FrancophonIA/ELRC3.0 huggingface dataset:
English: The signs may include swelling of the throat, face, lips and mouth, difficultly in breathing or swallowing.
Danish: Symptomerne kan inkludere opsvulmen af hals, ansigt, læber og mund samt åndedræts- eller synkebesvær.
English: • phenobarbital, a medicine used to treat epilepsy
Danish: • phenobarbital, medicin som bruges til at behandle epilepsi
English: It is unknown whether granisetron or its metabolites are excreted in human milk.
Danish: Det er ukendt, om granisetron eller dets metabolitter udskilles i human mælk.
English: • diarrhoea.
Danish: • diarré.
English: These tablets are not recommended in children.
Danish: Disse tabletter anbefales ikke til børn.
English: Frequency categories are as follows: Very common: 1/10;
Danish: Kategorier for hyppighed er som følger: Meget almindelig: ≥ 1/10
English: Children will be given a maximum of 2 doses a day, at least 10 minutes apart.
Danish: Børn vil maksimalt få 2 doser om dagen med mindst 10 minutter mellem injektionerne.
English: Neurological mechanisms, serotonin-mediated nausea and vomiting
Danish: Neurologiske mekanismer, serotonin-medieret kvalme og opkastning
English: Pharmacokinetics of the oral administration is linear up to 2.5-fold of the recommended dose in adults.
Danish: Farmakokinetikken af granisetron efter oral administration er lineær op til 2,5 gange den anbefalede dosis hos voksne.
English: In patients with pre-existing arrhythmias or cardiac conduction disorders this might lead to clinical consequences.
Danish: For patienter med præ-eksisterende arytmier eller ledningsforstyrrelser kan dette have kliniske konsekvenser.
English: Granisetron is metabolized primarily in the liver by oxidation followed by conjugation.
Danish: Granisetron bliver primært metaboliseret i leveren ved oxidation efterfulgt af konjugering.
English: If you notice the following problem you must see a doctor straight away:
Danish: Hvis du oplever nedenstående bivirkninger, skal du straks kontakte en læge:
English: • abnormal involuntary movements, such as shaking, muscle rigidity and muscle contractions.
Danish: • unormale, ufrivillige bevægelser, såsom rysten, muskelstivhed og muskelsammentrækninger.
English: {Name and address} {tel} {fax} {e-mail}
Danish: {Navn og adresse} {tlf.} {fax} {email}
English: It is clear from the extensive dose-finding programme that the antiemetic efficacy is not unequivocally correlated with either administered doses or plasma concentrations of granisetron.
Danish: Fra det omfattende dosisbestemmelsesprogram er det tydeligt, at den antiemetiske virkning ikke korrelerer entydigt med hverken de administrerede doser eller plasmakoncentrationen af granisetron.
English: The major compounds are 7-OH-granisetron and its sulphate and glycuronide conjugates.
Danish: Hovedmetabolitterne er 7-OH-granisetron og dens sulfat- og glukuronidkonjugater.
English: The solution for injection is for use in adults and children from 2 years old.
Danish: Injektionsvæsken bruges til voksne og børn fra 2 års alderen.
English: • have heart problems, are being treated for cancer with a medicine that is known to damage your heart or have problems with levels of salts, such as potassium, sodium or calcium, in your body (electrolyte abnormalities)
Danish: • hvis du har hjerteproblemer, er blevet behandlet for kræft med lægemidler, som er kendt for at kunne skade hjertet, eller har problemer med saltbalancen i kroppen, såsom kalium, natrium eller calcium (elektrolytforstyrrelser)
English: Additionally, granisetron has not shown any apparent medicinal product interaction with emetogenic cancer chemotherapies.
Danish: Desuden har granisetron ikke vist tydelige interaktioner med emetogene cancerkemoterapier.
English: There is no evidence to date for an increased incidence of adverse events in patients with hepatic disorders.
Danish: Til dato er der ikke evidens for en øget hyppighed af bivirkninger hos patienter med leversygdomme.
English: A study in cloned human cardiac ion channels has shown that granisetron has the potential to affect cardiac repolarisation via blockade of HERG potassium channels.
Danish: Et studie af klonede humane kardiale ionkanaler har vist, at granisetron potentielt kan påvirke hjertets repolarisering ved at blokere HERG-kaliumkanaler.
English: The other ingredients are sodium chloride, water for injections, citric acid monohydrate, hydrochloric acid and sodium hydroxide for pH (acidity) adjustment.
Danish: Øvrige indholdsstoffer: natriumchlorid, vand til injektionsvæsker, citronsyremonohydrat, saltsyre og natriumhydroxid til justering af pH (surhed).
