NU-LEFLUNOMIDE TABLET
Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
Produkta apraksts
(SPC)
02-02-2012
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Aktīvā sastāvdaļa:
LEFLUNOMIDE
Pieejams no:
NU-PHARM INC
ATĶ kods:
L04AK01
SNN (starptautisko nepatentēto nosaukumu):
LEFLUNOMIDE
Deva:
20MG
Zāļu forma:
TABLET
Kompozīcija:
LEFLUNOMIDE 20MG
Ievadīšanas:
ORAL
Vienības iepakojumā:
100
Receptes veids:
Prescription
Ārstniecības joma:
DISEASE-MODIFYING ANTIRHEUMATIC AGENTS
Produktu pārskats:
Active ingredient group (AIG) number: 0140182002; AHFS:
Autorizācija statuss:
CANCELLED (UNRETURNED ANNUAL)
Autorizācija datums:
2018-03-28
Produkta apraksts
Page 1 of 62
PRODUCT MONOGRAPH
Pr
NU-LEFLUNOMIDE
LEFLUNOMIDE TABLETS
HOUSE STANDARD
10 MG AND 20 MG
ANTIRHEUMATIC, IMMUNOMODULATOR AGENT
NU-PHARM INC.
DATE OF REVISION:
1165 CREDITSTONE ROAD, UNIT 2
FEBRUARY 2, 2012
VAUGHAN, ONTARIO
L4K 4N7
CONTROL #: 152701
Page 2 of 62
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.....................................................................3
SUMMARY PRODUCT INFORMATION
...........................................................................................3
INDICATIONS AND CLINICAL
USE.................................................................................................3
CONTRAINDICATIONS
......................................................................................................................3
WARNINGS AND
PRECAUTIONS.....................................................................................................5
ADVERSE REACTIONS
....................................................................................................................13
DRUG
INTERACTIONS.....................................................................................................................18
DOSAGE AND
ADMINISTRATION.................................................................................................21
OVERDOSAGE
...................................................................................................................................22
ACTION AND CLINICAL PHARMACOLOGY
...............................................................................23
STORAGE AND
STABILITY.............................................................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................26
PART II: SCIENTIFIC INFORMATION
...........................................................................................27
PHARMACEUTICAL
INFORMATION....................................................................................
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