Malta - English - Medicines Authority

laboratorio aldo-union s.l. baronesa de malda 73, 08950 esplugues de llobregat, barcelona, spain - budesonide - pressurised inhalation, suspension - budesonide 4 mg/ml - drugs for obstructive airway diseases

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

phebra pty ltd - ibuprofen, quantity: 100 mg/ml - injection, concentrated - excipient ingredients: hydrochloric acid; water for injections; arginine - caldolor injection is indicated in adults for the management of acute mild to moderate post-operative pain and moderate to severe post-operative pain with adjunctive reduced morphine dosage, where an intravenous route of administration is considered clinically necessary.,caldolor is indicated for the reduction of fever in adults where an intravenous route of administration is considered clinically necessary.

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

phebra pty ltd - ibuprofen, quantity: 100 mg/ml - injection, concentrated - excipient ingredients: arginine; water for injections; hydrochloric acid - caldolor injection is indicated in adults for the management of acute mild to moderate post-operative pain and moderate to severe post-operative pain with adjunctive reduced morphine dosage, where an intravenous route of administration is considered clinically necessary.,caldolor is indicated for the reduction of fever in adults where an intravenous route of administration is considered clinically necessary.

Australia - English - 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

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

cumberland pharmaceuticals inc. - ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - ibuprofen 400 mg in 4 ml - caldolor is indicated in adults and pediatric patients aged 3 months and older for the: - management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics - reduction of fever caldolor is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to ibuprofen or any components of the drug product [see warnings and precautions ( 5.7, 5.9 ) ] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7, 5.8) ] - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1) ] risk summary use of nsaids, including caldolor, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. because of

Israel - English - Ministry of Health

j-c health care ltd - haloperidol - tablets - haloperidol 5 mg - haloperidol - haloperidol - haldol is indicatedin adult patients aged 18 years and above for:• treatment of schizophrenia and schizoaffective disorder.• acute treatment of delirium when non-pharmacological treatments have failed.• treatment of moderate to severe manic episodes associated with bipolar i disorder when other treatments cannot be used.• treatment of acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar i disorder.• treatment of persistent aggression and psychotic symptoms in patients with moderate to severe alzheimer’s dementia and vascular dementia when non-pharmacological treatments have failed and when there is a risk of harm to self or others.• treatment of tic disorders, including tourette’s syndrome, in patients with severe impairment after educational, psychological and other pharmacological treatments have failed.• treatment of mild to moderate chorea in huntington’s disease, when other medicinal products are ineffective or not tolerated.in paediatric patients for:• schizophrenia in adolescents aged 13 to 17 years when other pharmacological treatments have failed or are not tolerated.• persistent, severe aggression in children and adolescents aged 6 to 17 years with autism or pervasive developmental disorders, when other treatments have failed or are not tolerated. • tic disorders, including tourette’s syndrome, in children and adolescents aged 10 to 17 years with severe impairment after educational, psychological and other pharmacological treatments have failed.

Israel - English - Ministry of Health

j-c health care ltd - haloperidol - solution (oral) - haloperidol 2 mg/ml - haloperidol - haloperidol - haldol is indicatedin adult patients aged 18 years and above for:• treatment of schizophrenia and schizoaffective disorder.• acute treatment of delirium when non-pharmacological treatments have failed.• treatment of moderate to severe manic episodes associated with bipolar i disorder when other treatments cannot be used.• treatment of acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar i disorder.• treatment of persistent aggression and psychotic symptoms in patients with moderate to severe alzheimer’s dementia and vascular dementia when non-pharmacological treatments have failed and when there is a risk of harm to self or others.• treatment of tic disorders, including tourette’s syndrome, in patients with severe impairment after educational, psychological and other pharmacological treatments have failed.• treatment of mild to moderate chorea in huntington’s disease, when other medicinal products are ineffective or not tolerated.in paediatric patients for:• schizophrenia in adolescents aged 13 to 17 years when other pharmacological treatments have failed or are not tolerated.• persistent, severe aggression in children and adolescents aged 6 to 17 years with autism or pervasive developmental disorders, when other treatments have failed or are not tolerated. • tic disorders, including tourette’s syndrome, in children and adolescents aged 10 to 17 years with severe impairment after educational, psychological and other pharmacological treatments have failed.

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

janssen pharmaceuticals, inc. - haloperidol lactate (unii: 6387s86pk3) (haloperidol - unii:j6292f8l3d) - haloperidol 5 mg in 1 ml - haldol (haloperidol) is indicated for the treatment of patients with schizophrenia. haldol (haloperidol) is contraindicated in patients with: - severe toxic central nervous system depression or comatose states from any cause. - hypersensitivity to this drug – hypersensitivity reactions have included anaphylactic reaction and angioedema (see warnings, hypersensitivity reactions and adverse reactions). - parkinson's disease (see warnings, neurological adverse reactions in patients with parkinson's disease or dementia with lewy bodies). - dementia with lewy bodies (see warnings, neurological adverse reactions in patients with parkinson's disease or dementia with lewy bodies).

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

janssen pharmaceuticals, inc. - haloperidol decanoate (unii: ac20pj4101) (haloperidol - unii:j6292f8l3d) - haloperidol 50 mg in 1 ml - haldol decanoate 50 and haldol decanoate 100 are indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy. since the pharmacologic and clinical actions of haldol decanoate 50 and haldol decanoate 100 are attributed to haldol (haloperidol) as the active medication, contraindications, warnings, and additional information are those of haldol, modified only to reflect the prolonged action. haldol is contraindicated in patients with: - severe toxic central nervous system depression or comatose states from any cause. - hypersensitivity to this drug – hypersensitivity reactions have included anaphylactic reaction and angioedema (see warnings, hypersensitivity reactions and adverse reactions). - parkinson's disease (see warnings, neurological adverse reactions in patients with parkinson's disease or dementia with lewy bodies). - dementia with lewy bodies (see warnings, neurological adverse reactions in patients with parkinson's disease or dementia with lewy bodies).

Australia - English - 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.