Zycortal
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
27-08-2020
Charakterystyka produktu
(SPC)
27-08-2020
Sprawozdanie z oceny publicznego
(PAR)
13-11-2015
Składnik aktywny:
desoxycortone pivalate
Dostępny od:
Dechra Regulatory B.V.
Kod ATC:
QH02AA03
INN (International Nazwa):
desoxycortone
Grupa terapeutyczna:
Dogs
Dziedzina terapeutyczna:
Corticosteroids for systemic use
Wskazania:
For use as replacement therapy for mineralocorticoid deficiency in dogs with primary hypoadrenocorticism (Addison's disease).
Podsumowanie produktu:
Revision: 4
Status autoryzacji:
Authorised
Data autoryzacji:
2015-11-06
Ulotka dla pacjenta
15
B. PACKAGE LEAFLET
16
PACKAGE LEAFLET:
ZYCORTAL 25 MG/ML PROLONGED-RELEASE SUSPENSION FOR INJECTION FOR DOGS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Dechra Regulatory B.V.
Handelsweg 25
5531 AE Bladel
The Netherlands
Manufacturer responsible for batch release:
Eurovet Animal Health B.V.
Handelsweg 25
5531 AE Bladel
The Netherlands
Dales Pharmaceuticals Limited
Snaygill Industrial Estate
Keighley Road
Skipton
North Yorkshire
BD23 2RW
United Kingdom
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Zycortal 25 mg/ml prolonged-release suspension for injection for dogs
Desoxycortone pivalate
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
ACTIVE SUBSTANCE:
Desoxycortone pivalate 25 mg/ml
EXCIPIENTS:
Chlorocresol 1 mg/ml
Zycortal is an opaque white suspension.
4.
INDICATION(S)
For use as replacement therapy for mineralocorticoid deficiency in
dogs with primary
hypoadrenocorticism (Addison’s disease).
5.
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
17
6.
ADVERSE REACTIONS
Polydipsia (excessive drinking) and polyuria (excessive urination)
were very common adverse
reactions in a clinical trial. Inappropriate urination, lethargy,
alopecia (hair loss), panting, vomiting,
decreased appetite, anorexia, decreased activity, depression,
diarrhoea, polyphagia (excessive eating),
shaking, tiredness and urinary tract infections were common adverse
reactions in a clinical trial.
.
Injection site pain has been reported uncommonly in post-authorisation
spontaneous reports following
the administration of Zycortal.
Pancreas disorders have been reported rarely in post-authorisation
spontaneous reports following use
of Zycortal. The concurrent administration of glucocorticoids may
contribute to these signs.
The frequency of adverse reactions is defined using the following
convention:
- very common (more than 1 in 10 anima
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Zycortal 25 mg/ml prolonged-release suspension for injection for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Desoxycortone pivalate 25 mg/ml
EXCIPIENTS:
Chlorocresol 1 mg/ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release suspension for injection.
Opaque white suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For use as replacement therapy for mineralocorticoid deficiency in
dogs with primary
hypoadrenocorticism (Addison’s disease).
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Before starting treatment with the veterinary medicinal product, it is
important that Addison’s disease
has been definitively diagnosed. Any dog presenting with severe
hypovolaemia, dehydration, pre-renal
azotaemia and inadequate tissue perfusion (also known as “Addisonian
crisis”) must be rehydrated
with intravenous fluid (saline) therapy before starting treatment with
the veterinary medicinal product.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Use with caution in dogs with congestive heart disease, severe renal
disease, primary hepatic failure or
oedema.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
Avoid contact with the eyes and skin. In case of accidental spillage
onto the skin or eyes, wash the
affected area with water. If irritation occurs, seek medical advice
immediately and show the package
leaflet or the label to the physician.
3
This veterinary medicinal product may cause pain and swelling at the
injection site if accidentally
self-administered.
This veterinary medicinal product may cause adverse effects on male
reproductive organs and, as a
result, fertility.
This veterinary medicinal product may cause ad
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