LIPIODOL ULTRA FLUID LIQUID

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

IODINE (ETHIODIZED OIL)

Διαθέσιμο από:

GUERBET

Φαρμακολογική κατηγορία (ATC):

V08AD01

INN (Διεθνής Όνομα):

ETHYL ESTERS OF IODISED FATTY ACIDS

Δοσολογία:

380MG

Φαρμακοτεχνική μορφή:

LIQUID

Σύνθεση:

IODINE (ETHIODIZED OIL) 380MG

Οδός χορήγησης:

INTRACAVITARY

Μονάδες σε πακέτο:

5ML/10ML

Τρόπος διάθεσης:

Ethical

Θεραπευτική περιοχή:

ROENTGENOGRAPHY

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0103970041; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2017-07-13

Αρχείο Π.Χ.Π.

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_Page 1 of 24_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
LIPIODOL
® ULTRA FLUID
ETHIODIZED OIL INJECTION, HOUSE STD
Solution for injection, 38% w/w (380 mg iodine/g or 480 mg iodine/mL)
V08AE non-watersoluble X-ray contrast media
For professional use only
Guerbet
BP 57400
95943 Roissy CdG Cedex
France
Date of Preparation:
July 12, 2017
Submission Control No: 196107
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_Page 2 of 24_
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
...................................................................................................
7
DRUG INTERACTIONS
...................................................................................................
9
DOSAGE AND ADMINISTRATION
.............................................................................
10
OVERDOSAGE
................................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 12
STORAGE AND STABILITY
.........................................................................................
12
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 12
PART II: SCIENTIFIC INFORMATION
..............................................................................
14
PHARMACEUTICAL INFORMATION
.........................................................................
14
CLINICAL TRIALS
................................................................