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

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Dexamethasone sodium phosphate

から入手可能:

LIVISTO Int'l, S.L.

ATCコード:

QH02AB02

INN（国際名）:

Dexamethasone sodium phosphate

投薬量:

2 milligram(s)/millilitre

医薬品形態:

Solution for injection

処方タイプ:

POM: Prescription Only Medicine as defined in relevant national legislation

治療領域:

dexamethasone

認証ステータス:

Authorised

承認日:

2019-01-25

製品の特徴

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