Diurizone Powder

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

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Lastnosti izdelka Lastnosti izdelka (SPC)
29-08-2019
Javno poročilo o oceni Javno poročilo o oceni (PAR)
12-06-2017
DSU DSU (DSU)
05-05-2023

Aktivna sestavina:

Dexamethasone; Hydrochlorothiazide

Dostopno od:

Vetoquinol Ireland Limited

Koda artikla:

QC03AX01

INN (mednarodno ime):

Dexamethasone; Hydrochlorothiazide

Odmerek:

0.25, 75.0 milligram(s)/gram

Farmacevtska oblika:

Oral powder

Tip zastaranja:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapevtska skupina:

Cattle, Non food-producing horses

Terapevtsko območje:

hydrochlorothiazide, combinations

Terapevtske indikacije:

Cardiovascular

Status dovoljenje:

Authorised

Datum dovoljenje:

1989-10-11

Lastnosti izdelka

                                Health Products Regulatory Authority
28 August 2019
CRN00987J
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Diurizone Powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substances
Hydrochlorothiazide
75.0
mg/g
Dexamethasone
0.25
mg/g
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral powder.
A fine, free-flowing powder
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle
Horses declared as not being intended for slaughter for human
consumption
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
_Cattle:_
Congestion and oedema of the udder
Persistent oedema during lactation
Pulmonary congestion and oedema
Oedema of surgical wounds
Oedema of allergic conditions
_Horses:_
Generalised congestion and oedema
Oedema of sheath
Anasarca
Oedema in allergic conditions
4.3 CONTRAINDICATIONS
Do not use in pregnant animals. Do not use in animals with viral
infections, during the viraemic phase. Do not use in animals
with diabetes mellitus, congestive heart failure, chronic nephritis,
osteoporosis or glaucoma. Do not use in animals with hepatic
encephalopathy. Do not use in cases of severe hypokalemia. Do not use
in animals with known hypersensitivity to the active
ingredients. Do not use in horses for the treatment of laminitis.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None.
Health Products Regulatory Authority
28 August 2019
CRN00987J
Page 2 of 4
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
None.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
The association Hydrochlorothiazide and Dexamethasone acetate may
induce hepatic encephalopathy.
Corticosteroids may delay wound healing and the immunosuppressant
actions may weaken resistance to or exacerbate existing
infections.
In the presence of bacterial infection, anti-bacterial therapy is
required when steroids are used.
In the presence of viral infections, steroids may
                                
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