Package Insert and Label Information: EQUUS CABALLUS SKIN
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- orris injection, solution
RABBIT- rabbit injection, solution
PERIPLANETA AMERICANA- periplaneta americana injection, solution
BLATELLA GERMANICA- blatella germanica injection, solution
ACREMONIUM STRICTUM- acremonium 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
PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM- penicillium chrysogenum var. chrysogenum injection, solution
PHOMA EXIGUA VAR EXIGUA- phoma exigua var. exigua injection, solution
RHIZOPUS ARRHIZUS VAR ARRHIZUS- rhizopus arrhizus var. 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
SACCHAROMYCES CEREVISIAE- saccharomyces cerevisiae injection, solution
ACACIA- acacia injection, solution
AILANTHUS ALTISSIMA POLLEN- ailanthus altissima pollen injection, solution
ALNUS INCANA SSP RUGOSA POLLEN- alnus incana subsp. rugosa pollen injection, solution
MEDICAGO SATIVA POLLEN- medicago sativa pollen injection, solution
FRAXINUS VELUTINA POLLEN- fraxinus velutina pollen injection, solution
FRAXINUS AMERICANA POLLEN- fraxinus americana pollen injection, solution
POPULUS TREMULOIDES POLLEN- populus tremuloides 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
POA ANNUA POLLEN- poa annua pollen injection, solution
ACER NEGUNDO POLLEN- acer negundo pollen injection, solution
BROMUS INERMIS POLLEN- bromus inermis 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
ZEA MAYS POLLEN- zea mays pollen injection, solution
POPULUS DELTOIDES POLLEN- populus deltoides pollen injection, solution
POPULUS FREMONTII POLLEN- populus fremontii pollen injection, solution
POPULUS DELTOIDES SSP MONILIFERA POLLEN- populus deltoides subsp. monilifera 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
EUPATORIUM CAPILLIFOLIUM POLLEN- eupatorium capillifolium pollen injection, solution
ULMUS AMERICANA POLLEN- ulmus americana 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
SOLIDAGO CANADENSIS POLLEN- solidago canadensis pollen injection, solution
CELTIS OCCIDENTALIS POLLEN- celtis occidentalis pollen injection, solution
CORYLUS AMERICANA POLLEN- corylus americana pollen injection, solution
SORGHUM HALEPENSE POLLEN- sorghum halepense pollen injection, solution
JUNIPERUS CALIFORNICA POLLEN- juniperus californica pollen injection, solution
KOCHIA SCOPARIA POLLEN- kochia scoparia pollen injection, solution
CHENOPODIUM ALBUM POLLEN- chenopodium album pollen injection, solution
ROBINIA PSEUDOACACIA POLLEN- robinia pseudoacacia pollen injection, solution
ACER RUBRUM POLLEN- acer rubrum pollen injection, solution
ACER SACCHARUM POLLEN- acer saccharum pollen injection, solution
IVA XANTHIFOLIA POLLEN- iva xanthifolia pollen injection, solution
IVA ANNUA VAR ANNUA POLLEN- iva annua var. annua pollen injection, solution
MELALEUCA QUINQUENERVIA POLLEN- melaleuca quinquenervia pollen injection, solution
PROSOPIS JULIFLORA POLLEN- prosopis juliflora pollen injection, solution
CHENOPODIUM AMBROSIOIDES POLLEN- chenopodium ambrosioides 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 AGRIFOLIA POLLEN- quercus agrifolia 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
SCHINUS MOLLE POLLEN- schinus molle pollen injection, solution
AMARANTHUS RETROFLEXUS POLLEN- amaranthus retroflexus pollen injection, solution
AMARANTHUS SPINOSUS POLLEN- amaranthus spinosus pollen injection, solution
CASUARINA EQUISETIFOLIA POLLEN- casuarina equisetifolia pollen injection, solution
PINUS STROBUS POLLEN- pinus strobus pollen injection, solution
PINUS ECHINATA POLLEN- pinus echinata 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 ACANTHICARPA POLLEN- ambrosia acanthicarpa pollen injection, solution
AMBROSIA TENUIFOLIA POLLEN- ambrosia tenuifolia pollen injection, solution
AMBROSIA BIDENTATA POLLEN- ambrosia bidentata pollen injection, solution
AMBROSIA ARTEMISIIFOLIA POLLEN- ambrosia artemisiifolia pollen injection, solution
AMBROSIA TRIFIDA POLLEN- ambrosia trifida pollen injection, solution
AMBROSIA PSILOSTACHYA POLLEN- ambrosia psilostachya pollen injection, solution
SALSOLA KALI POLLEN- salsola kali pollen injection, solution
LOLIUM PERENNE SSP MULTIFLORUM POLLEN- lolium perenne ssp. multiflorum pollen injection, solution
ARTEMISIA FRIGIDA POLLEN- artemisia frigida pollen injection, solution
ARTEMISIA TRIDENTATA POLLEN- artemisia tridentata pollen injection, solution
DISTICHLIS SPICATA POLLEN- distichlis spicata pollen injection, solution
ATRIPLEX WRIGHTII POLLEN- atriplex wrightii pollen injection, solution
LIQUIDAMBAR STYRACIFLUA POLLEN- liquidambar styraciflua pollen injection, solution
PLATANUS OCCIDENTALIS POLLEN- platanus occidentalis pollen injection, solution
HOLCUS LANATUS POLLEN- holcus lanatus pollen injection, solution
JUGLANS NIGRA POLLEN- juglans nigra pollen injection, solution
JUGLANS REGIA POLLEN- juglans regia pollen injection, solution
AMARANTHUS TUBERCULATUS POLLEN- amaranthus tuberculatus pollen injection, solution
TRITICUM AESTIVUM POLLEN- triticum aestivum pollen injection, solution
SALIX NIGRA POLLEN- salix nigra pollen injection, solution
ARTEMISIA ANNUA POLLEN- salix nigra pollen injection, solution
PYRETHRUM CINERARIIFOLIUM- pyrethrum cinerariifolium injection, solution
HOUSE DUST- house dust 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
ALK-Abello, Inc.
