Israel - English - Ministry of Health

neopharm ltd, israel - lacosamide - solution for infusion - lacosamide 10 mg / 1 ml - lacosamide - vimpat is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.שינוי משטר מינון : 17/5/20204.2 posology and method of administrationposologylacosamide must be taken twice a day (usually once in the morning and once in the evening).lacosamide may be taken with or without food.if a dose is missed, the patient should be instructed to take the missed dose immediately, and then to take the next dose of lacosamide at the regularly scheduled time. if the patient notices the missed dose within 6 hours of the next one, he/she should be instructed to wait to take the next dose of lacosamide at the regularly scheduled time. patients should not take a double dose.adolescents and children weighing 50 kg or more, and adultsthe following table summarises the recommended posology for adolescents and children weighing 50 kg or more, and for adults. more details are provided in the table below. monotherapy adjunctive therapystarting dose 100 mg/day or 200 mg/day 100 mg/daysingle loading dose (if applicable) 200 mg 200 mgtitration (incremental steps) 50 mg twice a day (100 mg/day) at weekly intervals 50 mg twice a day (100 mg/day) at weekly intervalsmaximum recommended dose up to 600 mg/day up to 400 mg/daymonotherapy the recommended starting dose is 50 mg twice a day which should be increased to an initial therapeutic dose of 100 mg twice a day after one week.lacosamide can also be initiated at the dose of 100 mg twice a day based on the physician's assessment of required seizure reduction versus potential side effects.depending on response and tolerability, the maintenance dose can be further increased at weekly intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 300 mg twice a day (600 mg/day). in patients having reached a dose greater than 400 mg/day and who need an additional antiepileptic medicinal product, the posology that is recommended for adjunctive therapy below should be followed.adjunctive therapy the recommended starting dose is 50 mg twice a day which should be increased to an initial therapeutic dose of 100 mg twice a day after one week. depending on response and tolerability, the maintenance dose can be further increased at weekly intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 400 mg (200 mg twice a day). initiation of lacosamide treatment with a loading dose lacosamide treatment may also be initiated with a single loading dose of 200 mg, followed approximately 12 hours later by a 100 mg twice a day (200 mg/day) maintenance dose regimen. subsequent dose adjustments should be performed according to individual response and tolerability as described above. a loading dose may be initiated in patients in situations when the physician determines that rapid attainment of lacosamide steady state plasma concentration and therapeutic effect is warranted. it should be administered under medical supervision with consideration of the potential for increased incidence of serious cardiac arrhythmia and central nervous system adverse reactions (see section 4.8). administration of a loading dose has not been studied in acute conditions such as status epilepticus.discontinuationin accordance with current clinical practice, if lacosamide has to be discontinued, it is recommended this be done gradually (e.g. taper the daily dose by 200 mg/week).in patients who develop serious cardiac arrhythmia, clinical benefit/risk assessment should be performed and if needed lacosamide should be discontinued.

Israel - English - Ministry of Health

super-pharm (israel) ltd, israel - lidocaine hydrochloride; nifedipine - cream - lidocaine hydrochloride 1.5 %w/w; nifedipine 0.3 %w/w - lidocaine, combinations - treatment of anal fissures and proctologies generally associated with anal sphincter hypertonia.

Israel - English - Ministry of Health

neopharm ltd, israel - bimekizumab - solution for injection - bimekizumab 160 mg / 1 ml - bimekizumab - bimzelx ® is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Israel - English - Ministry of Health

neopharm scientific ltd - a/california/7/2009 (h1n1)pdm09-like virus; a/hong kong/4801/2014 (h3n2) - like virus; b/brisbane/60/2008 - like virus - suspension for injection - b/brisbane/60/2008 - like virus 15 mcg / 0.5 ml; a/hong kong/4801/2014 (h3n2) - like virus 15 mcg / 0.5 ml; a/california/7/2009 (h1n1)pdm09-like virus 15 mcg / 0.5 ml - vaccinia immunoglobulin - vaccinia immunoglobulin - active immunisation against influenza in the elderly (65 years of age and over), especially for those with an infreased risk of associated complications (i.e. patients affected by underlying chronic diseases including diabetes, cardiovascular and respiratory diseases).

