FrancophonIA/ELRC3.0 huggingface dataset:
English: 20 mg/sachet Grannules for oral solution
Spanish: 20 mg/sachet Granulado para solución oral
English: CT-Arzneimittel Gmbh Lengeder Str. 42a D-13407 Berlin Germany
Spanish: Ct-Arzneimittel Gmbh Lengeder Str. 42a D-13407 Berlin Alemania
English: Combination therapy with gastro-protective agents (e.g. misoprostol or proton pump inhibitors) should also be carefully considered for all patients and in particular for the elderly.
Spanish: debe valorarse también cuidadosamente el tratamiento combinado con fármacos gastroprotectores (como misoprostol o inhibidores de la bomba de protones) para todos los pacientes y, en particular, para los de edad avanzada.
English: Via Giacomo Chiesi 43100 Parma Italy
Spanish: Via Giacomo Chiesi 43100 Parma Italia
English: D-85737 Ismaning Germany
Spanish: D-85737 Ismaning Alemania
English: 10mg/gm Cream
Spanish: 10mg/gm Crema
English: Pfizer Limited Walton Oaks, Dorking Road Walton-0n-The-Hill Surrey KT20 7NS United Kingdom
Spanish: Pfizer Limited Walton Oaks, Dorking Road Walton-0n-The-Hill Surrey KT20 7NS Reino Unido
English: Post-operative pain
Spanish: Dolor postoperatorio
English: 0.5g/50g - 50g Cream
Spanish: 0.5g/50g - 50g Crema
English: Boulevard De La Plaine 17 B-1050 Brussels Belgium
Spanish: Boulevard De La Plaine 17 B-1050 Brussels Bélgica
English: − The CHMP considered that the benefit/risk balance for systemic formulations of piroxicam is positive in the treatment of symptomatic relief of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis; however the CHMP considered that the benefit/risk balance of piroxicam in the treatment of acute conditions is negative and that these indications should be revoked.
Spanish: − que el CHMP ha concluido que la relación entre beneficio y riesgo para las formulaciones sistémicas de piroxicam es positiva en el tratamiento del alivio sintomático de la artrosis, la artritis reumatoide y la espondilitis anquilosante; que el CHMP ha estimado, no obstante, que la relación entre beneficio y riesgo del piroxicam en el tratamiento de procesos agudos es desfavorable y que esas indicaciones deben ser revocadas; que se han añadido una serie de restricciones de uso, se han reforzado las advertencias y se han añadido contraindicaciones al Resumen de las Características del Producto y al Prospecto con relación a la seguridad gastrointestinal y cutánea;
English: Oral
Spanish: Via oral
English: 3640 Ae Mijdrecht
Spanish: 3640 Ae Mijdrecht Paises Bajos
English: Keresztúri U. 30-38 1106 Budapest Hungary
Spanish: Keresztúri U. 30-38 1106 Budapest Hungría
English: United Kingdom Trinity-Chiesi Pharmaceuticals Limited Cheadlw Royal Business Park
Spanish: Trinity Chiesi Pharmaceuticals Ltd Cheadle Royal Business Park
English: Marketing Authorisation Holder
Spanish: Estado miembro Titular de la Autorización de Comercialización
English: Walton-0n-The-Hill Surrey KT20 7NS United Kingdom
Spanish: Dorking Road Walton-0n-The-Hill Surrey KT20 7NS Reino Unido
English: Box 158 Skøyen N-0212 Oslo Norway
Spanish: Alpharma P.O. Box 158 Skøyen N-0212 Oslo Noruega
English: • Patient history of gastrointestinal disorders that predispose to bleeding disorders such as ulcerative colitis, Crohn's disease, gastrointestinal cancers or diverticulitis.
Spanish: • Pacientes con antecedentes de alteraciones gastrointestinales que le predispongan a padecer trastornos hemorrágicos como colitis ulcerosa, enfermedad de Crohn, cánceres gatrointestinales o diverticulitis
English: Ratiopharm Gmbh Graf-Arco-Str. 3 D-89079 Ulm Germany
Spanish: Ratiopharm Gmbh Graf-Arco-Str. 3 D-89079 Ulm Alemania
English: Zerospam20 mg/cap Hard capsules
Spanish: Zerospam20 mg/cap Cápsula dura
English: Maximo Aguirre, 14 48940 Lamiaco-Lejona Spain
Spanish: Maximo Aguirre, 14 48940 Lamiaco-Lejona España
English: Felcam20 mg/cap Hard capsules
Spanish: Felcam20 mg/cap Cápsula dura
English: D-25870 Norderfriedrichskoog Germany
Spanish: D-25870 Norderfriedrichskoog Alemania
English: Bruxicam 0,5% 0.50% Eye Drops, Solution Ocular
Spanish: Bruxicam 0,5% 0.50% Colirio en solución Vía oftálmica
English: Merckle Gmbh Ludwig-Merckle-Strasse 3 P.O.