English: • changes in the heartbeat (rhythm) and changes seen on ECG readings (electrical recordings of the heart)
Danish: • ændringer i hjerterytmen (pulsen) og ændringer på ekg-udskrifter (optagelse af hjertets elektriske aktivitet)
English: The dose will usually be either one or two 1 mg tablets or one 2 mg tablet once a day, but your doctor may decide to increase your dose to upto nine 1 mg tablets a day.
Danish: Den sædvanlige dosis vil enten være én eller to 1 mg tabletter eller én 2 mg tablet én gang daglig, men lægen kan beslutte at øge din dosis til op til ni 1 mg tabletter om dagen.
English: Kytril can be given as an injection into the veins (intravenous).
Danish: Kytril indgives som injektion i en blodåre (intravenøst).
English: The chemoreceptor trigger zones are located at the caudal end of the fourth ventricle (area postrema).
Danish: Kemoreceptor-trigger-zonerne er lokaliseret kaudalt i fjerde ventrikel (area postrema).
English: SPECIAL STORAGE CONDITIONS Do not store above 30ºC.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 30 °C.
English: Although antiemetic properties have been observed for 7-OH-granisetron and indazoline N-desmethyl granisetron, it is unlikely that these contribute significantly to the pharmacological activity of granisetron in man.
Danish: Selvom der er blevet observeret antiemetiske egenskaber for 7-OH-granisetron og indazolin-N-desmethylgranisetron, er det dog usandsynligt, at disse bidrager signifikant til den farmakologiske virkning af granisetron hos mennesker.
English: Other side effects that may be experienced while taking this medicine are: Very common: affects more than 1 user in 10
Danish: Andre bivirkninger, som kan du kan få, når du tager denne medicin: Meget almindeligt: Forekommer hos flere end 1 ud af 10 patienter
English: • problems sleeping (insomnia)
Danish: • problemer med at sove
English: Granisetron Intravenous use
Danish: Granisetron Intravenøs anvendelse
English: Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Danish: Patienter med arvelig galactoseintolerans, en særlig form for arvelig lactasemangel (Lapp Lactase deficiency) eller glucose-galactosemalabsorption bør ikke tage denne medicin.
English: Granisetron has been shown to block both sodium and potassium channels, which potentially affects both depolarization and repolarization through prolongation of PR, QRS, and QT intervals.
Danish: Det er vist, at granisetron blokerer både natrium- og kaliumkanaler, hvilket potentielt kan påvirke både depolarisering og repolarisering gennem forlængelse af PR-, QRS- og QT-intervaller.
English: It receives major inputs from the chemoreceptor trigger zones, and a vagal and sympathetic input from the gut.
Danish: Det modtager væsentlige input fra kemoreceptor-trigger-zonerne og et vagalt og sympatisk input fra tarmene.
English: In the case of overdose with the injection, symptomatic treatment should be given.
Danish: I tilfælde af overdosering med injektionen gives symptomatisk behandling.
English: Although ketaconazole was shown to inhibit the ring oxidation of granisetron in vitro, this action is not considered clinically relevant.
Danish: På trods af at ketaconazol er vist at hæmme ring-oxidation af granisetron in vitro, anses dette ikke som klinisk relevant.
English: In the case of overdose with the tablets, symptomatic treatment should be given.
Danish: I tilfælde af overdosering med tabletterne gives symptomatisk behandling.
English: Post-operative nausea and vomiting (PONV)
Danish: Postoperativ kvalme og opkastning (PONV)
English: The first dose of Kytril should be administered within 1 hour before the start of therapy.
Danish: Den første Kytril-dosis skal administreres inden for 1 time, før behandlingen påbegyndes.
English: *Occurred at a similar frequency in patients receiving comparator therapy Description of selected adverse reactions
Danish: *Forekom med tilsvarende hyppighed hos patienter, som fik komparatorbehandling Beskrivelse af udvalgte bivirkninger
English: In patients with hepatic impairment due to neoplasic liver involvement, total plasma clearance of an intravenous dose was approximately halved compared to patients without hepatic involvement.
Danish: Hos patienter med nedsat leverfunktion som følge af neoplastisk leverforandring var den totale plasmaclearance af en intravenøs dosis næsten halveret sammenlignet med patienter uden leverpåvirkning.
English: • changes in how your liver is working shown by blood tests
Danish: • ændringer i leverfunktionen, hvilket kan ses i blodprøver
English: The following table of listed adverse reactions is derived from clinical trials and post-marketing data associated with Kytril and other 5-HT3 antagonists.
