FrancophonIA/ELRC3.0 huggingface dataset:
English: Benzyl benzoate
French: Benzoate de benzyle
English: If you are pregnant or breast-feeding, talk to your doctor or pharmacist before taking this medicine.
French: Si vous êtes enceinte ou que vous allaitez, parlezen à votre médecin ou à votre pharmacien avant de prendre ce médicament.
English: If you are addicted to alcohol, talk to your doctor or pharmacist before taking this medicine.
French: Si vous êtes dépendant à l'alcool, parlez-en à votre médecin ou à votre pharmacien avant de prendre ce médicament.
English: If you have epilepsy or liver problems, talk to your doctor or pharmacist before taking this medicine.
French: Si vous souffrez d'épilepsie ou d'une maladie du foie, parlez-en à votre médecin ou à votre pharmacien avant de prendre ce médicament.
English: Contains x g galactose per dose.
French: Contient x g de galactose par dose.
English: Cinnamyl alcohol
French: Cinnamyl alcohol (Alcool cinnamique) Citral
English: It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
French: Peut être dangereux pour les personnes atteintes de phénylcétonurie (PCU), une maladie génétique rare caractérisée par l'accumulation de phénylalanine ne pouvant être éliminée correctement.
English: 50 mg/kg/day If you suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor.
French: 09/10/2017 Orale, parentérale 50 mg/kg/jour Si vous souffrez d'une maladie du foie ou du rein, ne prenez ce médicament que sur avis de votre médecin.
English: 09/10/2017 Parenteral
French: 09/10/2017 Parentérale
English: Patients with HFI cannot break down fructose in this medicine, which may cause serious side effects.
French: Les patients atteints d'IHF ne peuvent pas décomposer le fructose contenu dans ce médicament, et ne doivent pas recevoir ce médicament en raison de risque d'effets indésirables graves.
English: May cause severe allergic reactions.
French: Peut provoquer de graves réactions allergiques.
English: May cause local skin reactions (e.g. contact dermatitis) and discolouration.
French: Peut provoquer des réactions cutanées locales (par exemple dermatite de contact), et une dépigmentation.
English: Contains x g glucose per dose.
French: Contient x g de glucose par dose.
English: May be irritant to the skin.
French: Peut causer une irritation cutanée.
English: Phosphate buffers
French: Phosphates
English: There is insufficient information on the effects of CDs in children < 2 years old.
French: Il n'existe pas suffisamment d'informations sur les effets des CD chez les enfants de moins de 2 ans. Par conséquent, le rapport bénéfice/risque pour le patient doit être évalué au cas par cas.
English: 1 mg/kg/day This medicine contains x mg propylene glycol in each <dosage unit><unit volume> <which is equivalent to x mg/<weight><volume>>.
French: 1 mg/kg/jour Ce médicament contient x mg de propylène glycol par <dose><volume unitaire> <équivalent à x mg/<poids> <volume >>.
English: 20 mg/kg/day This medicine contains x mg cyclodextrin(s) in each <dosage unit><unit volume> <which is equivalent to x mg/<weight><volume>>.
French: 20 mg/kg/jour Ce médicament contient x mg de cyclodextrine(s) par <dose><volume unitaire> <équivalent à x mg/<poids><volume >>.
English: Dimethyl sulphoxide
French: Diméthylsulfoxyde
English: Benzalkonium chloride 09/10/2017 Inhalation
French: 09/10/2017 Inhalation
English: May cause local skin reactions, (e.g. contact dermatitis).
French: Peut provoquer des réactions cutanées locales (par exemple dermatite de contact).
English: Butylated hydroxyanisole (E 320)
French: Butylhydroxyanisole (E
English: Sodium ethyl phydroxybenzoate (E 215) Propyl p-hydroxybenzoate Sodium propyl phydroxybenzoate Methyl p-hydroxybenzoate (E 218)
French: Dérivé sodique de l'ester propylique de l'acide phydroxybenzoïque p-hydroxybenzoate de méthyle (E 218) Dérivé sodique de l'ester méthylique de l'acide phydroxybenzoïque (E 219)
English: <Medicinal product> contains arachis oil (peanut oil).
French: <Médicament> contient de l'huile d'arachide.
English: 1 mmol per dose
French: Orale, parentérale 1 mmol par dose
English: Corrigendum
French: Rectificatif
English: SmPC proposal: Patients with rare hereditary problems of galactose intolerance e.g. galactosaemia<, or glucosegalactose malabsorption> should not take this medicine.
