HONEY BEE VENOM- apis mellifera venom injection, powder, lyophilized, for solution MIXED VESPID VENOM- vespula vulgaris venom p

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

APIS MELLIFERA VENOM (UNII: 76013O881M) (APIS MELLIFERA VENOM - UNII:76013O881M)

Disponibbli minn:

ALK-Abello A S

INN (Isem Internazzjonali):

APIS MELLIFERA VENOM

Kompożizzjoni:

APIS MELLIFERA VENOM 100 ug in 1 mL

Rotta amministrattiva:

SUBCUTANEOUS

Indikazzjonijiet terapewtiċi:

The Pharmalgen venom preparations are indicated for use in the diagnosis and treatment of Hymenoptera sting allergy. The following general considerations should be applied in determining the proper use of these preparations: - Approximately two-thirds of adult patients with a history of sting anaphylaxis and a positive venom skin test but who do not receive immunotherapy will experience a systemic reaction if stung by the implicated insect again. These patients should receive therapy4 . Children whose reactions have been limited to the skin have an approximately 10% risk of future reactions if stung and not immunized. The nature and severity of these reactions is in general similar to the original reaction and therefore children with this kind of history may not need venom therapy5 . - The risk of anaphylaxis following a future sting is unknown in patients who have been stung without experiencing a systemic reaction but who are currently venom skin test positive. At this time, no recommendation can be made th

Sommarju tal-prodott:

Diagnostic Kit: The diagnostic kit contains 5 vials of freeze-dried venom/venom protein extracts, one vial each of honey bee, yellow jacket, yellow hornet, white faced hornet, and wasp. When reconstituted with 1.2 ml of diluent, each vial contains 100 μ g/ml of venom/venom protein. Treatment Kits: The treatment kits contain 6 unit-dose vials of freeze-dried, venom/venom protein from either honey bee, yellow jacket, yellow hornet, white faced hornet, wasp, or mi- f xed vespid. When reconstituted with 1.2 ml of diluent, each vial of single-venom preparations will contain 100 μ g/ml of venom/venom protein, and the mixed vespid products will contain 300 μ g/ml of venom/venom protein. Multi-dose Vials: Multi-dose vials are single vials that contain enough venom/venom protein so that, when reconstituted as directed with 11 ml of diluent, will produce ten full maintenance doses. When reconstituted as directed with 11 ml of diluent, the multi-dose vials contain 100 μ g/ml of venom protein for single-venom products, and 300 μ g/ml for the mixed vespid product.  HSA Diluent: A diluent containing 0.03% human serum albumin (HSA), 0.9% sodium chloride, and 0.4% phenol should be used for re-constituting and diluting these preparations. This diluent is available in the US from ALK in vials containing 1.8 ml (packages of 100), or 30 ml (packages of 1 or 5) of diluent.

L-istatus ta 'awtorizzazzjoni:

Biologic Licensing Application

Karatteristiċi tal-prodott

HONEY BEE VENOM- APIS MELLIFERA VENOM INJECTION, POWDER, LYOPHILIZED,
FOR SOLUTION
MIXED VESPID VENOM- VESPULA VULGARIS VENOM PROTEIN, DOLICHOVESPULA
ARENARIA VENOM
PROTEIN AND DOLICHOVESPULA MACULATA VENOM PROTEIN INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
WASP VENOM PROTEIN- POLISTES FUSCATUS VENOM PROTEIN INJECTION, POWDER,
LYOPHILIZED, FOR
SOLUTION
WHITE FACED HORNET VENOM PROTEIN- DOLICHOVESPULA MACULATA VENOM
PROTEIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
YELLOW HORNET VENOM PROTEIN- DOLICHOVESPULA ARENARIA VENOM PROTEIN
INJECTION,
POWDER, LYOPHILIZED, FOR SOLUTION
YELLOW JACKET VENOM PROTEIN- VESPULA VULGARIS VENOM PROTEIN INJECTION,
POWDER,
LYOPHILIZED, FOR SOLUTION
ALK-ABELLO A S
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ALLERGENIC EXTRACTS HYMENOPTERA VENOM AND VENOM PROTEIN
1045063C
PRESCRIBING
INFORMATION
ALLERGENIC EXTRACTS
HYMENOPTERA
VENOM/VENOM PROTEIN
PHARMALGEN®
Honey Bee (Apis mellifera)
Yellow Jacket (Vespula spp.)
Yellow Hornet (Dolichovespula arenaria)
White Faced Hornet (Dolichovespula maculata)
Wasp (Polistes spp.)
Mixed Vespid (Yellow Jacket, Yellow Hornet & White Faced Hornet)
ALK-ABELLÓ A/S
DK-2970 HØRSHOLM, DENMARK
WARNING
HYMENOPTERA VENOM PREPARATIONS SHOULD BE USED ONLY BY OR UNDER THE
DIRECTION OF
PHYSICIANS EXPERIENCED IN ADMINISTERING ALLERGENS TO THE MAXIMUM
TOLERATED DOSE AND ONLY
WHERE ADEQUATE MEANS FOR TREATING SEVERE SYSTEMIC REACTIONS ARE
IMMEDIATELY AVAILABLE.
ALLERGENIC EXTRACTS MAY POTENTIALLY ELICIT A SEVERE LIFE-THREATENING
SYSTEMIC REACTION, RARELY
RESULTING IN DEATH1. BECAUSE OF THE POSSIBILITY OF SEVERE SYSTEMIC
REACTIONS, THE PATIENT
SHOULD BE INSTRUCTED IN THE RECOGNITION OF ANAPHYLACTIC SYMPTOMS,
OBSERVED IN THE OFFICE FOR
AT LEAST 30 MINUTES AFTER EACH INJECTION, AND WARNED TO RETURN TO THE
OFFICE IF SYMPTOMS OF AN
ALLERGIC REACTION OCCUR.
PATIENTS RECEIVING BETA-BLOCKERS MAY NOT BE RESPONSIVE TO EPINEPHRINE
OR INHALED
BRONCHODILATORS, AND THE RISK OF SEVERELY COMPLICATING THE TREATMENT
OF SYSTEMIC REACTIONS
SHOULD BE CAREFULLY CONSIDERED BEFORE A DECISION TO TREAT IS REACHED.
TRE