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

gland pharma limited - nelarabine (unii: 60158cv180) (nelarabine - unii:60158cv180) - nelarabine is indicated for the treatment of t-cell acute lymphoblastic leukemia (t-all) and t-cell lymphoblastic lymphoma (t-lbl) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. none.  risk summary based on its mechanism of action and findings in animal studies, nelarabine can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . limited available data with nelarabine use in pregnant women are insufficient to determine a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the pregnant woman associated with untreated leukemia or lymphoma (see clinical considerations) . in animal reproduction studies, intravenous administration of nelarabine to pregnant rabbits during the period of organogenesis resulted in teratogenicity at maternal doses below the recommended human adult dose of 1500 mg/m2 /day (see data) . advise pregnant women of the potential risk to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. clinical considerations   disease-associated maternal and/or embryo-fetal risk there are risks to the mother from untreated leukemia or lymphoma, including anemia, thrombocytopenia, and death. data   animal data   in an embryo-fetal development study in which pregnant rabbits were administered daily doses of nelarabine during organogenesis, increased incidences of fetal malformations, anomalies, and variations were observed at doses greater than or equal to 360 mg/m2 /day (8-hour iv infusion; approximately 25% of the recommended human adult dose compared on a mg/m2 basis), which was the lowest dose tested. cleft palate was seen in rabbits given 3,600 mg/m2 /day (approximately 2-fold the adult dose), absent pollices (digits) in rabbits given greater than or equal to 1,200 mg/m2 /day (approximately 75% of the recommended adult dose), while absent gall bladder, absent accessory lung lobes, fused or extra sternebrae, and delayed ossification was seen at all doses. maternal body weight gain and fetal body weights were reduced in rabbits given 3,600 mg/m2 /day (approximately 2-fold the adult dose), but could not account for the increased incidence of malformations seen at this or lower administered doses.   risk summary there are no data on the presence of nelarabine or ara-g in human or animal milk, the effect on the breastfed child, or the effect on milk production. because of the potential for serious adverse reactions in the breastfed child from nelarabine, such as severe neurological reactions, advise women not to breastfeed during treatment with nelarabine. pregnancy testing nelarabine can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . verify the pregnancy status of females of reproductive potential prior to starting treatment with nelarabine. contraception females nelarabine can cause fetal harm when administered to a pregnant woman [see warnings and precautions (5.3), use in specific populations (8.1)]. because of the potential for genotoxicity, advise females of reproductive potential to use effective contraception during treatment with nelarabine. males because of the potential for genotoxicity, advise males (including those who have had vasectomies) with female partners of reproductive potential to use condoms during treatment with nelarabine and for 3 months after the last dose [see nonclinical toxicology (13.1)]. the safety and effectiveness of nelarabine for relapsed or refractory t-all and t-lbl has been established in pediatric patients age 1 year and older. the effectiveness of nelarabine in pediatric patients is supported by one single-arm clinical trial, and safety has been assessed in 165 pediatric patients age 1 year and older across multiple phase i and phase ii trials. the trial establishing efficacy included 84 patients aged 21 years and younger, who had relapsed or refractory t-all or t-lbl. the most frequent adverse reactions of any grade occurring on treatment in this study were hematologic laboratory abnormalities. hematologic toxicity observed in the pediatric population was higher than that seen in the adult population. [see dosage and administration (2.1), adverse reactions (6.1), clinical  studies (14.2)] .  nervous system adverse reactions have been reported for 42% of pediatric patients across the phase i and phase ii trials. the incidence of nervous system adverse reactions was less in the pediatric population than that seen in adult patients with relapsed/refractory tall/t-lbl [see adverse reactions (6.1)] .  in a phase iii study of nelarabine in combination with multi-agent chemotherapy as first-line therapy, there were 411 patients with t-all or t-lbl treated with nelarabine. the safety profile in the 357 patients age 1 to 16 years was consistent with that seen in older patients in the study. [see adverse reactions (6.1)].  due to lack of long-term follow up data, a determination of the impact of nelarabine on the growth and pubertal development of pediatric patients cannot be made. clinical studies of nelarabine did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. in an exploratory analysis, increasing age, especially age 65 years and older, appeared to be associated with increased rates of neurologic adverse reactions. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, [see use in specific populations (8.6)] . ara-g clearance decreased as renal function decreased [see clinical pharmacology (12.3)]. because the risk of adverse reactions to this drug may be greater in patients with moderate (clcr 30 to 50 ml/min) or severe (clcr less than 30 ml/min) renal impairment, these patients should be closely monitored for toxicities when treated with nelarabine [see dosage and administration (2.3)]. the influence of hepatic impairment on the pharmacokinetics of nelarabine has not been evaluated. because the risk of adverse reactions to this drug may be greater in patients with severe hepatic impairment (total bilirubin greater than 3 times upper limit of normal), these patients should be closely monitored for toxicities when treated with nelarabine.

