Israel - English - Ministry of Health

lundbeck israel ltd. - zuclopenthixol as dihydrochloride - film coated tablets - zuclopenthixol as dihydrochloride 25 mg - zuclopenthixol - zuclopenthixol - acute schizophrenia. other acute psychoses.

Israel - English - Ministry of Health

lundbeck israel ltd. - zuclopenthixol as dihydrochloride - film coated tablets - zuclopenthixol as dihydrochloride 10 mg - zuclopenthixol - zuclopenthixol - acute schizophrenia .other acute psychoses.

Israel - English - Ministry of Health

lundbeck israel ltd. - zuclopenthixol as dihydrochloride - solution - zuclopenthixol as dihydrochloride 20 mg/ml - zuclopenthixol - zuclopenthixol - acute schizophrenia and other acute psychoses.

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

lundbeck pharmaceuticals llc - carbamazepine (unii: 33cm23913m) (carbamazepine - unii:33cm23913m) - carbamazepine 10 mg in 1 ml - carnexiv is indicated as replacement therapy for oral carbamazepine formulations, when oral administration is temporarily not feasible, in adults with the following seizure types: - partial seizures with complex symptomatology - generalized tonic-clonic seizures - mixed seizure patterns which include the above, or other partial or generalized seizures limitations of usage carnexiv is not indicated for the treatment of absence seizures (including atypical absence). carbamazepine has been associated with increased frequency of generalized convulsions in these patients.  carnexiv is contraindicated in patients with: - bone marrow depression [see warnings and precautions (5.2)] bone marrow depression [see warnings and precautions (5.2)] - known hypersensitivity to carbamazepine [see warnings and precautions (5.5)] known hypersensitivity to carbamazepine [see warnings and precautions (5.5)] - known hypersensitivity to any of the tricyclic antidepressants (e.g., amitriptyline, imipramine, and nortriptyline) [see drug interactions (7.1)] known hypersensitivity to any of the tricyclic antidepressants (e.g., amitriptyline, imipramine, and nortriptyline) [see drug interactions (7.1)] - concomitant use of boceprevir; carnexiv can reduce boceprevir concentrations through induction of cyp3a4; this can diminish boceprevir’s virologic activity [see drug interactions (7.1)] concomitant use of boceprevir; carnexiv can reduce boceprevir concentrations through induction of cyp3a4; this can diminish boceprevir’s virologic activity [see drug interactions (7.1)] - use of monoamine oxidase inhibitors (maois) within the past 14 days; concomitant use can cause serotonin syndrome [see drug interactions (7.3)] use of monoamine oxidase inhibitors (maois) within the past 14 days; concomitant use can cause serotonin syndrome [see drug interactions (7.3)] - concomitant use of nefazodone; this may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect [see drug interactions (7.1)] concomitant use of nefazodone; this may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect [see drug interactions (7.1)] -   concomitant use of delavirdine or other non-nucleoside reverse transcriptase inhibitors. carnexiv can substantially reduce the concentrations of these drugs through induction of cyp3a4. this can lead to loss of virologic response and possible resistance to these medications [see drug interactions (7.1)]   concomitant use of delavirdine or other non-nucleoside reverse transcriptase inhibitors. carnexiv can substantially reduce the concentrations of these drugs through induction of cyp3a4. this can lead to loss of virologic response and possible resistance to these medications [see drug interactions (7.1)] pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), including carnexiv, during pregnancy. encourage women who are taking carnexiv during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the toll-free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org, and must be done by the patient herself.    risk summary carbamazepine can cause fetal harm when administered to a pregnant woman. an association between the use of carbamazepine during pregnancy and congenital malformations, including spina bifida and malformations involving other body systems (e.g., craniofacial defects and cardiovascular malformations) has been demonstrated. developmental delays have been reported.  in animal studies, administration of carbamazepine during pregnancy resulted in developmental toxicity, including increased incidences of fetal malformations. women of childbearing potential should be informed of the potential risk to the fetus.   in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown.   clinical considerations disease-associated maternal and/or embryofetal risk consideration should be given to discontinuing carbamazepine in women who are pregnant or attempting to become pregnant if the benefits of discontinuation outweigh the risks of recurrent seizures. women with epilepsy should not discontinue carbamazepine abruptly due to the risk of status epilepticus and less severe seizures which may be life-threatening.   fetal/neonatal adverse reactions there have been a few cases of neonatal seizures and/or respiratory depression associated with maternal carbamazepine in combination with other antiepileptic drugs. a few cases of neonatal vomiting, diarrhea, and/or decreased feeding have also been reported in association with maternal carbamazepine use. these symptoms may represent a neonatal withdrawal syndrome.  tests to detect birth defects using currently accepted procedures should be considered a part of routine prenatal care in childbearing women receiving carbamazepine. evidence suggests that folic acid supplementation prior to conception and during the first trimester of pregnancy decreases the risk for congenital neural tube defects in the general population. it is not known whether the risk of neural tube defects in the offspring of women receiving carbamazepine is reduced by folic acid supplementation, but dietary folic acid supplementation both prior to conception and during pregnancy should be recommended for patients using carbamazepine. data human data pregnancy registry and epidemiological data suggest that there may be an association between the use of carbamazepine during pregnancy and congenital malformations, including spina bifida and malformations involving other body systems (e.g., craniofacial defects and cardiovascular malformations). the north american antiepileptic drug (naaed) pregnancy registry has reported a rate of major congenital malformations of 3.0% (95% ci: 2.1, 4.2) among mothers exposed to carbamazepine monotherapy (n=1,033) during the first trimester with a relative risk of 2.7 (95% ci: 1.0, 7.0) compared to pregnant women not taking an antiepileptic drug. there have also been postmarketing reports of developmental delays based on neurobehavioral assessments.  animal data in studies in which pregnant rodents were administered carbamazepine orally during organogenesis, dose-related increases in the rates of fetal structural abnormalities (craniofacial, skeletal, cardiac, and urogenital defects), intrauterine growth retardation, and embryofetal death occurred at clinically relevant doses. risk summary carbamazepine and its epoxide metabolite are excreted in human milk. there are no data to assess the effects of carbamazepine or its metabolites on milk production, or on the breastfed infant, of mothers taking carnexiv.  the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for carnexiv and any potential adverse effects on the breastfed infant from carnexiv or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. no studies in geriatric patients have been conducted with carnexiv. though no dose adjustment is necessary for patients with mild renal impairment, close monitoring during carnexiv treatment should be conducted due to potential accumulation of sulfobutylether beta-cyclodextrin sodium salt. accumulation of sulfobutylether beta-cyclodextrin sodium salt is associated with a greater risk for an adverse effect on renal function in patients with moderate or severe renal impairment. therefore, carnexiv should generally not be used in patients with moderate or severe renal impairment [see warnings and precautions (5.3) and clinical pharmacology (12.3)] . monitor serum carbamazepine concentrations in patients with hepatic impairment treated with carnexiv, as the first-pass effect may be reduced in these patients [see clinical pharmacology (12.3)] .