French: Proposition de RCP : Les patients présentant des problèmes héréditaires rares d'intolérance au galactose (ex. : galactosémie ) <ou un syndrome de malabsorption du glucose et du galactose> ne doivent pas prendre ce médicament.
English: This medicine contains x mg <benzoic acid/benzoate salt> in each <dosage unit><unit volume> <which is equivalent to x mg/<weight><volume>>.
French: Ce médicament contient x mg <d'acide benzoïque/de sel de benzoate> par <dose><volume unitaire> <équivalent à x mg/<poids><volume>>.
English: Contains x g of sucrose per dose.
French: Contient x g de saccharose par dose.
English: Sodium methyl phydroxybenzoate (E 219)
French: Par exemple : p-hydroxybenzoate d'éthyle (E 214)
English: Geraniol
French: Géraniol
English: This medicine contains x mg of alcohol (ethanol) in each <dosage unit><unit volume> <which is equivalent to x mg/<weight><volume>><(y% w/<w><v>)>.
French: Ce médicament contient x mg d'alcool (éthanol) par <dose><volume unitaire> <équivalent à x mg/<poids><volume>><(y% p/<p><v>)>.
English: Butylated hydroxytoluene (E 321)
French: Butylhydroxytoluène (E
English: Less than 1 mmol (23 mg) per dose
French: 09/10/2017 Orale, parentérale Inférieur à 1 mmol (23 mg) par dose
English: SmPC proposal: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucosegalactose malabsorption should not take this medicine.
French: Proposition de RCP : Les patients présentant une intolérance au galactose, un déficit total en lactase ou un syndrome de malabsorption du glucose et du galactose (maladies héréditaires rares) ne doivent pas prendre ce médicament.
English: This medicine contains x mg benzalkonium chloride in each <dosage unit><unit volume> <which is equivalent to x mg/<weight><volume>>.
French: Ce médicament contient x mg de chlorure de benzalkonium par <dose><volume unitaire> <équivalent à x mg/<poids><volume>>.
English: This medicine contains x mg benzyl alcohol in each <dosage unit><unit volume> <which is equivalent to x mg/<weight><volume>>.
French: Ce médicament contient x mg d'alcool benzylique par <dose><volume unitaire> <équivalent à x mg/<poids><volume>>.
English: 1 mmol (23 mg) per dose
French: 09/10/2017 Orale, parentérale 1 mmol (23 mg) par dose
English: This medicine contains x mg aspartame in each <dosage unit><unit volume> <which is equivalent to x mg/<weight><volume>>.
French: Ce médicament contient x mg d'aspartam par <dose><volume unitaire> <équivalent à x mg/<poids><volume >>.
English: SmPC proposal: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
French: Proposition de RCP : Les patients présentant une intolérance au fructose, un syndrome de malabsorption du glucose et du galactose ou un déficit en sucrase/isomaltase (maladies héréditaires rares) ne doivent pas prendre ce médicament.
English: This medicine contains x mg sorbitol in each <dosage unit><unit volume> <which is equivalent to x mg/<weight><volume>>.
French: Ce médicament contient x mg de sorbitol par <dose><volume unitaire> <équivalent à x mg/<poids><volume >>.
English: This medicine contains x mg phosphates in each <dosage unit><unit volume> <which is equivalent to x mg/<weight><volume>>.
French: Ce médicament contient x mg de phosphates par <dose><volume unitaire> <équivalent à x mg/<poids><volume >>.
English: Macrogolglycerol hydroxystearate (castor oil polyoxyl hydrogenated)
French: Maltitol liquide (sirop de glucose hydrogéné)
English: SmPC proposal: Patients with rare hereditary problems of fructose intolerance or glucose-galactose malabsorption should not take this medicine.
French: Proposition de RCP : Les patients présentant une intolérance au fructose ou un syndrome de malabsorption du glucose et du galactose (maladies héréditaires rares) ne doivent pas prendre ce médicament.
English: This medicine contains x mg fructose in each <dosage unit><unit volume> <which is equivalent to x mg/<weight><volume>>.
French: Ce médicament contient x mg de fructose par <dose><volume unitaire> <équivalent à x mg/<poids><volume >>.
English: This medicine contains x mg sodium laurilsulfate in each <dosage unit><unit volume> <which is equivalent to x mg/<weight><volume>>.
French: Ce médicament contient x mg de laurylsulfate de sodium par <dose><volume unitaire> <équivalent à x mg/<poids><volume >>.
