Kenya - English - Pharmacy and Poisons Board

ondasetron as hcl dihydrate - injection - 8mg/4ml - ondansetron

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

genzyme corporation - alemtuzumab (unii: 3a189dh42v) (alemtuzumab - unii:3a189dh42v) - alemtuzumab 12 mg in 1.2 ml - lemtrada is indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include relapsing-remitting disease and active secondary progressive disease, in adults. because of its safety profile, the use of lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of ms [see warnings and precautions (5)] . limitations of use lemtrada is not recommended for use in patients with clinically isolated syndrome (cis) because of its safety profile [see warnings and precautions (5)]. lemtrada is contraindicated in patients: - with known hypersensitivity or anaphylactic reactions to alemtuzumab or any of the excipients in lemtrada - who are infected with human immunodeficiency virus (hiv) because lemtrada causes prolonged reductions of cd4+ lymphocyte counts - with active infection risk summary there are no adequate data on the developmental risk associated with the use of lemtrada in pregnant women. lemtrada was embryolethal in pregnant hucd52 transgenic mice when administered during organogenesis [see animal data] . auto-antibodies may develop after administration of lemtrada. placental transfer of anti-thyroid antibodies resulting in neonatal graves' disease has been reported. 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. the background risk of major birth defects and miscarriage for the indicated population is unknown. there is a pregnancy surveillance program for lemtrada. if lemtrada exposure occurs during pregnancy, healthcare providers and patients are encouraged to report pregnancies by calling 1-800-745-4447, option 2. clinical considerations lemtrada induces persistent thyroid disorders [see warnings and precautions (5.8)] . untreated hypothyroidism in pregnant women increases the risk for miscarriage and may have effects on the fetus including mental retardation and dwarfism. in mothers with graves' disease, maternal thyroid stimulating hormone receptor antibodies can be transferred to a developing fetus and can cause neonatal graves' disease. in a patient who developed graves' disease after treatment with alemtuzumab, placental transfer of anti-thyrotropin receptor antibodies resulted in neonatal graves' disease with thyroid storm in her infant who was born 1 year after alemtuzumab dosing [see warnings and precautions (5.1)] . data animal data when lemtrada was administered to pregnant hucd52 transgenic mice during organogenesis (gestation days [gd] 6–10 or gd 11–15) at doses of 3 or 10 mg/kg iv, no teratogenic effects were observed. however, there was an increase in embryolethality (increased postimplantation loss and the number of dams with all fetuses dead or resorbed) in pregnant animals dosed during gd 11–15. in a separate study in pregnant hucd52 transgenic mice, administration of lemtrada during organogenesis (gd 6–10 or gd 11–15) at doses of 3 or 10 mg/kg iv, decreases in b- and t-lymphocyte populations were observed in the offspring at both doses tested. in pregnant hucd52 transgenic mice administered lemtrada at doses of 3 or 10 mg/kg/day iv throughout gestation and lactation, there was an increase in pup deaths during the lactation period at 10 mg/kg. decreases in t- and b-lymphocyte populations and in antibody response were observed in offspring at both doses tested. risk summary there are no data on the presence of alemtuzumab in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. alemtuzumab was detected in the milk of lactating hucd52 transgenic mice administered lemtrada [see animal data]. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for lemtrada and any potential adverse effects on the breastfed child from lemtrada or from the underlying maternal conditions. data animal data alemtuzumab was detected in the milk of lactating hucd52 transgenic mice following intravenous administration of lemtrada at a dose of 10 mg/kg on postpartum days 8–12. serum levels of alemtuzumab were similar in lactating mice and offspring on postpartum day 13 and were associated with evidence of pharmacological activity (decrease in lymphocyte counts) in the offspring. contraception before initiation of lemtrada treatment, women of childbearing potential should be counselled on the potential for a serious risk to the fetus. to avoid in utero exposure to lemtrada, women of childbearing potential should use effective contraceptive measures when receiving a course of treatment with lemtrada and for 4 months following that course of treatment [see use in specific populations (8.1)] . infertility in hucd52 transgenic mice, administration of lemtrada prior to and during the mating period resulted in adverse effects on sperm parameters in males and reduced number of corpora lutea and implantations in females [see nonclinical toxicology (13.1)] . safety and effectiveness in pediatric patients less than 17 years of age have not been established. use of lemtrada is not recommended in pediatric patients due to the risks of autoimmunity, infusion reactions, and stroke, and because it may increase the risk of malignancies (thyroid, melanoma, lymphoproliferative disorders, and lymphoma) [see warnings and precautions (5.1, 5.2, 5.3, 5.4)] . clinical studies of lemtrada did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients.

