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Each tablet contains 600 mg praziquantel for oral application
These tablets are donated by Merck KGaA, Darmstadt, Germany,
to the World Health Organization(WHO) for distribution
free of charge in designated schistosomiasis control projects.
INDICATIONS
Treatment of schistosoma infections (e. g. due to S. haematobium, S. mansoni, S. intercalatum, S. japonicum, S. mekongi).
Treatment of infections with liver flukes (e. g. Clonorchis sinensis, Opisthorchis viverrini) and lung flukes (e. g. Paragonimus westermani and other species).
POSOLOGY AND METHOD OF ADMINISTRATION
Individual doses in each case must be administered depending on the diagnosis. Based on clinical experience, the following dosages are recommended for the treatment of patients infected by:
Schistosoma haematobium: 1 x 40 mg/kg bodyweight as 1-day treatment
Schistosoma mansoni, S. intercalatum: 1 x 40 mg or 2 x 20 mg/kg bodyweight as 1-day treatment
Schistosoma japonicum, S mekongi: 1 x 60 mg or 2 x 30 mg/kg bodyweight as 1-day treatment
Clonorchis sinensis, Opisthorchis viverrini: 3 x 25 mg/kg bodyweight as 1- to 3-day treatment
Paragonimus westermani and others: 3 x 25 mg/kg bodyweight as 2- to 3-day treatment
The tablets should be swallowed whole with a little liquid, preferably during or after meals.
With single daily doses it is recommended to take the tablets in the evening.
If ingestion of tablets several times a day is prescribed, the interval between administration should not be less than 4 h and not more than 6 h.
Special monitoring advice: When broken, each of the four segments contain 150 mg of active ingredient, so that the dosage can be easily adjusted to the patient's bodyweight.
Children: Safety in children under 4 years of age has not been established
Hepatic impairment: see „Special Warnings and Precautions for Use“
Renal impairment: see „Special Warnings and Precautions for Use“
CONTRAINDICATIONS
Praziquantel must not be used in cases of known hypersensitivity to praziquantel.
Since parasite destruction within the eye may cause irreparable lesions, ocular cysticercosis should not be treated with this compound.
The concomitant administration of strong inducers of cytochrome P 450 such as rifampin must be avoided as therapeutically effective plasma levels may not be achieved.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Since 80% of praziquantel and its metabolites are excreted in the kidneys, excretion might be delayed in patients with impaired renal function. Nephrotoxic effects of praziquantel are not known.
In uncompensated liver insufficiency and in patients with hepatosplenic schistosomiasis caution should be taken, since due to reduced drug metabolization in the liver, considerably higher and longer lasting concentrations of unmetabolized praziquantel can occur in vascular and/or collateral circulation, leading to prolonged plasma half-life. If necessary, the patient may be hospitalized for the duration of the treatment.
Patients suffering from cardiac irregularities should be monitored during treatment.
When schistosomiasis or fluke infection is found in patients living in or coming from areas with endemic human cysticercosis, it is advised to hospitalise the patient for the duration of treatment.
Ability to drive and use machines: Because of possible effects on vigilance patients should be warned not to drive a car and not to operate machinery on the day of treatment (and during the subsequent 24 hours).
INTERACTION WITH OTHER MEDICAMENTS AND OTHER FORMS OF
INTERACTION
Concomitant administration of drugs increasing the activity of drug metabolizing liver enzymes (cytochrome P450), e.g. antiepileptic drugs, dexamethasone may reduce plasma levels of praziquantel. Concomitant administration of strong inducers of cytochrome P450 such as rifampin must be avoided. Praziquantel should also not be taken together with grape fruit juice. Concomitant administration of drugs decreasing the activity of drug metabolizing liver enzymes (cytochrome P 450) e.g. cimetidine, may increase plasma levels of praziquantel. Chloroquine, when taken simultaneously, can lead to lower concentrations of praziquantel in blood.
PREGNANCY AND LACTATION
In accordance with the general guidelines on the use of drugs in pregnancy, the application of praziquantel especially in the first 3 months of pregnancy is recommended only after a careful risk/benefit evaluation. Animal studies did not reveal any feto- or embryotoxic effects.