Israel - English - Ministry of Health

eisai israel ltd., israel - eribulin as mesilate - solution for injection - eribulin as mesilate 0.44 mg/ml - eribulin - eribulin - halaven is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments.halaven is indicated for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.

Israel - English - Ministry of Health

neopharm ltd, israel - lacosamide - film coated tablets - lacosamide 50 mg - lacosamide - lacosamide - vimpat is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.שינוי משטר מינון: 10/5/20204.2 posology and method of administrationposologylacosamide must be taken twice a day (usually once in the morning and once in the evening).lacosamide may be taken with or without food.if a dose is missed, the patient should be instructed to take the missed dose immediately, and then to take the next dose of lacosamide at the regularly scheduled time. if the patient notices the missed dose within 6 hours of the next one, he/she should be instructed to wait to take the next dose of lacosamide at the regularly scheduled time. patients should not take a double dose.adolescents and children weighing 50 kg or more, and adultsthe following table summarises the recommended posology for adolescents and children weighing 50 kg or more, and for adults. more details are provided in the table below. monotherapy adjunctive therapystarting dose 100 mg/day or 200 mg/day 100 mg/daysingle loading dose (if applicable) 200 mg 200 mgtitration (incremental steps) 50 mg twice a day (100 mg/day) at weekly intervals 50 mg twice a day (100 mg/day) at weekly intervalsmaximum recommended dose up to 600 mg/day up to 400 mg/daymonotherapy the recommended starting dose is 50 mg twice a day which should be increased to an initial therapeutic dose of 100 mg twice a day after one week.lacosamide can also be initiated at the dose of 100 mg twice a day based on the physician's assessment of required seizure reduction versus potential side effects.depending on response and tolerability, the maintenance dose can be further increased at weekly intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 300 mg twice a day (600 mg/day). in patients having reached a dose greater than 400 mg/day and who need an additional antiepileptic medicinal product, the posology that is recommended for adjunctive therapy below should be followed.adjunctive therapy the recommended starting dose is 50 mg twice a day which should be increased to an initial therapeutic dose of 100 mg twice a day after one week. depending on response and tolerability, the maintenance dose can be further increased at weekly intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 400 mg (200 mg twice a day). initiation of lacosamide treatment with a loading dose lacosamide treatment may also be initiated with a single loading dose of 200 mg, followed approximately 12 hours later by a 100 mg twice a day (200 mg/day) maintenance dose regimen. subsequent dose adjustments should be performed according to individual response and tolerability as described above. a loading dose may be initiated in patients in situations when the physician determines that rapid attainment of lacosamide steady state plasma concentration and therapeutic effect is warranted. it should be administered under medical supervision with consideration of the potential for increased incidence of serious cardiac arrhythmia and central nervous system adverse reactions (see section 4.8). administration of a loading dose has not been studied in acute conditions such as status epilepticus.discontinuationin accordance with current clinical practice, if lacosamide has to be discontinued, it is recommended this be done gradually (e.g. taper the daily dose by 200 mg/week).in patients who develop serious cardiac arrhythmia, clinical benefit/risk assessment should be performed and if needed lacosamide should be discontinued.