English: This medicine contains x mg phenylalanine in each <dosage unit><unit volume> <which is equivalent to x mg/<weight><volume>>.
French: Ce médicament contient x mg de phénylalanine par <dose><volume unitaire> <équivalent à x mg/<poids><volume>>.
English: May cause skin reactions.
French: Peut provoquer des réactions cutanées.
English: Tree moss
French: Mousse d'arbre
English: Benzalkonium chloride 09/10/2017 Nasal
French: 09/10/2017 Nasale
English: 09/10/2017 Cutaneous
French: 09/10/2017 Cutanée
English: Oak moss
French: Mousse de chêne
English: Organic mercury compounds e.g.:
French: Composés organomercuriels
English: This summary was last updated in 03-2016.
French: Ovaj sažetak je posljednji put ažuriran u 03.2016.
English: EPAR summary for the public
French: EPAR, sažetak za javnost
English: It is used specifically in adults with advanced cancer in the following situations:
French: Primjenjuje se isključivo u odraslih bolesnika s uznapredovalim rakom u sljedećim situacijama:
English: The tablets should be taken without food and no food should be eaten for at least 3 hours before and 1 hour after taking the tablets.
French: Tablete se uzimaju bez hrane, a hrana se ne smije konzumirati najmanje tri sata prije te najmanje jedan sat poslije uzimanja lijeka.
English: The full EPAR for Giotrif can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
French: Cjeloviti EPAR za lijek Giotrif nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Treatment should continue for as long as possible, until the disease worsens or the side effects become too severe.
French: Terapiju treba nastaviti koliko je god dugo moguće, dok se bolest ne pogorša ili dok nuspojave ne postanu preozbiljne.
English: Giotrif is available as tablets (20, 30, 40 and 50 mg) and is only available with a prescription.
French: Giotrif je dostupan u tabletama (od 20, 30, 40 i 50 mg) i izdaje se samo na liječnički recept.
English: It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
French: Objašnjava kako je Agencija ocijenila lijek da bi preporučila njegovo odobrenje u EU-u te uvjete za njegovu primjenu.
English: The recommended dose is 40 mg once daily but this may be increased to up to 50 mg per day in patients who tolerate the 40 mg dose, or interrupted and reduced in patients experiencing side effects.
French: Preporučena doza je 40 mg jedanput dnevno, no može se povećati do 50 mg dnevno u bolesnika koji dobro podnose dozu od 40 mg, a u bolesnika s nuspojavama liječenje se može prekinuti ili se doza može smanjiti.
English: The most common side effects with Giotrif (which may affect more than 1 in 10 people) are paronychia (nail bed infection), reduced appetite, epistaxis (nosebleeds), diarrhoea, nausea (feeling sick), vomiting, stomatitis (inflammation of the lining of the mouth), rash, acneiform dermatitis (acne-like skin conditions), pruritus (itching), and dry skin.
French: Najčešće nuspojave lijeka Giotrif (koje se mogu javiti u više od 1 na 10 osoba) su paronihija (upala podloge nokta), smanjeni apetit, epitaksa (krvarenje iz nosa), proljev, mučnina (osjećaj slabosti), povraćanje, stomatitis (upala sluznice usne šupljine), osip, akneformni dermatitis (stanje kože slično aknama), pruritus (svrbež) i suha koža.
English: This means that it blocks the action of a group of proteins known as ‘ErbB family' which are found on the surface of cancer cells and are involved in stimulating the cells to divide.
French: To znači da blokira djelovanje skupine proteina poznate pod nazivom „obitelj ErbB” koji se nalaze na površini stanica raka i uključeni su u poticanje diobe stanica.
English: This is a summary of the European public assessment report (EPAR) for Giotrif.
French: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Giotrif.
English: In addition, the side effects of the medicine were considered to be manageable and similar to those seen with medicines of the same class.
French: Nadalje, smatra se da se nuspojave lijeka mogu kontrolirati te da su slične onima za lijekove istog razreda.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Giotrif on 25 September 2013.
French: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Giotrif na snazi u Europskoj uniji od 25. rujna 2013.
English: Other information about Giotrif
French: Ostale informacije o lijeku Giotrif
English: It is not intended to provide practical advice on how to use Giotrif.
French: Svrha sažetka nije davati praktične savjete o načinu primjene lijeka Giotrif.
English: EGFR proteins are part of the ErbB family.
French: Proteini EGFR dio su obitelji ErbB.
