CICLOSPORIN GENFARMA
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
CICLOSPORIN
Available from:
Actavis Group PTC ehf
Dosage:
100 Milligram
Pharmaceutical form:
Capsules, Soft
Authorization date:
2008-01-11
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ciclosporin Genfarma 100 mg Soft Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100
mg ciclosporin.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, soft
Ciclosporin Genfarma 100 mg Capsules are grey soft gelatin capsules with imprinting “DX 100 mg”.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_ORGAN TRANSPLANTATION_
Prevention of graft rejection following kidney, liver, heart, combined heart-lung, lung or pancreas transplants.
Treatment of transplant rejection in patients previously receiving other immunosuppressive agents.
_BONE MARROW TRANSPLANTATION_
Prevention of graft rejection following bone marrow transplantation and prophylaxis of graft-versus-host disease
(GVHD).
Treatment of established graft-versus-host disease (GVHD).
_PSORIASIS_
Ciclosporin Genfarma are indicated in patients with severe psoriasis in whom conventional therapy is ineffective or
inappropriate.
_ATOPIC DERMATITIS_
Ciclosporin Genfarma are indicated for short term treatment (8 weeks) of patients with severe atopic dermatitis in
whom conventional therapy is ineffective or inappropriate.
_NEPHROTIC SYNDROME_
Ciclosporin Genfarma are indicated in the treatment of adults and children with steroid-dependent and steroid-resistant
nephrotic syndrome owing to glomerular diseases such as minimal change nephropathy, focal segmental
glomerulosclerosis or membranous glomerulonephritis.
Ciclosporin Genfarma can be used to induce remissions and for maintenance treatment.
_RHEUMATOID ARTHRITIS_
Ciclosporin Genfarma are indicated for the treatment of severe, active rheumatoid arthritis in patients in whom classical
slow-acting anti-rheumatic agents are inappropriate or ineffective.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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