Israel - English - Ministry of Health

bristol - myers squibb, israel - atazanavir as sulfate - capsules - atazanavir as sulfate 300 mg - atazanavir - reyataz is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection.

Bahrain - English - الهيئة الوطنية لتنظيم المهن والخدمات الصحية، مملكة البحرين

wael pharmacy - boceprevir - capsule - 200

Philippines - English - FDA (Food And Drug Administration)

schering-plough labo., n.v. - belgium; importer: merck sharp & dohme (i.a.) corp.; distributor: merck sharp & dohme (i.a.) corp. - boceprevir - capsule - 200mg

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

merck sharp & dohme ltd - boceprevir - capsule - 200mg

Israel - English - Ministry of Health

merck sharp & dohme israel ltd - ribavirin - capsules - ribavirin 200 mg - ribavirin - ribavirin - tritherapy:rebetol in combination with boceprevir and peginterferon alfa-2b is indicated for the treatment of chronic hepatitis c (chc) genotype1 infection in adults patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy.bitherapy:rebetol is indicated for the treatment of chronic hepatitis c virus infection in adults and must only be used as part of a combination regimen with peginterferon alfa-2b or interferon alfa-2b .rebetol monotherapy must not be used. there is no safety or efficacy information on the use of rebetol with other forms of interferon (i.e., not alfa-2b).previously untreated (naïve) patientsadult patients (18 years of age or older): rebetol is indicated for:• tritherapy- in combination with peginterferon alfa-2b and boceprevir for the treatment of adult patients with chronic hepatitis c genotype1 infection with compensated liver disease.• bitherapy- in combination with interferon alfa-2b or peginterferon alfa-2b, fo

Singapore - English - HSA (Health Sciences Authority)

boehringer ingelheim singapore pte. ltd. - nevirapine - tablet - 200 mg - nevirapine 200 mg

Singapore - English - HSA (Health Sciences Authority)

boehringer ingelheim singapore pte. ltd. - nevirapine anhydrous - tablet, extended release - 400 mg - nevirapine anhydrous 400 mg

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)] .

Israel - English - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - efavirenz - film coated tablets - efavirenz 600 mg - efavirenz - efavirenz - stocrin in combination with other antiretroviral agents, is indicated for the treatment of hiv-1-infection .

Ireland - English - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd t/a gerard laboratories - efavirenz - film-coated tablet - 600 milligram(s) - non-nucleoside reverse transcriptase inhibitors; efavirenz