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

rockwell medical, inc - ferric pyrophosphate citrate (unii: uby79oco9g) (ferric cation - unii:91o4lml611) - triferic is an iron replacement product indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (hdd-ckd). triferic is not intended for use in patients receiving peritoneal dialysis. triferic has not been studied in patients receiving home hemodialysis. none risk summary there are no data on triferic use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. in pregnant rats and rabbits, ferric pyrophosphate citrate caused adverse developmental outcomes at maternally toxic dose levels that were higher than the maximum theoretical amount of iron transferred to patients from triferic. use triferic during pregnancy only if the potential benefit justifies 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 of birth defect, loss, or other adverse outcomes. in the us. general populati

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

bayer australia ltd - interferon beta-1b, quantity: 0.25 mg/ml - injection, powder for - excipient ingredients: albumin; mannitol - betaferon is indicated for the treatment of: - ambulatory patients with relapsing-remitting multiple sclerosis (ms) characterised by at least two attacks of neurologic dysfunction over a two year period followed by complete or incomplete recovery. - betaferon is also indicated for the reduction of frequency and severity of clinical relapses, and for the slowing of progression of disease in patients with secondary progressive multiple sclerosis. - the treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent magnetic resonance imaging (mri) lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded.

European Union - English - EMA (European Medicines Agency)

bayer ag  - interferon beta-1b - multiple sclerosis - immunostimulants, - betaferon is indicated for the treatment ofpatients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis;patients with relapsing-remitting multiple sclerosis and two or more relapses within the last two years;patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.

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

rockwell medical, inc - ferric pyrophosphate citrate (unii: uby79oco9g) (ferric cation - unii:91o4lml611) - ferric cation 5.44 mg in 1 ml - triferic is an iron replacement product indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (hdd-ckd). triferic is not intended for use in patients receiving peritoneal dialysis. triferic has not been studied in patients receiving home hemodialysis. none risk summary there are no data with triferic use in pregnant women to inform a drug-associated risk. no teratogenicity was observed in animal reproduction studies with administration of ferric pyrophosphate citrate to pregnant rats and rabbits during organogenesis at doses 96 and 128 times, respectively, the maximum recommended human dose (mrhd) of 27.2 mg per dialysis [see data]. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%–4% and 15%–20%, respectively. data animal data in a fertility and early embryonic development study in female rats, the maternally toxic ferric py

Singapore - English - HSA (Health Sciences Authority)

intervent pte ltd - obstetrics & gynaecology - the ovusense advanced fertility monitor is intended for measuring and recording body temperature on a nightly basis during the non-menstruating phases of the monthly female reproductive cycle. ovusense detects the presence and absence of ovulation, as well as predicting the fertile period for the next monthly cycle.

European Union - English - EMA (European Medicines Agency)

merck sharp dohme ltd  - peginterferon alfa-2b - hepatitis c, chronic - immunostimulants, - adults (tritherapy)viraferonpeg in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-c (chc) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy.please refer to the ribavirin and boceprevir summaries of product characteristics (smpcs) when viraferonpeg is to be used in combination with these medicines.adults (bitherapy and monotherapy)viraferonpeg is indicated for the treatment of adult patients (18 years of age and older) with chc who are positive for hepatitis-c-virus rna (hcv-rna), including patients with compensated cirrhosis and / or co-infected with clinically stable hiv.viraferonpeg in combination with ribavirin (bitherapy) is indicated for the treatment of chc infection in adult patients who are previously untreated including patients with clinically stable hiv co-infection and in adult patients who have failed previous treatment with interferon alpha (pegylated or non-pegylated) and ribavirin combination therapy or interferon alpha monotherapy.interferon monotherapy, including viraferonpeg, is indicated mainly in case of intolerance or contraindication to ribavirin.please refer to the ribavirin smpc when viraferonpeg is to be used in combination with ribavirin.paediatric population (bitherapy)viraferonpeg is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents, who have chronic hepatitis c, previously untreated, without liver decompensation, and who are positive for hcv-rna.when deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible in some patients. the decision to treat should be made on a case-by-case basis.please refer to the ribavirin smpc for capsules or oral solution when viraferonpeg is to be used in combination with ribavirin.

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

linear medical pty ltd - 37165 - transfer aid, person, turning sheet - a manual device used by healthcare professionals to assist in the physical movement and transfer of a person/patient (e.g., a hospitalized, a person with a disability, or a geriatric) from one position to another. the device typically has no lifting capabilities and utilizes sliding/rolling techniques to move the person. it is typically designed to turn the person from one side to another whilst he/she is lying in bed; a practice done in order to prevent bedsores and improve blood circulation.

New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - interferon beta-1b 0.25mg (20% excess in quantity filled) - injection with diluent - 8 miu - active: interferon beta-1b 0.25mg (20% excess in quantity filled) excipient: albumin hydrochloric acid mannitol sodium hydroxide hydrochloric acid sodium chloride water for injection - betaferon is indicated for: · the treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent magnetic resonance imaging (mri) lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded, · the treatment of ambulatory patients, with relapsing-remitting multiple sclerosis characterised by at least two attacks of neurological dysfunction over a two year period followed by complete or incomplete recovery. · the reduction of frequency and severity of clinical relapses and for slowing the progression of disease in patients with secondary progressive multiple sclerosis

Israel - English - Ministry of Health

sanofi israel ltd - iron as iron iii sodium ferric glugonate compl. - solution for injection/ concentrate for solution for infusion - iron as iron iii sodium ferric glugonate compl. 62.5 mg / 5 ml - various combinations - various combinations - ferrlecit is indicated in adults and children 6 years and above.severe iron deficiency states only when oral administration has been found impossible; in cases of gastrointestinal malabsorption which rules out oral iron therapy; patients treated by dialysis getting erythropoietin.

European Union - English - EMA (European Medicines Agency)

schering-plough europe - interferon alfa-2b - hepatitis c, chronic; hepatitis b, chronic - immunostimulants, - chronic hepatitis b: treatment of adult patients with chronic hepatitis b associated with evidence of hepatitis b viral replication (presence of hbv-dna and hbeag), elevated alanine aminotransferase (alt) and histologically proven active liver inflammation and/or fibrosis.chronic hepatitis c:adult patients:introna is indicated for the treatment of adult patients with chronic hepatitis c who have elevated transaminases without liver decompensation and who are positive for serum hcv-rna or anti-hcv (see section 4.4).the best way to use introna in this indication is in combination with ribavirin.chidren and adolescents:introna is intended for use, in a combination regimen with ribavirin, for the treatment of children and adolescents 3 years of age and older, who have chronic hepatitis c, not previously treated, without liver decompensation, and who are positive for serum hcv-rna. the decision to treat should be made on a case by case basis, taking into account any evidence of disease progression such as hepatic inflammation and fibrosis, as well as prognostic factors for response, hcv genotype and viral load. the expected benefit of treatment should be weighed against the safety findings observed for paediatric subjects in the clinical trials (see sections 4.4, 4.8 and 5.1).