Singapoo - Kiingereza - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - sodium iodide [i-131] - injection - 74 mbq/ml - sodium iodide [i-131] 74 mbq/ml

Singapoo - Kiingereza - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - sodium iodide [i-131] - injection - 925 mbq/ml - sodium iodide [i-131] 925 mbq/ml

Marekani - Kiingereza - NLM (National Library of Medicine)

aquabounty technologies, inc. - atlantic salmon transgenic whole (opafp-ghc2 rdna construct inserted into .alpha.-locus in the eo-1.alpha. lineage) (unii: ec8tzl340i) (atlantic salmon transgenic whole (opafp-ghc2 rdna construct inserted into .alpha.-locus in the eo-1.alpha. lineage)atlantic salmon transgenic whole (opafp-ghc2 rdna construct inserted into .alpha.-locus in the eo-1.alpha. lineage) - unii:ec8tzl340i) - atlantic salmon transgenic whole (opafp-ghc2 rdna construct inserted into .alpha.-locus in the eo-1.alpha. lineage)atlantic salmon transgenic whole (opafp-ghc2 rdna construct inserted into .alpha.-locus in the eo-1.alpha. lineage) 1 [amb'a'1'u] in 1 [amb'a'1'u] - 1. product definition 1.1 identity a single copy of the -form of the opafp-ghc2 recombinant dna construct at the -locus in the eo-1 lineage of triploid, hemizygous, all-female atlantic salmon (salmo salar) known as aquadvantage salmon. 1.2 claim significantly more aquadvantage salmon grow to at least 100 g within 2700°c-days than their comparators. 1.3 limitations aquadvantage salmon are produced as eyed-eggs and grown-out only in physically-contained, freshwater culture facilities specified in an fda-approved application. 2. product use 2.1 initial receipt remove the exterior cardboard packaging from the shipping container, then clean and disinfect the outside of the interior plastic crate before bringing it into the culture facility. open the plastic crate in an area that is designated for egg receipt, and remove the eggs for disinfection as described in §2.2. dispose of all packaging and the empty egg trays according to local regulations. 2.2 handling & disinfection important:this product was disinfected prior to packaging for shipment. if egg hatch has initiated during transit, do not subject to further disinfection as described below. open the plastic crate and determine the temperature of the eggs in the top and bottom trays. if the egg temperature is greater than that of the receiving water by 2°c, slowly equilbrate the eggs to the receiving temperature by pouring receiving water gently over the eggs until the difference is less than 2°c disinfect the eggs in accordance with local regulations; following disinfection, rinse the eggs gently but thoroughly in running water at the receiving temperature before placing them in incubators. 2.3 incubation & hatch in a vertically-stacked heath type incubator system, stock no more than 10,000 eggs in a single tray, preferably in a single layer. adjust water flow to ~10 l/min and maintain egg-incubation temperature at ~6-8°c.* clean the individual trays, removing dead eggs, a minimum of twice per week. following hatch, use a substrate when alevin become more active, typically at ~20% yolk sac absorption. * eggs may be incubated at water temperatures lower than the range stated for the purpose of delaying hatch. 2.4 first-feeding & initial culture before yolk sac absorption is complete, transfer the alevin to tanks appropriate for 1st-feeding and gradually increase water temperature to a maximum of ~15-16°c. when the yolk sac is fully absorbed, increase water flow rate to ~20 l/min. aquadvantage salmon grow very rapidly at this life stage. for maximum growth performance: it is recommended to use freshwater flow-through, rather than recirculation, until they are feeding well; increase the number of hours of light to 24 hours in a period of 5 7 days; and, feed to satiety at least once per hour using a manual and automated feeding system and appropriate pellet size, which will change several times during the first 2-3 months. if capabilities do not allow for optimum conditions, feed fry to satiety a minimum of six times, and preferably once per hour, during operational day-length. in either scenario, flushexcess feed from tanks once a day. observe fry carefully during this period for any change in behavior, which could indicate a deterioration of culture conditions that might lead to unnecessary mortality. it is recommended to grade these fish as needed; taking into account the accelerated growth of these fish. 2.5 grow-out & processing transfer fry to larger tanks for grow-out at a body weight consistent with established practices. to optimize growth performance, maintain dissolved oxygen content at a minimum value of 7 mg/l and stocking density at a value less than the maximum sustainable under local culture conditions. feed fish to satiety a minimum of twice per day according to manufacturers guidelines using a high-fat commercial diet of appropriate pellet-size; automatic feeders are recommended. important:you must euthanizeaquadvantage salmon before they leave the grow-out facility for processing. 