Israel - English - Ministry of Health

neopharm ltd, israel - brivaracetam - solution for injection / infusion - brivaracetam 10 mg / 1 ml - brivaracetam - briviact is indicated as 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.

Israel - English - Ministry of Health

neopharm ltd, israel - epinephrine as tartrate - solution for injection - epinephrine as tartrate 1 mg / 1 ml - epinephrine - emerade is indicated in the emergency treatment of severe allergic reactions (type i) including anaphylaxis to stinging insects (e.g., order hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.emerade is intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. emerade is intended for immediate administration as emergency supportive therapy only and is not a substitute for immediate medical care.

Israel - English - Ministry of Health

neopharm ltd, israel - epinephrine as tartrate - solution for injection - epinephrine as tartrate 1 mg / 1 ml - epinephrine - emerade is indicated in the emergency treatment of severe allergic reactions (type i) including anaphylaxis to stinging insects (e.g., order hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.emerade is intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. emerade is intended for immediate administration as emergency supportive therapy only and is not a substitute for immediate medical care.

Israel - English - Ministry of Health

neopharm ltd, israel - epinephrine as tartrate - solution for injection - epinephrine as tartrate 1 mg / 1 ml - epinephrine - emerade is indicated in the emergency treatment of severe allergic reactions (type i) including anaphylaxis to stinging insects (e.g., order hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.emerade is intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. emerade is intended for immediate administration as emergency supportive therapy only and is not a substitute for immediate medical care.

Israel - English - Ministry of Health

neopharm ltd, israel - mannitol - powder for inhalation in hard capsules - mannitol 40 mg - mannitol - bronchitol is indicated for the treatment of cystic fibrosis (cf) in adults aged 18 years and above as an add-on therapy to best standard of care.

Israel - English - Ministry of Health

neopharm ltd, israel - lacosamide - film coated tablets - lacosamide 100 mg - 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 150 mg - 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 - 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 ltd, israel - lacosamide - film coated tablets - lacosamide 50 mg - 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 - syrup - lacosamide 10 mg/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.