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.בקשה לשינוי 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

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.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

novo nordisk pharma (malaysia) sdn. bhd. - insulin detemir -

Australia - English - Department of Health (Therapeutic Goods Administration)

more group pty ltd - 42347 - dental implant, endosseous - abutments (various models and sizes) are prosthesis attached to dental implants

Australia - English - Department of Health (Therapeutic Goods Administration)

implant direct oceania pty ltd - 44879 - dental implant suprastructure device, permanent - these devices are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations and terminal or immediate abutment support for fixed bridgework. the devices can be used for the attachment of denture prostheses, fixed or removable bridgework, or as a freestanding single tooth replacement. these devices include categories of prosthetics such as: cement retained straight abutments, cement retained angled abutments, screw receiving overdenture abutments, ball abutments, and gold custom cast abutments. these devices are also ancillary components such as: copings, transfers, analogs, healing collars, and surgical cover screws.

Australia - English - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 44879 - dental implant suprastructure device, permanent - these devices are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations and terminal or immediate abutment support for fixed bridgework. the devices can be used for the attachment of denture prostheses, fixed or removable bridgework, or as a freestanding single tooth replacement. these devices include categories of prosthetics such as: cement retained straight abutments, cement retained angled abutments, screw receiving overdenture abutments, ball abutments, and gold custom cast abutments. these devices are also ancillary components such as: copings, transfers, analogs, healing collars, and surgical cover screws.

Australia - English - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 44879 - dental implant suprastructure device, permanent - these devices are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations and terminal or immediate abutment support for fixed bridgework. the devices can be used for the attachment of denture prostheses, fixed or removable bridgework, or as a freestanding single tooth replacement. these devices include categories of prosthetics such as: cement retained straight abutments, cement retained angled abutments, screw receiving overdenture abutments, ball abutments, and gold custom cast abutments. these devices are also ancillary components such as: copings, transfers, analogs, healing collars, and surgical cover screws.

Australia - English - Department of Health (Therapeutic Goods Administration)

dentsply sirona pty ltd - 44879 - dental implant suprastructure device, permanent - this group contains abutments intended for permanent use. mis abutments are intended to be used in a variety of clinical procedures for aiding in the reconstruction of single teeth, bridges, and overdentures. they are manufactured so that the compatibility with mis implants is assured. this group includes: screw-retained abutments, cement-retained abutments, overdenture abutments, cad-cam components. these are single use devices.

Australia - English - Department of Health (Therapeutic Goods Administration)

race dental pty ltd - 44879 - dental implant suprastructure device, permanent - dental abutments placed into a dental implant to provide support for dental prosthetic restorations. the abutments include: - titanium bases to be attached to the underlying implant and upon which a cad/cam designed superstructure may be fitted to complete a two-piece dental abutment; - titanium abutment blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using cad/cam techniques; - abutment screws to permanently fix the abutments to the underlying implant. abutments are intended for use to support single-tooth (unit) and multiple-tooth (bridges and bars) prostheses, in the mandible or maxilla for functional and aesthetic restorations.

Australia - English - Department of Health (Therapeutic Goods Administration)

dentsply sirona pty ltd - 44880 - dental implant suprastructure device, temporary - this group contains abutments intended for temporary use (up to 6 months). this group contains healing caps and cover screws, titanium or peek temporary abutments. the temporary abutments are used in order to maintain an acceptable function and aesthetic appearance until a permanent restoration is placed, as well as to shape the emergence profile of the soft tissue for future appropriate fitting of a permanent abutment. the connection is above the gingival tissue. the superstructures are not connected directly to the implant.