3. conditions of use rear only in contained, freshwater culture facilities specified in an fda-approved application. do not grow aquadvantage salmon in net pens or release them into the environment. dispose of dead or morbid fish in a manner consistent with local regulations. 4. growth performance in a controlled study conducted for 2700°c-days after first-feeding, aquadvantage salmon and diploid comparators achieved average body weights of 261.0 g and 73.6 g, respectively; the proportion of individual aquadvantage salmon with a body weight greater than 100 g was 98.6% compared to 4.9% for the comparators. these differences in average body weight and proportion of fish weighing more than 100 g at 2700°c-days were significant (p < 0.0001). growth performance at 2700°c-days salmon 5. animal safety in a controlled study, some juvenile aquadvantage salmon exhibited changes in gross morphology similar in number and severity to those observed in diploid comparator salmon; these changes most often affected the operculum and gill structure, jaw, or fins. the degree of change from a perfectly-formed fish was ranked as none, slight, moderate, or severe; the vast majority of these malformations were regarded as slight. no remarkable differences were observed in the morphology of internal body structures or relative organ weights. gross morphologic change in juveniles aquadvantage salmon comparator diploid salmon (n) (%) (n) (%) none 150 89.8 156 83.4 slight 12 7.2 31 16.6 moderate 4 2.4 severe 1 0.6 totals 167 100.0 187 100.0 based on a sampling and assessment of three batches of pre-smolt (~20-60 g) fish from the 2010 and 2012 year classes of aquadvantage salmon, the following types and rates of gross morphologic irregularities were observed: % spinal % jaw % operculum % other moderate irregularities 0 - 4.3 0.1 – 1.4 0 - 5.6 0 - 2.5 severe irregularities1 0 - 0.4 1 severe irregularities are those which could have a significant impact on viability or render the fish unfit for commercial sale. based on data collected on the 2008-2012 year classes of aquadvantage salmon, the following tables present reported typical ranges for mortality and morbidity, respectively, on a monthly basis for different life-stages. mortality observed in aquadvantage salmon by life-stage on a monthly basis1 life stage approximate time period post first feeding in months range of % mortality on a monthly basis eggs and yolk-sac fry 2.2 to 5.1 fry from first feeding to 5 g size ~1 to 2 1.0 to 9.8 pre-smolt ~3 to 5 0.1 to 4.0 juveniles ~6 to 11 0.1 to 1.8 late juveniles to adults ~12 to 24 0.2 to 5.2 1 non-representative high values due to one-time events or atypical conditions have been excluded. morbidity observed in aquadvantage salmon by life-stage on a monthly basis1 life stage approximate time period post first feeding in months range of % morbidity on a monthly basis eggs and yolk-sac fry fry from first feeding to 5 g size ~1 to 2 0 to 0.4 pre-smolt ~3 to 5 0 to 3.2 juveniles ~6 to 11 0 to 2.2 late juveniles to adults ~12 to 24 0 to 3.4 1 observations made on fish that were eventually discarded, which included moribund fish with actual or presumptive disease conditions, those with gross morphological irregularities, and fish of inappropriate size. document and report substantial increases in morbidity, mortality, or incidence of gross morphologic change in aquadvantage salmon as soon as possible to customer support at aquabounty technologies. manufactured, packaged & distributed by aquabounty canada, inc., a wholly-owned subsidiary of aquabounty technologies, inc. approved by fda under nada # 141-454. for more information, contact: customer support 877-824-8544 aquabounty technologies, inc. www.aquabounty.com 233 ayer road ste 4 harvard, ma 01451 usa 1. definición de producto 1.1 identidad una sola copia de la forma-a de unidad compuesta de adn recombinante opafp-ghc2 en el locus-a de la línea eo-1a del salmón atlántico (salmo salar), triploide, hemicigoto y 100% hembra, conocido como salmón aquadvantage. 