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

abbott vascular division of abbott medical australia pty ltd - 58865 - vascular introducer kit - a collection of sterile devices intended to be used for the percutaneous introduction of a guidewire and/or catheter into the vascular system for procedures that involve vascular access; it is not dedicated to a specific type of procedure. these are single-use devices.

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

abbott vascular division of abbott medical australia pty ltd - 58865 - vascular introducer kit - a collection of sterile devices intended to be used for the percutaneous introduction of a guidewire and/or catheter into the vascular system for procedures that involve vascular access; it is not dedicated to a specific type of procedure. these are single-use devices.

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

recordati rare diseases australia pty ltd - pasireotide embonate, quantity: 82.26 mg (equivalent: pasireotide, qty 60 mg) - injection, modified release - excipient ingredients: polyglactin glucose; polyglactin - signifor lar is indicated for the treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative or who are inadequately controlled on treatment with other somatostatin analogues.

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

recordati rare diseases australia pty ltd - pasireotide embonate, quantity: 54.84 mg (equivalent: pasireotide, qty 40 mg) - injection, modified release - excipient ingredients: polyglactin glucose; polyglactin - signifor lar is indicated for the treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative or who are inadequately controlled on treatment with other somatostatin analogues.

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

recordati rare diseases australia pty ltd - pasireotide embonate, quantity: 27.42 mg (equivalent: pasireotide, qty 20 mg) - injection, modified release - excipient ingredients: polyglactin glucose; polyglactin - signifor lar is indicated for the treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative or who are inadequately controlled on treatment with other somatostatin analogues.

Philippines - English - FDA (Food And Drug Administration)

getz pharma phils., inc. - regular, regular insulin (rdna, human) - regular insulin (im, iv, sc) - 100 iu / ml - anti-diabetic - for the treatment of diabetes mellitus type i; diabetes mellitus type ii either alone or in combination with oral anti-diabetic agents; emergency management of diabetic ketoacidosis; adult patients with diabetes mellitus for the control of hyperglycemia should be used in regimens that include a longer-acting insulin.

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - canakinumab 150 mg/ml - solution for injection - 150 mg/ml - active: canakinumab 150 mg/ml excipient: histidine mannitol polysorbate 80 water for injection - ilaris is indicated for the treatment of cryopyrin-associated periodic syndromes (caps), in adults and children aged 2 years and older including: · familial cold autoinflammatory syndrome (fcas) /familial cold urticaria (fcu) · muckle-wells syndrome (mws) · neonatal-onset multisystem inflammatory disease (nomid) / chronic infantile neurological, cutaneous, articular syndrome (cinca).

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

avallon pharmaceuticals pty ltd - atorvastatin calcium trihydrate, quantity: 86.76 mg (equivalent: atorvastatin, qty 80 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; croscarmellose sodium; microcrystalline cellulose; calcium carbonate; magnesium stearate; polysorbate 80; hyprolose; purified water; sodium chloride; dimeticone 100; benzoic acid; sorbic acid; methylcellulose; polysorbate 65; glyceryl distearate; silicon dioxide; dimeticonol; peg-4 stearate; titanium dioxide; macrogol 8000; hypromellose; purified talc - as an adjunct to diet for the treatment of patients with hypercholesterolaemia. prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy and alcoholism) should be identified and treated.,indicated in hypertensive patients with multiple risk factors for coronary heart disease (chd), which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic chd (see clinical trials, prevention of cardiovascular disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

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

avallon pharmaceuticals pty ltd - atorvastatin calcium trihydrate, quantity: 43.38 mg (equivalent: atorvastatin, qty 40 mg) - tablet, film coated - excipient ingredients: polysorbate 80; lactose monohydrate; hyprolose; croscarmellose sodium; euphorbia antisyphilitica; magnesium stearate; calcium carbonate; microcrystalline cellulose; purified water; sodium chloride; dimeticone 100; benzoic acid; sorbic acid; methylcellulose; polysorbate 65; glyceryl distearate; silicon dioxide; dimeticonol; peg-4 stearate; titanium dioxide; macrogol 8000; hypromellose; purified talc - as an adjunct to diet for the treatment of patients with hypercholesterolaemia. prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy and alcoholism) should be identified and treated.,indicated in hypertensive patients with multiple risk factors for coronary heart disease (chd), which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic chd (see clinical trials, prevention of cardiovascular disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.