Dexafast 2 mg/ml solution for injection for horses, cattle, pigs, dogs and cats

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Dexamethasone sodium phosphate

Pieejams no:

LIVISTO Int'l, S.L.

ATĶ kods:

QH02AB02

SNN (starptautisko nepatentēto nosaukumu):

Dexamethasone sodium phosphate

Deva:

2 milligram(s)/millilitre

Zāļu forma:

Solution for injection

Receptes veids:

POM: Prescription Only Medicine as defined in relevant national legislation

Ārstniecības joma:

dexamethasone

Autorizācija statuss:

Authorised

Autorizācija datums:

2019-01-25

Produkta apraksts

2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Dexafast 2 mg/ml solution for injection for horses, cattle, pigs, dogs
and cats (AT, BG, CZ, DE, DK,
EL, ES, FI, HR, HU, IE,
IT, PL, PT, SK, RO, UK)
Fordexin 2 mg/ml Solution for injection for horses, cattle, pigs, dogs
and cats (BE, CY, EE, FR, LT,
LV NL, SI)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Dexamethasone
2.0 mg
(as dexamethasone sodium phosphate)
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE
COMPOSITION
IF THAT INFORMATION
IS ESSENTIAL
FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
_ _
Benzyl alcohol (E1519)
15.6 mg
Sodium chloride
Sodium citrate dihydrate
Sodium hydroxide (for pH adjustment)
Citric acid monohydrate (for pH adjustment)
Water for injections
Solution for injection.
Clear, colourless solution.
3.
CLINICAL INFORMATION
3.1.
TARGET SPECIES
Horses, cattle, pigs, dogs and cats.
3.2.
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Horses, cattle, pigs, dogs and cats:
Treatment of inflammatory or allergic conditions.
Cattle:
Induction of parturition.
Treatment of primary ketosis (acetonaemia).
Horses:
Treatment of arthritis, bursitis or tenosynovitis.
3.3.
CONTRAINDICATIONS
3
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 hypersensitivity to the active substance, to
corticosteroids or to any of the
excipients.
See also section 3.7.
3.4.
SPECIAL WARNINGS
None.
3.5.
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Response to long-term therapy should be monitored at regular