Praziquantel appears in the milk of nursing women at a concentration of 20-25% that of maternal serum. It is not known, whether a pharmacological effect is likely to occur in infants. Nevertheless, accurate diagnosis is imperative during lactation. For short-term therapy breastfeeding should be suspended for the day(s) of treatment and the following 24 hours.
The issue of schistosomiasis, pregnancy and lactation has been addressed by a meeting of experts at the WHO in Geneva in 2002. After reviewing two decades of clinical experience with praziquantel and the results of an extensive risk/benefit analysis, it has been recommended that, in areas where schistosomiasis is endemic, all pregnant and lactating women should be considered as high risk group and should be treated with praziquantel (Olds, 2003, WHO, 2002).
UNDESIRABLE EFFECTS
Side effects vary according to dose and duration of praziquantel medication; furthermore they are dependent on the parasite species, extent of parasitisation, duration of infection and localisation of the parasites in the body.
Adverse Reactions based on publications and on spontaneous reports sorted by CIOMS III categories of frequency and COSTART (5th, edition 1995) body system and calculated on patient exposure (status: 30.04.1999).
Incidence of frequency > 10 %
Digestive system: abdominal pain; nausea; vomiting
Nervous system: headache; dizziness
Incidence of frequency >1 % - < 10 %
Digestive system: anorexia (inappetence)
Nervous system: vertigo; somnolence (drowsiness)
Body as a whole: asthenia (weakness); fever (elevated temperature)
Musculo skeletal system: myalgia
Skin and appendages: urticaria
Incidence of frequency < 0.01 %
Body as a whole: allergic reaction (generalised hypersensitivity) including polyserositis
Digestive system: bloody diarrhea
Cardiovascular system: arrhythmia
Nervous system: convulsion (seizures)
It is often not clear, whether the complaints reported by patients or the undesirable effects reported by the physician are caused by praziquantel itself (I, direct relation), or may be considered to be an endogenous reaction to the death of the parasites produced by praziquantel (II, indirect relation), or are symptomatic observations of the infestation (III, no relation). It may be difficult to differentiate between the possible variations I, II and III.
OVERDOSE
In rats and mice the acute LD50 was about 2.500 mg/kg. No data are available in humans. In the event of overdose a fast acting laxative should be given.
PHARMACODYNAMIC PROPERTIES
In vitro studies on trematodes and cestodes (tapeworms) have shown that praziquantel induces a rapid contraction of schistosomes by a specific effect on the permeability of the cell membranes. The drug further causes vacuolization and disintegration of the schistosome tegument. An increased Ca2 - influx may play an important role.
Secondary effects are inhibition of glucose uptake, lowering of glycogen levels and stimulation of lactate release. The action of praziquantel is limited very specifically to trematodes and cestodes; nematodes (including filariae) are not affected.
PHARMACOKINETIC PROPERTIES
Absorption: After oral administration praziquantel is rapidly and completely absorbed. Maximal plasma concentrations are achieved within 1-2 hours.
The drug's concentration is 0,05 to 5,0 mg/L in peripheral blood after administration of 5 to 50 mg/kg;the concentration in the mesenteric vein is 3 to 4 times higher compared to peripheral blood.
The half-life of unchanged praziquantel is 1-2,5 hours. The half-life of total radioactivity (praziquantel plus metabolites) after administration of 14C-praziquantel is 4 hours.
For attaining a therapeutic effect plasma levels of 0,6 M/L (= 0.19 mg/L) have to be maintained for 4- 6 (up to 10) hours.
Distribution: Unchanged praziquantel passes the liquor barrier; its concentration in liquor is estimated to be 10% to 20% of the plasma concentration.
Metabolism: Praziquantel is rapidly metabolized by a first pass effect. Main metabolites are hydroxylated degradation products of praziquantel.
Excretion: Praziquantel is eliminated predominantly via the kidneys. More than 80% of the dose administered is eliminated renally within 4 days, 90% of this amount within the first 24 hours.
PRECLINICAL SAFETY DATA
The acute toxicity in rats, mice, rabbits and dogs is very low.
Praziquantel was not found to be carcinogenic in chronic toxicity studies in rats and hamsters.
Praziquantel did not cause any teratogenic or embryotoxic effects in mice, rats and rabbits and did not affect fertility of rats.
Extensive studies in various test systems have yielded no evidence of mutagenicity.
