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

symbion pharmacy services pty ltd - zinc oxide -

European Union - English - EMA (European Medicines Agency)

sun pharmaceutical industries (europe) b.v. - bortezomib - multiple myeloma - antineoplastic agents - bortezomib sun as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.bortezomib sun in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.bortezomib sun in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.bortezomib sun in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.

European Union - English - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - capecitabine - stomach neoplasms; breast neoplasms; colonic neoplasms; colorectal neoplasms - capecitabine - capecitabine is indicated for the adjuvant treatment of patients following surgery of stage-iii (dukes’ stage-c) colon cancer.capecitabine is indicated for the treatment of metastatic colorectal cancer.capecitabine is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.capecitabine in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. previous therapy should have included an anthracycline. capecitabine is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.

European Union - English - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - levetiracetam - epilepsy - other antiepileptics - levetiracetam sun is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.levetiracetam sun is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults and children from four years of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.levetiracetam sun concentrate is an alternative for patients when oral administration is temporarily not feasible.

European Union - English - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - temozolomide - glioma; glioblastoma - antineoplastic agents - temozolomide sun is indicated for the treatment of:adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (rt) and subsequently as monotherapy treatment;children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

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

sun pharma anz pty ltd - rabeprazole sodium, quantity: 20 mg - tablet, enteric coated - excipient ingredients: heavy magnesium oxide; diacetylated monoglycerides; mannitol; iron oxide yellow; hypromellose phthalate; titanium dioxide; light magnesium oxide; purified talc; magnesium stearate; ethylcellulose; hyprolose; propylene glycol; butan-1-ol; allura red ac aluminium lake; industrial methylated spirit; ethanol; shellac; strong ammonia solution; sulfuric acid - treatment and prevention of relapse of gastro-oesophageal reflux disease. symptomatic treatment of gastro-oesophageal reflux disease. treatment of duodenal ulcers. treatment of gastric ulcers.,patients whose gastric and duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (nsaids) usually require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence.,also indicated, in combination with clarithromycin and amoxycillin, for: - eradication of helicobacter pylori in patients with peptic ulcer disease or chronic gastritis - healing of peptic ulcers in patients with helicobacter pylori associated ulcers.

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

sun pharma anz pty ltd - zoledronic acid monohydrate, quantity: 5.33 mg (equivalent: zoledronic acid, qty 5 mg) - injection, solution - excipient ingredients: sodium citrate dihydrate; mannitol; water for injections - treatment of paget?s disease of bone.

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

sun pharmaceutical industries, inc. - isotretinoin (unii: eh28up18if) (isotretinoin - unii:eh28up18if) - isotretinoin 10 mg - absorica and absorica ld are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. because of significant adverse reactions associated with its use, absorica and absorica ld are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. limitations of use : if a second course of absorica/absorica ld therapy is needed, it is not recommended before a two-month waiting period because the patient’s acne may continue to improve following a 15 to 20-week course of therapy [see dosage and administration (2.2)]. absorica/absorica ld is contraindicated in pregnancy [see warnings and precautions (5.1) and use in specific populations (8.1)]. absorica/absorica ld is contraindicated in patients with hypersensitivity to isotretinoin (or vitamin a, given the chemical similarity to isotretinoin) or to any of its components (anaphy

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

sun pharmaceutical industries, inc. - fluoxetine hydrochloride (unii: i9w7n6b1kj) (fluoxetine - unii:01k63sup8d) - fluoxetine 40 mg - fluoxetine capsules, usp are indicated for the treatment of: fluoxetine capsules, usp monotherapy is not indicated for the treatment of depressive episodes associated with bipolar i disorder. when using fluoxetine capsules, usp and olanzapine in combination, also refer to the clinical studies section of the package insert for olanzapine and fluoxetine hydrochloride capsules. when using fluoxetine and olanzapine in combination, also refer to the contraindications section of the package insert for olanzapine and fluoxetine hydrochloride capsules. the use of maois intended to treat psychiatric disorders with fluoxetine or within 5 weeks of stopping treatment with fluoxetine is contraindicated because of an increased risk of serotonin syndrome. the use of fluoxetine within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.9) and warnings and precautions (5.2)] . starting fluoxetine in a patient who is being treated with maois such as line

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

sun pharmaceutical industries, inc. - dextroamphetamine saccharate (unii: g83415v073) (dextroamphetamine - unii:tz47u051fi), amphetamine aspartate (unii: h527kap6l5) (amphetamine - unii:ck833kgx7e), dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi), amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e) - dextroamphetamine saccharate 1.25 mg - dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets are indicated for the treatment of attention deficit hyperactivity disorder (adhd) and narcolepsy. 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. the symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. the symptoms must not be better accounted for by another mental disorder. for the inattentive type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. for the hyperactive-impulsive type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/ squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can’t wait turn; intrusive. the combined type requires both inattentive and hyperactive-impulsive criteria to be met. in patients known to be hypersensitive to amphetamine, or other components of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see adverse reactions ]. patients taking monoamine oxidase inhibitors (maois), or within 14 days of stopping maois (including maois such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [see warnings and drug interactions ]. dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets contain amphetamine, a schedule ii controlled substance. dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction [see warnings and precautions]. dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets can be diverted for non-medical use into illicit channels or distribution. abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. misuse and abuse of amphetamines may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with cns stimulants abuse and/or misuse. misuse and abuse of cns stimulants, including dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets, can result in overdose and death [see overdosage], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. physical dependence dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets may produce physical dependence. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of cns stimulants including dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. tolerance dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets may produce tolerance. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).