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.

New Zealand - English - Medsafe (Medicines Safety Authority)

stallergenes greer new zealand ltd - allergen extracts 0.1 ir/ml (dermatophagoides pteronyssinus body extract); allergen extracts 1 ir/ml (dermatophagoides pteronyssinus body extract); allergen extracts 10 ir/ml (dermatophagoides pteronyssinus body extract) - solution for injection - active: allergen extracts 0.1 ir/ml (dermatophagoides pteronyssinus body extract) excipient: aluminium hydroxide gel mannitol phenol sodium chloride water active: allergen extracts 1 ir/ml (dermatophagoides pteronyssinus body extract) excipient: aluminium hydroxide gel mannitol phenol sodium chloride water active: allergen extracts 10 ir/ml (dermatophagoides pteronyssinus body extract) excipient: aluminium hydroxide gel mannitol phenol sodium chloride water

New Zealand - English - Medsafe (Medicines Safety Authority)

stallergenes greer new zealand ltd - allergen extracts 10 ir/ml (dermatophagoides pteronyssinus body extract) - solution for injection - 10 ir/ml - active: allergen extracts 10 ir/ml (dermatophagoides pteronyssinus body extract) excipient: aluminium hydroxide gel mannitol phenol sodium chloride water

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

alvix laboratories, llc - dermatophagoides pteronyssinus (unii: 57l1z5378k) (dermatophagoides pteronyssinus - unii:57l1z5378k) - dermatophagoides pteronyssinus 10000 [au] in 1 ml

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:

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.

New Zealand - English - Medsafe (Medicines Safety Authority)

stallergenes greer new zealand ltd - allergen extracts 0.1 ir/ml (dermatophagoides farinae body extract); allergen extracts 1 ir/ml (dermatophagoides farinae body extract); allergen extracts 10 ir/ml (dermatophagoides farinae body extract) - solution for injection - active: allergen extracts 0.1 ir/ml (dermatophagoides farinae body extract) excipient: aluminium hydroxide gel mannitol phenol sodium chloride water active: allergen extracts 1 ir/ml (dermatophagoides farinae body extract) excipient: aluminium hydroxide gel mannitol phenol sodium chloride water active: allergen extracts 10 ir/ml (dermatophagoides farinae body extract) excipient: aluminium hydroxide gel mannitol phenol sodium chloride water

Canada - English - Health Canada

greer laboratories inc - dermatophagoides pteronyssinus - liquid - 5000unit - dermatophagoides pteronyssinus 5000unit - allergenic extracts

Canada - English - Health Canada

greer laboratories inc - dermatophagoides pteronyssinus - liquid - 10000unit - dermatophagoides pteronyssinus 10000unit - allergenic extracts