Israel - English - Ministry of Health

sanofi israel ltd - alemtuzumab - concentrate for solution for infusion - alemtuzumab 12 mg / 1.2 ml - alemtuzumab - lemtrada is indicated as a single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (rrms) for the following patient groups: • patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) or • patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

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

gilead sciences, inc. - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s) - emtricitabine 200 mg - emtriva® is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection. emtriva is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the products. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to emtriva during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary available data from the apr show no increase in the overall risk of major birth defects with first trimester exposure for emtricitabine (ftc) (2.3%) compared with the background rate for major birth defects of 2.7% in a u.s. reference population of the metropolitan atlanta congenital defects program (macdp) (see data) . the rate of miscarriage for individual drugs is not reported in the apr. in the u.s. general population, the estimated background risk of miscarriage in clinically recognized p

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

excella gmbh - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s) - emtricitabine 200 mg - emtriva® is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection. additional important information regarding the use of emtriva for the treatment of hiv-1 infection: - emtriva should not be coadministered with atripla® , truvada® , or lamivudine-containing products [see warnings and precautions (5.3)]. - in treatment-experienced patients, the use of emtriva should be guided by laboratory testing and treatment history [see clinical pharmacology (12.4)]. emtriva is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the products. pregnancy category b the incidence of fetal variations and malformations was not increased in embryofetal toxicity studies performed with emtricitabine in mice at exposures (auc) approximately 60-fold higher and in rabbits at approximately 120-fold higher than human exposures at the recommended daily dose. there are, however, no adequate and well-controlled studies in pregnant women. because an

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

physicians total care, inc. - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s) - emtricitabine 200 mg - emtriva® is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection. additional important information regarding the use of emtriva for the treatment of hiv-1 infection: - emtriva should not be coadministered with atripla® , complera™, truvada® , or lamivudine-containing products [see warnings and precautions (5.3)]. - in treatment-experienced patients, the use of emtriva should be guided by laboratory testing and treatment history [see clinical pharmacology (12.4)]. emtriva is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the products. pregnancy category b the incidence of fetal variations and malformations was not increased in embryofetal toxicity studies performed with emtricitabine in mice at exposures (auc) approximately 60-fold higher and in rabbits at approximately 120-fold higher than human exposures at the recommended daily dose. there are, however, no adequate and well-controlled studies in pregnant women

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

state of florida doh central pharmacy - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s) - emtricitabine 200 mg - emtriva® is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection. additional important information regarding the use of emtriva for the treatment of hiv-1 infection: - emtriva should not be coadministered with atripla® , truvada® , or lamivudine-containing products [see warnings and precautions (5.3)]. - in treatment-experienced patients, the use of emtriva should be guided by laboratory testing and treatment history [see clinical pharmacology (12.4)]. emtriva is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the products. pregnancy category b the incidence of fetal variations and malformations was not increased in embryofetal toxicity studies performed with emtricitabine in mice at exposures (auc) approximately 60-fold higher and in rabbits at approximately 120-fold higher than human exposures at the recommended daily dose. there are, however, no adequate and well-controlled studies in pregnant women. because an

New Zealand - English - Medsafe (Medicines Safety Authority)

gilead sciences (nz) - emtricitabine 200mg;  ;  ;   - capsule - 200 mg - active: emtricitabine 200mg       excipient: crospovidone gelatin indigo carmine magnesium stearate microcrystalline cellulose povidone titanium dioxide - emtriva is indicated for the treatment of hiv in combination with other antiretroviral agents in adults and paediatric patients 12 years of age and older, weighing more than 33 kg. evidence to support this claim is based on surrogate markers (plasma hiv rna and cd4 count) in antiretroviral na?ve individuals and in antiretroviral experienced individuals with virological suppression.

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

sanofi-aventis australia pty ltd - alemtuzumab, quantity: 10 mg/ml - injection, concentrated - excipient ingredients: disodium edetate; potassium chloride; monobasic potassium phosphate; sodium chloride; dibasic sodium phosphate heptahydrate; polysorbate 80; water for injections - lemtrada is indicated for the treatment of relapsing forms of multiple sclerosis (ms) for patients with active disease defined by clinical or imaging features to slow the accumulation of physical disability and reduce the frequency of clinical relapses.

European Union - English - EMA (European Medicines Agency)

sanofi belgium - alemtuzumab - multiple sclerosis - selective immunosuppressants - lemtrada is indicated for adult patients with relapsing-remitting multiple sclerosis (rrms) with active disease defined by clinical or imaging features.