USA - engelska - NLM (National Library of Medicine)

primus pharmaceuticals, inc. - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - sernivo spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. none. there are no available data on sernivo spray use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. advise pregnant women that sernivo spray may increase the risk of having a low birthweight infant and to use sernivo spray on the smallest area of skin and for the shortest duration possible. in animal reproduction studies, increased malformations, including umbilical hernias, cephalocele, and cleft palate, were observed after intramuscular administration of betamethasone dipropionate to pregnant rabbits during the period of organogenesis (see data ). the available data do not allow the calculation of relevant comparisons between the systemic exposure of betamethasone dipropionate observed in animal studies to the systemic exposure that would be expected in humans after topical use of sernivo spray. 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 risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data administration of 0.05 mg/kg betamethasone dipropionate intramuscularly to pregnant rabbits during the period of organogenesis caused malformations. the abnormalities observed included umbilical hernias, cephalocele, and cleft palate. risk summary there are no data regarding the presence of betamethasone dipropionate in human milk, the effects on the breastfed infant, or the effects on milk production after topical application of sernivo spray to women who are breastfeeding. it is possible that topical administration of betamethasone dipropionate could result in sufficient systemic absorption to produce detectable quantities in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for sernivo spray and any potential adverse effects on the breastfed infant from sernivo spray or from the underlying maternal condition. clinical considerations to minimize potential exposure to the breastfed infant via breast milk, use sernivo spray on the smallest area of skin and for the shortest duration possible while breastfeeding. advise breastfeeding women not to apply sernivo spray directly to the nipple and areola to avoid direct infant exposure [see use in specific populations (8.4) ]. safety and effectiveness of sernivo spray in patients younger than 18 years of age have not been studied, therefore use in pediatric patients is not recommended. because of a higher ratio of skin surface area to body mass, pediatric patients are at greater risk of systemic toxicity, including hpa axis suppression and adrenal insufficiency, when treated with topical drugs. [see warnings and precautions (5.1)] rare systemic effects such as cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids. local adverse reactions including skin atrophy have also been reported with use of topical corticosteroids in pediatric patients. clinical studies of sernivo spray did not include sufficient numbers of subjects who were 65 years of age or older to determine whether they respond differently from younger subjects. instructions for use sernivo™ (ser-ne-vo) (betamethasone dipropionate) spray, 0.05% important: sernivo spray is for use on the skin only. do not get sernivo spray near or in your eyes, mouth, or vagina. read this “instructions for use” before you start using sernivo spray and each time you get a refill. there may be new information. this information does not take the place of talking with your doctor about your medical condition or treatment. parts of the sernivo spray bottle. (see figure a) figure a how to apply sernivo spray: step 1: shake the sernivo spray bottle well. remove the cap from the pump top. step 2: hold the bottle in an upright position while pointing the opening of the pump top in the direction of the affected area. to spray, push down on the pump top. apply sernivo spray to the affected area as instructed by your doctor. (see figure b) figure b step 3: spray only enough sernivo spray to cover the affected area, for example, the elbow (see figure c) . rub in sernivo spray gently. figure c repeat steps 2 and 3 to apply sernivo spray to other affected areas as instructed by your doctor. step 4: after applying sernivo spray, place the cap back onto the pump top. (see figure d) figure d how should i store sernivo spray? - store sernivo spray at room temperature between 68°f to 77°ff (20°fc to 25°c). - throw away (discard) any unused sernivo spray after 28 days. keep sernivo spray and all medicines out of the reach of children. this "instructions for use" has been approved by the u.s. food and drug administration. manufactured by: dpt laboratories, ltd., san antonio, tx 78215 distributed by: encore dermatology, inc., scottsdale az 85254 sernivo is a registered trademark of encore dermatology, inc issued: 02/2016 revised: 04/2019 ser1289 4/19

Bangladesh - engelska - DGDA (Directorate General of Drug Administration)

beacon pharmaceuticals plc - nivolumab - injection - 40 mg/4 ml

Bangladesh - engelska - DGDA (Directorate General of Drug Administration)

beacon pharmaceuticals plc - nivolumab - injection - 100 mg/10 ml

Irland - engelska - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - memantine hydrochloride - oral solution - 10 milligram(s)/millilitre - other anti-dementia drugs; memantine

Irland - engelska - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd., t/a gerard laboratories - memantine hydrochloride - oral solution - 10 milligram(s)/millilitre - other anti-dementia drugs; memantine

Storbritannien - engelska - MHRA (Medicines & Healthcare Products Regulatory Agency)

bristol-myers squibb pharmaceuticals ltd - nivolumab - solution for infusion - 10mg/1ml

Storbritannien - engelska - MHRA (Medicines & Healthcare Products Regulatory Agency)

bristol-myers squibb pharmaceuticals ltd - nivolumab - solution for infusion - 10mg/1ml

Malta - engelska - Medicines Authority

sandoz pharmaceuticals d.d. verovškova ulica 57, si-1000 ljubljana, slovenia - memantine hydrochloride - oral solution - memantine hydrochloride 10 mg - psychoanaleptics

Malta - engelska - Medicines Authority

clonmel healthcare limited waterford road, clonmel, co. tipperary e91 d768, ireland - memantine hydrochloride - oral solution - memantine hydrochloride 10 mg/ml - psychoanaleptics

Israel - engelska - Ministry of Health

bristol, myers squibb (israel) limited, israel - nivolumab; relatlimab - concentrate for solution for infusion - relatlimab 4 mg/ml; nivolumab 12 mg/ml - nivolumab - opdualag is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.