Spanish: Merckle Gmbh Ludwig-Merckle-Strasse 3 P.O. Box 1161
English: 4870 Ag Etten Leur The Netherlands
Spanish: 4870 Ag Etten Leur Paises Bajos dispersable
English: Pharmagenus ,S.A Passeig De Gracia, 55 5º 1ª.
Spanish: Pharmagenus ,S.A Passeig De Gracia, 55 5º 1ª. 08007 Barcelona España
English: 10 mg/1 g Cream
Spanish: 10 mg/1 g Crema
English: Gerakas 15344 Greece
Spanish: Gerakas 15344 Grecia
English: United Kingdom Manx Healthcare Taylor Group House Wedgnock Lane
Spanish: Manx Healthcare Taylor Group House Wedgnock Lane Warwick CV34 5YA Reino Unido
English: Tad Pharma Gmbh Heinz-Lohmann-Str. 5 D-27472 Cuxhaven Germany
Spanish: Tad Pharma Gmbh Heinz-Lohmann-Str. 5 D-27472 Cuxhaven Alemania
English: Chiesi España, S.A. Av. Berlin, 38-48 7ª Planta 08029 Barcelona Spain
Spanish: Av. Berlin, 38-48 7ª Planta 08029 Barcelona España
English: Docpharma N.V. Ambachtenlaan B-3001 Heverlee Belgium
Spanish: Ambachtenlaan B-3001 Heverlee Bélgica
English: Granulát
Spanish: Granulado
English: Chiesi Farmaceutici Spa, Via Palermo, 26/A 43100 Parma Italy
Spanish: Chiesi Farmaceutici Spa, Via Palermo, 26/A 43100 Parma Italia
English: Following dental treatment and in the course of infections Relief of fever and pain associated with acute upper respiratory tract inflammation.
Spanish: Después del tratamiento dental y en el transcurso de infecciones dentales Alivio de la fiebre y del dolor asociado con inflamación aguda del tracto respiratorio superior Trastornos musculoesqueléticos agudos (por ejemplo bursitis, tendinitis) Trastornos postraumáticos agudos
English: De Burgos 16 D - 5ª Planta 28036 Madrid
Spanish: Ratiopharm España, S.A. Avda. De Burgos 16 D - 5ª Planta 28036 Madrid
English: Hotemin Injection 20 mg/ml -1ml Solution for injection Intramuscular use
Spanish: Hotemin Injection 20 mg/ml -1ml Solución inyectable
English: HOW TO TAKE PIROXICAM
Spanish: ANTES DE TOMAR PIROXICAM
English: Aliud Pharma Gmbh &Co. Kg. Gottlieb-Daimler Str. 19 89150 Laichingen Germany
Spanish: Aliud Pharma Gmbh &Co. Kg. Gottlieb-Daimler Str. 19 89150 Laichingen Alemania
English: Dental treatment and in the course of infections Relief of fever and pain associated with acute upper respiratory tract inflammation.
Spanish: Tratamiento dental y en el transcurso de infecciones dentales Alivio de la fiebre y del dolor asociado con inflamación aguda del tracto respiratorio superior Trastornos musculoesqueléticos agudos (por ejemplo bursitis, tendinitis) Trastornos postraumáticos agudos
English: Laboratorios Faes Farma Sa Maximo Aguirre, 14 48940 Lamiaco-Lejona Spain
Spanish: Laboratorios faes Farma Sa maximo Aguirre, 14 48940 Lamiaco-Lejona España
English: Aliud Pharma Gmbh & Co.Kg Gottlieb-Daimler-Str. 19 D-89150 Laichingen Germany
Spanish: Aliud Pharma Gmbh & Co.Kg Gottlieb-Daimler-Str. 19 D-89150 Laichingen Alemania
English: Sublingual Tablet
Spanish: Comprimido sublingual Vía oral
English: • “If you previously had a stomach or intestinal ulcer, bleeding or perforation.
