Stati Uniti - Ingliż - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - velaglucerase alfa (unii: 23hye36b0i) (velaglucerase alfa - unii:23hye36b0i) - velaglucerase alfa 2.5 mg in 1 ml - vpriv is indicated for long-term enzyme replacement therapy (ert) for patients with type 1 gaucher disease. none. risk summary available data on use of velaglucerase alfa in pregnant women includes more than 300 pregnancies reported from the pharmacovigilance database and published observational cohort studies, including the international gaucher disease registry. while available data cannot definitively establish or exclude the absence of a velaglucerase alfa associated risk during pregnancy, these data have not identified an association with use of velaglucerase alfa during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies no fetal harm was observed in rats or rabbits when velaglucerase alfa was administered intravenously during organogenesis at doses with exposures up to 1.8 times and 4.3 times, respectively, the recommended human daily dose (see data) . the estimated background risk of major birth defects and miscarriage for the indicate

Stati Uniti - Ingliż - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc - taliglucerase alfa (unii: 0r4nlx88o4) (taliglucerase alfa - unii:0r4nlx88o4) - taliglucerase alfa 200 u in 5 ml - elelyso is indicated for the treatment of patients 4 years of age and older with a confirmed diagnosis of type 1 gaucher disease. none. risk summary the limited available data on elelyso use in pregnant women are not sufficient to inform a drug-associated risk. however, there are clinical considerations [see clinical considerations] . in animal reproduction studies when pregnant rats and rabbits were administered taliglucerase alfa at intravenous doses up to 5 times the recommended human dose (rhd), there was no evidence of embryo-fetal toxicity [see data] . the estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. 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. clinical considerations disease-associated maternal and/or embryo/fetal risk women with type 1 gaucher disease have an increased risk of spontaneous abortion if disease symptoms are not treated and controlled pre-conception and during a pregnancy. pregnancy may exacerbate existing type 1 gaucher disease symptoms or result in new disease manifestations. type 1 gaucher disease manifestations may lead to adverse pregnancy outcomes, including hepatosplenomegaly which can interfere with the normal growth of a fetus and thrombocytopenia which can lead to increased bleeding and possible postpartum hemorrhage requiring transfusion. data animal data reproduction studies have been performed with taliglucerase alfa administered during the period of organogenesis in rats and rabbits. in rats, intravenous doses up to 55 mg/kg/day (about 5 times the rhd of 60 units/kg based on the body surface area) did not cause any adverse effects on embryo-fetal development. in rabbits, intravenous doses up to 27.8 mg/kg/day (about 5 times the rhd of 60 units/kg based on the body surface area) did not show any embryo-fetal toxicity. risk summary there are no data on the presence of taliglucerase alfa in human milk, the effects on the breast fed 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 elelyso and any potential adverse effects on the breastfed child from elelyso or from the underlying maternal condition. the safety and effectiveness of elelyso for the treatment of pediatric patients 4 years of age and older with a confirmed diagnosis of type 1 gaucher disease has been established. the use of elelyso for this indication is supported by evidence of effectiveness from adequate and well-controlled trials of elelyso in adults, with additional pharmacodynamic data from 5 pediatric patients and pharmacokinetic data from 9 pediatric patients who participated in clinical trials [see clinical studies (14.1, 14.2), clinical pharmacology (12.3)]. data from 14 pediatric patients were included in the safety evaluation [see adverse reactions (6.1)]. the safety and effectiveness of elelyso has not been established in patients less than 4 years of age. pediatric patients experienced a higher frequency of vomiting during elelyso treatment (4 of 9 treatment-naïve patients) than adult patients, and this may be a symptom of hypersensitivity reaction. the frequencies of other adverse reactions were similar between pediatric and adult patients treated with elelyso [see adverse reactions (6.1)] . during clinical trials, 8 patients aged 65 or older were treated with elelyso. clinical trials of elelyso did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - imiglucerase, quantity: 10 ml (equivalent: imiglucerase, qty 400 u) - injection, powder for - excipient ingredients: citric acid monohydrate; nitrogen; polysorbate 80; sodium citrate dihydrate; mannitol - cerezyme (imiglucerase) is indicated for long-term enzyme replacement therapy for patients with a confirmed diagnosis of non-neuronopathic (type 1) or chronic neuronopathic (type 3) gaucher disease who exhibit clinically significant non-neurological manifestations of the disease. the non-neurological manifestations of gaucher disease include one or more of the following conditions: a) anaemia; - b) thrombocytopenia; - c) bone disease; - d) hepatomegaly or splenomegaly.

Stati Uniti - Ingliż - NLM (National Library of Medicine)

genzyme corporation - imiglucerase (unii: q6u6j48bwy) (imiglucerase - unii:q6u6j48bwy) - imiglucerase 40 u in 1 ml - cerezyme is indicated for treatment of adults and pediatric patients 2 years of age and older with type 1 gaucher disease that results in one or more of the following conditions: - anemia - thrombocytopenia - bone disease - hepatomegaly or splenomegaly none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to cerezyme during pregnancy. pregnant women exposed to cerezyme and health care providers are encouraged to contact the gaucher patient registry at 1-800-745-4447, extension 15500 or visit www.registrynxt.com. risk summary available data on more than 500 pregnancies from the international gaucher disease registry, postmarketing reports, published observational studies and case reports with cerezyme or non–us-licensed imiglucerase use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. there are risks associated with symptomatic type i gaucher disease

Iżrael - Ingliż - Ministry of Health

pfizer pharmaceuticals israel ltd - taliglucerase alfa - powder for solution for infusion - taliglucerase alfa 200 u/vial - taliglucerase alfa - taliglucerase alfa - elelyso™ (taliglucerase alfa) for injection is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ert) for adults and pediatric patients with a confirmed diagnosis of type 1 gaucher disease

Iżrael - Ingliż - Ministry of Health

takeda israel ltd - velaglucerase alfa - lyophilized powder for solution for infusion - velaglucerase alfa 400 u/vial - velaglucerase alfa - velaglucerase alfa - vpriv is a hydrolytic glucocerebroside – specific enzyme indicated for the long term replacement therapy (ert) for pediatric and adult patients with type 1 gaucher disease.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - taliglucerase alfa, quantity: 212 u - injection, powder for - excipient ingredients: mannitol; citric acid; sodium citrate dihydrate; polysorbate 80 - elelyso is indicated for long-term enzyme replacement therapy for adult and paediatric patients with a confirmed diagnosis of type 1 gaucher disease associated with at least one of the following: splenomegaly, hepatomegaly, anaemia, thrombocytopenia.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - velaglucerase alfa, quantity: 400 u - injection, powder for - excipient ingredients: citric acid monohydrate; sucrose; polysorbate 20; sodium citrate dihydrate - vpriv is indicated for long-term enzyme replacement therapy (ert) for paediatric and adult patients with type 1 gaucher disease.

Iżrael - Ingliż - Ministry of Health

sanofi israel ltd - imiglucerase - powder for concentrate for solution for infusion - imiglucerase 400 u/vial - imiglucerase - imiglucerase - for the long term enzyme replacement therapy for patients with a confirmed diagnosis of type 1 gaucher disease that results in one or more of the following conditions: - anemia - thrombocytopenia - bone disease - hepatomegaly or splenomegaly.

Stati Uniti - Ingliż - NLM (National Library of Medicine)

washington homeopathic products - laurocerasus - to relieve the symptoms of dry cough. indications: laurocerasus   dry cough if symptoms persist/worsen or if pregnant/nursing, stop use and consult your practitioner.