HOUSE DUST: Package Insert and Label Information
HOUSE DUST- house dust injection, solution
BLATELLA GERMANICA- blattella germanica injection, solution
ACREMONIUM STRICTUM- sarocladium strictum injection, solution
ALTERNARIA TENUIS- alternaria alternata injection, solution
ASPERGILLUS FUMIGATUS- aspergillus fumigatus injection, solution
ASPERGILLUS NIGER VAR NIGER- aspergillus niger var. niger injection, solution
AUREOBASIDIUM PULLULANS VAR PULLULANS- aureobasidium pullulans var. pullutans injection, solution
BOTRYTIS CINEREA- botrytis cinerea injection, solution
CANDIDA ALBICANS- candida albicans injection, solution
CHAETOMIUM GLOBOSUM- chaetomium globosum injection, solution
CLADOSPORIUM CLADOSPORIOIDES- cladosporium cladosporioides injection, solution
CLADOSPORIUM SPHAEROSPERMUM- cladosporium sphaerospermum injection, solution
COCHLIOBOLUS SATIVUS- cochliobolus sativus injection, solution
EPICOCCUM NIGRUM- epicoccum nigrum injection, solution
FUSARIUM OXYSPORUM VASINFECTUM- fusarium oxysporum vasinfectum injection, solution
HELMINTHOSPORIUM SOLANI- helminthosporium solani injection, solution
MUCOR PLUMBEUS- mucor plumbeus injection, solution
NEUROSPORA INTERMEDIA- neurospora intermedia injection, solution
KHUSKIA ORYZAE- khuskia oryzae injection, solution
PHOMA EXIGUA VAR EXIGUA- phoma exigua var. exigua injection, solution
RHIZOPUS ARRHIZUS VAR ARRHIZUS- rhizopus arrhizus injection, solution
RHODOTORULA RUBRA- rhodotorula rubra injection, solution
USTILAGO MAYDIS- ustilago maydis injection, solution
USTILAGO TRITICI- ustilago tritici injection, solution
STEMPHYLIUM SOLANI- stemphylium solani injection, solution
TRICHOPHYTON MENTAGROPHYTES- trichophyton mentagrophytes injection, solution
KARAYA GUM- karaya gum injection, solution
BOS TAURUS SKIN- bos taurus skin injection, solution
COTTON FIBER- cotton fiber injection, solution
COTTON SEED- cotton seed injection, solution
CANIS LUPUS FAMILIARIS SKIN- canis lupus familiaris skin injection, solution
CAVIA PORCELLUS SKIN- cavia porcellus skin injection, solution
EQUUS CABALLUS SKIN- equus caballus skin injection, solution
CEIBA PENTANDRA FIBER- ceiba pentandra fiber injection, solution
MUS MUSCULUS SKIN- mus musculus skin injection, solution
ORRIS- iris x germanica root injection, solution
PYRETHRUM CINERARIIFOLIUM- tanacetum cinerariifolium flower injection, solution
RABBIT- rabbit injection, solution
SOLENOPSIS INVICTA- solenopsis invicta injection, solution
PERIPLANETA AMERICANA- periplaneta americana injection, solution
PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM- penicillium chrysogenum var. chrysogenum injection, solution
ACACIA- acacia injection, solution
ALNUS INCANA SSP RUGOSA POLLEN- alnus incana subsp. rugosa pollen injection, solution
MEDICAGO SATIVA POLLEN- medicago sativa pollen injection, solution
FRAXINUS AMERICANA POLLEN- fraxinus americana pollen injection, solution
PASPALUM NOTATUM POLLEN- paspalum notatum pollen injection, solution
MORELLA CERIFERA POLLEN- morella cerifera pollen injection, solution
FAGUS GRANDIFOLIA POLLEN- fagus grandifolia pollen injection, solution
BETULA LENTA POLLEN- betula lenta pollen injection, solution
BETULA NIGRA POLLEN- betula nigra pollen injection, solution
ACER NEGUNDO POLLEN- acer negundo pollen injection, solution
AMARANTHUS PALMERI POLLEN- amaranthus palmeri pollen injection, solution
JUNIPERUS ASHEI POLLEN- juniperus ashei pollen injection, solution
JUNIPERUS VIRGINIANA POLLEN- juniperus virginiana pollen injection, solution
XANTHIUM STRUMARIUM VAR CANADENSE POLLEN- xanthium strumarium var. canadense pollen injection, solution
POPULUS DELTOIDES POLLEN- populus deltoides pollen injection, solution
