Fendicam 20 mg/ml Solution for Injection for Cattle, Pigs and Horses

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Meloxicam

Available from:

Boehringer Ingelheim Animal Health UK Ltd

ATC code:

QM01AC06

INN (International Name):

Meloxicam

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Horses, Pigs

Therapeutic area:

Anti Inflammatory NSAID

Authorization status:

Authorized

Authorization date:

2016-09-28

Summary of Product characteristics

Revised: November 2018
AN: 01111/2018
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
FENDICAM 20 mg/ml solution for injection for cattle, pigs and horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Meloxicam
20 mg/ml
EXCIPIENT:
Ethanol
159.8 mg/ml
(as ethanol 96 per cent)
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
Cattle, pigs and horses.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
CATTLE:
For use in acute respiratory infection with appropriate antibiotic
therapy to
reduce clinical signs in cattle.
For use in diarrhoea in combination with oral re-hydration therapy to
reduce
clinical signs in calves of over one week of age and young,
non-lactating cattle.
For adjunctive therapy in the treatment of acute mastitis, in
combination with
antibiotic therapy.
PIGS:
For use in non-infectious locomotor disorders to reduce the symptoms
of
lameness and inflammation.
For adjunctive therapy in the treatment of puerperal septicaemia and
toxaemia
(mastitis-metritis-agalactia syndrome) with appropriate antibiotic
therapy.
HORSES:
For use in the alleviation of inflammation and relief of pain in both
acute and
chronic musculo-skeletal disorders.
For the relief of pain associated with equine colic.
Page 1 of 6
Revised: November 2018
AN: 01111/2018
4.3
CONTRAINDICATIONS
See also section 4.7.
Do not use in horses less than 6 weeks of age.
Do not use in animals suffering from impaired hepatic, cardiac or
renal function
and haemorrhagic disorders, or where there is evidence of ulcerogenic
gastrointestinal lesions.
Do not use in case of hypersensitivity to the active substance or to
any of the
excipients.
For the treatment of diarrhoea in cattle, do not use in animals of
less than one
week of age.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
If adverse reactions o