1.2. aseveración la proporción de salmones aquadvantage que llega a alcanzar 100 gramos o más a los 2700°c-día, es significativamente mayor que los salmones atlánticos comparables. 1.3. restricciones el salmón aquadvantage es producido como ova con ojo y criado únicamente en sistemas cerrados de agua dulce especificados en una solicitud aprobada por el u.s. fda. 2. uso del producto 2.1. recepción inicial remueva el empaque exterior de cartón del contenedor de envío. luego limpie y desinfecte el exterior del contenedor de plástico antes de ingresarlo a la instalación de cultivo. abra el contenedor de plástico en un área designada para la recepción de ovas y remueva las ovas para realizar la desinfección descrita en el punto 2.2. disponga todo el material de empaque y bandejas de ovas vacías acorde a las regulaciones locales. 2.2 manejo y desinfección importante: este producto fue desinfectado previo a su empaque para transporte. si el proceso de eclosión se ha iniciado durante el tránsito, no proceda con la desinfección descrita más abajo. abra la caja de plástico y mida la temperatura de las ovas tanto en la bandeja superior como inferior. si la temperatura de las ovas es 2°c que la temperatura de recepción del agua, iguale lentamente las ovas a la temperatura de recepción, vertiendo suavemente el agua de recepción sobre las ovas hasta que esta diferencia sea menor a 2°c. desinfecte las ovas de acuerdo a las regulaciones locales. después de la desinfección, proceda a lavar las ovas suave pero minuciosamente con agua corriendo a la temperatura de recepción antes de colocarlas en las incubadoras. 2.3 incubación y eclosión considerando un sistema de incubación vertical, coloque no más de 10.000 ovas por bandeja, preferentemente en una capa. ajuste el flujo de agua a ~10 l/min y mantenga la temperatura de a ~6-8°c.* limpie las bandejas individuales, removiendo las ovas muertas, al menos 2 veces por semana. a continuación de la eclosión, use sustratos cuando los alevines estén más activos, típicamente cuando hayan absorbido el ~20% del saco vitelino. * las ovas pueden ser incubadas a temperaturas menores a las indicadas con el propósito de retardar la eclosión. 2.4. primera alimentación y cultivo inicial antes de que el saco vitelino se haya absorbido completamente, transfiera los alevines a tanques apropiados para primera alimentación y gradualmente incremente la temperatura hasta un máximo de ~15-16°c. cuando el saco vitelino este completamente absorbido, incremente el flujo de agua a ~20 l/min. el salmon aquadvantage crece en forma muy rápida en esta etapa de vida. para un máximo crecimiento: es recommendable utilice agua dulce con flujo abierto, en vez de recirculación, hasta que estos estén alimentándose adecuadamente. incremente el numero de horas de luz hasta alcanzar un ciclo de 24 horas luz continua en un periodo de 5 7 dias desde primera alimentracion. alimente a los peces a mano o utilizando un sistema de alimentacion automatico, alimente a saciedad utilizando el adecuando tamaño de pellet, el cual cambiará varias veces durante los 2-3 primeros meses. si las capacidades no permiten óptimas condiciones, alimente los alevines a saciedad un mínimo de 6 veces por día, preferentemente cada hora, durante la jornada diaria de trabajo. bajo cualquier escenario, descargue de los tanques el exceso de alimento al menos una vez al día. durante este periodo, observe los alevines cuidadosamente de tal manera de detectar cambios de comportamiento que pudieran indicar deterioros en las condiciones de cultivo que pueden conllevar mortalidades innecesarias. se recomienda graduar acorde a necesidad teniendo en cuenta el crecimiento acelerado de estos peces. 2.5. engorda y proceso transfiera los alevines a tanques más grandes para su engorde, acorde a prácticas establecidas. para optimizar el crecimiento mantenga el nivel de oxígeno disuelto en un valor mínimo de 7 mg/l y densidades de cultivo menores a las condiciones máximas de cultivo local sustentable. alimente a los peces a saciedad, mínimo dos veces al día acorde a las recomendaciones de los proveedores de alimento, usando dietas altas en lípidos, tamaños de pellets adecuados y sistemas de alimentación automáticos. importante: los salmones aquadvantage deben ser sacrificados antes de salir de las instalaciones de cultivo para ser procesados. 