Danish: Nedenstående tabel over bivirkninger bygger på data fra kliniske forsøg og post-marketing data for Kytril og andre 5-HT3-antagonister.
English: Children should not be given this injection to treat sickness or the feeling of sickness after surgery.
Danish: Børn bør ikke få denne injektion til behandling af kvalme eller opkastning efter operation.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTER
English: Extrapyramidal Reactions
Danish: Ekstrapyramidale reaktioner
English: Radioligand binding studies have demonstrated that granisetron has negligible affinity for other receptor types including 5-HT and dopamine D2 binding sites.
Danish: Bindingsstudier med radioaktivt mærket ligand har vist, at granisetron har negligeabel affinitet til andre receptorer, herunder 5-HT- og dopamin D2-bindingssteder.
English: Nonetheless it is advisable to monitor both ECG and clinical abnormalities when treating patients concurrently with drugs known to prolong the QT (see section 4.5).
Danish: Ikke desto mindre anbefales monitorering af både ekg og kliniske anormaliteter, når patienter sideløbende behandles med lægemidler, som er kendt for at forlænge QT (se pkt.
English: In studies in healthy subjects, no evidence of any interaction has been indicated between granisetron and benzodiazepines (lorazepam), neuroleptics (haloperidol) or anti-ulcer medicinal products (cimetidine).
Danish: Studier med raske forsøgspersoner antyder ikke evidens for interaktion mellem granisetron og benzodiazepiner (lorazepam), neuroleptika (haloperidol) eller lægemidler mod mavesår (cimetidin).
English: In children, after single intravenous doses, pharmacokinetics are similar to those in adults when appropriate parameters (volume of distribution, total plasma clearance) are normalized for body weight.
Danish: Efter administration af en intravenøs engangsdosis til børn er de farmakokinetiske parametre sammenlignelige med de tilsvarende parametre hos voksne, når de relevante parametre (distributionsvolumen, total plasmaclearance) normaliseres i forhold til legemsvægt.
English: The active substance is granisetron.
Danish: Det aktive stof er granisetron.
English: Clearance is predominantly by hepatic metabolism.
Danish: Clearance sker hovedsageligt via levermetabolisering.
English: A fourfold increase in the initial prophylactic dose of granisetron made no difference in terms of either the proportion of patient responding to treatment or in the duration of symptoms control.
Danish: En firdobling af den initiale profylaktiske granisetron-dosis viste ingen forskel hverken med hensyn til andelen af patienter, som responderede på behandlingen, eller på varigheden af symptomkontrollen.
English: • if you are allergic (hypersensitive) to granisetron or any of the other ingredients of Kytril (listed in Section 6: Further information).
Danish: • hvis du er overfølsom (allergisk) over for granisetron eller et af de øvrige indholdsstoffer i Kytril (anført i afsnit 6: Yderligere oplysninger) .
English: Clinical application of granisetron was reported by Candiotti et al. A prospective, multicentre, randomized, double-blind, parallel-group study evaluated 157 children 2 to 16 years of age undergoing elective surgery.
Danish: Et prospektivt, multicenter, randomiseret, dobbeltblindet, parallel-gruppestudie vurderede 157 børn i alderen 2 til 16 år, som gennemgik elektiv kirurgi.
English: • the antibiotic erythromycin used to treat bacterial infections.
Danish: • erythromycin, som bruges til at behandle bakterieinfektioner
English: For the prevention of PONV, administration should be completed prior to induction of anaesthesia.
Danish: Til forebyggelse af postoperativ kvalme og opkastning bør administrationen være færdig inden anæstesi-induktion.
English: The vomiting centre is located in the brainstem medullary structures.
Danish: Opkastningscentret er lokaliseret i hjernestammens medullære strukturer.
English: Chemo- and radiotherapy-induced nausea and vomiting (CINV and RINV) Prevention (acute and delayed nausea)
Danish: Kemoterapi- og strålebehandlingsinduceret kvalme og opkastning (CINV og RINV) Forebyggelse (akut og forsinket kvalme)
English: *Occurred at a similar frequency in patients receiving comparator therapy
Danish: *Forekom med tilsvarende hyppighed hos patienter, som fik komparatorbehandling
English: Following exposure to radiation or catotoxic substances, serotonin (5-HT) is released from enterochromaffine cells in the small intestinal mucosa, which are adjacent to the vagal afferent neurons on which 5-HT3 receptors are located.
Danish: Efter eksponering for stråling eller cytotoksiske stoffer frigives serotonin (5-HT) fra de enterokromaffine celler i tyndtarmens slimhinde, nærliggende til de vagale afferente neuroner, hvorpå 5-HT3-receptorer er lokaliseret.
