САЩ - английски - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - fingolimod hydrochloride (unii: g926ec510t) (fingolimod - unii:3qn8byn5qf) - fingolimod 0.5 mg - gilenya is indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. gilenya is contraindicated in patients who have: - in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (tia), decompensated heart failure requiring hospitalization or class iii/iv heart failure - a history or presence of mobitz type ii second-degree or third-degree av block or sick sinus syndrome, unless patient has a functioning pacemaker [see warnings and precautions (5.1)] - a baseline qtc interval ≥ 500 msec - cardiac arrhythmias requiring anti-arrhythmic treatment with class ia or class iii anti-arrhythmic drugs - had a hypersensitivity reaction to fingolimod or any of the excipients in gilenya. observed reactions include rash, urticaria and angioedema upon treatment initiation [see warnings and precautions (5.14)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to gilenya during pregnancy. physicians are encouraged to enroll pregnant patients, or pregnant women may register themselves in the gilenya pregnancy registry by calling 1-877-598-7237, sending an email to gpr@quintiles.com, or visiting www.gilenyapregnancyregistry.com. risk summary based on findings from animal studies, gilenya may cause fetal harm when administered to a pregnant woman. data from prospective reports to the gilenya pregnancy registry (gpr) are currently not sufficient to allow for an adequate assessment of the drug-associated risk for birth defects and miscarriage in humans. in oral studies conducted in rats and rabbits, fingolimod demonstrated developmental toxicity, including an increase in malformations (rats) and embryolethality, when given to pregnant animals. in rats, the highest no-effect dose was less than the recommended human dose of 0.5 mg/day on a body surface area (mg/m2 ) basis. the most common fetal visceral malformations in rats were persistent truncus arteriosus and ventricular septal defect. the receptor affected by fingolimod (sphingosine 1-phosphate receptor) is known to be involved in vascular formation during embryogenesis (see data ). advise pregnant women of the potential risk to a fetus. in the us 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. clinical considerations in females planning to become pregnant, gilenya should be stopped 2 months before planned conception. the possibility of severe increase in disability should be considered in women who discontinue or are considering discontinuation of gilenya because of pregnancy or planned pregnancy. in many of the cases in which increase in disability was reported after stopping gilenya, patients had stopped gilenya because of pregnancy or planned pregnancy [see warnings and precautions (5.9)] . data animal data when fingolimod was orally administered to pregnant rats during the period of organogenesis (0, 0.03, 0.1, and 0.3 mg/kg/day or 0, 1, 3, and 10 mg/kg/day), increased incidences of fetal malformations and embryofetal deaths were observed at all but the lowest dose tested (0.03 mg/kg/day), which is less than the recommended human dose (rhd) on a mg/m2 basis. oral administration to pregnant rabbits during organogenesis (0, 0.5, 1.5, and 5 mg/kg/day) resulted in increased incidences of embryofetal mortality and fetal growth retardation at the mid and high doses. the no-effect dose for these effects in rabbits (0.5 mg/kg/day) is approximately 20 times the rhd on a mg/m2 basis. when fingolimod was orally administered to female rats during pregnancy and lactation (0, 0.05, 0.15, and 0.5 mg/kg/day), pup survival was decreased at all doses and a neurobehavioral (learning) deficit was seen in offspring at the high dose. the low-effect dose of 0.05 mg/kg/day is similar to the rhd on a mg/m2 basis. risk summary there are no data on the presence of fingolimod in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. fingolimod is excreted in the milk of treated rats. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for gilenya and any potential adverse effects on the breastfed infant from gilenya or from the underlying maternal condition. pregnancy testing the pregnancy status of females of reproductive potential should be verified prior to starting treatment with gilenya [see use in specific populations (8.1)] . contraception before initiation of gilenya treatment, females of reproductive potential should be counseled on the potential for a serious risk to the fetus and the need for effective contraception during treatment with gilenya [see warnings and precautions (5.8) and use in specific populations (8.1)] . since it takes approximately 2 months to eliminate the compound from the body after stopping treatment, the potential risk to the fetus may persist and women should use effective contraception during this period [see warnings and precautions (5.8, 5.13)] . safety and effectiveness of gilenya for the treatment of relapsing forms of multiple sclerosis in pediatric patients 10 to less than 18 years of age were established in one randomized, double-blind clinical study in 215 patients (gilenya n = 107; intramuscular interferon (ifn) beta-1a n = 108) [see clinical studies (14.2)] . in the controlled pediatric study, the safety profile in pediatric patients (10 to less than 18 years of age) receiving gilenya 0.25 mg or 0.5 mg daily was similar to that seen in adult patients. in the pediatric study, cases of seizures were reported in 5.6% of gilenya-treated patients and 0.9% of interferon beta-1a-treated patients. it is recommended that pediatric patients, if possible, complete all immunizations in accordance with current immunization guidelines prior to initiating gilenya therapy. safety and effectiveness of gilenya in pediatric patients below the age of 10 years have not been established. juvenile animal toxicity data in a study in which fingolimod (0.3, 1.5, or 7.5 mg/kg/day) was orally administered to young rats from weaning through sexual maturity, changes in bone mineral density and persistent neurobehavioral impairment (altered auditory startle) were observed at all doses. delayed sexual maturation was noted in females at the highest dose tested and in males at all doses. the bone changes observed in fingolimod-treated juvenile rats are consistent with a reported role of s1p in the regulation of bone mineral homeostasis. when fingolimod (0.5 or 5 mg/kg/day) was orally administered to rats from the neonatal period through sexual maturity, a marked decrease in t-cell dependent antibody response was observed at both doses. this effect had not fully recovered by 6-8 weeks after the end of treatment. overall, a no-effect dose for adverse developmental effects in juvenile animals was not identified. clinical ms studies of gilenya did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently than younger patients. gilenya should be used with caution in patients aged 65 years and over, reflecting the greater frequency of decreased hepatic, or renal, function and of concomitant disease or other drug therapy. because fingolimod, but not fingolimod-phosphate, exposure is doubled in patients with severe hepatic impairment, patients with severe hepatic impairment should be closely monitored, as the risk of adverse reactions may be greater [see warnings and precautions (5.5), clinical pharmacology (12.3)] . no dose adjustment is needed in patients with mild or moderate hepatic impairment. the blood level of some gilenya metabolites is increased (up to 13-fold) in patients with severe renal impairment [see clinical pharmacology (12.3)] . the toxicity of these metabolites has not been fully explored. the blood level of these metabolites has not been assessed in patients with mild or moderate renal impairment.

