SAIZEN POWDER FOR SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

SOMATROPIN

Διαθέσιμο από:

EMD SERONO, A DIVISION OF EMD INC., CANADA

Φαρμακολογική κατηγορία (ATC):

H01AC01

INN (Διεθνής Όνομα):

SOMATROPIN

Δοσολογία:

5MG

Φαρμακοτεχνική μορφή:

POWDER FOR SOLUTION

Σύνθεση:

SOMATROPIN 5MG

Οδός χορήγησης:

INTRAMUSCULAR

Μονάδες σε πακέτο:

3.5ML/10ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

PITUITARY

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0131827001; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

1998-05-13

Αρχείο Π.Χ.Π.

_SAIZEN_
_®_
_ Product Monograph _
_Page 1 of 83_
PRODUCT MONOGRAPH
PR
SAIZEN
®
Somatropin for Injection
Lyophilized Powder for reconstitution
5 mg/vial
PR
SAIZEN
®
Somatropin
Solution for Injection in a Cartridge
6 mg (5.83 mg/mL)
12 mg (8 mg/mL)
20 mg (8 mg/mL)
Pharmaceutical Standard: Professed
Therapeutic Classification: Human Growth Hormone
EMD Serono, a Division of EMD Inc., Canada
2695 North Sheridan Way, Suite 200
Mississauga, Ontario, Canada L5K 2N6
www.emdserono.ca
EMD Serono is a business of Merck KGaA, Darmstadt, Germany
DATE OF INITIAL APPROVAL: May 13, 1998
Submission Control No.: 237857
DATE OF REVISION: June 8, 2020
®
Registered trademark of Merck KGaA, Darmstadt, Germany
_SAIZEN_
_®_
_ Product Monograph _
_Page 2 of 83_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY
PRODUCT
INFORMATION
............................................................................
3
DESCRIPTION
.........................................................................................................................
3
INDICATIONS
AND
CLINICAL
USE
...................................................................................
3
CONTRAINDICATIONS
........................................................................................................
4
WARNINGS
AND
PRECAUTIONS
.......................................................................................
6
ADVERSE
REACTIONS
.......................................................................................................
13
DRUG
INTERACTIONS
.......................................................................................................
38
DOSAGE
AND
ADMINISTRATION
...................................................................................
39
OVERDOSAGE
......................................................................................................................
41
ACTIONS
AND
CLINICAL
PHARMACOLOGY
...................................................