CUPRESSUS ARIZONICA POLLEN- cupressus arizonica pollen injection, solution
TAXODIUM DISTICHUM POLLEN- taxodium distichum pollen injection, solution
RUMEX ACETOSELLA POLLEN- rumex acetosella pollen injection, solution
RUMEX CRISPUS POLLEN- rumex crispus pollen injection, solution
ULMUS AMERICANA POLLEN- ulmus americana pollen injection, solution
SOLIDAGO CANADENSIS POLLEN- solidago canadensis pollen injection, solution
CELTIS OCCIDENTALIS POLLEN- celtis occidentalis pollen injection, solution
CARYA OVATA POLLEN- carya ovata pollen injection, solution
SORGHUM HALEPENSE POLLEN- sorghum halepense pollen injection, solution
JUNIPERUS CALIFORNICA POLLEN- juniperus californica pollen injection, solution
KOCHIA SCOPARIA POLLEN- bassia scoparia pollen injection, solution
CHENOPODIUM ALBUM POLLEN- chenopodium album pollen injection, solution
ACER RUBRUM POLLEN- acer rubrum pollen injection, solution
ACER SACCHARUM POLLEN- acer saccharum pollen injection, solution
IVA XANTHIFOLIA POLLEN- cyclachaena xanthifolia pollen injection, solution
IVA ANNUA VAR ANNUA POLLEN- iva annua pollen injection, solution
PROSOPIS JULIFLORA POLLEN- prosopis juliflora pollen injection, solution
ARTEMISIA VULGARIS POLLEN- artemisia vulgaris pollen injection, solution
MORUS RUBRA POLLEN- morus rubra pollen injection, solution
MORUS ALBA POLLEN- morus alba pollen injection, solution
QUERCUS RUBRA POLLEN- quercus rubra pollen injection, solution
QUERCUS VIRGINIANA POLLEN- quercus virginiana pollen injection, solution
QUERCUS ALBA POLLEN- quercus alba pollen injection, solution
OLEA EUROPAEA POLLEN- olea europaea pollen injection, solution
SYAGRUS ROMANZOFFIANA POLLEN- syagrus romanzoffiana pollen injection, solution
CARYA ILLINOINENSIS POLLEN- carya illinoinensis pollen injection, solution
AMARANTHUS RETROFLEXUS POLLEN- amaranthus retroflexus pollen injection, solution
PINUS STROBUS POLLEN- pinus strobus pollen injection, solution
PLANTAGO LANCEOLATA POLLEN- plantago lanceolata pollen injection, solution
POPULUS ALBA POLLEN- populus alba pollen injection, solution
LIGUSTRUM VULGARE POLLEN- ligustrum vulgare pollen injection, solution
ELYMUS REPENS POLLEN- elymus repens pollen injection, solution
AMBROSIA TRIFIDA POLLEN- ambrosia trifida pollen injection, solution
SALSOLA KALI POLLEN- salsola kali pollen injection, solution
ARTEMISIA TRIDENTATA POLLEN- artemisia tridentata pollen injection, solution
LIQUIDAMBAR STYRACIFLUA POLLEN- liquidambar styraciflua pollen injection, solution
PLATANUS OCCIDENTALIS POLLEN- platanus occidentalis pollen injection, solution
JUGLANS NIGRA POLLEN- juglans nigra pollen injection, solution
AILANTHUS ALTISSIMA POLLEN- ailanthus altissima pollen injection, solution
POPULUS TREMULOIDES POLLEN- populus tremuloides pollen injection, solution
POA ANNUA POLLEN- poa annua pollen injection, solution
BROMUS INERMIS POLLEN- bromus inermis pollen injection, solution
ZEA MAYS POLLEN- zea mays pollen injection, solution
POPULUS FREMONTII POLLEN- populus fremontii pollen injection, solution
POPULUS DELTOIDES SSP MONILIFERA POLLEN- populus deltoides subsp. monilifera pollen injection, solution
EUPATORIUM CAPILLIFOLIUM POLLEN- eupatorium capillifolium pollen injection, solution
ULMUS CRASSIFOLIA POLLEN- ulmus crassifolia pollen injection, solution
ULMUS PUMILA POLLEN- ulmus pumila pollen injection, solution
EUCALYPTUS GLOBULUS POLLEN- eucalyptus globulus pollen injection, solution
CORYLUS AMERICANA POLLEN- corylus americana pollen injection, solution
ROBINIA PSEUDOACACIA POLLEN- robinia pseudoacacia pollen injection, solution
MELALEUCA QUINQUENERVIA POLLEN- melaleuca quinquenervia pollen injection, solution
