Emdocam 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:

Emdoka bvba

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:

2022-02-08

Summary of Product characteristics

Issued: June 2021
AN: 01449/2019
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Emdocam 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 150 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs, 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 cases of hypersensitivity to the active substance or to
any of the
excipients.
Do not use in pregnant or lactating dogs and cats.
Issued: June 2021
AN: 01449/2019
Page 2 of 6
Do not use in dogs and cats suffering from gastrointestinal disorders
such as irritation
and haemorrhage, impaired hepatic, cardiac or renal function and
haemorrhagic
disorders.
Do not use in dogs and cats less than 6 weeks of age nor in cats of
less than 2 kg.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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 severely dehydrated, hypovolaemic or hypotensive animals
which require
parenteral rehydratation, as there may be 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
Meloxicam may cause allergic reactions. People with known
hypersensitivity to Non
Steroidal Anti-Inflammatory Drugs (NSAIDs) should avoid contact with
the veterin