INPROSUB SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

PROGESTERONE

Disponibil de la:

IBSA INSTITUT BIOCHIMIQUE SA

Codul ATC:

G03DA04

INN (nume internaţional):

PROGESTERONE

Dozare:

25MG

Forma farmaceutică:

SOLUTION

Compoziție:

PROGESTERONE 25MG

Calea de administrare:

SUBCUTANEOUS

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

PROGESTINS

Rezumat produs:

Active ingredient group (AIG) number: 0106327010; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2021-04-30

Caracteristicilor produsului

_INPROSUB™ (progesterone injection) _
_ _
_Page 1 of 33_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
INPROSUB™
Progesterone Injection
Solution, 25 mg / 1.112 mL (22.5 mg / mL) progesterone, subcutaneous
injection
House Standard
Progestin
Institut Biochimique SA (IBSA)
Via del Piano 266
CH-6915 Pambio-Noranco,
Switzerland
Imported by:
Progress Therapeutics Inc.
14-320 Harry Walker Parkway North
Newmarket ON
Canada, L3Y 7B4
Date of Initial Authorization:
June 21, 2021
Submission Control No: 239820
_ _
_INPROSUB™ (progesterone injection) _
_Page 2 of 33_
TABLE OF CONTENTS
TABLE OF CONTENTS
.......................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION ....................................................... 4
1
INDICATIONS ...........................................................................................................
4
1.1
Pediatr
ics.............................................................................................................4
1.2
Ger iatr
ics.............................................................................................................4
2
CONTRAINDICATIONS ...........................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.............................................................. 5
4
DOSAGE AND ADMINISTRATION .........................................................................
5
4.1
Dosing Considerations
.........................................................................................5
4.2
Recommended Dose and Dosage Adjustment
.......................................................5
4.3
Administration.....................................................................................................5
4.4
Missed Dose
........................................................................................................6
5
OVERDOSAGE ......................................................