NEOTIGASON 25 MG

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

ACITRETIN

Dostupné z:

ABIC MARKETING LTD, ISRAEL

ATC kód:

D05BB02

Forma lieku:

CAPSULES

Zloženie:

ACITRETIN 25 MG

Spôsob podávania:

PER OS

Typ predpisu:

Required

Výrobca:

ACTAVIS GROUP PTC EHF, ICELAND

Terapeutické skupiny:

ACITRETIN

Terapeutické oblasti:

ACITRETIN

Terapeutické indikácie:

Severe disorders of keratinization such as erythrodermic psoriasis local or generalized pustular psoriasis congenital ichthyosis pityriasis rubra pilaris darier's disease.

Dátum Autorizácia:

2017-01-31

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Súhrn charakteristických

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