Trexan tablets

Země: Arménie

Jazyk: angličtina

Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivní složka:

methotrexate

Dostupné s:

Orion Corporation / Orion Pharma

ATC kód:

L04AX03

INN (Mezinárodní Name):

methotrexate

Dávkování:

10mg

Léková forma:

tablets

Jednotky v balení:

(15) in plastic container, (25) in plastic container, (50) in plastic container, (16/4x4/) in blister, (30/3x10/) in blister

Druh předpisu:

Prescription

Stav Autorizace:

Registered

Datum autorizace:

2023-03-10

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Trexan 2.5 mg tablets
Trexan 10 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Trexan 2.5 mg tablets:
Each tablet contains methotrexate disodium equivalent to 2.5 mg
methotrexate (anhydrous).
Excipient with known effect: 77.8 mg lactose (as lactose monohydrate).
Trexan 10 mg tablets:
Each tablet contains methotrexate disodium equivalent to 10 mg
methotrexate (anhydrous).
Excipient with known effect: 311.2 mg lactose (as lactose
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Trexan 2.5 mg tablets:
Yellow, round, uncoated, flat tablet, scored and engraved with ORN 57
on one side, diameter 6 mm.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
Trexan 10 mg tablets:
Yellow, capsule-shaped, convex, uncoated tablet, engraved with ORN 59
on one side and score on
other side, length of 14 mm and width of 6 mm.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
_Antirheumatic:_ Active rheumatoid arthritis in adult patients
-
_Antipsoriatic:_ Severe recalcitrant disabling psoriasis, which is not
adequately responsive to
other forms of therapy such as phototherapy, PUVA, and retinoids, and
severe psoriatic arthritis
in adult patients
-
_Cytostatic_: Maintenance treatment of acute lymphoblastic leukaemia
(ALL) in adults,
adolescents and children aged 3 years and over.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Methotrexate should only be prescribed by physicians with expertise in
the use of methotrexate and a
full understanding of the risks of methotrexate therapy.
IMPORTANT WARNING WITH REFERENCE TO THE DOSING OF TREXAN
(METHOTREXATE):
In the treatment of rheumatic diseases, psoriasis or severe psoriatic
arthritis, Trexan (methotrexate)
MUST ONLY BE TAKEN ONCE A WEEK. Dosage errors in the use of Trexan
(methotrexate) can result in
serious adverse reactions, including death. Please read this section
of t