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:

6MG; 1ML

Zāļu forma:

POWDER FOR SOLUTION

Kompozīcija:

SOMATROPIN 6MG; WATER 1ML

Ievadīšanas:

SUBCUTANEOUS

Vienības iepakojumā:

7X1ML

Receptes veids:

Prescription

Ārstniecības joma:

PITUITARY

Produktu pārskats:

Active ingredient group (AIG) number: 0228557004; AHFS:

Autorizācija statuss:

CANCELLED POST MARKET

Autorizācija datums:

2013-07-15

Produkta apraksts

_ _
_Serostim_
_®_
_ Product Monograph_
_ _
_Page 1 of 47_
PRODUCT MONOGRAPH
PR SEROSTIM
®
Somatropin for Injection
Lyophilized Powder for reconstitution
4 mg/vial, 5 mg/vial, 6 mg/vial, 8.8 mg/vial
PR SEROSTIM
® 8.8 MG (5.83 MG/ML) CLICK.EASY
Somatropin for Injection
Lyophilized Powder for reconstitution
8.8 mg (5.83 mg/mL)
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:
JUNE 22, 2012 SUBMISSION CONTROL NO.: 155220
®
Registered trademark of Ares Trading S.A.
_ _
_Serostim_
_®_
_ Product Monograph_
_ _
_Page 2 of 47_
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
..............................................................................................................
19
ACTIONS AND CLINICAL PHARMACOLOGY
..................................................... 19
STORAGE AND STABILITY
...................................................................