PHARMALGEN MIXED VESPID VENOM PROTEIN POWDER FOR SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

YELLOW JACKET VENOM PROTEIN; YELLOW HORNET VENOM PROTEIN; WHITE FACED HORNET VENOM PROTEIN

Commercializzato da:

ALK-ABELLO A/S

Codice ATC:

V01AA07

INN (Nome Internazionale):

INSECTS

Dosaggio:

120MCG; 120MCG; 120MCG

Forma farmaceutica:

POWDER FOR SOLUTION

Composizione:

YELLOW JACKET VENOM PROTEIN 120MCG; YELLOW HORNET VENOM PROTEIN 120MCG; WHITE FACED HORNET VENOM PROTEIN 120MCG

Via di somministrazione:

INTRADERMAL

Confezione:

1.2ML

Tipo di ricetta:

Schedule D

Area terapeutica:

ALLERGENIC EXTRACTS

Dettagli prodotto:

Active ingredient group (AIG) number: 0315776004; AHFS:

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2023-02-07

Scheda tecnica

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_Pharmalgen _
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_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
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_Pharmalgen _
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_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
.................