European Union - English - EMA (European Medicines Agency)

theravia - cholic acid - digestive system diseases; metabolism, inborn errors - bile acids and derivatives - orphacol is indicated for the treatment of inborn errors in primary bile-acid synthesis due to 3β-hydroxy-Δ5-c27-steroid oxidoreductase deficiency or Δ4-3-oxosteroid-5β-reductase deficiency in infants, children and adolescents aged one month to 18 years and adults.

European Union - English - EMA (European Medicines Agency)

theravia - dexamethasone - multiple myeloma - corticosteroids for systemic use - treatment of multiple myeloma.

European Union - English - EMA (European Medicines Agency)

theravia - hydroxycarbamide - anemia, sickle cell - antineoplastic agents - siklos is indicated for the prevention of recurrent painful vaso-occlusive crises including acute chest syndrome in paediatric and adult patients suffering from symptomatic sickle-cell syndrome.

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

medunik - hydroxyurea (unii: x6q56qn5qc) (hydroxyurea - unii:x6q56qn5qc) - hydroxyurea 100 mg - siklos® is indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in adult and pediatric patients, 2 years of age and older, with sickle cell anemia with recurrent moderate to severe painful crises siklos is contraindicated in: risk summary siklos can cause fetal harm based on findings from animal studies and the drug's mechanism of action [see clinical pharmacology (12.1)] . there are no studies with the use of siklos in pregnant women, and limited available data on siklos use during pregnancy are insufficient to inform drug-associated risks. drugs which affect dna synthesis, such as hydroxyurea, may be potential mutagenic agents. in animal reproduction studies, administration of hydroxyurea to pregnant rats and rabbits during organogenesis produced embryotoxic and teratogenic effects at doses 0.8 times and 0.3 times, respectively, the maximum recommended human daily dose on a mg/m2 basis. in rats and rabbits, fetal malformations were observed with partially ossified cranial bones, absence of eye sockets, hydrocephaly, bipartite sternebrae, and missing lumbar vertebrae. embryotoxicity was characterized by decreased fetal viability, reduced live litter sizes, and developmental delays (see data) . advise pregnant women of the potential risk to a fetus (see clinical considerations). background risk of major birth defects and miscarriage for the indicated population are 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%–4% and 15%–20%, respectively. clinical considerations fetal/neonatal adverse reactions although the data on a limited number of exposed pregnancies indicate no adverse effects on pregnancy or on the health of the fetus/newborn, patients on siklos should be made aware of the potential risks to the fetus. based on the limited amount of available information, in case of an exposure to siklos of pregnant female patients or pregnant partners of male patients, treated by siklos, a careful follow-up with adequate clinical, biological and ultrasonographic examinations should be considered. data human data according to a retrospective analysis of a cohort of 123 adult patients treated with hydroxyurea, twenty-three pregnancies have been reported from 15 women treated with hydroxyurea and partners of 3 men not using barrier contraception treated with hydroxyurea. most (61%) had no adverse developmental outcomes. in the other cases with known evolution, pregnancy had been interrupted either voluntarily or upon medical advice. in retrospective cohorts of 352 children and adolescents with sickle cell disease older than 2 years treated with hydroxyurea for a period of up to 12 years, 3 pregnancies under hydroxyurea were reported with no adverse developmental outcomes. from post-marketing data of siklos, 3 pregnancies have been reported while the father was treated with siklos and 16 pregnancies have been reported in 15 females treated with siklos. among the 13 cases with known evolution, 5 pregnancies had no adverse developmental outcomes, 4 led to premature birth, and 4 were early terminated. animal data hydroxyurea has been demonstrated to be a potent teratogen in a wide variety of animal models, including mice, hamsters, cats, miniature swine, dogs, and monkeys at doses within 1-fold of the human dose given on a mg/m2 basis. hydroxyurea is embryotoxic and causes fetal malformations (partially ossified cranial bones, absence of eye sockets, hydrocephaly, bipartite sternebrae, missing lumbar vertebrae) at 180 mg/kg/day (about 0.8 times the maximum recommended human daily dose on a mg/m2 basis) in rats and at 30 mg/kg/day (about 0.3 times the maximum recommended human daily dose on a mg/m2 basis) in rabbits. embryotoxicity was characterized by decreased fetal viability, reduced live litter sizes, and developmental delays. hydroxyurea crosses the placenta. single doses of ≥375 mg/kg (about 1.7 times the maximum recommended human daily dose on a mg/m2 basis) to rats caused growth retardation and impaired learning ability. risk summary it is not known whether siklos is excreted in human milk, the effects of siklos on the breastfed child, or the effects of siklos on milk production. because of the potential for serious adverse reactions in a breastfed child from siklos, including carcinogenicity, advise patients not to breastfeed during treatment with siklos. pregnancy testing siklos 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 initiating siklos therapy. contraception females advise females of reproductive potential to use effective contraception during and after treatment with siklos for at least 6 months after