3. condiciones de uso sólo para ser cultivados en sistemas de agua dulce, especificados en una solicitud aprobada por el u.s. fda. no cultive los salmones aquadvantage en redes - jaulas ni los libere al medio ambiente. disponga los peces muertos o moribundos acorde a las regulaciones locales. 4. crecimiento en un estudio bajo condiciones controladas desarrollado por 2700°c-día después de primera alimentación, los salmones aquadvantage y los diploides comparables, obtuvieron un peso de 261.0 g. y 73.6 g. respectivamente. además, la proporción de individuos aquadvantage con un peso superior a 100 g fue de 98.6% en comparación con 4.9% de sus similares no transgénicos. estas diferencias en promedio de peso y proporción de peces con pesos mayores a 100 g a los 2700°c-día son estadísticamente significativas (p < 0.0001). crecimiento a los 2700°c-día salmón aquadvantage salmón diploide comparable número de peces 369 306 peso promedio (g)  ± es 261.0 ± 3.3 72.6 ± 1.0 rango de peso 16.9 - 426.3 11.0 - 118.0 peces >100 g (%) 364 (98.6) 15 (4.9) 5. seguridad animal en un estudio controlado, algunos juveniles de salmón aquadvantage presentaron cambios morfológicos similares en número y severidad a los observados en salmones diploides no transgénicos: estos cambios en la mayoría de los casos afectaron a los opérculos, branquias, mandíbula o aletas. el grado de cambio morfológico puede variar entre no existente, ligero, moderado o severo. en el caso de los salmones aquadvantage es considerado como leve. no se observaron diferencias marcadas en la morfología interna o peso relativo de órganos. cambios morfológicos generales en juveniles salmón aquadvantage salmón diploide comparable (n) (%) (n) (%) ninguno 150 89.8 156 83.4 leve 12 7.2 31 16.6 moderado 4 2.4 severo 1 0.6 totales 167 100.0 187 100.0 basado en muestreos y evaluaciones de tres grupos de peces pre-smolt (~20-60 g) de las generaciones de los anos 2010 y 2012 del salmón aquadvantage, se observaron los siguientes tipos y porcentajes de evidentes irregularidades morfológicas: % columna vertebral % mandibula % operculo % otros irregularidades moderadas 0 - 4.3 0.1 – 1.4 0 - 5.6 0 - 2.5 irregularidades severas1 0 - 0.4 1 irregularidades severas son aquellas que pueden tener un impacto significativo sobre la viabilidad o valor comercial de los peces. las siguientes tablas - basadas en los datos recogidos de las generaciones de los anos 2008-2012 del salmón aquadvantage -presentan los rangos típicos mensuales de mortalidad y morbididad observadas en las diferentes etapas de vida. mortalidad mensual, por etapa de vida, observada en el salmón aquadvantage 1 etapa de vida periodo de tiempo aproximado (en meses) despues de primera alimentacion rango  de mortalidad por mes (%) ovas y alevines de saco 2.2 - 5.1 alevines – desde primera alimentación hasta 5 g ~1 - 2 1.0 - 9.8 pre-smolt ~3 - 5 0.1 - 4.0 juveniles ~6 - 11 0.1 - 1.8 pre-adulto hasta adulto ~12 - 24 0.2 - 5.2 1 valores altos no-representativos resultando de eventos singulares o condiciones atipicas han sido excluidos.     morbididad mensual, por etapa de vida, observada en el salmón aquadvantage 1 etapa de vida periodo de tiempo aproximado (en meses) despues de primera alimentacion rango de mortalidad por mes (%) ovas y alevines de saco alevines – desde primera alimentación hasta 5 g ~1 - 2 0 – 0.4 pre-smolt ~3 - 5 0 – 3.2 juveniles ~6 -11 0 – 2.2 pre-adulto hasta adulto ~12 - 24 0 – 3.4 1  observaciones realizadas en peces que luego fueron eventualmente descartados, incluyendo peces moribundos con signos evidentes o presuntos de enfermedad, peces con reales irregularidades morfologicas y peces de un tamano inapropriado. registre y reporte incrementos sustanciales de morbilidad, mortalidad o incidencia de cambios morfológicos generales en los salmones aquadvantage tan pronto como sea posible a servicios al cliente de aquabounty technologies. producido, empacado y distribuido por aquabounty canadá, subsidiario de aquabounty technologies inc. aprobado por la fda bajo nada # 141-454. para mayor información contacte a: servicio al cliente 877-824-8544 aquabounty technologies, inc. www.aquabounty.com 233 ayer road ste 4 harvard, ma 01451 usa