DIRECTIONS FOR USE OF
THERAPEUTIC
ALLERGENIC EXTRACTS
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.
Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact the physician’s office if reaction symptoms occur. As with all allergenic extracts, severe systemic reactions may occur. In certain individuals, these reactions may rarely result in death. Patients should be observed for 20 to 30 minutes following treatment, and emergency measures, as well as personnel trained in their use, 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. Adverse Events are to be reported to Med Watch (1-800 FDA-1088), Adverse Experience Reporting HFM-210 Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448.
This product should not be injected intravenously. Deep subcutaneous routes have proven to be safe. 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.
DESCRIPTION
Sterile therapeutic extracts are supplied in either Phenol Saline Diluent or in Diluent containing Glycerin 50% (v/v) for subcutaneous injection. Inactive ingredients may include: Sodium Chloride for isotonicity, Glycerin, and Sodium Bicarbonate as buffering agents. Inactive ingredients in mold extracts may include residual: Potassium Phosphate, Citrate, Magnesium Phosphate and Calcium Carbonate from growth media. These products are compounded and diluted on a w/v or PNU basis.
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.
House Dust, a heterogenous, widely distributed allergen, is among the most frequently encountered allergens that can be a primary or accompanying cause of allergic symptoms. Allergens found in house dust may include mites, insects, mold spores, feathers, animal dander, pollens, hairs, and foods. Individual environs may contain certain items not ordinarily found so that a stock house dust extract may not elicit a response on testing. House Dust Extracts are prepared from dust collected from homes and from establishments which clean household rugs. It is extracted with buffered, aqueous extracting fluid. House Dust Extract is dialyzed, filtered aseptically, and is tested for sterility and safety.
Molds 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.
Miscellaneous inhalants and epidermals are individually extracted in phenol preserved saline, filtered aseptically and after final packaging are tested for sterility and safety.
CLINICAL PHARMACOLOGY
The treatment consists of the subcutaneous injection of gradually increasing doses of the allergens to which the patient is allergic. It has been demonstrated that this method of treatment induces an increased tolerance to the allergens responsible for the symptoms on subsequent exposure. The exact relationships between allergen, skin-sensitizing antibody (IgE) and the blocking antibody (IgG) have not been precisely established. Clinically confirmed immunological studies have adduced evidence of the efficacy of hyposensitization therapy.
Numerous controlled studies have demonstrated the clinical efficacy of immunotherapy with cat, dust mites and some pollen extracts. Nevertheless, responses are variable, and in a few studies patients reported no appreciable benefit.
Extracts containing Short Ragweed pollen bear a labeled potency declaration in terms of Antigen E content. Numerous studies have confirmed Antigen E (AgE) as the major antigen associated with Short Ragweed pollinosis.1 Therefore, it is essential that the physician be aware of AgE content of allergenic extract administered for hyposensitization therapy.
Some studies have indicated that for most patients a cumulative Antigen E dosage of less than 0.1 units is not immunizing (sufficient to stimulate specific IgG antibodies.)2 This, however, does not suggest that 0.1 unit is a maximum tolerated dose. Most moderately sensitive patients may tolerate a dosage of ten to fifty times greater. If results with this product are unsatisfactory with exquisitely sensitive patients who cannot tolerate an immunizing dose, the physician should consider alternative therapy.
One well-controlled study demonstrated that standard immunotherapy (gradually increasing doses of antigen given subcutaneously to a maximum tolerated peak dose), using crude ragweed extract of known Antigen E potency, was significantly superior to placebo and low dose immunotherapy ( 0.1 units AgE cumulative dose) in amelioration of symptoms associated with ragweed hay fever. These patients received a cumulative dose of 18-350 units Antigen E (median = 84.9 units). The maximum single dose ranged from 3.7 to 46.8 units (median = 11.1 units) prior to the ragweed hay fever season10.
Patients for this study were sensitive to Ragweed Antigen E, as determined by intradermal skin testing at a dose 0.01 units AgE/mL. A series of 24 weekly injections were administered. Forty-seven percent of the patients experienced at least one systemic reaction with an average of 1.2 systemic reactions per patient. None of the patients were able to achieve the expected maximum dose (90 units of Antigen E) in the 24 weekly injection dosage schedule.
EQUUS CABALLUS SKIN Indications and Usage
Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal dander, various other inhalants, and in situations where the offending allergen cannot be avoided.
Prior to initiation of therapy, the clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided.
CONTRAINDICATIONS
A patient should not be immunized with preparations of allergens to which the patient has not demonstrated symptoms, IgE antibodies, positive skin tests, or properly controlled challenge testing. In most cases, immunotherapy is not indicated for those allergens that can be eliminated or minimized by environmental control.
Patients on beta-blockers are not candidates for immunotherapy, as they can be non-responsive to beta-agonists that may be required to reverse a systemic reaction (also see WARNINGS AND ADVERSE REACTIONS).
In the presence of active symptoms such as rhinitis, wheezing, dyspnea, etc., the indication of immunotherapy must be weighed carefully against the risk of temporarily aggravating the symptoms by the injection itself.
Also, there is some evidence, although inconclusive, that routine immunizations may exacerbate autoimmune diseases.3 , 4, 5 Hyposensitization should be given cautiously to patients with this predisposition. Patients with severe cardiorespiratory symptoms are at an additional risk during a systemic reaction. The physician must weigh risk to benefit in these cases.