English: Lung cancer cells with mutated EGFR proteins are particularly sensitive to afatinib.
French: Stanice raka pluća s mutiranim proteinima EGFR posebno su osjetljive na afatinib.
English: What measures are being taken to ensure the safe and effective use of Giotrif?
French: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Giotrif?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Giotrif outweigh its risks and recommended that it be granted marketing authorisation in the EU.
French: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Giotrif nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: Why is Giotrif approved?
French: Zašto je Giotrif odobren?
English: What is Giotrif and what is it used for?
French: Što je Giotrif i za što se koristi?
English: Treatment with Giotrif should be started and supervised by a doctor experienced in the use of cancer medicines.
French: Liječenje lijekom Giotrif mora započeti i nadzirati liječnik s iskustvom u primjeni lijekova protiv raka.
English: A risk management plan has been developed to ensure that Giotrif is used as safely as possible.
French: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Giotrif.
English: By blocking these proteins, afatinib helps to control cell division and thereby slows down the growth and spread of the non-small cell lung cancer.
French: Inhibiranjem tih proteina afatinib pomaže pri kontroli diobe stanica, a terapija usporava rast i širenje raka pluća nemalih stanica.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Giotrif, including the appropriate precautions to be followed by healthcare professionals and patients.
French: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Giotrif nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: • when the cancer has a mutation in the gene for a protein called EGFR and has not been previously treated with tyrosine kinase inhibitor medicines.
French: • kada rak ima mutaciju na genu za protein naziva EGFR, a prethodno nije liječen inhibitorima tirozin kinaze.
English: The active substance in Giotrif, afatinib, is an ErbB family blocker.
French: Djelatna tvar u lijeku Giotrif, afatinib, blokator je obitelji ErbB.
English: What are the risks associated with Giotrif?
French: Koji su rizici povezani s lijekom Giotrif?
English: • when the cancer is of a squamous cell type (from cells of the lining of the lungs) and has worsened despite treatment with platinum-based chemotherapy.
French: • kada se radi o raku skvamoznih stanica (stanica ovojnice pluća) koji se pogoršao unatoč kemoterapiji na bazi platine.
English: For more information about treatment with Giotrif, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
French: Više informacija o terapiji lijekom Giotrif pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Giotrif has been shown to significantly delay disease progression in patients with non-small cell lung cancer.
French: Dokazano je da Giotrif značajno odgađa progresiju bolesti u bolesnika s rakom pluća nemalih stanica.
English: In a second study in 795 patients with the squamous cell cancer type, patients treated with Giotrif lived on average for 2.6 months without their disease worsening compared with 1.9 months for patients treated with another cancer medicine, erlotinib.
French: U drugom ispitivanju koje je obuhvatilo 795 bolesnika s rakom skvamoznih stanica bolesnici liječeni lijekom Giotrif živjeli su prosječno 2,6 mjeseci bez pogoršanja bolesti u usporedbi s 1,9 mjeseci u bolesnika koji su liječeni drugim lijekom protiv raka, erlotinibom.
English: In a main study in 345 patients with tumours that have mutated EGFR genes, patients treated with Giotrif lived on average for 11 months without their disease getting worse compared with 7 months for patients who were treated with two other cancer medicines, pemetrexed and cisplatin.
French: U glavnom ispitivanju, koje je obuhvatilo 345 bolesnika s tumorima koji imaju mutirane gene EGFR, bolesnici koji su liječeni lijekom Giotrif živjeli su prosječno 11 mjeseci bez pogoršanja bolesti u usporedbi sa 7 mjeseci u bolesnika koji su liječeni dvama drugim lijekovima protiv raka, pemetreksedom i cisplatinom.
English: Giotrif contains the active substance afatinib.
French: Giotrif sadrži djelatnu tvar afatinib.
English: Giotrif is a medicine used to treat a type of lung cancer known as non-small cell lung cancer.
French: Giotrif je lijek za liječenje vrste raka pluća poznatog pod nazivom rak pluća nemalih stanica.
English: The CHMP considered that in patients treated with Giotrif the improvement in progression-free survival (how long they lived without the disease getting worse) was a meaningful benefit for patients.
French: Mišljenje je CHMP-a da bolja stopa preživljenja bez progresije bolesti (koliko su dugo živjeli bez pogoršanja bolesti) u bolesnika liječenih lijekom Giotrif predstavlja značajnu korist za bolesnike.
English: How does Giotrif work?
French: Kako djeluje Giotrif?
English: What benefits of Giotrif have been shown in studies?