Spanish: • Si ha tenido úlcera, sangrado o perforación de estomago o intestino
English: Evidence from observational studies suggests that piroxicam may be associated with a higher risk of serious skin reactions than other non-oxicam NSAIDs.
Spanish: Las evidencias epidemiológicas muestran que piroxicam puede asociarse con un riesgo más elevado de reacciones cutáneas graves, en comparación con otros AINEs (no-oxicam).
English: Identification of at-risk subjects
Spanish: Complicaciones Gastrointestinales Graves Identificación de individuos de riesgo
English: United Kingdom Clonmel Healthcare Limited Waterford Road
Spanish: Clonmel Healthcare Limited Waterford Road Clonmel, Co. Tipperary, Irlanda
English: The possible need for combination therapy with gastro-protective agents (e.g. misoprostol or proton pump inhibitors) should be carefully considered.
Spanish: Se considerará la necesidad de terapia combinada con gastro-protectores (por ejemplo misoprostol o inhibidores de la bomba de protones).
English: Rectal use
Spanish: Vía Rectal
English: 20 mg/cap Hard capsules
Spanish: 20 mg/cap Dura capsules
English: As with other NSAIDs, the use of piroxicam in combination with protective agents (e.g. misoprostol or proton pump inhibitors) must be considered for these atrisk patients.
Spanish: Al igual que con otros AINEs, para estos pacientes se debe considerar la combinación con agentes gastroprotectores (por ejemplo misoprostol o inhibidores de la bomba de protones).
English: Nycomed Belgium N.V. Gentsesteenweg 615 B-1080 Brussels Belgium
Spanish: Gentsesteenweg 615 B-1080 Brussels Bélgica
English: • If you currently have stomach or intestinal ulcer, bleeding or perforation.
Spanish: • Si tiene úlcera, sangrado o perforación de estomago o intestino
English: A. Menarini Portugal - Farmacêutica, S.A. Quinta Da Fonte Edifício D. Manuel I - Piso 2
Spanish: Quinta Da Fonte Edifício D. Manuel I - Piso 2
English: Injection 20mg/Ml
Spanish: Intramuscular Injection 20mg/Ml
English: Katwijk Farma B.V. Postbus 408
Spanish: Katwijk Farma B.V.
English: 10 mg/cap Hard capsules
Spanish: 10 mg/cap Cápsula dura
English: Esplanade Heysel, B 22 B-1020 Bruxelles Belgium
Spanish: Esplanade Heysel, B 22 B-1020 Bruxelles
English: Feldene 20 Mg/1 Ml, Solution Injectable En Ampoule (Im)
Spanish: Feldene 20 Mg/1 Ml, Solution Injectable En Ampolla (Im)
English: Laboratories Fournier S.A. 28, Boulevard Clemenceau 21000 Dijon
Spanish: Laboratories Fournier S.A. 42, Rue De Longvic 21300 Chenove Francia
English: Posology relating to the following indications are to be deleted from this section in line with Section
Spanish: Se ha de eliminar la posología de las siguientes indicaciones para estar en línea con el apartado 4.1: Gota aguda
English: Quimifar, S.A. Comadran 37
Spanish: Quimifar, S.A.
English: 20MG/ML Solution for injection Intramuscular use
Spanish: 20MG/ML Solución inyectable
English: United Kingdom Actavis Uk Limited Whiddon Vally
Spanish: Actavis Uk Limited Whiddon Vally Barnstaple Devon Ex32 8ns Reino Unido
English: Docpharma S.A. Ambachtenlaan 13h B-3001 Heverlee Belgium
Spanish: Ambachtenlaan 13h B-3001 Heverlee
English: Intramuscular
Spanish: Via intramuscular
English: Egis Pharmaceuticals Plc Kereszturi Ut 30-38 H-1106 Budapest Hungary
Spanish: Egis Pharmaceuticals Plc Kereszturi Ut 30-38 H-1106 Budapest Hungría
English: Parenteral use
Spanish: Vía Parenteral
English: Aktuapharma N.V. Ambachtenlaan 13e B-3001 Leuven Belgium
Spanish: Ambachtenlaan 13e B-3001 Leuven Bélgica
English: “Skin reactions
Spanish: Reacciones cutáneas
English: Sanofi-Synthelabo B.V. Postbus 2043
Spanish: Sanofi-Synthelabo B.V.
