Glucadex 2 mg/ml Solution for Injection for Horses, Cattle, Pigs, Dogs and Cats

Country: United Kingdom

Bahasa: Inggeris

Sumber: VMD (Veterinary Medicines Directorate)

Bahan aktif:

Dexamethasone

Boleh didapati daripada:

Alfasan Nederland B.V.

Kod ATC:

QH02AB02

INN (Nama Antarabangsa):

Dexamethasone

Borang farmaseutikal:

Solution for injection

Jenis preskripsi:

POM-V - Prescription Only Medicine – Veterinarian

Kumpulan terapeutik:

Cats, Cattle, Dogs, Horses, Pigs

Kawasan terapeutik:

Anti Inflammatory corticosteroid

Status kebenaran:

Authorized

Tarikh kebenaran:

2021-09-14

Ciri produk

Revised: July 2022
AN: 00932/2022
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Glucadex 2 mg/ml Solution for Injection for Horses, Cattle, Pigs, Dogs
and Cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
Dexamethasone
2.0 mg
(as dexamethasone sodium phosphate)
2.63 mg
EXCIPIENTS:
Benzyl alcohol (E1519)
15.6 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to slightly brownish aqueous solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses, cattle, pigs, dogs and cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Horses, cattle, pigs, dogs and cats:
Treatment of inflammation and allergic reactions.
Horses:
Treatment of arthritis, bursitis or tenosynovitis.
Cattle:
Treatment of primary ketosis (Acetonemia).
Induction of parturition.
4.3
CONTRAINDICATIONS
Except in emergency situations, do not use in animals suffering from
diabetes mellitus,
renal insufficiency, cardiac insufficiency, hyperadrenocorticism or
osteoporosis.
Do not use in viral infections during the viraemic stage or in cases
of systemic mycotic
infections.
Do not use in animals suffering from gastrointestinal or corneal
ulcers, or demodicosis.
Do not administer intra-articularly where there is evidence of
fractures, bacterial joint
infections and aseptic bone necrosis.
Do not use in cases of known hypersensitivity to the active substance,
to corticosteroids or
to any of the excipients.
See also section 4.7.
Revised: July 2022
AN: 00932/2022
Page 2 of 7
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Response to long-term therapy should be monitored at regular intervals
by a veterinary
surgeon. Use of corticosteroids in horses has been reported to induce
laminitis. Therefore,
horses treated with such preparations should be monitored frequently
during the treatment
period.
Because of the pharmacological properties of the act