CHENOPODIUM AMBROSIOIDES POLLEN- chenopodium ambrosioides pollen injection, solution
QUERCUS AGRIFOLIA POLLEN- quercus agrifolia pollen injection, solution
SCHINUS MOLLE POLLEN- schinus molle pollen injection, solution
AMARANTHUS SPINOSUS POLLEN- amaranthus spinosus pollen injection, solution
CASUARINA EQUISETIFOLIA POLLEN- casuarina equisetifolia pollen injection, solution
PINUS ECHINATA POLLEN- pinus echinata pollen injection, solution
AMBROSIA ACANTHICARPA POLLEN- ambrosia acanthicarpa pollen injection, solution
AMBROSIA TENUIFOLIA POLLEN- ambrosia tenuifolia pollen injection, solution
AMBROSIA BIDENTATA POLLEN- ambrosia bidentata pollen injection, solution
AMBROSIA PSILOSTACHYA POLLEN- ambrosia psilostachya pollen injection, solution
LOLIUM PERENNE SSP MULTIFLORUM POLLEN- lolium multiflorum pollen injection, solution
ARTEMISIA FRIGIDA POLLEN- artemisia frigida pollen injection, solution
DISTICHLIS SPICATA POLLEN- distichlis spicata pollen injection, solution
HOLCUS LANATUS POLLEN- holcus lanatus pollen injection, solution
JUGLANS REGIA POLLEN- juglans regia pollen injection, solution
TRITICUM AESTIVUM POLLEN- triticum aestivum pollen injection, solution
ARTEMISIA ANNUA POLLEN- artemisia annua pollen injection, solution
AMARANTHUS TUBERCULATUS POLLEN- amaranthus tuberculatus pollen injection, solution
ACREMONIUM STRICTUM- acremonium strictum injection, solution
SACCHAROMYCES CEREVISIAE- saccharomyces cerevisiae injection, solution
FRAXINUS VELUTINA POLLEN- fraxinus velutina pollen injection, solution
SALIX NIGRA POLLEN- salix nigra pollen injection, solution
ALK-Abello, Inc.
ALLERGENIC EXTRACTS,
FOR DIAGNOSTIC USE ONLY
DIRECTIONS FOR USE
WARNING
This product is intended for use by physicians who are experienced in the administration of allergenic extracts and the emergency care of anaphylaxis, or for use under the guidance of an allergy specialist.
As with all allergenic extracts, severe systemic reactions may occur. In certain individuals these life-threatening reactions may result in death. Fatalities associated with skin testing have been reported. Patients should be observed for at least 20 — 30 minutes following testing. Emergency measures and adequately trained personnel should be immediately available in the event of a life-threatening reaction.
Patients with unstable asthma or steroid dependent asthmatics and patients with underlying cardiovascular disease are at greater risk to a fatal outcome from a systemic allergic reaction.
Sensitive patients may experience severe anaphlactic reactions resulting in respiratory obstruction, shock, coma and/or death. Adverse events are to be reported to MedWatch (1-800-FDA-1088), Adverse Event Reporting, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852-9787. This product should not be injected intravenously. Patients receiving beta blockers may not be responsive to epinephrine or inhaled bronchodilators. Respiratory obstruction not responding to parenteral or inhaled bronchodilators may require theophylline, oxygen, intubation and the use of life support systems. Parenteral fluid and/or plasma expanders may be utilized for the treatment of shock. Adrenocorticosteroids may be administered parenterally or intravenously. Refer to WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections below.
Port Washington, NY 11050
U.S. Government License No. 1256
DESCRIPTION
Sterile diagnostic extracts are supplied in either phenol-saline diluent for Intradermal Testing or in diluent containing glycerin 50% (v/v) for Percutaneous Testing and phenol 0.4% (preservative). Inactive ingredients may include: sodium chloride for isotonicity, glycerin, and sodium bicarbonate as a buffer.