therapy. advise females to immediately report pregnancy. males siklos may damage spermatozoa and testicular tissue, resulting in possible genetic abnormalities. males with female sexual partners of reproductive potential should use effective contraception during and after treatment with siklos for at least 6 months after therapy [see nonclinical toxicology (13.1)] . infertility males based on findings in animals and humans, male fertility may be compromised by treatment with siklos. azoospermia or oligospermia, sometimes reversible, has been observed in men. before the start of therapy, inform male patients about the possibility of sperm conservation [see adverse reactions (6) and nonclinical toxicology (13.1)] . the safety and effectiveness of siklos have been established in pediatric patients aged 2-18 years with sickle cell anemia with recurrent moderate to severe painful crises. use of siklos in these age groups is supported by evidence from a non-interventional cohort study, the european sickle cell disease prospective cohort study, escort-hu, in which 405 pediatric patients ages 2 to <18 were enrolled. among the 405 pediatric patients treated with siklos, 274 were children (2-11) and 108 were adolescents (12-16) [see clinical studies (14)] . continuous follow-up of the growth of treated children is recommended. pediatric patients aged 2-16 years had a higher risk of neutropenia than patients more than 16 years old. the safety and effectiveness of siklos have not been established in pediatric patients less than 2 years of age. the exposure to siklos is higher in patients with creatinine clearance of less than 60 ml/min. reduce dosage and closely monitor the hematologic parameters when siklos is to be administered to these patients [see dosage and administration (2.2) and clinical pharmacology (12.3)] . monitor hematologic parameters more frequently in patients with hepatic impairment receiving siklos. siklos (see – k – los) (hydroxyurea) tablets read this instructions for use before you start taking siklos and each time you get a refill. there may be new information. this instructions for use does not take the place of talking to your healthcare provider about your medical condition or treatment. you and your healthcare provider should talk about siklos when you start taking it and at regular checkups. important information: - wash your hands with soap and water before and after handling siklos tablets or bottles containing siklos. - wear disposable gloves when handling siklos tablets or bottles containing siklos. - take siklos 1 time a day at the same time each day. - powder spilled from a broken tablet should be wiped up right away with a damp disposable paper towel and thrown away in a closed container, such as a plastic bag to avoid harm to other people. the spill area should then be cleaned using a detergent solution followed by clean water. - when the tablet is broken, avoid touching the broken surfaces. - if contact with crushed tablets happens on the skin, wash the skin area right away and thoroughly with soap and water. - if contact with crushed tablets happens in the eyes, flush the eyes thoroughly with water or isotonic eyewash used for that purpose for at least 15 minutes. siklos is supplied in 2 different strengths: siklos 100 mg tablet has one separation line (score line) and can be broken at this score line to provide smaller doses. each 100 mg tablet can be divided into 2 equal parts (each part is 50 mg). siklos 1,000 mg tablet has three separation lines (score lines) and can be broken at these score lines to provide smaller doses. each 1,000 mg tablet can be divided into 4 equal parts (each part is 250 mg). siklos tablet breaking instructions you will need the following supplies to break a siklos tablet: - siklos tablets - a damp disposable paper towel - a tablet cutter - disposable gloves - 1/2 of a tablet for a dose of 50 mg of siklos:   1/2 of a tablet for a dose of 50 mg of siklos:   - a whole tablet for a dose of 100 mg of siklos (no breaking needed) :   a whole tablet for a dose of 100 mg of siklos (no breaking needed) :   - 1/4 of a tablet for a dose of 250 mg of siklos:   1/4 of a tablet for a dose of 250 mg of siklos:   - 1/2 of a tablet for a dose of 500 mg of siklos:   1/2 of a tablet for a dose of 500 mg of siklos:   - 3/4 of a tablet for a dose of 750 mg of siklos:   3/4 of a tablet for a dose of 750 mg of siklos:   - a whole tablet for a dose of 1,000 mg of siklos (no breaking needed) :   a whole tablet for a dose of 1,000 mg of siklos (no breaking needed) :   for people who cannot swallow siklos tablets you will need the following supplies to prepare and take your dose by dissolving the tablet: - your bottle of siklos tablets note: if you need to break your tablets, use the siklos tablet breaking instructions above to get your prescribed dose before you begin the steps below. - note: if you need to break your tablets, use the siklos tablet breaking instructions above to get your prescribed dose before you begin the steps below. - a teaspoon - water to dissolve tablets storing your siklos tablets: - store siklos at room temperature between 68°f to 77°f (20°c to 25°c). - keep the siklos bottle tightly closed. keep siklos and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. revised 11/2023

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

orthomolecular medisearch laboratories pty ltd trading as biological therapies - thiamine hydrochloride, quantity: 100 mg/ml - injection - excipient ingredients: disodium edetate; benzyl alcohol; water for injections - thiamine hydrochloride injection is used for the prevention and treatment of vitamin b1 deficiency.

