United States - English - NLM (National Library of Medicine)

alk-abello a s - dermatophagoides pteronyssinus (unii: 57l1z5378k) (dermatophagoides pteronyssinus - unii:57l1z5378k), dermatophagoides farinae (unii: pr9u2ypf3q) (dermatophagoides farinae - unii:pr9u2ypf3q) - dermatophagoides pteronyssinus 6 [arb'u] - odactra™ is an allergen extract indicated as immunotherapy for the treatment of house dust mite (hdm)-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive in vitro testing for ige antibodies to dermatophagoides   farinae or dermatophagoides   pteronyssinus house dust mites, or by positive skin testing to licensed house dust mite allergen extracts. odactra is approved for use in persons 12 through 65 years of age.  odactra is not indicated for the immediate relief of allergic symptoms. odactra is contraindicated in patients with: - severe, unstable or uncontrolled asthma - a history of any severe systemic allergic reaction - a history of any severe local reaction after taking any sublingual allergen immunotherapy - a history of eosinophilic esophagitis - hypersensitivity to any of the inactive ingredients contained in this product [see description ( 11 )] risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. available data on odactra administered to pregnant women are insufficient to inform associated risks in pregnancy. in an embryo/fetal developmental toxicity study performed in mice, administration of odactra during gestation did not reveal adverse developmental outcomes in fetuses (see 8.1 data ). data animal data in a developmental toxicity study, the effect of odactra on embryo/fetal development was evaluated in mice. animals were administered odactra subcutaneously daily from day 6 to day 17 of the gestation period at doses up to 5 times the human sublingual dose. there were no odactra-related post-implantation losses, fetal malformations or variations. risk summary it is not known whether odactra is excreted in human milk. data are not available to assess the effects of odactra on the breastfed child or on milk production and excretion in the nursing woman. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for odactra and any potential adverse effects on the breastfed child from odactra or from the underlying maternal condition. the safety and effectiveness of odactra have been established in adolescents 12 through 17 years of age. the safety and effectiveness have not been established in persons below 12 years of age. safety and effectiveness have not been established in persons older than 65 years of age.

United States - English - NLM (National Library of Medicine)

jubilant hollisterstier llc - dermatophagoides farinae (unii: pr9u2ypf3q) (dermatophagoides farinae - unii:pr9u2ypf3q), dermatophagoides pteronyssinus (unii: 57l1z5378k) (dermatophagoides pteronyssinus - unii:57l1z5378k) - dermatophagoides farinae 5000 [au] in 1 ml - 16, 17, 18, 26 standardized glycerinated allergenic extracts are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific environmental allergens. the selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing.20, 21 the use of mixed or unrelated antigens for skin testing is not recommended since, in the case of a positive reaction, it does not indicate which component of the mix is responsible for the reaction, while, in the case of a negative reaction, it fails to indicate whether the individual antigens at full concentration would give a positive reaction. utilization of such mixes for compounding a treatment may result, in the former case, in administering unnecessary antigens and, in the latter case, in the omission of a needed allergen. allergens to which a patient is extremely sensitive should not be included in treatment mixes with

United States - English - NLM (National Library of Medicine)

alk-abello, inc. - dermatophagoides farinae (unii: pr9u2ypf3q) (dermatophagoides farinae - unii:pr9u2ypf3q), dermatophagoides pteronyssinus (unii: 57l1z5378k) (dermatophagoides pteronyssinus - unii:57l1z5378k) - dermatophagoides farinae 5000 [au] in 1 ml - this product is indicated for the diagnosis and treatment of hypersensitivity in patients with symptoms compatible with dust mite allergy. hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants, in situations where the offending allergen cannot be avoided. mixtures of standardized mite (d. farinae and d. pteronyssinus) should be considered for treatment of patients who are sensitive to both species. prior to the initiation of therapy, 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 be easily avoided. there are no known absolute contraindications to immunotherapy. however, a patient should not be immunized with preparations of allergens to which the patient has not demonstrated symptoms and positive skin tests. in most case

United States - English - NLM (National Library of Medicine)

allermed laboratories, inc. - dermatophagoides farinae (unii: pr9u2ypf3q) (dermatophagoides farinae - unii:pr9u2ypf3q) - dermatophagoides farinae 10000 [au] in 1 ml - standardized mite extract is indicated for use in the diagnosis of patients with a history of allergy to mites or house dust and for the treatment of patients with a history of mite allergy who have established sensitivity to mites by diagnostic skin testing. the use of mite extract for the above purposes should be made only by physicians with special familiarity and knowledge of allergy as described in a standard allergy textbook 10 . injections of mite extract should not be administered in the presence of diseases characterized by a bleeding diathesis. immunotherapy should not be started in patients until a specific diagnosis of type i allergy to mite is made by a physician based on skin testing with this product. other contraindications include: extreme sensitivity to mite: determined from previous anaphylaxis following skin testing, immunotherapy, or natural exposure. autoimmune disease: individuals with autoimmune disease maybe at risk, due to the possibility of routine immunizations e

