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

janssen-cilag pty ltd - rilpivirine hydrochloride, quantity: 27.5 mg (equivalent: rilpivirine, qty 25 mg) - tablet, film coated - excipient ingredients: hypromellose; lactose monohydrate; macrogol 3000; croscarmellose sodium; silicon dioxide; magnesium stearate; povidone; polysorbate 20; titanium dioxide; triacetin; microcrystalline cellulose - edurant, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in antiretroviral treatment-naive adult patients with viral load less than or equal to 100,000 copies/ml at baseline. this indication is based on week 48 safety and efficacy analyses from 2 randomised double-blind, controlled phase iii trials in treatment-naive adult patients and on week 96 safety and efficacy analyses from the phase iib trial tmc278-c204 in treatment-naive adult patients (see clinical trials section).

Australia - inglés - APVMA (Australian Pesticides and Veterinary Medicines Authority)

janssen pharmaceutica n.v. - imazalil present as the sulfate - soluble powder - imazalil present as the sulfate imidazole active 1000.0 g/kg - fungicide

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

janssen-cilag pty ltd - haloperidol decanoate, quantity: 70.52 mg/ml (equivalent: haloperidol, qty 50 mg/ml) - injection, solution - excipient ingredients: benzyl alcohol; sesame oil - haldol decanoate is indicated for the maintenance therapy of psychoses in adults; particularly for patients requiring prolonged parenteral neuroleptic therapy

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

janssen-cilag pty ltd - haloperidol decanoate, quantity: 70.52 mg/ml (equivalent: haloperidol, qty 50 mg/ml) - injection, solution - excipient ingredients: sesame oil; benzyl alcohol - haldol decanoate is indicated for the maintenance therapy of psychoses in adults; particularly for patients requiring prolonged parenteral neuroleptic therapy.

Estados Unidos - inglés - NLM (National Library of Medicine)

janssen biotech, inc. - guselkumab (unii: 089658a12d) (guselkumab - unii:089658a12d) - guselkumab 100 mg in 1 ml - tremfya is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. tremfya is indicated for the treatment of adult patients with active psoriatic arthritis. tremfya is contraindicated in patients with a history of serious hypersensitivity reaction to guselkumab or to any of the excipients [see warnings and precautions (5.1)] . pregnancy exposure registry there is a pregnancy registry that monitors pregnancy outcomes in women exposed to tremfya during pregnancy. patients should be encouraged to enroll in the registry by visiting www.mothertobaby.org/ongoing-study/tremfya-guselkumab, by calling 1-877-311-8972, or emailing mothertobaby@health.ucsd.edu. risk summary there are no available data on tremfya use in pregnant women to inform a drug associated risk of adverse developmental outcomes. human igg antibodies are known to cross the placental barrier; therefore, tremfya may be transmitted from the mother to the devel

Estados Unidos - inglés - NLM (National Library of Medicine)

janssen pharmaceuticals, inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 18 mg - concerta is indicated for the treatment of attention deficit hyperactivity disorder (adhd) in children 6 years of age and older, adolescents, and adults up to the age of 65 [see clinical studies (14)] . hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been observed in patients treated with concerta. therefore, concerta is contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product [see adverse reactions (6.5)] . concerta is contraindicated during treatment with monoamine oxidase (mao) inhibitors, and also within a minimum of 14 days following discontinuation of a mao inhibitor (hypertensive crises may result) [see drug interactions (7.1)] . pregnancy category c methylphenidate has been shown to have teratogenic effects in rabbits when given in doses of 200 mg/kg/day, which is approximately 100 times and 40 times the maximum recommended human dose on a mg/kg and mg/m 2 basis

Australia - inglés - APVMA (Australian Pesticides and Veterinary Medicines Authority)

janssen pharmaceutica n.v. - propiconazole - emulsifiable concentrate - propiconazole triazole active 250.0 g/l - fungicide - mushroom bed | mushroom growing tray - control adhesion of mushroom mycelium | allow easy tip out of compost | tray

Nueva Zelanda - inglés - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - methylphenidate hydrochloride 18mg (drug layer 1, drug layer 2 & drug coat) - modified release tablet - 18 mg - active: methylphenidate hydrochloride 18mg (drug layer 1, drug layer 2 & drug coat) excipient: butylated hydroxytoluene carnauba wax cellulose acetate hypromellose ferric oxide, green (push layer) iron oxide yellow opacode black ns-78-17715 opadry clear ys-1-19025-a opadry yellow ys-30-12788a phosphoric acid poloxamer 188 polyethylene oxide povidone sodium chloride stearic acid succinic acid - concerta is indicated for the treatment of attention deficit hyperactivity disorder (adhd). a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. need for comprehensive treatment programme: concerta is indicated as an integral part of a total treatment program for adhd that may include other measures (psychological, educational and social) for patients with this syndrome. stimulants are not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. appropriate educational placement is essential and psychosocial intervention is often helpful. when remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms. long term use: the effectiveness of concerta for long-term use has not been systematically evaluated in controlled trials. therefore the physician who elects to use concerta for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Nueva Zelanda - inglés - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - methylphenidate hydrochloride 27mg - modified release tablet - 27 mg - active: methylphenidate hydrochloride 27mg excipient: butylated hydroxytoluene cellulose acetate hypromellose caranuba wax iron oxide black iron oxide red iron oxide yellow opacode black ns-78-17715 opadry clear ys-1-19025-a opadry grey y-30-17528 phosphoric acid poloxamer polyethylene oxide povidone sodium chloride stearic acid succinic acid - concerta is indicated for the treatment of attention deficit hyperactivity disorder (adhd). a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. need for comprehensive treatment programme: concerta is indicated as an integral part of a total treatment program for adhd that may include other measures (psychological, educational and social) for patients with this syndrome. stimulants are not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. appropriate educational placement is essential and psychosocial intervention is often helpful. when remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms. long term use: the effectiveness of concerta for long-term use has not been systematically evaluated in controlled trials. therefore the physician who elects to use concerta for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Nueva Zelanda - inglés - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - methylphenidate hydrochloride 36mg (drug layer 1, drug layer 2 & drug coat) - modified release tablet - 36 mg - active: methylphenidate hydrochloride 36mg (drug layer 1, drug layer 2 & drug coat) excipient: butylated hydroxytoluene carnauba wax cellulose acetate hypromellose ferric oxide, green (push layer) iron oxide yellow opacode black ns-78-17715 opadry clear ys-1-19025-a opadry white y-30-18037 phosphoric acid poloxamer 188 polyethylene oxide povidone sodium chloride stearic acid succinic acid - concerta is indicated for the treatment of attention deficit hyperactivity disorder (adhd). a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. need for comprehensive treatment programme: concerta is indicated as an integral part of a total treatment program for adhd that may include other measures (psychological, educational and social) for patients with this syndrome. stimulants are not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. appropriate educational placement is essential and psychosocial intervention is often helpful. when remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms. long term use: the effectiveness of concerta for long-term use has not been systematically evaluated in controlled trials. therefore the physician who elects to use concerta for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.