PHARMACEUTICAL PARTICULARS
The tablets are oblong shaped, have three both-sided breaking scores and are embossed at one side with “E M”.
List of exciepients:starch, povidone, microcrystalline cellulose, magnesium stearate, sodium lauryl sulfate.
Incompatibilities: None
Shelf life: climatic zone IV: 3 years
Special precautions for use: None
Nature and contents of container: quadrangular flask (polyethylene) with a blue cap (polypropylene). Each flask contains 1000 praziquantel tablets and a sachet with silicagel as drying agent.
Instructions for use / handling: These tablets should not be used after the expiry date. The expiry date and batch number are printed at the bottom of the container.
Medicinal product, keep out of reach of children.
Store below 30°C. Protect from light and humidity.
Manufactured by Merck, S.A. de C.V., Mexico for
Merck KGaA, Darmstadt, Germany, Frankfurter Str. 250
Internet: http://www.merck.de
Translation - English Prazicuantel comprimidos 600 mg
Cesol® 600
Cada comprimido de administración oral contiene 600 mg de prazicuantel.
Estos comprimidos han sido donados por Merck KGaA, Darmstadt, Alemania a la Organización Mundial de la Salud para su distribución gratuita en proyectos especiales de lucha contra la esquistosomiasis.
INDICACIONES
Tratamiento de las infecciones causadas por esquistosomas (e.g., S. haematobium, S. mansoni, S. intercalatum, S. japonicum, S. mekongi).
Tratamiento de las infecciones causadas por trematodos hepáticos (e.g., Clonorchis sinensis, Opisthorchis viverrini) y trematodos pulmonares (e.g., Paragonimus westermani y otras especies).
POSOLOGÍA Y FORMA DE ADMINISTRACIÓN
En todos los casos, las dosis se deben administrar de acuerdo con el diagnóstico. Sobre la base de la experiencia clínica, se recomiendan las siguientes dosificaciones para tratar a pacientes infectados por:
Schistosoma haematobium: 1 x 40 mg/kg de peso corporal para tratamientos de 1 día.
Schistosoma mansoni, S. intercalatum: 1 x 40 mg/kg o 2x 20 mg/kg de peso corporal para tratamientos de 1 día.
Schistosoma japonicum, S mekongi: 1 x 60 mg/kg o 2x 30 mg/kg de peso corporal para tratamientos de 1 día.
Clonorchis sinensis, Opisthorchis viverrini: 3 x 25 mg/kg de peso corporal para tratamientos de 1 a 3 días.
Paragonimus westermani y otros: 3 x 25 mg/kg de peso corporal para tratamientos de 2 a 3 días.
Los comprimidos se deben tragar enteros con un poco de líquido, preferiblemente con las comidas o después de ellas.
Cuando se toma una sola dosis diaria, se recomienda tomarla por la noche.
Si se prescriben comprimidos varias veces al día, el intervalo entre las tomas no debe ser inferior a 4 horas ni superar las 6 horas.
Recomendaciones y advertencias especiales: Cuando se fracciona el comprimido, cada uno de los cuatro segmentos contiene 150 mg de ingrediente activo, de modo que es sencillo ajustar la dosis de acuerdo con el peso corporal del paciente.
Niños: No se ha establecido su inocuidad en niños menores de 4 años.
Insuficiencia hepática: ver Advertencias y precauciones especiales de uso
Insuficiencia renal: ver Advertencias y precauciones especiales de uso
CONTRAINDICACIONES
No se debe administrar prazicuantel a personas con hipersensibilidad conocida al principio activo.
Como la destrucción del parásito en el ojo puede causar lesiones irreparables, no se debe tratar con este compuesto la cisticercosis ocular.
Se debe evitar la administración simultánea con inductores potentes del citocromo P 450, como rifampina, ya que es posible que no se alcancen niveles terapéuticos eficaces del compuesto.
ADVERTENCIAS Y PRECAUCIONES ESPECIALES DE USO
Como el 80% del prazicuantel y sus metabolitos se excretan por vía renal, la excreción puede ser más lenta en pacientes con deterioro de la función renal. No se han observado efectos nefrotóxicos del prazicuantel.