Israeli - Kiingereza - Ministry of Health

j-c health care ltd - infliximab - powder for concentrate for infusion - infliximab 100.0 mg/vial - infliximab - infliximab - - adult :- crohn's disease: treatment of moderate to severe active crohn's disease in patients who have not responded despite of a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant. treatment of fistulising crohn's disease in patients who have not responded despite of a full and adequate course of therapy with conventional treatment. - paediatric crohn's disease: remicade is indicated for: treatment of severe active crohn's disease in paediatric patients aged 6 to 17 years who have not responded to conventional therapy including a corticosteroid an immunomodulator and primary nutrition therapy or who are intolerant to or have contraindications for such therapies. remicade has been studied only in combination with conventional immunosuppressive therapy - ankylosing spondylitis: remicade is indicated for: treatment of ankylosing spondylitis in patients who have severe axial symptoms elevated serological markers of inflammatory activity and who have responded inadequately to conventional therapy. - psoriatic arthritis : remicade is indicated for : treatment of active and progressive psoriatic arthritis in adults when the response to previous dmard therapy has been inadequate. remicade should be administered : either in combination with methotrexate or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated. - remicade has been shown to improve physical function in patients with psoriatic arthritis and to reduce the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease. - rheumatoid arthritis: remicade in combination with methotrexate is indicated for the reduction of signs and symptoms as well as the improvement in physical function in: patients with active disease when the response to disease-modifying drugs including methotrexate has been inadequate. patients with severe active and progressive disease not previously treated with methotrexate or other dmards. in this these patient populations a reduction in the rate of the progression of joint damage as measured by x-ray has been demonstrated - psoriasis: remicade is indicated for: treatment of moderate to severe plaque psoriasis in adults who failed to respond to or who have a contraindication to or are intolerant to other systemic therapy including cyclosporine methotrexate or puva. - ulcerative colitis: remicade is indicated for: treatment of moderately to severely active ulcerative colitis in patients who have had an inadequate response to convential therapy including corticosteroids and 6-mp or aza or who are intolerant to or have medical contraindications for such therapies.- paediatric ulcerative colitis: remicade is indicated for treatment of severely active ulcerative colitis, in paediatric patients aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6 mp or aza, or who are intolerant to or have medical contraindications for such therapies

Ayalandi - Kiingereza - HPRA (Health Products Regulatory Authority)

statens serum institute - mycobacterium bovis (bcg) stam 1331 - pdr+solv for susp for inj - %v/v - tuberculosis vaccines