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

orthomolecular medisearch laboratories pty ltd trading as biological therapies - folic acid, quantity: 5 mg/ml - injection - excipient ingredients: water for injections; sodium hydroxide; disodium edetate - 1. megaloblastic anaemia where the anaemia has been proven to be due to folate deficiency only. 2. prevention of folic acid deficiency in pregnancy and lactation.

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

orthomolecular medisearch laboratories pty ltd trading as biological therapies - folic acid, quantity: 15 mg/ml - injection, solution - excipient ingredients: water for injections; sodium hydroxide; disodium edetate - 1. megaloblastic anaemia where the anaemia has been proven to be due to folate deficiency only. 2. prevention of folic acid deficiency in pregnancy and lactation.

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

orthomolecular medisearch laboratories pty ltd trading as biological therapies - thiamine hydrochloride, quantity: 5 mg/ml; riboflavine sodium phosphate, quantity: 2.5 mg/ml; nicotinamide, quantity: 50 mg/ml; dexpanthenol, quantity: 10 mg/ml; pyridoxine hydrochloride, quantity: 25 mg/ml - injection, solution - excipient ingredients: disodium edetate; water for injections - b vitamin deficiencies may exist that are unable to be corrected by oral intake and in these cases parenteral administration may be preferable. oral administration of b vitamins may be insufficient in; alcoholism, pernicious anaemia, malabsorption disorders, gastrectomy, gastrointestinal pathologies and debilitated and elderly patients. specific indications include: 1. rapid saturation of the b group vitamins. 2. when oral administration is not feasible or appropriate. 3. for alcoholic, debilitated and elderly patients when their diet is inadequate. 4. patients requiring parenteral b vitamin therapy who cannot tolerate intramuscular injections. 5. recovery from beriberi and wernicke's syndrome as a result of vitamin b1 deficiency. please note that iv b-dose 2ml injection does not contain sufficient thiamine for acute treatment of wernicke's syndrome. 6. pellagra as a result of vitamin b3 deficiency. patients with pellagra may have a concurrent deficiency of b1, b2 and b6. 7. peripheral neuritis caused by vari

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

orthomolecular medisearch laboratories pty ltd trading as biological therapies - thiamine hydrochloride, quantity: 100 mg/ml; riboflavine sodium phosphate, quantity: 2 mg/ml; nicotinamide, quantity: 20 mg/ml; dexpanthenol, quantity: 20 mg/ml; pyridoxine hydrochloride, quantity: 40 mg/ml; cyanocobalamin, quantity: 0.4 mg/ml - injection, solution - excipient ingredients: disodium edetate; benzyl alcohol; water for injections - b vitamin deficiencies may exist that are unable to be corrected by oral intake and in these cases parenteral administration may be preferable. oral administration of b vitamins may be insufficient in; alcoholism, pernicious anaemia, malabsorption disorders, gastrectomy, gastrointestinal pathologies and debilitated and elderly patients. specific indications include: 1. rapid saturation of the b group vitamins. 2. when oral administration is not feasible or appropriate. 3. for alcoholic, debilitated and elderly patients when their diet is inadequate. 4. beriberi and wernicke's syndrome as a result of vitamin b1 deficiency. 5. pellagra as a result of vitamin b3 deficiency. patients with pellagra may have a concurrent deficiency of b1, b2, b6 and b12. 6. peripheral neuritis caused by various b group deficiencies. 7. carpal tunnel syndrome. 8. pernicious anaemia as a result of in situ b12 deficiency. general indications include: 1. angular stomatitis and glossitis have been shown in some instances to respond to t

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

orthomolecular medisearch laboratories pty ltd trading as biological therapies - thiamine hydrochloride, quantity: 10 mg/ml; riboflavine sodium phosphate, quantity: 2.5 mg/ml; pyridoxine hydrochloride, quantity: 5 mg/ml; dexpanthenol, quantity: 2.5 mg/ml; nicotinamide, quantity: 25 mg/ml; cyanocobalamin, quantity: 0.5 mg/ml - injection, solution - excipient ingredients: water for injections - b vitamin deficiencies may exist that are unable to be corrected by oral intake and in these cases parenteral administration may be preferable. oral administration of b vitamins may be insufficient in; alcoholism, pernicious anaemia, malabsorption disorders, gastrectomy, gastrointestinal pathologies and debilitated and elderly patients. commonly, several b vitamin deficiencies may occur similtaneously. specific indications include: 1. rapid saturation of the b group vitamins. 2. when oral administration is not feasible or appropriate. 3. for alcoholic, debilitated and elderly patients when their diet is inadequate. 4. recovery from beriberi and wernicke's syndrome as a result of vitamin b1 deficiency. please note that b-dose 2ml injection does not contain sufficient thiamine for acute treatment of wernicke's syndrome. 5. pellagra as a result of vitamin b3 deficiency. patients with pellagra may have a concurrent deficiency of b1, b2, b6 and b12. 6. peripheral neuritis caused by various b group deficiencies. 7.