Pollens are individually extracted from pure pollen extracted in a phenol-preserved sodium bicarbonate solution. Short Ragweed and Mixed (Tall and Short) Ragweed extracts are standardized by Antigen E content and so labeled. The Antigen E content of extracts containing Short Ragweed at a concentration more dilute than a weight/volume ratio of 1:10 are obtained by calculating the Antigen E content based on the assay value of more concentrated extract. Pollen extracts are filtered aseptically and after final packaging, they are tested for sterility and safety. Molds are individually extracted from pure powdered inactivated mold source material extracted in phenol preserved saline. Mold extracts are filtered aseptically and after final packaging are tested for sterility and safety.
Molds (fungi) are present in all inhabited places at all seasons of the year; they are so ubiquitous that they are prevalent at times when common allergic pollens and other inhalants are not. In the home and surroundings, molds are found in upholstered furniture, mattresses, drapes, cellar and storage room dust, woolens, leather goods, fruits, meats, cheeses, garden soil and on plants. Spores, mycelial fragments and mold residues are thus inhaled, contacted and ingested continuously.
Foods, miscellaneous inhalants and epidermals are individually extracted in phenol preserved saline or glycerin, filtered aseptically and after final packaging are tested for sterility and safety.
CLINICAL PHARMACOLOGY
Diagnostically (for skin testing) the allergen combines with IgE antibodies fixed to mast cells in the skin. This complexing causes an increase in cellular permeability and degranulation of the mast cells releasing chemical mediators. These mediators (such as histamine) are responsible for a local inflammatory response of wheal and erythema typical of a positive skin test reaction and also, the symptoms commonly associated with allergic disease.1 The more mediator release, the larger the reaction (wheal and erythema).
HOUSE DUST Indications and Usage
These products are for diagnostic use only. Diagnostic allergenic extracts are indicated for use in skin testing to establish the clinical relevance of specific allergens to which the patient has been exposed. By measuring skin test response, the physician may assess the degree of sensitivity that patients have to the allergens. For extracts standardized in AU and BAU, see individual directions for use. Allergenic extracts for diagnostic use only of coffee, mosquito, cottonseed, and flaxseed have not been shown by adequate data to be safe and effective for therapeutic use.
CONTRAINDICATIONS
Patients on beta blockers can be non-responsive to beta agonists that may be required to reverse a systemic reaction (also, see boxed WARNING statement and ADVERSE REACTIONS). The physician should carefully weigh the benefit derived from skin testing vs. the risk to the patient should a systemic reaction arise.
Patients with unstable asthma or steroid dependent asthmatics and patients with underlying cardiovascular disease are at greater risk to a fatal outcome from a systemic allergic reaction2,3. See also PRECAUTIONS and ADVERSE REACTIONS.
WARNING S
Severe Allergic Reactions :
Patients should always be observed for at least 20 — 30 minutes after skin testing. In the event of a marked systemic reaction such as urticaria, angioedema, wheezing, dyspnea, respiratory obstruction, hypotension, coma and death (see ADVERSE REACTIONS), applications of a tourniquet above the injection site and administration of 0.2 mL to 1 mL (0.01 mg/kg) of epinephrine injection (1:1,000) are recommended. Maximal recommended dose for children between 2 and 12 years of age is 0.5 mL. The tourniquet is then gradually released at 15-minute intervals. Patients under treatment with beta blockers may be refractory to the usual dose of epinephrine.
Volume expanders and vasopressor agents may be required to reverse hypotension, inhalation bronchodilators and parenteral aminophylline may be required to reverse bronchospasm. In case of respiratory obstruction, oxygen and intubation may be necessary. Life-threatening reactions unresponsive to the above may require cardiopulmonary resuscitation.
Anaphylaxis Following False Negative Food Allergen Skin Test Results:
False negative skin test results associated with anaphylaxis from subsequent exposure to the allergen have been reported during postmarketing diagnostic use of some food allergenic extracts. Based on the patient’s clinical history and the index of suspicion, healthcare providers should consider confirming negative skin testing with serologic testing by measuring specific serum IgE or with a medically-supervised oral food challenge.
PRECAUTIONS
INFORMATION FOR PATIENTS:
Patients should be instructed to describe any active allergic symptoms such as rhinitis, wheezing, dyspnea, etc. prior to testing. Also, see ADVERSE REACTIONS and WARNINGS Sections.
Patients should always be observed 20 to 30 minutes after testing.
DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.