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

stallergènes s.a. - dermatophagoides farinae, allergens 50 ir (tablet 100 ir); dermatophagoides pteronyssinus, allergens 50 ir (tablet 100 ir); dermatophagoides farinae, allergens 150 ir (tablet 300 ir); dermatophagoides pteronyssinus, allergens 150 ir (tablet 300 ir) - sublingual tablet - 100 ir - 300 ir - dermatophagoides farinae, allergens 50 ir; dermatophagoides pteronyssinus, allergens 50 ir; dermatophagoides farinae, allergens 150 ir; dermatophagoides pteronyssinus, allergens 150 ir - house dust mites

United States - English - NLM (National Library of Medicine)

antigen laboratories, inc. - dermatophagoides pteronyssinus (unii: 57l1z5378k) (dermatophagoides pteronyssinus - unii:57l1z5378k) - dermatophagoides pteronyssinus 10000 [au] in 1 ml - indications and usage     standardized mite allergenic extract is indicated for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. confirmation is determined by skin testing. an orderly approach to the diagnostic use of allergenic extracts usually begins with direct skin testing. this product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.     mite mixtures should not be used for diagnostic skin testing. the individual mites should be used. mite mixtures may be used for immunotherapy to treat patients who demonstrated sensi­tivity to both d. farinae and d. pteronyssinus mites. patients who react to both d. farinae and d. pteronyssinus have demonstrated a significant cross-reactivity. caution should be used in esca­lating treatment with mite mixtures.21 prick-puncture testing:

United States - English - NLM (National Library of Medicine)

nelco laboratories, inc. - dermatophagoides farinae (unii: pr9u2ypf3q) (dermatophagoides farinae - unii:pr9u2ypf3q) - dermatophagoides farinae 10000 [au] in 1 ml - standardized mite allergenic extracts are intended for use in the diagnosis and therapy of d.farinae and d.pteronyssinus mite allergy, as established by allergy history and skin test reactivity (6,10) . standardized mite extracts are not interchangeable with non standardized mite extracts. to select patients for a confirmation of allergic disease diagnosis and/or treatment with allergen extracts, screening tests should be done using in vivo identification testing methods (i.e. scratch or intradermal testing).(13) standardized mite extract containing equal parts of d.farinae and d.pteronyssinus is intended for therapy only. the use of standardized mites extract is indicated for hypersensitization treatment and may be used as part of the over-all management of the allergic patient. this treatment is particularly to be recommended when a patient's sensitivity to mite has been determined initially by scratch or intradermal skin tests. this product should not be used if the patient has asthma, cardiovascular disea

United States - English - NLM (National Library of Medicine)

allergy laboratories, inc. - dermatophagoides farinae (unii: pr9u2ypf3q) (dermatophagoides farinae - unii:pr9u2ypf3q) - dermatophagoides farinae 10000 [au] in 1 ml - standardized mite extract is used for the diagnosis and treatment of allergic disease to mite. diagnosis of allergic disease to mite is made through a combined medical history sufficiently complete to identify allergic symptoms to mite and identification of mite allergy by diagnostic skin testing. hyposensitization therapy to mite is treatment for patients exhibiting allergic reactions to mite. immunotherapy is intended for patients whose symptoms cannot be satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. (5) there are no known absolute contraindications to hyposensitization therapy. see precautions section for pregnancy risks. a patient should not be treated with allergens unless a history of symptoms and a positive skin test reaction have been demonstrated. allergenic extracts should only be administered to patients that show symptoms of allergy or asthma. the physician must determine if the benefits outweigh the risks in using these products for tre

New Zealand - English - Medsafe (Medicines Safety Authority)

stallergenes greer new zealand ltd - dermatophagoides farinae allergen extract 50 ir ((american house dust mite)); dermatophagoides pteronyssinus allergen extract 50 ir ((european house dust mite)); dermatophagoides farinae allergen extract 150 ir ((american house dust mite)); dermatophagoides pteronyssinus allergen extract 150 ir ((dermatophagoides pteronyssinus)) - sublingual tablet - 100ir & 300ir - active: dermatophagoides farinae allergen extract 50 ir ((american house dust mite)) dermatophagoides pteronyssinus allergen extract 50 ir ((european house dust mite)) excipient: colloidal silicon dioxide croscarmellose sodium lactose monohydrate magnesium stearate microcrystalline cellulose active: dermatophagoides farinae allergen extract 150 ir ((american house dust mite)) dermatophagoides pteronyssinus allergen extract 150 ir ((dermatophagoides pteronyssinus)) excipient: colloidal silicon dioxide croscarmellose sodium lactose monohydrate magnesium stearate microcrystalline cellulose - actair is indicated for the treatment of house dust mite allergic rhinitis with or without conjunctivitis in adults, adolescents and children 5 years and over diagnosed with house dust mite allergy.

New Zealand - English - Medsafe (Medicines Safety Authority)

stallergenes greer new zealand ltd - dermatophagoides farinae allergen extract 150 ir ((american house dust mite)); dermatophagoides pteronyssinus allergen extract 150 ir ((european house dust mite)) - sublingual tablet - 300 ir - active: dermatophagoides farinae allergen extract 150 ir ((american house dust mite)) dermatophagoides pteronyssinus allergen extract 150 ir ((european house dust mite)) excipient: colloidal silicon dioxide croscarmellose sodium lactose monohydrate magnesium stearate microcrystalline cellulose - actair is indicated for the treatment of house dust mite allergic rhinitis with or without conjunctivitis in adults, adolescents and children 5 years and over diagnosed with house dust mite allergy.