Ülke: Avustralya
Dil: İngilizce
Kaynak: Department of Health (Therapeutic Goods Administration)
acitretin, Quantity: 10 mg
Teva Pharma Australia Pty Ltd
Acitretin
Capsule, hard
Excipient Ingredients: iron oxide yellow; spray-dried liquid glucose; iron oxide black; titanium dioxide; iron oxide red; microcrystalline cellulose; Gelatin; sodium ascorbate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; ethanol; Shellac; sulfuric acid
Oral
10 Capsules Starter Pack, 30 capsules, 100 capsules
(S4) Prescription Only Medicine
Acitretin may be used for the treatment of Severe intractable psoriasis in all its forms. Severe forms of disorders of keratinisation such as: hyperkeratosis palmaris et plantaris; pustulosis palmaris et plantaris; ichthyosis; keratosis follicularis (Darier's disease); lichen planus affecting the skin or the mucosae; pityriasis rubra pilaris.
Visual Identification: Hard gelatin capsules with a white opaque body and a brown opaque cap printed in black ink on the cap, and '10' on the body.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2011-01-12
AUSTRALIAN PI – ACITRETIN TEVA (ACITRETIN) CAPSULES 1 NAME OF THE MEDICINE Acitretin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACITRETIN TEVA (acitretin) is a retinoid for the oral treatment of severe cases of psoriasis and disorders of keratinisation. It is available as 10 and 25 mg capsules. The chemical name of acitretin is all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl- 2,4,6,8-nonatetranoic acid. Its empirical formula is C 21 H 26 O 3 with a molecular weight of 326.44. Each 10 mg Acitretin TEVA capsule contains 10 mg of acitretin. Each 25 mg Acitretin TEVA capsule contains 25 mg of acitretin. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Acitretin is a metabolite of etretinate and is related to both retinoic acid and retinol (Vitamin A). Acitretin is a green-yellow crystalline powder. It is virtually insoluble in water (< 0.1 mg/100 mL). The pKa is approximately 5. It is present in the capsules as a spray-dried powder. The hard gelatin capsules have a white opaque body and a brown opaque cap with the number “10” printed in black ink on the body. The hard gelatin capsules have a yellow opaque body and a brown opaque cap with the number “25” printed in black ink on the body. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Acitretin may be used for the treatment of: • Severe intractable psoriasis in all its forms • Severe forms of disorders of keratinisation such as − hyperkeratosis palmaris et plantaris − pustulosis palmaris et plantaris − ichthyosis − keratosis follicularis (Darier's disease) − lichen planus affecting the skin or the mucosae − pityriasis rubra pilaris Teva Pharma Australia Pty Limited Version 4.0 1 Based on Teva CCSI: No. 918/03/07/19 4.2 D OSE AND METHOD OF ADMINISTRATION ACITRETIN TEVA should only be prescribed by physicians who are experienced in the use of systemic retinoids and understand the risk of teratogenicity associated with acitretin therapy. ADULTS Because there are differences in the absorpti Belgenin tamamını okuyun