English: Egis Pharmaceuticals Ltd. Keresztúri Út 30-38 1106 Budapest Hungary
Spanish: Egis Pharmaceuticals Ltd. Keresztúri Út 30-38 1106 Budapest Hungría
English: Via Palermo 26 A 43100, Parma Italy
Spanish: Via Palermo 26 A 43100, Parma Italia
English: Piroxicam Beral 20 Mg/1 Ml, Solution Injectable En Ampoule (Im)
Spanish: Piroxicam Beral 20 Mg/1 Ml, Solution Injectable En Ampolla (Im)
English: Dispersible Sécable
Spanish: Polvo efervescente
English: 20 mg/ml, 1ml Solution for injection Intramuscular use
Spanish: 20 mg/ml, 1ml Solucióninyectable
English: United Kingdom Tillomed Laboratories Limited
Spanish: Crescent Pharma Limited
English: Indications regarding osteoarthritis, rheumatoid arthritis and ankylosing spondylitis should read as follows: “Piroxicam is indicated for symptomatic relief of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis.
Spanish: “Piroxicam está indicado para el alivio sintomático de la artrosis, artritis reumatoide y espondilitis anquilosante.
English: Egis Pharmaceuticals Ltd. Kereszturi Ut 30-38 H-1106, Budapest Hungary
Spanish: Egis Pharmaceuticals Ltd. Kereszturi Ut 30-38 H-1106, Budapest Hungría
English: Basildon, Essex SS14 3FR United Kingdom
Spanish: Waymade Plc Sovereign House Miles Gray Road Basildon, Essex SS14 3FR Reino Unido
English: Pharmachemie B.V. Postbus 552
Spanish: Pharmachemie B.V.
English: Ratiopharm España, S.A. Avda.
Spanish: Chiesi España, S.A.
English: Gastro resistant tablet Oral
Spanish: Comprimido gastrorresistente
English: H-1106, Budapest Hungary
Spanish: 1133 Budapest Hungría
English: Euro-Medic N.V. Astridlaan 20
Spanish: Euro-Medic N.V.
English: Box 1161
Spanish: Telčská 114000
English: Eurogenerics N.V. Heizel Esplanade 22 B-1020 Brussels Belgium
Spanish: Eurogenerics S.A. Esplanade Heysel B 22 B-1020 Bruxelles Bélgica
English: Ratiopharm 20 Mg Comprimidos
Spanish: Piroxicam Ratiopharm 20 Mg Comprimidos
English: Egis Pharmaceuticals Ltd. Keresztúri Út 30-38 H-1106 Budapest Hungary
Spanish: Egis Pharmaceuticals Ltd. Keresztúri Út 30-38 H-1106 Budapest Hungría
English: 11347, Post Box 23033 SE-10435 Stockholm Sweden
Spanish: Merck NM AB Ynglingagatan 14 11347, Post Box 23033 SE-10435 Stockholm Suecia
English: Your doctor may need to give you check-ups and will tell you how often you need to be checked, due to your taking piroxicam.
Spanish: Debido al tratamiento con piroxicam, el médico puede precisar la realización de controles periódicos y le informará de la frecuencia de los mismos.
English: ANNEX III AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET Note: These sections of the Summary of Product Characteristics are the ones that were annexed to the Commission Decision on this Article 31 referral.
Spanish: Nota: La sección de este RCP es la que estaba anexa a la Decisión de la Comisión de esta remisión conforme al Artículo 31.
English: Via Palermo, 26/A 43100 Parma Italy
Spanish: Via Palermo, 26/A 43100 Parma Italia
English: Solution for injection Injection
Spanish: Solución inyectable
English: 55216, Ingelheim Am Rhein Germany
Spanish: 55216, Ingelheim Am Rhein Alemania
English: • “History of gastro-intestinal ulceration, bleeding or perforation.
Spanish: • Cualquier antecedente de ulceración, sangrado o perforación gastrointestinal
English: Soluble Tablet
Spanish: Comprimido soluble Vía oral
English: United Kingdom Sandoz Limited
Spanish: Neolab Limited
English: 55216 Ingelheim Am Rhein Germany
Spanish: 55216 Ingelheim Am Rhein Alemania
English: Via Palermo 26/A 43100 Parma Italy
Spanish: Via Palermo 26/A 43100 Parma Italia
English: Esplanade Heysel B 22 B-1020 Bruxelles Belgium
Spanish: Heizel Esplanade 22 B-1020 Brussels Bélgica
English: Pfizer Aps Lautrupvang 8 Dk-2750 Ballerup Denmark
Spanish: Dk-2750 Ballerup Dinamarca
English: Effervescent tablets
Spanish: Comprimido efervescente
English: Bruschettini SRL Via Isonzo 4 16147 Genova Italy
Spanish: Bruschettini SRL Via Isonzo 4
English: Teva Generics Belgium N.V. Laarstraat 16
Spanish: Teva Generics Bélgica N.V.