Este fármaco se debe administrar con precaución a pacientes con insuficiencia hepática no compensada y a pacientes con esquistosomiasis hepatoesplénica, porque la menor metabolización del compuesto en el hígado puede generar concentraciones considerablemente más elevadas y más prolongadas de prazicuantel inalterado en la circulación vascular y/o colateral, y, por lo tanto, la semivida plasmática podría ser más larga. Si es necesario, se puede hospitalizar al paciente durante el tratamiento.
Se debe monitorizar durante el tratamiento a los pacientes con trastornos cardíacos.
Cuando se detecta esquistosomiasis o infección por trematodos en pacientes que residen en zonas con cisticercosis humana endémica, o que provienen de esas zonas, se recomienda la hospitalización durante el tratamiento.
Efectos sobre la capacidad para conducir vehículos y manejar maquinaria A causa de los posibles efectos sobre el estado de vigilia, se debe advertir a los pacientes que no conduzcan vehículos ni operen maquinaria el día del tratamiento (y tampoco el día siguiente).
INTERACCIONES MEDICAMENTOSAS Y OTRAS INTERACCIONES
La administración simultánea con sustancias que aumentan la actividad de las enzimas hepáticas que metabolizan fármacos (citocromo P450), como antiepilépticos y dexametasona, puede disminuir los niveles plasmáticos de prazicuantel. Se debe evitar la administración simultánea con inductores potentes del citocromo P450, como rifampina. También se debe evitar tomar prazicuantel con jugo de pomelo. La administración simultánea con sustancias que disminuyen la actividad de enzimas hepáticas (citocromo P450) que metabolizan el fármaco, como cimetidina, puede hacer que aumenten los niveles plasmáticos de prazicuantel. La cloroquina, cuando se administra simultáneamente, puede disminuir las concentraciones sanguíneas de prazicuantel.
EMBARAZO Y LACTANCIA
De acuerdo con las directrices generales para la administración de medicamentos durante el embarazo, se recomienda una evaluación cuidosa de la relación riesgo/beneficio antes de administrar prazicuantel a embarazadas, especialmente en los tres primeros meses de gestación. Estudios en animales no revelaron efectos fetotóxicos/embriotóxicos.
Prazicuantel está presente en la leche materna en concentraciones que representan un 20-25% de las observadas en el suero materno. No se sabe si tiene algún efecto farmacológico en los lactantes. De todos modos, el diagnóstico preciso es imperativo durante la lactancia. En caso de tratamientos breves, la lactancia se debe interrumpir durante el día o los días de tratamiento y las siguientes 24 horas.
El tema de la esquistosomiasis, el embarazo y la lactancia ha sido analizado en una reunión de expertos realizada en la OMS, en Ginebra, en el año 2002. Después de revisar la experiencia clínica con prazicuantel durante dos décadas y los resultados de un extenso análisis sobre la relación riesgo/beneficio, se recomendó considerar grupo de alto riesgo a todas las mujeres embarazadas y en período de lactancia de las zonas en las que la esquistosomiasis es endémica, y tratarlas con prazicuantel (Olds, 2003, WHO 2002).
EFECTOS NO DESEADOS
Los efectos colaterales varían de acuerdo con la dosis y la duración del tratamiento con prazicuantel; además, dependen de la especie del parásito, la extensión de la parasitosis, la duración de la infección y la localización de los parásitos en el organismo.
Reacciones adversas basadas en publicaciones e informes espontáneos clasificados por categorías de frecuencia CIOMS III y términos y sistemas corporales COSTART (5ta edición, 1995), y calculadas por paciente expuesto (al 30.04.1999).
Incidencia o frecuencia > 10%
Sistema digestivo: dolor abdominal, náuseas, vómitos.
Sistema nervioso: cefalea, mareos.
Incidencia o frecuencia >1 % - < 10 %
Sistema digestivo: anorexia (falta de apetito)
Sistema nervioso: vértigo, somnolencia.
Sistémicos astenia (debilidad), fiebre (aumento de la temperatura).
Sistema musculoesquelético: mialgia.
Piel y faneras: urticaria
Incidencia o frecuencia
Spanish to English: Malaria
Source text - Spanish ORIGINAL TRANSLATION
FACT FILE
10 facts on malaria
1
Malaria is a disease which can be transmitted to people of all ages. It is caused by parasites of the species plasmodium that are spread from person to person through the bites of infected mosquitoes. If not treated promptly with effective medicines, malaria can often be fatal.