French: Koje su koristi lijeka Giotrif utvrđene u ispitivanjima?
English: For the full list of all side effects and restrictions with Giotrif, see the package leaflet.
French: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Giotrif potražite u uputi o lijeku.
English: How is Giotrif used?
French: Kako se Giotrif koristi?
English: For practical information about using Giotrif, patients should read the package leaflet or contact their doctor or pharmacist.
French: Praktične informacije o primjeni lijeka Giotrif pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: EMA/CVMP/19896/2007 EMEA/V/C/000082
French: EMA/67093/2007 EMEA/V/C/000082
English: Other information about Previcox:
French: Autres informations relatives à Previcox :
English: Wash hands after use of the product.
French: Se laver les mains après utilisation du produit.
English: This document is a summary of the European Public Assessment Report.
French: Ce document est un résumé du rapport européen public d'évaluation.
English: Avoid contact with eyes and skin.
French: Eviter tout contact avec les yeux ou la peau.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Previcox on 13 September 2004.
French: La Commission européenne a délivré une autorisation de mise sur le marché valide dans toute l'Union européenne pour Previcox le 13 septembre 2004.
English: This summary was last updated in April 2012.
French: Dernière mise à jour du présent résumé : avril 2012.
English: Horse:
French: Cheval :
English: These reactions are generally of a transitory nature and are reversible when the treatment is stopped.
French: Ces réactions sont généralement passagères et réversibles à l'arrêt du traitement.
English: After the last day of treatment with Previcox, horses should not be slaughtered for 26 days (when treated with the oral paste).
French: Après le dernier jour de traitement par Previcox, les chevaux ne doivent pas être abattus pendant 26 jours (en cas de traitement avec la pâte orale).
English: Information on the prescription status of this product may be found on the label of the carton.
French: Les informations relatives à la prescription de ce produit figurent sur l'étiquette de l'emballage.
English: The dose, duration of treatment and frequency will depend on the weight and type of animal and condition to be treated.
French: La dose, la durée et la fréquence de traitement dépendent du poids et du type de l'animal, ainsi que de la pathologie à traiter.
English: Dog:
French: Chien :
English: Women of child-bearing age should avoid contact with, or wear disposable gloves, when administering the product.
French: Les femmes en âge de procréer doivent éviter le contact avec le produit ou porter des gants jetables lorsqu'elles administrent le produit.
English: Previcox must not be administered with corticosteroids or other NSAIDs.
French: Previcox ne doit pas être administré avec des corticostéroïdes ou d'autres AINS.
English: What benefit has Previcox shown during the studies?
French: Quel est le bénéfice démontré par Previcox au cours des études ?
English: As the prostaglandins are substances that trigger pain, inflammation and fever, Previcox, therefore, reduces those responses.
French: Comme les prostaglandines sont des substances qui déclenchent la douleur, l'exsudation et l'inflammation, Previcox réduit donc ces réponses.
English: Two multi-centre studies were conducted (one in the US and one in Europe) to investigate the efficacy, safety and acceptability of firocoxib under field conditions when administered to horses orally once daily for 14 days at a dose of 0.1 mg/kg.
French: Deux études multicentriques ont été menées (l'une aux États Unis et l'autre en Europe) pour étudier l'efficacité, la sécurité et l'acceptabilité du firocoxib dans des conditions de terrain lorsqu'il est administré aux chevaux par voie orale une fois par jour pendant 14 jours à une dose de 0,1 mg/kg.
English: Previcox has been studied in laboratory animals, as well as in dogs and horses that were treated in various veterinary practices/clinics across Europe (“clinical studies”).
French: Previcox a été étudié sur des animaux de laboratoire, ainsi que sur des chiens et des chevaux qui ont été traités dans différents cabinets/cliniques vétérinaires en Europe (« études cliniques »).
English: The product was shown to be comparable to other reference products (carprofen and meloxicam, respectively).
French: Le produit s'est montré d'une efficacité comparable aux autres produits de référence (carprofène et méloxicam, respectivement).
English: In case of accidental ingestion, it is necessary to seek medical advice immediately and show the package leaflet or the label to the physician.
French: En cas d'ingestion accidentelle, demandez immédiatement conseil à un médecin et montrez-lui la notice ou l'étiquetage.
English: If it occurs, rinse affected area immediately with water.
French: En cas de contact, rincer immédiatement à l'eau.
English: What is the risk associated with Previcox?
French: Quel est le risque associé à l'utilisation de Previcox ?