English: Feldene Intramuscular
Spanish: Vía intramuscular
English: 1x50 g/0,5 g Dermálny krém topical use
Spanish: 1x50 g/0,5 g Gel
English: Eye drops, solution Ocular use
Spanish: Colirio en solución Vía oftálmica
English: Oral powder in sachet Oral use
Spanish: Polvo oral en sobre
English: Strength Pharmaceutical Form Route of Administration Immediate Packaging
Spanish: Número de la UE Marca de fantasía Dosis Forma farmacéutica
English: The average improvement was about 1.4 points.
Spanish: La mejoría media fue de aproximadamente 1,4 puntos.
English: • Patients with certain immune disorders.
Spanish: • Pacientes con determinados trastornos inmunes.
English: Further information can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Privigen.
Spanish: Puede encontrar información adicional sobre Privigen en la página web de la Agencia: ema.europa.eu/medicines/human/EPAR/Privigen.
English: The patients had an average of 0.08 serious infections per year.
Spanish: Estos pacientes presentaron un promedio de 0,08 infecciones graves al año.
English: Other information about Privigen
Spanish: Otras informaciones sobre Privigen
English: Privigen received a marketing authorisation valid throughout the EU on 25 April 2008.
Spanish: Privigen ha recibido una autorización de comercialización válida en toda la EU el 25 de abril de 2008.
English: The European Medicines Agency concluded that Privigen's benefits are greater than its risks and recommended that it be given marketing authorisation.
Spanish: La Agencia Europea de Medicamentos concluyó que los beneficios de Privigen son mayores que sus riesgos y recomendó autorizar su comercialización.
English: What is Privigen and what is it used for?
Spanish: ¿Qué es Privigen y para qué se utiliza?
English: As for all medicines, data on the use of Privigen are continuously monitored.
Spanish: Como para todos los medicamentos, los datos sobre el uso de Privigen se controlan de forma continua.
English: What measures are being taken to ensure the safe and effective use of Privigen?
Spanish: ¿Qué medidas se han adoptado para garantizar un uso seguro y eficaz de Privigen?
English: The dose and frequency of infusions (how often it is given) depend on the disease being treated.
Spanish: La dosis y la frecuencia de las perfusiones (con qué frecuencia se administran) dependen de la enfermedad que se vaya a tratar.
English: Since this is below the predefined threshold of one serious infection per year, this indicates that the medicine is effective as replacement therapy.
Spanish: Dado que este valor está por debajo del umbral predefinido de una infección grave al año, este medicamento es eficaz como terapia sustitutiva.
English: The dose may need to be adjusted for patients depending on their response.
Spanish: Es posible que haya que ajustar la dosis en función de la respuesta del paciente.
English: Privigen was given on two consecutive days.
Spanish: Privigen se administró en dos días consecutivos.
English: As human normal immunoglobulin has been used to treat these diseases for a long time, and in accordance with current guidelines, only three small studies were needed to establish the effectiveness and safety of Privigen in patients.
Spanish: Dado que la inmunoglobulina humana normal se ha utilizado durante mucho tiempo para el tratamiento de estas enfermedades y de conformidad con las directrices vigentes, solo han sido necesarios tres pequeños estudios para confirmar la eficacia y la seguridad de Privigen en pacientes.
English: The company that markets Privigen has made some changes in the way it is produced to reduce this risk and is performing a study to monitor the effect of the changes.
Spanish: La empresa que comercializa Privigen ha hecho algunos cambios en la producción del medicamento para reducir este riesgo y está llevando a cabo un estudio para vigilar los efectos de esos cambios.
English: Why is Privigen authorised in the EU?
Spanish: ¿Por qué se ha autorizado Privigen en la UE?
English: Privigen was not compared to other treatments in the studies.
Spanish: Privigen no se comparó con ningún otro tratamiento en estos estudios.
English: For more information about using Privigen, see the package leaflet or contact your doctor or pharmacist.
Spanish: Para mayor información sobre el uso de Privigen, consulte el prospecto o contacte con su médico o farmacéutico.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Privigen have also been included in the summary of product characteristics and the package leaflet.
