DELTACORTRIL ENTERIC

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

PREDNISOLONE

Mevcut itibaren:

PCO Manufacturing

Doz:

5 Milligram

Farmasötik formu:

Tablets

Yetkilendirme tarihi:

2006-07-07

Ürün özellikleri

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Deltacortril Enteric Coated Tablets 5mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains 5mg prednisolone.
Excipients: Lactose
_For a full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
_Product imported from UK:_
Round, biconvex, coated, maroon-coloured tablets
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_ALLERGY AND ANAPHYLAXIS_: bronchial asthma, drug hypersensitivity reactions, serum sickness, angioneurotic oedema,
anaphylaxis.
_ARTERITIS/COLLAGENOSIS_: giant cell arteritis/polymyalgia rheumatica, mixed connective tissue disease, polyarteritis
nodosa, polymyositis.
_BLOOD DISORDERS_: haemolytic anaemia (auto-immune), leukaemia (acute and chronic lymphocytic), lymphoma, multiple
myeloma, idiopathic thrombocytopenic purpura.
_CARDIOVASCULAR DISORDERS_: post-myocardial infarction syndrome, rheumatic fever with severe carditis.
_ENDOCRINE DISORDERS_: primary and secondary adrenal insufficiency, congenital adrenal hyperplasia.
_GASTRO-INTESTINAL DISORDERS_: Crohn's disease, ulcerative colitis, persistent coeliac syndrome (coeliac disease
unresponsive to gluten withdrawal), auto-immune chronic active hepatitis, multisystem disease affecting liver, biliary
peritonitis.
_HYPERCALCAEMIA_: sarcoidosis, vitamin D excess.
_INFECTIONS (WITH APPROPRIATE CHEMOTHERAPY)_: helminthic infestations, Herxheimer reaction, infectious mononucleosis,
miliary tuberculosis, mumps orchitis (adult), tuberculous meningitis, rickettsial disease.
_MUSCULAR DISORDERS_: polymyositis, dermatomyositis.
_NEUROLOGICAL DISORDERS_: infantile spasms, Shy-Drager syndrome, sub-acute demyelinating polyneuropathy.
_OCULAR DISEASE_: scleritis, posterior uveitis, retinal vasculitis, pseudo-tumours of the orbit, giant cell arteritis, malignant
IRISH MEDI