Australia - English - Department of Health (Therapeutic Goods Administration)

stallergenes australia pty ltd - plantago lanceolata -

Australia - English - Department of Health (Therapeutic Goods Administration)

stallergenes australia pty ltd - plantago lanceolata -

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 - grass pollen extract 300 ir - sublingual tablet - active: grass pollen extract 300 ir excipient: colloidal silicon dioxide croscarmellose sodium lactose magnesium stearate microcrystalline cellulose - treatment of grass pollen allergic rhinitis with or without conjunctivitis in adults, adolescents and children (above the age of 5) with clinically relevant symptoms, confirmed by a positive cutaneous test and/or a positive titre of the specific ige to the grass pollen.

Malta - English - Medicines Authority

stallergenes s.a. 6 rue alexis de tocqueville, 92160 antony, france - grass pollen, allergen extract - sublingual tablet - grass pollen allergen extract - allergens

Canada - English - Health Canada

bencard allergy laboratories, an allergy therapeutics (canada) ltd. company - allergenic extracts - liquid - 100% - allergenic extracts 100% - allergenic extracts

Canada - English - Health Canada

hollister-stier, unit pharm, division of miles canada inc. - dermatophagoides pteronyssinus; dermatophagoides farinae - liquid - 15000unit; 15000unit - dermatophagoides pteronyssinus 15000unit; dermatophagoides farinae 15000unit - allergenic extracts

Canada - English - Health Canada

hollister-stier, unit pharm, division of miles canada inc. - dermatophagoides pteronyssinus - liquid - 30000unit - dermatophagoides pteronyssinus 30000unit - allergenic extracts

Canada - English - Health Canada

hollister-stier, unit pharm, division of miles canada inc. - dermatophagoides pteronyssinus; dermatophagoides farinae - liquid - 5000unit; 5000unit - dermatophagoides pteronyssinus 5000unit; dermatophagoides farinae 5000unit - allergenic extracts

Canada - English - Health Canada

hollister-stier, unit pharm, division of miles canada inc. - dermatophagoides pteronyssinus - liquid - 10000unit - dermatophagoides pteronyssinus 10000unit - allergenic extracts