Великобритания - английски - MHRA (Medicines & Healthcare Products Regulatory Agency)

wockhardt uk ltd - risperidone - oral solution - 1mg/1ml

Ирландия - английски - HPRA (Health Products Regulatory Authority)

wockhardt uk limited - risperidone - oral solution - 1 milligram(s)/millilitre - other antipsychotics; risperidone

Нова Зеландия - английски - Medsafe (Medicines Safety Authority)

bayer new zealand limited - drospirenone 3mg (micro 15); ethinylestradiol betadex clathrate 0.02mg (ethinylestradiol betadex clathrade amount equivalent ethinylestradiol 0.02mg) - tablet - 3mg/0.02mg - active: drospirenone 3mg (micro 15) ethinylestradiol betadex clathrate 0.02mg (ethinylestradiol betadex clathrade amount equivalent ethinylestradiol 0.02mg) excipient: lactose monohydrate magnesium stearate maize starch opadry pink 02a34744 hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose purified talc titanium dioxide hypromellose lactose monohydrate magnesium stearate maize starch povidone purified talc titanium dioxide - yaz is indicated for use as: - an oral contraceptive. - treatment of moderate acne vulgaris in women who seek oral contraception. - treatment of symptoms of premenstrual dysphoric disorder (pmdd) in women who have chosen oral contraceptives as their method of birth control. the efficacy of yaz for pmdd was not assessed beyond 3 cycles. yaz has not been evaluated for treatment of pms (premenstrual syndrome).

Ирландия - английски - HPRA (Health Products Regulatory Authority)

bayer limited - drospirenone micronized ethinylestradiol (as betadex clathrate micronized) - film coated tablet - 0.02/3 milligram

Сингапур - английски - HSA (Health Sciences Authority)

bayer (south east asia) pte ltd - (tablet core, product) drospirenone; (tablet core, product) ethinylestradiol betadex clathrate - tablet, film coated - 3.000 mg - (tablet core, product) drospirenone 3.000 mg; (tablet core, product) ethinylestradiol betadex clathrate 0.020 mg

Австралия - английски - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - drospirenone,ethinylestradiol -

Бангладеш - английски - DGDA (Directorate General of Drug Administration)

beximco pharmaceuticals ltd. - propranolol hydrochloride - tablet - 10 mg

Бангладеш - английски - DGDA (Directorate General of Drug Administration)

beximco pharmaceuticals ltd. - propranolol hydrochloride - tablet - 40 mg

Индия - английски - Central Drugs Standard Control Organization

ikon rem - syr - 200ml