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

abbvie pty ltd - adalimumab, quantity: 50 mg/ml - injection, solution - excipient ingredients: sodium chloride; monobasic sodium phosphate dihydrate; citric acid monohydrate; dibasic sodium phosphate dihydrate; polysorbate 80; water for injections; sodium citrate dihydrate; mannitol - rheumatoid arthritis: humira is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. humira can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis: - polyarticular juvenile idiopathic arthritis: humira in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. - enthesitis-related arthritis: humira is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis: humira is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis: humira is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn's disease in adults and children (6 years and older): humira is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; - who have had an inadequate response to conventional therapies or, - who have lost response to or are intolerant of infliximab.,ulcerative colitis: humira is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time. (see clinical trials).,psoriasis in adults and children: humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. humira is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,,hidradenitis suppurativa in adults and adolescents (from 12 years of age): humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,,uveitis: humira is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

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

abbvie pty ltd - adalimumab, quantity: 50 mg/ml - injection, solution - excipient ingredients: sodium citrate dihydrate; monobasic sodium phosphate dihydrate; dibasic sodium phosphate dihydrate; citric acid monohydrate; water for injections; polysorbate 80; mannitol; sodium chloride - rheumatoid arthritis: humira is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. humira can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis: - polyarticular juvenile idiopathic arthritis: humira in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. - enthesitis-related arthritis: humira is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis: humira is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis: humira is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn's disease in adults and children (6 years and older): humira is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; - who have had an inadequate response to conventional therapies or, - who have lost response to or are intolerant of infliximab.,ulcerative colitis: humira is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time. (see clinical trials).,psoriasis in adults and children: humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. humira is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,,hidradenitis suppurativa in adults and adolescents (from 12 years of age): humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,,uveitis: humira is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

nova laboratories, ltd - mercaptopurine (unii: e7wed276i5) (mercaptopurine anhydrous - unii:pkk6muz20g) - mercaptopurine 20 mg in 1 ml - purixan is indicated for the treatment of patients with acute lymphoblastic leukemia (all) as part of a combination chemotherapy maintenance regimen. read these instructions for use before you start taking purixan, and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. important information about measuring purixan oral suspension • always use the oral dispensing syringe provided with your purixan oral suspension to make sure you measure the right amount. • you will be provided: - 1 bottle of purixan oral suspension - 1 bottle adapter - 2 oral dispensing syringes (one 1 ml and one 5 ml) if you did not receive an oral dispensing syringe with your purixan oral suspension, ask your pharmacist to give you one. you will need disposable gloves. - do not forcefully push on the plunger. - do not squirt the medicine to the back of your mouth or throat. this may cause you to ch

Irlanda - engleză - HPRA (Health Products Regulatory Authority)

imed healthcare ltd. - mercaptopurine monohydrate - tablet - 50 milligram(s) - mercaptopurine

Irlanda - engleză - HPRA (Health Products Regulatory Authority)

pco manufacturing ltd. - mercaptopurine monohydrate - tablet - 50 milligram(s) - mercaptopurine

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

stason pharmaceuticals, inc. - mercaptopurine (unii: e7wed276i5) (mercaptopurine anhydrous - unii:pkk6muz20g) - purinethol is indicated for treatment of adult and pediatric patients with acute lymphoblastic leukemia (all) as part of a combination chemotherapy maintenance regimen. none. purinethol can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . pregnant women who receive mercaptopurine have an increased incidence of miscarriage and stillbirth (see data) . advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated population(s) 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 is 2% to 4% and 15% to 20%, respectively. women receiving mercaptopurine in the first trimester of pregnancy have an increased incidence of miscarriage; the risk of malformation in offspring surviving first trimester exposure is not known. in a series of 28 women receiving mercaptopurine after the first trimester of pregnancy, 3 mothers died prior to delivery, 1 delivered a stillborn child, and 1 aborted; there were no cases of macroscopically abnormal fetuses. mercaptopurine was embryo-lethal and teratogenic in several animal species (rat, mouse, rabbit, and hamster) at doses less than the recommended human dose. there are no data on the presence of mercaptopurine or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with purinethol and for 1 week after the last dose. purinethol can cause fetal harm when administered to pregnant women [see use in specific populations (8.1)] . verify the pregnancy status in females of reproductive potential prior to initiating purinethol  [see use in specific populations (8.1)] . advise females of reproductive potential to use effective contraception during treatment with purinethol and for 6 months after the last dose. based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with purinethol and for 3 months after the last dose [see nonclinical toxicology (13.1)] . based on findings from animal studies, purinethol can impair female and male fertility [see nonclinical toxicology (13.1)] . the long-term effects of mercaptopurine on female and male fertility, including the reversibility have not been studied. safety and effectiveness of purinethol has been established in pediatric patients. use of purinethol in pediatrics is supported by evidence from the published literature and clinical experience. symptomatic hypoglycemia has been reported in pediatric patients with all receiving mercaptopurine. reported cases were in pediatrics less than 6 years of age or with a low body mass index. clinical studies of mercaptopurine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or another drug therapy. use the lowest recommended starting dosage for purinethol or increase the dosing interval to every 36-48 hours in patients with renal impairment (clcr less than 50 ml/min). adjust the dose to maintain absolute neutrophil count (anc) at a desirable level and for adverse reactions [see dosage and administration (2.3)] . use the lowest recommended starting dosage for purinethol in patients with hepatic impairment. adjust the dose to maintain absolute neutrophil count (anc) at a desirable level and for adverse reactions [see dosage and administration (2.3)] .

Irlanda - engleză - HPRA (Health Products Regulatory Authority)

fontus health limited - mercaptopurine - tablet - 50 milligram(s) - purine analogues; mercaptopurine

Noua Zeelandă - engleză - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - mercaptopurine monohydrate 50mg; mercaptopurine monohydrate 50mg - tablet - 50 mg - active: mercaptopurine monohydrate 50mg excipient: lactose monohydrate magnesium stearate maize starch stearic acid active: mercaptopurine monohydrate 50mg excipient: lactose monohydrate magnesium stearate maize starch stearic acid - puri-nethol is indicated for the treatment of acute leukaemia. it may be utilised in remission induction and is particularly indicated for maintenance therapy in: · acute lymphoblastic leukaemia; · acute myelogenous leukaemia.

Irlanda - engleză - HPRA (Health Products Regulatory Authority)

aspen pharma trading limited - mercaptopurine monohydrate - tablet - 50 milligram(s) - purine analogues; mercaptopurine

Irlanda - engleză - HPRA (Health Products Regulatory Authority)

ltt pharma limited - mercaptopurine - tablet - 50 milligram(s) - purine analogues; mercaptopurine