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

rebel distributors corp - paliperidone (unii: 838f01t721) (paliperidone - unii:838f01t721) - paliperidone 6 mg - invega® (paliperidone) extended-release tablets are indicated for the acute and maintenance treatment of schizophrenia [see clinical studies (14)] . monotherapy invega® (paliperidone) extended-release tablets are indicated for the acute treatment of schizoaffective disorder as monotherapy. adjunctive therapy invega® (paliperidone) extended-release tablets are indicated for the acute treatment of schizoaffective disorder as an adjunct to mood stabilizers and/or antidepressants. hypersensitivity reactions, including anaphylactic reactions and angioedema, have been observed in patients treated with risperidone and paliperidone. invega® (paliperidone) is a metabolite of risperidone and is therefore contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in invega® . pregnancy category c . there are no adequate and well controlled studies of invega® in pregnant women. invega® should be used during pregnancy only if the potential benefit jus

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

janssen pharmaceuticals, inc. - paliperidone (unii: 838f01t721) (paliperidone - unii:838f01t721) - paliperidone 3 mg - invega ® (paliperidone) extended-release tablets are indicated for the treatment of schizophrenia [see clinical studies (14.1)] . the efficacy of invega ® in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults. invega ® (paliperidone) extended-release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy [see clinical studies (14.2)] . the efficacy of invega ® in schizoaffective disorder was established in two 6-week trials in adults. invega ® is contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the invega ® formulation. hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. pali

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

janssen pharmaceuticals, inc - paliperidone palmitate (unii: r8p8usm8fr) (paliperidone - unii:838f01t721) - paliperidone palmitate 273 mg in 0.875 ml - invega trinza® (paliperidone palmitate), a 3-month injection, is indicated for the treatment of schizophrenia in patients after they have been adequately treated with invega sustenna® (1-month paliperidone palmitate extended-release injectable suspension) for at least four months [see dosage and administration (2.2) and clinical studies (14)] . invega trinza® is contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the invega trinza® formulation. hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. paliperidone palmitate is converted to paliperidone, which is a metabolite of risperidone. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including invega trinza® , during pregnancy. healthcare providers are encouraged to

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

janssen pharmaceuticals, inc. - paliperidone palmitate (unii: r8p8usm8fr) (paliperidone - unii:838f01t721) - paliperidone palmitate 39 mg in 0.25 ml - invega sustenna® (paliperidone palmitate) is indicated for the treatment of: - schizophrenia in adults [see clinical studies (14.1)]. - schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants [see clinical studies (14.2)]. invega sustenna® is contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the invega sustenna® formulation. hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. paliperidone palmitate is converted to paliperidone, which is a metabolite of risperidone. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including invega sustenna® , during pregnancy. healthcare providers are encouraged to register patients by contacting the national pregnancy registry for

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

janssen pharmaceuticals, inc - paliperidone palmitate (unii: r8p8usm8fr) (paliperidone - unii:838f01t721) - invega hafyera, an every-six-month injection, is indicated for the treatment of schizophrenia in adults after they have been adequately treated with: - a once-a-month paliperidone palmitate extended-release injectable suspension (e.g., invega sustenna) for at least four months, or - an every-three-month paliperidone palmitate extended-release injectable suspension (e.g., invega trinza) for at least one three-month cycle. invega hafyera is contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the invega hafyera formulation. hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. paliperidone palmitate is converted to paliperidone, which is a metabolite of risperidone. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotic

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - paliperidone 12mg (drug layer 1 = 3.6 mg, drug layer 2 = 8.4 mg.) - modified release tablet - 12 mg - active: paliperidone 12mg (drug layer 1 = 3.6 mg, drug layer 2 = 8.4 mg.) excipient: butylated hydroxytoluene carnauba wax cellulose acetate hyetellose hypromellose iron oxide red iron oxide yellow macrogol 3350 macrogol 400 opacode black ns-78-17821 polyethylene oxide povidone sodium chloride stearic acid titanium dioxide - invega prolonged release tablet is indicated for the treatment of schizophrenia, including acute treatment and recurrence prevention.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - paliperidone 3mg (drug layer 1 = 0.9 mg, drug layer 2 = 2.1 mg) - modified release tablet - 3 mg - active: paliperidone 3mg (drug layer 1 = 0.9 mg, drug layer 2 = 2.1 mg) excipient: butylated hydroxytoluene carnauba wax cellulose acetate glycerol hyetellose hypromellose iron oxide red iron oxide yellow lactose macrogol 3350 opacode black ns-78-17821 polyethylene oxide povidone sodium chloride stearic acid titanium dioxide - invega is indicated for the treatment of acute exacerbations of schizoaffective disorder as monotherapy and in combination with antidepressants and/ or mood stabilisers (lithium and valproate).

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - paliperidone 6mg (drug layer 1 = 1.8 mg, drug layer 2 = 4.2 mg.) - modified release tablet - 6 mg - active: paliperidone 6mg (drug layer 1 = 1.8 mg, drug layer 2 = 4.2 mg.) excipient: butylated hydroxytoluene carnauba wax cellulose acetate hyetellose hypromellose iron oxide red iron oxide yellow macrogol 3350 macrogol 400 opacode black ns-78-17821 polyethylene oxide povidone sodium chloride stearic acid titanium dioxide - invega is indicated for the treatment of acute exacerbations of schizoaffective disorder as monotherapy and in combination with antidepressants and/ or mood stabilisers (lithium and valproate).

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - paliperidone 9mg (drug layer 1: 2.7 mg, drug layer 2: 6.3 mg) - modified release tablet - 9 mg - active: paliperidone 9mg (drug layer 1: 2.7 mg, drug layer 2: 6.3 mg) excipient: butylated hydroxytoluene carnauba wax cellulose acetate hyetellose hypromellose iron oxide black iron oxide red macrogol 3350 macrogol 400 opacode black ns-78-17821 polyethylene oxide povidone sodium chloride stearic acid titanium dioxide - invega prolonged release tablet is indicated for the treatment of schizophrenia, including acute treatment and recurrence prevention.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - paliperidone palmitate 156mg equivalent to 100 mg paliperidone base;   - suspension for injection - 100 mg - active: paliperidone palmitate 156mg equivalent to 100 mg paliperidone base   excipient: citric acid monohydrate dibasic sodium phosphate macrogol 4000 monobasic sodium phosphate monohydrate polysorbate 20 sodium hydroxide water for injection - invega sustenna® is indicated for the acute and maintenance treatment of schizophrenia in adults.