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

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

janssen-cilag pty ltd - paliperidone palmitate, quantity: 156 mg (equivalent: paliperidone, qty 100 mg) - injection - excipient ingredients: dibasic sodium phosphate; water for injections; macrogol 4000; monobasic sodium phosphate monohydrate; polysorbate 20; citric acid monohydrate; sodium hydroxide - invega sustenna is indicated for the acute and maintenance treatment of schizophrenia in adults.

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

janssen-cilag pty ltd - paliperidone palmitate, quantity: 117 mg (equivalent: paliperidone, qty 75 mg) - injection - excipient ingredients: sodium hydroxide; polysorbate 20; macrogol 4000; water for injections; dibasic sodium phosphate; monobasic sodium phosphate monohydrate; citric acid monohydrate - invega sustenna is indicated for the acute and maintenance treatment of schizophrenia in adults.

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

janssen-cilag pty ltd - paliperidone palmitate, quantity: 39 mg (equivalent: paliperidone, qty 25 mg) - injection - excipient ingredients: dibasic sodium phosphate; sodium hydroxide; monobasic sodium phosphate monohydrate; citric acid monohydrate; polysorbate 20; water for injections; macrogol 4000 - invega sustenna is indicated for the acute and maintenance treatment of schizophrenia in adults.

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

janssen-cilag pty ltd - paliperidone palmitate, quantity: 234 mg (equivalent: paliperidone, qty 150 mg) - injection - excipient ingredients: monobasic sodium phosphate monohydrate; citric acid monohydrate; water for injections; polysorbate 20; macrogol 4000; dibasic sodium phosphate; sodium hydroxide - invega sustenna is indicated for the acute and maintenance treatment of schizophrenia in adults.

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

janssen-cilag pty ltd - paliperidone palmitate, quantity: 78 mg (equivalent: paliperidone, qty 50 mg) - injection - excipient ingredients: macrogol 4000; polysorbate 20; water for injections; citric acid monohydrate; dibasic sodium phosphate; sodium hydroxide; monobasic sodium phosphate monohydrate - invega sustenna is indicated for the acute and maintenance treatment of schizophrenia in adults.

European Union - English - EMA (European Medicines Agency)

janssen-cilag international nv - paliperidone palmitate - schizophrenia - psycholeptics - trevicta, a 3 monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1 monthly paliperidone palmitate injectable product.

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

janssen-cilag pty ltd - paliperidone palmitate, quantity: 1560 mg - injection, suspension - excipient ingredients: polysorbate 20; macrogol 4000; citric acid monohydrate; monobasic sodium phosphate monohydrate; sodium hydroxide; water for injections - invega hafyera, a 6-month injection, is indicated for the maintenance treatment of schizophrenia in adult patients who have been adequately treated with the 1-month paliperidone palmitate injectable product for at least four months or the 3-month paliperidone palmitate injectable product following at least one 3-month injection cycle.

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

janssen-cilag pty ltd - paliperidone palmitate, quantity: 1092 mg - injection, suspension - excipient ingredients: polysorbate 20; macrogol 4000; citric acid monohydrate; monobasic sodium phosphate monohydrate; sodium hydroxide; water for injections - invega hafyera, a 6-month injection, is indicated for the maintenance treatment of schizophrenia in adult patients who have been adequately treated with the 1-month paliperidone palmitate injectable product for at least four months or the 3-month paliperidone palmitate injectable product following at least one 3-month injection cycle.

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

teva pharma belgium sa-nv - paliperidone palmitate 156 mg/ml - eq. paliperidone 100 mg/ml - prolonged-release suspension for injection - 50 mg - paliperidone palmitate 156 mg/ml - paliperidone