Israel - English - Ministry of Health

neopharm ltd, israel - lacosamide - film coated tablets - lacosamide 100 mg - lacosamide - lacosamide - vimpat is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.שינוי משטר מינון: 10/5/20204.2 posology and method of administrationposologylacosamide must be taken twice a day (usually once in the morning and once in the evening).lacosamide may be taken with or without food.if a dose is missed, the patient should be instructed to take the missed dose immediately, and then to take the next dose of lacosamide at the regularly scheduled time. if the patient notices the missed dose within 6 hours of the next one, he/she should be instructed to wait to take the next dose of lacosamide at the regularly scheduled time. patients should not take a double dose.adolescents and children weighing 50 kg or more, and adultsthe following table summarises the recommended posology for adolescents and children weighing 50 kg or more, and for adults. more details are provided in the table below. monotherapy adjunctive therapystarting dose 100 mg/day or 200 mg/day 100 mg/daysingle loading dose (if applicable) 200 mg 200 mgtitration (incremental steps) 50 mg twice a day (100 mg/day) at weekly intervals 50 mg twice a day (100 mg/day) at weekly intervalsmaximum recommended dose up to 600 mg/day up to 400 mg/daymonotherapy the recommended starting dose is 50 mg twice a day which should be increased to an initial therapeutic dose of 100 mg twice a day after one week.lacosamide can also be initiated at the dose of 100 mg twice a day based on the physician's assessment of required seizure reduction versus potential side effects.depending on response and tolerability, the maintenance dose can be further increased at weekly intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 300 mg twice a day (600 mg/day). in patients having reached a dose greater than 400 mg/day and who need an additional antiepileptic medicinal product, the posology that is recommended for adjunctive therapy below should be followed.adjunctive therapy the recommended starting dose is 50 mg twice a day which should be increased to an initial therapeutic dose of 100 mg twice a day after one week. depending on response and tolerability, the maintenance dose can be further increased at weekly intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 400 mg (200 mg twice a day). initiation of lacosamide treatment with a loading dose lacosamide treatment may also be initiated with a single loading dose of 200 mg, followed approximately 12 hours later by a 100 mg twice a day (200 mg/day) maintenance dose regimen. subsequent dose adjustments should be performed according to individual response and tolerability as described above. a loading dose may be initiated in patients in situations when the physician determines that rapid attainment of lacosamide steady state plasma concentration and therapeutic effect is warranted. it should be administered under medical supervision with consideration of the potential for increased incidence of serious cardiac arrhythmia and central nervous system adverse reactions (see section 4.8). administration of a loading dose has not been studied in acute conditions such as status epilepticus.discontinuationin accordance with current clinical practice, if lacosamide has to be discontinued, it is recommended this be done gradually (e.g. taper the daily dose by 200 mg/week).in patients who develop serious

Israel - English - Ministry of Health

neopharm ltd, israel - lacosamide - film coated tablets - lacosamide 150 mg - lacosamide - lacosamide - vimpat is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.שינוי משטר מינון : 10/5/20204.2 posology and method of administrationposologylacosamide must be taken twice a day (usually once in the morning and once in the evening).lacosamide may be taken with or without food.if a dose is missed, the patient should be instructed to take the missed dose immediately, and then to take the next dose of lacosamide at the regularly scheduled time. if the patient notices the missed dose within 6 hours of the next one, he/she should be instructed to wait to take the next dose of lacosamide at the regularly scheduled time. patients should not take a double dose.adolescents and children weighing 50 kg or more, and adultsthe following table summarises the recommended posology for adolescents and children weighing 50 kg or more, and for adults. more details are provided in the table below. monotherapy adjunctive therapystarting dose 100 mg/day or 200 mg/day 100 mg/daysingle loading dose (if applicable) 200 mg 200 mgtitration (incremental steps) 50 mg twice a day (100 mg/day) at weekly intervals 50 mg twice a day (100 mg/day) at weekly intervalsmaximum recommended dose up to 600 mg/day up to 400 mg/daymonotherapy the recommended starting dose is 50 mg twice a day which should be increased to an initial therapeutic dose of 100 mg twice a day after one week.lacosamide can also be initiated at the dose of 100 mg twice a day based on the physician's assessment of required seizure reduction versus potential side effects.depending on response and tolerability, the maintenance dose can be further increased at weekly intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 300 mg twice a day (600 mg/day). in patients having reached a dose greater than 400 mg/day and who need an additional antiepileptic medicinal product, the posology that is recommended for adjunctive therapy below should be followed.adjunctive therapy the recommended starting dose is 50 mg twice a day which should be increased to an initial therapeutic dose of 100 mg twice a day after one week. depending on response and tolerability, the maintenance dose can be further increased at weekly intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 400 mg (200 mg twice a day). initiation of lacosamide treatment with a loading dose lacosamide treatment may also be initiated with a single loading dose of 200 mg, followed approximately 12 hours later by a 100 mg twice a day (200 mg/day) maintenance dose regimen. subsequent dose adjustments should be performed according to individual response and tolerability as described above. a loading dose may be initiated in patients in situations when the physician determines that rapid attainment of lacosamide steady state plasma concentration and therapeutic effect is warranted. it should be administered under medical supervision with consideration of the potential for increased incidence of serious cardiac arrhythmia and central nervous system adverse reactions (see section 4.8). administration of a loading dose has not been studied in acute conditions such as status epilepticus.discontinuationin accordance with current clinical practice, if lacosamide has to be discontinued, it is recommended this be done gradually (e.g. taper the daily dose by 200 mg/week).in patients who develop serious cardiac arrhythmia, clinical benefit/risk assessment should be performed and if needed lacosamide should be discontinued.

