Trexan tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

methotrexate

Available from:

Orion Corporation / Orion Pharma

ATC code:

L04AX03

INN (International Name):

methotrexate

Dosage:

2,5mg

Pharmaceutical form:

tablets

Units in package:

(30) in plastic container, (100) in plastic container, (24/2x12/) in blister, (100/10x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2023-03-10

Summary of Product characteristics

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