Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

promius pharma, llc - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - betamethasone 0.5 mg in 1 g - sernivo spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. none. pregnancy category c there are no adequate and well-controlled studies in pregnant women. sernivo spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. the abnormalities observed included umbilical hernias, cephalocele, and cleft palate. systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. it is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in human milk. because many drugs are excreted in human milk, caution should be exercised when sernivo spray is administered to a nursing woman. safet

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

encore dermatology 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. risk summary 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 comparis

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - 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

Բանգլադեշ - անգլերեն - DGDA (Directorate General of Drug Administration)

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

Բանգլադեշ - անգլերեն - DGDA (Directorate General of Drug Administration)

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

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

bristol-myers squibb australia pty ltd - nivolumab, quantity: 255.6 mg; relatlimab, quantity: 85.2 mg - injection, concentrated - excipient ingredients: histidine hydrochloride monohydrate; water for injections; pentetic acid; sucrose; polysorbate 80; histidine - opdualag is indicated for the treatment of patients with unresectable or metastatic melanoma who are at least 12 years old.

Միացյալ Թագավորություն - անգլերեն - MHRA (Medicines & Healthcare Products Regulatory Agency)

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

Միացյալ Թագավորություն - անգլերեն - MHRA (Medicines & Healthcare Products Regulatory Agency)

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

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

e.r. squibb & sons, l.l.c. - nivolumab (unii: 31yo63lbsn) (nivolumab - unii:31yo63lbsn), relatlimab (unii: af75xof6w3) (relatlimab - unii:af75xof6w3) - opdualag™ is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. none.       risk summary based on findings in animals and mechanism of action, opdualag can cause fetal harm when administered to a pregnant woman. administration of nivolumab to cynomolgus monkeys from the onset of organogenesis through delivery resulted in increased abortion and premature infant death (see data ). human igg4 is known to cross the placenta; therefore, nivolumab and relatlimab have the potential to be transmitted from the mother to the developing fetus. the effects of opdualag are likely to be greater during the second and third trimesters of pregnancy. there are no available data on opdualag in pregnant women to evaluate a drug-associated risk. advise the patient of the potential risk to a fetus. 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 opdualag injection for intravenous use contains nivolumab and relatlimab [see description (11)] . nivolumab: one function of the pd-1/pd-l1 pathway is to preserve pregnancy by maintaining immune tolerance to the fetus. the effects of nivolumab on prenatal and postnatal development were evaluated in monkeys that received nivolumab twice weekly from the onset of organogenesis through delivery, at exposure levels of between 9 and 42 times higher than those observed at the clinical dose of 3 mg/kg (based on auc). nivolumab administration resulted in a non-dose-related increase in spontaneous abortion and increased neonatal death. in surviving infants (18 of 32 compared to 11 of 16 vehicle-exposed infants) of cynomolgus monkeys treated with nivolumab, there were no apparent malformations and no effects on neurobehavioral, immunological, or clinical pathology parameters throughout the 6-month postnatal period. relatlimab: there are no available animal data on relatlimab. the effects of a murine surrogate anti-lag-3 antibody was evaluated in mice using syngeneic and allogeneic breeding models. when anti-lag-3 antibodies were administered beginning on gestation day 6, there were no maternal or developmental effects in either syngeneic or allogeneic breedings. risk summary there are no data on the presence of nivolumab and relatlimab in human milk, the effects on the breastfed child, or the effects on milk production. because nivolumab and relatlimab may be excreted in human milk and because of the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with opdualag and for at least 5 months after the last dose [see pharmacokinetics (12.3)] . opdualag can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating opdualag [see use in specific populations (8.1)] . contraception advise females of reproductive potential to use effective contraception during treatment and for at least 5 months following the last dose of opdualag [see clinical pharmacology (12.3)] . the safety and effectiveness of opdualag for the treatment of unresectable or metastatic melanoma have been established in pediatric patients 12 years of age or older who weigh at least 40 kg. use of opdualag for this indication is supported by evidence from an adequate and well-controlled study in adults and additional data analyses that suggest that nivolumab and relatlimab exposures in pediatric patients 12 years of age who weigh at least 40 kg are expected to result in similar safety and efficacy to that of adults. the pharmacokinetics of monoclonal antibodies and the course of unresectable or metastatic melanoma are sufficiently similar in adults and pediatric patients 12 years of age or older to allow extrapolation of data from adult patients to pediatric patients 12 years of age or older (who weigh at least 40 kg). a recommended dosage for pediatric patients 12 years of age or older who weigh less than 40 kg has not been established [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14)] . the safety and effectiveness of opdualag have not been established in pediatric patients 12 years of age or older who weigh less than 40 kg, and pediatric patients younger than 12 years of age. of the 355 patients treated with opdualag in relativity-047, 47% of patients were 65 years or older, 29% were 65 to 74 years, 17% were 75 to 84 years, and 1.7% were 85 years and older. no overall differences in safety or effectiveness were observed between elderly patients and younger patients.

Իսրայել - անգլերեն - 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.