LETROZOLE TABLETS
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
10-11-2017
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
LETROZOLE
Fáanlegur frá:
FRESENIUS KABI CANADA LTD
ATC númer:
L02BG04
INN (Alþjóðlegt nafn):
LETROZOLE
Skammtar:
2.5MG
Lyfjaform:
TABLET
Samsetning:
LETROZOLE 2.5MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
14
Gerð lyfseðils:
Prescription
Lækningarsvæði:
ANTINEOPLASTIC AGENTS
Vörulýsing:
Active ingredient group (AIG) number: 0132937001; AHFS:
Leyfisstaða:
CANCELLED PRE MARKET
Leyfisdagur:
2023-03-10
Vara einkenni
PRODUCT MONOGRAPH
PR
LETROZOLE TABLETS
(letrozole)
2.5 mg
Manufacturer’s Standard
Non-steroidal aromatase inhibitor; inhibitor of estrogen biosynthesis;
anti-tumour agent
FRESENIUS KABI CANADA LTD.
Date of Revision:
165 Galaxy Blvd, Suite 100
November 10, 2017
Toronto, ON M9W 0C8
Submission Control No:
209100
_Letrozole-PM-ENG-v2.0 _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_Page 2 of 62 _
_ _
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT
INFORMATION................................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
10
DRUG INTERACTIONS
.........................................................................................................
27
DOSAGE AND ADMINISTRATION
.....................................................................................
28
OVERDOSAGE
........................................................................................................................
29
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
30
STORAGE AND STABILITY
.................................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 32
PART II: SCIENTIFIC INFORMATION
...............................................................................
33
PHARMACEUTICAL INFORMATION
.................................................................................
33
CLINICAL
Lestu allt skjalið