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

lundbeck pharmaceuticals ireland ltd - benzatropine mesilate - solution for injection - 1mg/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

lundbeck pharmaceuticals ireland ltd - indometacin sodium trihydrate - powder for solution for injection - 1mg

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

lundbeck pharmaceuticals llc - eptinezumab (unii: 8202ay8i7h) (eptinezumab - unii:8202ay8i7h) - vyepti is indicated for the preventive treatment of migraine in adults. vyepti is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients in vyepti. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.1)] . risk summary there are no adequate data on developmental risks associated with the use of vyepti in pregnant women. no adverse developmental effects were observed following administration of eptinezumab-jjmr to pregnant animals at doses greater than those used clinically [see data] . in the u.s. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. the estimated rate of major birth defects (2.2%-2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. clinical considerations disease-associated maternal and/or embryo/fetal risk published data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy. data animal data when eptinezumab-jjmr (0, 75, or 150 mg/kg) was administered weekly to female rats and rabbits by intravenous injection throughout organogenesis, no adverse effects on embryofetal development were observed. the higher dose tested (150 mg/kg) is 30 times the maximum recommended human dose (mrhd) of 300 mg, on a body weight basis (mg/kg). when eptinezumab-jjmr (0, 75, or 150 mg/kg) was administered weekly to female rats throughout pregnancy and lactation, no adverse effects on pre- and postnatal development were observed. the higher dose tested (150 mg/kg) is 30 times the mrhd, on a mg/kg basis. risk summary there are no data on the presence of eptinezumab-jjmr in human milk, the effects on the breastfed 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 vyepti and any potential adverse effects on the breastfed infant from vyepti or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. clinical studies of vyepti did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

Israel - English - Ministry of Health

lundbeck israel ltd. - aripiprazole as monohydrate - powder and solvent for prolonged-release suspension for injection - aripiprazole as monohydrate 300 mg/vial - aripiprazole - abilify maintena is indicated for maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.

Israel - English - Ministry of Health

lundbeck israel ltd. - aripiprazole as monohydrate - powder and solvent for prolonged-release suspension for injection - aripiprazole as monohydrate 400 mg/vial - aripiprazole - abilify maintena is indicated for maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.

Israel - English - Ministry of Health

lundbeck israel ltd. - vortioxetine as hydrobromide - film coated tablets - vortioxetine as hydrobromide 10 mg - vortioxetine - brintellix is indicated for the treatment of major depressive episodes in adults.