Valsts: Izraēla
Valoda: angļu
Klimata pārmaiņas: Ministry of Health
ACITRETIN
ABIC MARKETING LTD, ISRAEL
D05BB02
CAPSULES
ACITRETIN 10 MG
PER OS
Required
ACTAVIS GROUP PTC EHF, ICELAND
ACITRETIN
ACITRETIN
Severe disorders of keratinization such as erythrodermic psoriasis local or generalized pustular psoriasis congenital ichthyosis pityriasis rubra pilaris darier's disease.
2017-01-31
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SUMMARY OF PRODUCT CHARACTERISTICS ▼THIS MEDICINAL PRODUCT IS SUBJECT TO ADDITIONAL MONITORING. THIS WILL ALLOW QUICK IDENTIFICATION OF NEW SAFETY INFORMATION. HEALTHCARE PROFESSIONALS ARE ASKED TO REPORT ANY SUSPECTED ADVERSE REACTIONS. SEE SECTION “UNDESIRABLE EFFECTS” FOR HOW TO REPORT ADVERSE REACTIONS. NEOTIGASON 10MG AND 25MG CAPSULES ************************************************************************************* 1 NAME OF THE MEDICINAL PRODUCT Neotigason 10mg Capsules Neotigason25mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 10 mg Capsules: Each capsule, contains Acitretin 10 mg 25 mg Capsules: Each capsule, contains Acitretin 25 mg Excipients with known affect: Glucose (see section _4.3 Contraindications_). This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’. For a full list of excipients, see section _6.1 List of excipients_. 3 PHARMACEUTICAL FORM Capsules for oral administration 10 mg Capsules: Hard gelatin capsules with white body and brown cap with “10” printed in black on the body, containing 10 mg acitretin. 25mg Capsules: Hard gelatin capsules with yellow body and brown cap with “25” printed in black on the body, containing 25 mg acitretin. Neotigason Capsules 10mg, 25mg, SPC, 02-2020, HH, Notification 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Severe disorders of keratinization such as erythrodermic psoriasis local or generalized or pustular psoriasis congenital ichthyosis pityriasis rubra pilaris darier's disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Neotigason 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 (see Section 4.6). The capsules should be taken once daily with meals or with milk. There is a wide variation in the absorption and rate of metabolism of Neotigason. This necessitates individual adjustment of dosage. For this reason the following dosage recommendations can Izlasiet visu dokumentu