Dexrapid 2 mg/ml solution for injection

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Dexamethasone sodium phosphate

Предлага се от:

VetViva Richter GmbH

АТС код:

QH02AB02

INN (Международно Name):

Dexamethasone sodium phosphate

Лекарствена форма:

Solution for injection

Вид предписание :

POM: Prescription Only Medicine as defined in relevant national legislation

Терапевтична област:

dexamethasone

Дата Оторизация:

2020-10-30

Данни за продукта

1
_[Version 8.1,01/2017] _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Dexrapid 2 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains
ACTIVE SUBSTANCE:
Dexamethasone
2.0 mg
(equivalent to 2.63 mg dexamethasone sodium phosphate)
EXCIPIENT:
Benzyl alcohol (E 1519) 15.6 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
Clear and colourless to almost colourless 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 inflammatory or allergic conditions.
Horses:
Treatment of arthritis, bursitis or tenosynovitis.
Cattle
Induction of parturition.
Treatment of primary ketosis (acetonemia).
Dogs and cats
Short-term treatment of shock.
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 known cases of hypersensitivity to the active substance,
to corticosteroids and to any
other ingredient of the product.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
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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 active ingredient,
special care should be taken when
t