PHARMALGEN WHITE FACED HORNET VENOM POWDER FOR SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

DOLICHOVESPULA MACULATA VENOM PROTEIN EXTRACT

Mevcut itibaren:

ALK-ABELLO A/S

ATC kodu:

V01AA07

INN (International Adı):

INSECTS

Doz:

120MCG

Farmasötik formu:

POWDER FOR SOLUTION

Kompozisyon:

DOLICHOVESPULA MACULATA VENOM PROTEIN EXTRACT 120MCG

Uygulama yolu:

INTRADERMAL

Paketteki üniteler:

6X1.2ML

Reçete türü:

Schedule D

Terapötik alanı:

ALLERGENIC EXTRACTS

Ürün özeti:

Active ingredient group (AIG) number: 0123308001; AHFS:

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2023-02-07

Ürün özellikleri

_ _
_Pharmalgen _
_Page 1 of 31 _
_ALK-Abelló A/S _
PRODUCT MONOGRAPH
PHARMALGEN
Allergenic Extracts
Hymenoptera Venom/Venom Protein
Honey Bee (Apis mellifera)
Yellow Jacket (Vespula spp.)
Yellow Hornet (Dolichovespula arenaria)
White Faced Hornet (Dolichovespula maculate)
Wasp (Polistes spp.)
Mixed Vespid (Yellow Jacket, White Faced Hornet & Yellow Hornet)
Powder for solution, 100 g/mL for single-venom, 300 g/mL for the mixed
vespid
MANUFACTURED BY:
ALK-ABELLÓ A/S
BØGE ALLÉ 6-8
HØRSHOLM, DENMARK 2970
DISTRIBUTED BY:
ALK- ABELLÓ PHARMACEUTICALS, INC.
MISSISSAUGA, ON
L4Z 2H6
DATE OF APPROVAL:
OCTOBER 3, 2014
SUBMISSION CONTROL NO: 174496
_ _
_Pharmalgen _
_Page 2 of 31 _
_ALK-Abelló A/S_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
4
CONTRAINDICATIONS
..................................................................................................
6
WARNINGS AND PRECAUTIONS
.................................................................................
7
ADVERSE REACTIONS
.................................................................................................
12
DOSAGE AND ADMINISTRATION
.............................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 23
STORAGE AND STABILITY
.........................................................................................
24
SPECIAL HANDLING INSTRUCTIONS
......................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 25
PART II: SCIENTIFIC INFORMATION
...............................................................................
26
PHARMACEUTICAL INFORMATION
.................