Israel - English - Ministry of Health

neopharm ltd, israel - lacosamide - film coated tablets - lacosamide 200 mg - lacosamide - lacosamide - vimpat is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.בקשה לעדכון משטר מינון: 11/5/20204.2 posology and method of administrationposologylacosamide must be taken twice a day (usually once in the morning and once in the evening).lacosamide may be taken with or without food.if a dose is missed, the patient should be instructed to take the missed dose immediately, and then to take the next dose of lacosamide at the regularly scheduled time. if the patient notices the missed dose within 6 hours of the next one, he/she should be instructed to wait to take the next dose of lacosamide at the regularly scheduled time. patients should not take a double dose.adolescents and children weighing 50 kg or more, and adultsthe following table summarises the recommended posology for adolescents and children weighing 50 kg or more, and for adults. more details are provided in the table below. monotherapy adjunctive therapystarting dose 100 mg/day or 200 mg/day 100 mg/daysingle loading dose (if applicable) 200 mg 200 mgtitration (incremental steps) 50 mg twice a day (100 mg/day) at weekly intervals 50 mg twice a day (100 mg/day) at weekly intervalsmaximum recommended dose up to 600 mg/day up to 400 mg/daymonotherapy the recommended starting dose is 50 mg twice a day which should be increased to an initial therapeutic dose of 100 mg twice a day after one week.lacosamide can also be initiated at the dose of 100 mg twice a day based on the physician's assessment of required seizure reduction versus potential side effects.depending on response and tolerability, the maintenance dose can be further increased at weekly intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 300 mg twice a day (600 mg/day). in patients having reached a dose greater than 400 mg/day and who need an additional antiepileptic medicinal product, the posology that is recommended for adjunctive therapy below should be followed.adjunctive therapy the recommended starting dose is 50 mg twice a day which should be increased to an initial therapeutic dose of 100 mg twice a day after one week. depending on response and tolerability, the maintenance dose can be further increased at weekly intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 400 mg (200 mg twice a day). initiation of lacosamide treatment with a loading dose lacosamide treatment may also be initiated with a single loading dose of 200 mg, followed approximately 12 hours later by a 100 mg twice a day (200 mg/day) maintenance dose regimen. subsequent dose adjustments should be performed according to individual response and tolerability as described above. a loading dose may be initiated in patients in situations when the physician determines that rapid attainment of lacosamide steady state plasma concentration and therapeutic effect is warranted. it should be administered under medical supervision with consideration of the potential for increased incidence of serious cardiac arrhythmia and central nervous system adverse reactions (see section 4.8). administration of a loading dose has not been studied in acute conditions such as status epilepticus.discontinuationin accordance with current clinical practice, if lacosamide has to be discontinued, it is recommended this be done gradually (e.g. taper the daily dose by 200 mg/week).in patients who develop serious cardiac arrhythmia, clinical benefit/risk assessment should be performed and if needed lacosamide should be discontinued.

Israel - English - Ministry of Health

neopharm scientific ltd - cannabidiol drug substance ( cbd bds ); delta-9-tetrahydrocannabinol drug substance ( thc bds ) - oromucosal spray - cannabidiol drug substance ( cbd bds ) 25 mg / 1 ml; delta-9-tetrahydrocannabinol drug substance ( thc bds ) 27 mg / 1 ml - nabiximols - sativex is indicated, as add-on treatment, for symptom relief in patients with moderate to severe spasticity due to multiple sclerosis (ms) who have not responded adequately to other medication and who demonstrate at least 20 % improvement in spasticity related symptoms during a four week trial of therapy.