ISOTRETINOIN-GA isotretinoin 40mg capsule blister pack

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Beli sekarang

Download Laporan Penilaian Awam (PAR)
28-11-2017

Bahan aktif:

isotretinoin, Quantity: 40 mg

Boleh didapati daripada:

Douglas Pharmaceuticals Australia Pty Ltd

INN (Nama Antarabangsa):

Isotretinoin

Borang farmaseutikal:

Capsule, soft

Komposisi:

Excipient Ingredients: titanium dioxide; yellow beeswax; purified water; disodium edetate; butylated hydroxyanisole; Soya Oil; partially hydrogenated soya oil; glycerol; Gelatin; dl-alpha-tocopherol; hydrogenated soya oil; sorbitol solution (70 per cent) (non-crystallising); sunset yellow FCF

Laluan pentadbiran:

Oral

Unit dalam pakej:

60 capsules, 15 capsules, 90 capsules, 30 capsules

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

ISOTRETINOIN-GA is indicated for the treatment of severe cystic acne and a single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. If a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. Because of significant adverse effects associated with its use, isotretinoin should be reserved for patients with severe cyctic acne who are unresponsive to conventional therapy, including systemic antibiotics.

Ringkasan produk:

Visual Identification: Light orange, oval, soft gelatin capsule containing a yellow/orange, opaque, viscous liquid.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Status kebenaran:

Licence status A

Tarikh kebenaran:

2012-06-08