FATROCORTIN 1 mg/ml solution for injection for cattle, swine, horses, dogs and cats

Land: Kýpur

Tungumál: gríska

Heimild: Κυπριακή Δημοκρατία, Υπουργείο Γεωργίας, Αγροτικής Ανάπτυξης και Περιβάλλοντος, Κτηνιατρικές Υπηρεσίες

Virkt innihaldsefni:

GRANTED

Fáanlegur frá:

QH02AB02

ATC númer:

DEXAMETHASONE 1 MG/ML

INN (Alþjóðlegt nafn):

GRANTED

Lyfjaform:

FATRO SpA ITALY

Stjórnsýsluleið:

SOLUTION FOR INJECTION

Meðferðarhópur:

N. A. CHANCE TRADING CO

Vörulýsing:

Withdrawal period: CATTLE PIGS HORSES DOGS CATS; Distributor: CORTICOSTEROIDS FOR SYSTEMIC USE

Vara einkenni

ΠΑΡΑΡΤΗΜΑ 1: ΠΕΡΙΛΗΨΗ ΤΩΝ
ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
FATROCORTIN 1 mg/ml solution for injection for cattle, swine, horses,
dogs and
cats.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
100 ml bottle
1 ml contains:
ACTIVE SUBSTANCE: dexamethasone............1 mg
EXCIPIENTS q.s. to….....................................1 ml
For a complete list of the excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, swine, horses, dogs and cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Dexamethasone is indicated in the treatment of inflammatory and
metabolic syndromes and allergic phenomena in cattle, swine, horse,
dogs and cats, particularly in cases of: acetonemia (ketosis) -
rheumatoid
arthritis - inflammatory disorders in general, articular or tendinous
in
particular (bursitis, synovitis, hydrarthrosis, hygroma, tendonitis) -
edema
disease of piglets - allergies and pruritus “sine materia” -
dermatosis in the
dog - control of inflammatory and stressful phenomena (in combination
with antibiotic treatment) in the course of infectious bacterial
diseases -
acute mastitis in the cow and sow.
4.3
CONTRAINDICATIONS
Administration of dexamethasone or of glucocorticoids in general is
contraindicated in subjects affected by diabetes mellitus,
osteoporosis,
renal disorders, cardiac insufficiency, corneal, gastric or duodenal
ulcers,
glaucoma. Infectious diseases must not be treated with
corticosteroids,
unless concurrent specific antiinfectious therapy is also conducted.
Do not use in animals in cases of known hypersensitivity to the active
substance or to any of the excipients.
1/14
Dexamethasone must not be administered in cases of systemic
thrombocytopenia.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
In cases of intra-articular use, administration of the medicinal
product
must be performed by a veterinary surgeon.
The corticosteroids can cause immuno-s