SEROSTIM POWDER FOR SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

SOMATROPIN; WATER

Pieejams no:

EMD SERONO, A DIVISION OF EMD INC., CANADA

ATĶ kods:

H01AC01

SNN (starptautisko nepatentēto nosaukumu):

SOMATROPIN

Deva:

5MG; 1ML

Zāļu forma:

POWDER FOR SOLUTION

Kompozīcija:

SOMATROPIN 5MG; WATER 1ML

Ievadīšanas:

SUBCUTANEOUS

Vienības iepakojumā:

7X1ML

Receptes veids:

Prescription

Ārstniecības joma:

PITUITARY

Produktu pārskats:

Active ingredient group (AIG) number: 0228557003; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

1998-11-06

Produkta apraksts

_ _
_Serostim_
_®_
_ Product Monograph_
_ _
_Page 1 of 36_
_ _
PRODUCT MONOGRAPH
PR SEROSTIM
®
Somatropin for Injection
Lyophilized Powder for reconstitution
5 mg/vial
Pharmaceutical Standard: Professed
Therapeutic Classification: Human Growth Hormone
For more information contact:
EMD Serono, A Division of EMD Inc., Canada
2695 North Sheridan Way, Suite 200
Mississauga, Ontario, Canada L5K 2N6
Date of Authorization:
March 6, 2017
Submission Control No.: 200215
®
Registered trademark of Ares Trading S.A.
_ _
_Serostim_
_®_
_ Product Monograph_
_ _
_Page 2 of 36_
_ _
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
..............................................................................
4
ADVERSE REACTIONS
...............................................................................................
10
DRUG INTERACTIONS
...............................................................................................
16
DOSAGE AND ADMINISTRATION
..........................................................................
17
OVERDOSAGE
..............................................................................................................
18
ACTIONS AND CLINICAL PHARMACOLOGY
..................................................... 18
STORAGE AND
STABILITY.......................................................................................
20
SPECIAL HANDLING INSTRUCTIONS
................................................................... 21
DOSAGE FORMS, COMPOSITION AND PA