New Zealand - English - 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.

New Zealand - English - 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.

New Zealand - English - 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - methylphenidate hydrochloride 54mg (drug layer 1, drug layer 2 & drug coat);   - modified release tablet - 54 mg - active: methylphenidate hydrochloride 54mg (drug layer 1, drug layer 2 & drug coat)   excipient: butylated hydroxytoluene carnauba wax cellulose acetate hypromellose ferric oxide, green (push layer) iron oxide red opacode black ns-78-17715 opadry clear ys-1-19025-a opadry red y-30-15567-a 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - rilpivirine hydrochloride 27.5mg equivalent to rilpivirine 25 mg;   - film coated tablet - 25 mg - active: rilpivirine hydrochloride 27.5mg equivalent to rilpivirine 25 mg   excipient: croscarmellose sodium hypromellose lactose monohydrate   macrogol 3000 magnesium stearate microcrystalline cellulose polysorbate 20 povidone titanium dioxide triacetin - 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-na?ve patients with viral load nmt 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 na?ve adult patients and on week 96 safety and efficacy analyses from the phase iib trial tmc278-c204 in treatment na?ve adult patients.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - haloperidol decanoate 50 mg/ml - injection (depot) - 50 mg/ml - active: haloperidol decanoate 50 mg/ml excipient: benzyl alcohol sesame oil - the maintenance therapy of psychoses, particularly for patients requiring prolonged parenteral neuroleptic therapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - haloperidol decanoate 100 mg/ml - injection (depot) - 100 mg/ml - active: haloperidol decanoate 100 mg/ml - the maintenance therapy of psychoses, particularly for patients requiring prolonged parenteral neuroleptic therapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - telaprevir 375mg;   - film coated tablet - 375 mg - active: telaprevir 375mg   excipient: calcium hydrogen phosphate colloidal silicon dioxide croscarmellose sodium hypromellose acetate succinate iron oxide yellow macrogol 3350 microcrystalline cellulose polyvinyl alcohol purified talc sodium laurilsulfate sodium stearyl fumarate titanium dioxide - incivo, in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype 1 chronic hepatitis c in adult patients with compensated liver disease (including cirrhosis): - who are treatment naive - who have previously been treated with interferon alfa (pegylated or nonpegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - etravirine 100mg - tablet - 100 mg - active: etravirine 100mg excipient: colloidal silicon dioxide croscarmellose sodium hypromellose as a spray dried powder lactose magnesium stearate microcrystalline cellulose - etravirine, in combination with other antiretroviral agents is indicated for the treatment of hiv-1 infection in antiretroviral treatment-experienced adults who have evidence of viral replication and resistance to non-nucleoside transcriptase inhibitors and other antiretroviral agents.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - etravirine 200mg - tablet - 200 mg - active: etravirine 200mg excipient: colloidal silicon dioxide croscarmellose sodium hypromellose as a spray dried powder silicified microcrystalline cellulose magnesium stearate microcrystalline cellulose - etravirine, in combination with other antiretroviral agents is indicated for the treatment of hiv-1 infection in antiretroviral treatment-experienced adults who have evidence of viral replication and resistance to non-nucleoside transcriptase inhibitors and other antiretroviral agents.