Ayalandi - Kiingereza - HPRA (Health Products Regulatory Authority)

aj vaccines a/s - mycobacterium bovis (bcg) stam 1331 - powder and solvent for suspension for injection - 0 colony forming unit(s)/millilitre - tuberculosis vaccines; tuberculosis, live attenuated

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

juno pharmaceuticals pty ltd - 44670 - bladder instillation, barrier - procedure pack consisting of a clear plastic pre-filled syringe containing a sterile aqueous solution of hyaluronic acid sodium salt (1.6%), sodium chondroitin sulphate (2%) and calcium chloride administered as a bladder instillation via connection to a catheter using the leur lock adaptor and the ialuadapter included in the pack. the ialuadapter allows for administration by either the patient or healthcare professional. ialuril is indicated to re-establish the glycosaminoglycan layers (gags) of the urothelial vesical tissue in cases in which their loss can cause frequent and recurring problems such as painful bladder syndrome (pbs), interstitial cystitis, treatment and prevention of recurrent urinary tract infection, cystitis as a result of bacillus calmette ? guerin therapy, or chemical and radiation therapy. ialuril is also indicated in the cases where the loss of the glycosaminoglycan layers (gags) is associated with forms of chronic inflammation, in which their composition and integrity appears compromised in different ways.

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

juno pharmaceuticals pty ltd - 44670 - bladder instillation, barrier - clear plastic pre-filled syringe containing a sterile aqueous solution of hyaluronic acid sodium salt (1.6%), sodium chondroitin sulphate (2%) and calcium chloride administered as a bladder instillation via a catheter. ialuril prefill is indicated to re-establish the glycosaminoglycan layers (gags) of the urothelial vesical tissue in cases in which their loss can cause frequent and recurring problems such as painful bladder syndrome (pbs), interstitial cystitis, treatment and prevention of recurrent urinary tract infection, cystitis as a result of bacillus calmette ? guerin therapy, or chemical and radiation therapy. ialuril prefill is also indicated in the cases where the loss of the glycosaminoglycan layers (gags) is associated with forms of chronic inflammation, in which their composition and integrity appears compromised in different ways.

Marekani - Kiingereza - NLM (National Library of Medicine)

boehringer ingelheim animal health usa inc. - cephapirin sodium (unii: 431lff7i7j) (cephapirin - unii:89b59h32vn) - cephapirin 200 mg in 10 ml - for lactating cows only / for the treatment of bovine mastitis today (cephapirin sodium) for intramammary infusion should be used at the first signs of inflammation or at the first indication of any alteration in the milk. treatment is indicated immediately upon determining, by c.m.t. or other tests, that the leukocyte count is elevated, or that a susceptible pathogen has been cultured from the milk. today for intramammary infusion has been shown to be efficacious in the treatment of mastitis in lactating cows caused by susceptible strains of streptococcus agalactiae and staphylococcus aureus including strains resistant to penicillin. indicaciones Únicamente para vacas lactantes / para el tratamiento de mastitis bovina today (cefapirina sódica) para infusión intramamaria deberá administrarse desde los primeros signos de inflamación o al primer indicio de cualquier alteración de la leche. el tratamiento resulta indicado inmediatamente después de determinar mediante la prueba de california para mastitis (c.m.

Marekani - Kiingereza - NLM (National Library of Medicine)

janssen biotech, inc. - infliximab (unii: b72hh48flu) (infliximab - unii:b72hh48flu) - infliximab, license holder unspecified 100 mg in 10 ml - remicade is indicated for: - reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active crohn's disease (cd) who have had an inadequate response to conventional therapy. - reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing cd. remicade is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active cd who have had an inadequate response to conventional therapy. remicade is indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis (uc) who have had an inadequate response to conventional therapy. remicade is indicated for reducing signs and symptoms and inducing and maintaining clinical remi