APO-FAMCICLOVIR TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Cumpara asta acum

Ingredient activ:

FAMCICLOVIR

Disponibil de la:

APOTEX INC

Codul ATC:

J05AB09

INN (nume internaţional):

FAMCICLOVIR

Dozare:

250MG

Forma farmaceutică:

TABLET

Compoziție:

FAMCICLOVIR 250MG

Calea de administrare:

ORAL

Unități în pachet:

30

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

NUCLEOSIDES AND NUCLEOTIDES

Rezumat produs:

Active ingredient group (AIG) number: 0127885001; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2007-02-19

Caracteristicilor produsului

                                PRODUCT MONOGRAPH
APO-FAMCICLOVIR
FAMCICLOVIR TABLETS
125 MG, 250 MG AND 500 MG
ANTIVIRAL AGENT
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
MAY 24, 2017
WESTON, ONTARIO
M9L 1T9
_Control No. 204192_
_ _
Page 2 of 30
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
...................................................................................................
5
DRUG INTERACTIONS
....................................................................................................
8
DOSAGE AND ADMINISTRATION
...............................................................................
9
OVERDOSAGE
................................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 11
STORAGE AND STABILITY
.........................................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 14
PART II: SCIENTIFIC INFORMATION
.............................................................................
15
PHARMACEUTICAL INFORMATION
.........................................................................
15
CLINICAL TRIALS
.........................................................................................................
16
TOXICOLOGY
.................................................................................................................
21
REFERENCES
...............
                                
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