2
About 40% of the world’s population, mostly those living in the poorest countries, are at risk of malaria. Of these 2.5 billion people at risk, more than 500 million people become severely ill with malaria every year and more than 1 million people die from the effects of the disease.
3
One in five (20%) of all childhood deaths in Africa are due to malaria. It is estimated that an African child has on average between 1.6 and 5.4 episodes of malaria fever each year. Every 30 seconds a child dies from malaria in Africa.
4
Early diagnosis and prompt treatment are two basic elements of malaria control. Early and effective treatment of malaria can shorten the duration of the infection and prevent further complications including the great majority of deaths. Access to disease management should be seen not only as a component of malaria control but a fundamental right of all populations at risk.
5
Inappropriate use of antimalarial drugs in the past century contributed to widespread resistance in the malaria parasite to drugs such as chloroquine, leading to rising rates of sickness and death. Over the past decade, a new group of antimalarials – known as artemisinin-based combination therapies -- has brought new hope in the fight against malaria.
6
The main objective of malaria vector control is to significantly reduce the rate and number of cases of both parasite infection and clinical malaria. This is achieved by controlling the malaria-bearing mosquito and thereby reducing or interrupting transmission.
7
Long-lasting insecticidal nets can be used to provide protection to risk groups, especially young children and pregnant women in high transmission areas. This provides personal protection. The nets can also protect communities when coverage is high enough (more than 80% of people in a target community sleeping inside them). The nets are effective for a number of years (3 to 5 years, depending on models and conditions of use).
8
Indoor residual spraying is the most effective means of rapidly reducing mosquito density. Its full potential is obtained when at least 80 % of premises with malaria vectors are sprayed. Indoor spraying is effective for 3 to 6 months, depending on the insecticide used and the type of surface on which it is sprayed. (DDT is effective for longer periods, up to 12 months in some cases).
9
Pregnant women are at high risk not only of dying from the complications of severe malaria, but also spontaneous abortion, premature delivery or stillbirth. Malaria is also a cause of severe maternal anaemia and is responsible for about one third of preventable low birth weight babies. It contributes to the deaths of an estimated 10 000 pregnant women and up to 200 000 infants each year in Africa alone.
10
Malaria causes an average loss of 1.3% of annual economic growth in countries with intense transmission. It traps families and communities in a downward spiral of poverty, disproportionately affecting marginalized and poor people who cannot afford treatment or who have limited access to health care. Malaria has lifelong effects through increased poverty and impaired learning. It cuts attendance at schools and workplaces. However, it is preventable and curable.
Translation - English TRANSLATION
Cifras y datos
10 datos sobre el paludismo
El paludismo es una enfermedad que pueden contraer personas de todas las edades. Causada por parásitos de la especie Plasmodium, se transmite de persona a persona a través de la picadura de mosquitos infectados. Si no se trata rápidamente con medicamentos eficaces, puede ser letal.
Aproximadamente el 40% de la población mundial está expuesta al paludismo, especialmente las personas que viven en los países más pobres. De esos 2.500 millones de personas en riesgo, más de 500 millones enferman gravemente cada año y más de 1 millón muere a causa de esta enfermedad.
El paludismo es la causa de una de cada cinco muertes infantiles (20%) en África. Se calcula que un niño africano tiene en promedio de 1,6 a 5,4 episodios de fiebre palúdica por año. En África, cada 30 segundos muere un niño de paludismo.
El diagnóstico y el tratamiento tempranos son elementos básicos para controlar la enfermedad. El tratamiento temprano y eficaz puede acortar la duración de la infección y prevenir complicaciones posteriores, entre ellas la gran mayoría de las muertes. El acceso al tratamiento debe ser considerado no sólo un componente del control del paludismo sino un derecho fundamental de toda la población en riesgo.
En el pasado siglo, el uso inadecuado de los fármacos antipalúdicos contribuyó a generalizar la resistencia del parásito del paludismo a medicamentos como cloroquina, y aumentó las tasas de morbilidad y mortalidad de la enfermedad. En la última década, un nuevo grupo de antipalúdicos –los tratamientos combinados basados en artemisina- ha reavivado la esperanza en la lucha contra el paludismo.
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