinical trials (slight urticaria, diarrhoea). Symptoms were
reversible.
Loss of appetite, lethargy, abdominal pain and colitis have been
reported in very rare
cases.
A