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

takeda pharmaceuticals america, inc. - ecallantide (unii: 5q6tzn2hnm) (ecallantide - unii:5q6tzn2hnm) - ecallantide 10 mg in 1 ml - kalbitor® (ecallantide) is indicated for treatment of acute attacks of hereditary angioedema (hae) in patients 12 years of age and older. do not administer kalbitor to a patient who has known clinical hypersensitivity to kalbitor. [see warnings and precautions (5.1) ]. risk summary the available data from the pharmacovigilance database for kalbitor have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in an animal reproduction study, increased early fetal deaths resulting in decreased live fetuses were observed in rats following treatment during the period of organogenesis at an intravenous dose approximately 1.6 times the maximum recommended human dose (mrhd) in the presence of maternal toxicity. there were no effects on embryofetal survival or structural abnormalities in rats and rabbits following treatment during the period of organogenesis with intravenous doses up to approximately 1.1 and 6 times the mrhd, respectively, or rats treated with subcutaneous doses up to 2.4 times the mrhd. in a pre- and post-natal development study with rats, there were no effects on pup survival and development with subcutaneous doses up to approximately 2.7 times the mrhd. 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 is 2% to 4% and 15% to 20%, respectively. data animal data in an embryofetal development study with rats, ecallantide administered by the intravenous route during the period of organogenesis from gestation days 7 to 17 at a dose approximately 1.6 times the mrhd (on a mg/m2 basis at a maternal intravenous dose of 15 mg/kg/day) caused increased numbers of early resorptions and percentages of resorbed conceptuses per litter resulting in decreased numbers of live fetuses in the presence of mild maternal toxicity. no effects on embryofetal survival or structural abnormalities were observed in rats with intravenous doses up to approximately 1.1 times the mrhd (on a mg/m2 basis with maternal intravenous dose of 10 mg/kg/day). in an embryofetal development study with rats, ecallantide administered by the subcutaneous route during the period of organogenesis from gestation days 7 to 17 at doses up to approximately 2.4 times the mrhd (on an auc basis with maternal subcutaneous doses up to 20 mg/kg/day) had no effects on embryofetal survival or structural abnormalities. in an embryofetal development study with rabbits, ecallantide administered by the intravenous route during the period of organogenesis from gestation days 7 to 19 at doses up to approximately 6 times the mrhd (on an auc basis with maternal intravenous doses up to 5 mg/kg/day in rabbits) had no effects on embryofetal survival or structural abnormalities. in a pre- and post-natal development study with rats, ecallantide administered by the subcutaneous route from gestation day 7 through lactation day 20 at doses up to approximately 2.7 times the mrhd (on a mg/m2 basis with maternal subcutaneous doses up to 25 mg/kg/day) had no effects on pup survival and behavioral or physical development. risk summary there are no data on the presence of ecallantide in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for kalbitor and any potential adverse effects on the breastfed child from kalbitor or from the underlying maternal condition. the safety and effectiveness of kalbitor have been established in patients 12 to 17 years of age. the efficacy of kalbitor in the 12-15 year age group is extrapolated from efficacy in patients 16 years of age and older with support from population pharmacokinetic analyses showing similar drug exposure levels in adults and adolescents [see clinical pharmacology (12.3) and clinical studies (14)] . the safety profile observed in pediatric patients 12-17 years of age was similar to the adverse reactions observed in the overall clinical trial population [see adverse reactions (6.1)] . safety and effectiveness of kalbitor in patients less than 12 years of age have not been established. clinical trials of kalbitor did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 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 other drug therapy.

Israel - English - Ministry of Health

neopharm scientific ltd - ecallantide 10 mg / 1 ml - solution for injection - kalbitor is a plasma kallikrein inhibitor indicated for treatment of acute attacks of hereditary angioedema (hae) in patients 16 years of age and older.

Canada - English - Health Canada

takeda canada inc - lanadelumab - solution - 300mg - lanadelumab 300mg - complement inhibitors

Canada - English - Health Canada

takeda canada inc - lanadelumab - solution - 300mg - lanadelumab 300mg - complement inhibitors

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

astrazeneca pharmaceuticals lp - pramlintide acetate (unii: 726i6te06g) (pramlintide - unii:d3fm8fa78t) - pramlintide 1000 ug in 1 ml - symlin is indicated as an adjunctive treatment in patients with type 1 or type 2 diabetes who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy. symlin is contraindicated in patients with any of the following: risk summary available data from a small number of reports in the manufacturer’s safety database on symlin use in pregnant women are not sufficient to determine a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations). ex-vivo studies using term perfused human, rabbit, and rat placentas indicate that symlin has low potential to cross the maternal/fetal placental barrier. in animal reproduction studies, congenital abnormalities were observed in fetuses of pregnant rats but not in fetuses of pregnant rabbits exposed during organogenesis to pramlintide at 10 times the c

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

cipla australia pty ltd - doxylamine succinate, quantity: 5.1 mg; codeine phosphate hemihydrate, quantity: 10 mg; paracetamol, quantity: 500 mg - tablet, uncoated - excipient ingredients: maize starch; povidone; purified talc; magnesium stearate; pregelatinised maize starch; sodium lauryl sulfate; colloidal anhydrous silica; hyprolose; stearic acid - for the temporary relief of acute moderate pain

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

pharmacor pty ltd - paracetamol, quantity: 500 mg; codeine phosphate hemihydrate, quantity: 10 mg; doxylamine succinate, quantity: 5.1 mg - tablet, uncoated - excipient ingredients: crospovidone; lactose monohydrate; stearic acid; magnesium stearate; maize starch; ethanol; povidone; microcrystalline cellulose - for the temporary relief of acute moderate pain and fever.

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

sandoz pty ltd - codeine phosphate hemihydrate,doxylamine succinate,paracetamol -

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

generic health pty ltd - codeine phosphate hemihydrate,doxylamine succinate,paracetamol -

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

generic health pty ltd - codeine phosphate hemihydrate,doxylamine succinate,paracetamol -