Spanish: Las recomendaciones y precauciones que deben seguir los profesionales sanitarios y los pacientes para un uso seguro y eficaz de Privigen se han incluido también en la Ficha Técnica o Resumen de las Características del Producto y el Prospecto.
English: Privigen is a medicine used to support the immune system (the body's natural defences) in two main groups of patients:
Spanish: Privigen es un medicamento que se utiliza para reforzar el sistema inmunitario (las defensas naturales del organismo) en dos grupos fundamentales de pacientes:
English: The main measure of effectiveness was the number of patients who showed improvement of their disability, measured by a decrease on a 10point scale of disability in their arms and legs.
Spanish: El criterio principal de eficacia fue el número de pacientes que mostraron una mejoría de la discapacidad, determinada por una disminución en una escala de 10 puntos de discapacidad en brazos y piernas.
English: In this third study, 17 (61%) of the 28 patients responded to treatment with an improvement of at least one point on the disability scale.
Spanish: En este tercer estudio, 17 (61 %) de los 28 pacientes respondieron al tratamiento con una mejoría de al menos un punto en la escala de discapacidad.
English: What are the risks associated with Privigen?
Spanish: ¿Cuál es el riesgo asociado a Privigen?
English: In this study, 46 (81%) of the 57 patients had a platelet count above 50 million platelets per millilitre at least once during the study.
Spanish: En este estudio, 46 (81 %) de los 57 pacientes alcanzaron un recuento plaquetario superior a 50 millones de plaquetas por mililitro al menos una vez durante el estudio.
English: Severe haemolysis has previously been reported to be slightly more frequent with Privigen than with some other products containing the same active substance.
Spanish: Se ha notificado previamente hemólisis grave con una frecuencia ligeramente mayor con Privigen que con algunos de los demás productos que contienen el mismo principio activo.
English: • Patients who are at risk of infection because they do not have enough antibodies (also called immunoglobulins, proteins in the blood that help the body to fight disease).
Spanish: • Pacientes con riesgo de contraer una infección porque no tienen suficientes anticuerpos (también llamados inmunoglobulinas, proteínas de la sangre que ayudan al organismo a combatir las enfermedades).
English: Side effects reported with Privigen are carefully evaluated and any necessary action taken to protect patients.
Spanish: Los efectos adversos notificados con Privigen se evalúan cuidadosamente, adoptándose las medidas que pudieran resultar necesarias para proteger a los pacientes.
English: An overview of Privigen and why it is authorised in the EU
Spanish: Información general sobre Privigen y sobre los motivos por los que se autoriza su uso en la UE
English: Privigen can only be obtained with a prescription and treatment for patients with a lack of antibodies should be started and monitored by a doctor experienced in treating such conditions.
Spanish: Privigen solo se podrá dispensar con receta médica y el tratamiento de los pacientes con falta de anticuerpos debe iniciarlo y supervisarlo un médico con experiencia en el tratamiento de estas dolencias.
English: The active substance in Privigen, human normal immunoglobulin, is a highly purified protein extracted from human plasma (part of the blood).
Spanish: El principio activo de Privigen, la inmunoglobulina humana normal, es una proteína muy purificada extraída del plasma humano (parte de la sangre).
English: What benefits of Privigen have been shown in studies?
Spanish: ¿Qué beneficios ha demostrado tener Privigen en los estudios realizados?
English: Privigen (human normal immunoglobulin)
Spanish: Privigen (inmunoglobulina humana normal)
English: Privigen must not be used in patients with hyperprolinaemia type I or II (a genetic disorder causing high levels of the amino acid proline in the blood).
Spanish: Privigen no debe utilizarse en pacientes con hiperprolinemia de tipo I o II (un trastorno genético que produce niveles altos del aminoácido prolina en la sangre).
English: Privigen works by restoring abnormally low IgG levels to their normal range in the blood.
Spanish: Privigen actúa restableciendo las concentraciones anormalmente bajas de IgG en la sangre hasta sus valores normales.
English: The most common side effects with Privigen (seen in more than 1 patient in 10) are headache, nausea, pain (including in the back, neck, limbs, joints and face), fever, chills and a flu-like illness.
Spanish: Los efectos adversos más frecuentes de Privigen (observados en más de un paciente de cada diez) son dolor de cabeza, náuseas, dolor (incluidos dolores de espalda, cuello, extremidades, articulaciones y cara), fiebre, escalofríos y enfermedad de tipo gripal.