English: This belongs to a group of medicines called ‘5-HT3 receptor antagonists' or ‘anti-emetics'.
Danish: Det tilhører en gruppe lægemidler, som kaldes 5-HT3receptorantagonister eller antiemetika.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS AMPOULES
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER AMPULLER
English: Granisetron is a potent anti-emetic and highly selective antagonist of 5-hydroxytryptamine (5-HT3) receptors.
Danish: Granisetron er et potent antiemetikum og en meget selektiv 5-hydroxytryptamin (5-HT3)-receptorantagonist.
English: The remainder is excreted in faeces as metabolites.
Danish: Resten udskilles med fæces som metabolitter.
English: In vitro studies have shown that the cytochrome P450 sub-family 3A4 (involved in the metabolism of some of the main narcotic agents) is not modified by granisetron.
Danish: In vitro studier har vist, at CYP3A4 (involveret i metaboliseringen af nogle af de vigtigste narkotiske stoffer) ikke bliver påvirket af granisetron.
English: The medicine may be diluted before it is injected into your veins.
Danish: Medicinen kan fortyndes, før den sprøjtes ind i blodåren.
English: The symptoms of overdose include mild headaches.
Danish: Symptomerne på overdosis inkluderer let hovedpine.
English: • if you are allergic (hypersensitive) to granisetron or any of the other ingredients of Kytril (listed in section 6: Further information and “Important Information about some of the ingredients Kytril below”.
Danish: • hvis du er overfølsom (allergisk) over for granisetron eller et af de øvrige indholdsstoffer i Kytril (anført i afsnit 6: ”Yderligere oplysninger” og ”Vigtig information om nogle af de øvrige indholdsstoffer i Kytril” nedenfor).
English: The maximum dose of Kytril to be administered over 24 hours should not exceed 3 mg.
Danish: Den maksimale Kytril-dosis i løbet af 24 timer bør ikke overstige 3 mg.
English: 1 mg twice a day or 2 mg once a day for up to one week following radiotherapy or chemotherapy.
Danish: 1 mg to gange dagligt eller 2 mg én gang dagligt i op til én uge efter strålebehandling eller kemoterapi.
English: If you are given too much Kytril
Danish: Hvis du har fået for meget Kytril
English: You should not take these tablets if you are pregnant, trying to get pregnant or are breast-feeding, unless your doctor has told you to.
Danish: Du må ikke tage disse tabletter, hvis du er gravid, planlægger at blive gravid eller ammer, medmindre lægen har sagt, at du må.
English: What Kytril contains
Danish: Kytril indeholder:
English: There is insufficient clinical evidence to recommend administration of the solution for injection to children in prevention and treatment of Post-operative nausea and vomiting (PONV).
Danish: Der er utilstrækkelig klinisk evidens til at anbefale administration af injektionsvæsken til børn til forebyggelse og behandling af postoperativ kvalme og opkastning (PONV).
English: Serotonin is the main neurotransmitter responsible for emesis after chemo- or radio-therapy.
Danish: Serotonin er den neurotransmitter, som primært er ansvarlig for kvalme efter kemo- eller strålebehandling.
English: Your first dose of Kytril will usually be given an hour before your radio- or chemotherapy.
Danish: Første dosis af Kytril vil normalt blive givet en time før strålebehandling eller kemoterapi.
English: This is because Kytril can affect the way some medicines work.
Danish: Det er vigtigt, fordi Kytril kan påvirke virkningen af anden medicin, eller anden medicin kan påvirke virkningen af Kytril.
English: It depends on your age, weight, and whether you are being given the medicine to prevent, or treat, nausea and vomiting.
Danish: Dosis afhænger af din alder, vægt, og om du får lægemidlet for at forebygge eller for at behandle kvalme og opkastning.
English: The released serotonin activates vagal neurons via the 5-HT3 receptors which lead ultimately to a severe emetic response mediated via the chemoreceptor trigger zone within the area postrema.
Danish: Det frigivne serotonin aktiverer vagale neuroner via 5-HT3receptorerne, hvilket i sidste ende udløser et svært emetisk respons, medieret via kemoreceptortrigger-zonen i area postrema.
English: If you stop taking Kytril
Danish: Hvis du holder op med at tage Kytril
English: This medicine contains lactose (a type of sugar).
Danish: Kytril indeholder lactose (en sukkerart).
English: {Name and address} {tel}
Danish: {Navn og adresse} {tlf} {fax} {email}
English: PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet.
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Filmovertrukken tablet.
English: 4.4 Special warnings and precautions for use As granisetron may reduce lower bowel motility, patients with signs of sub-acute intestinal obstruction should be monitored following its administration.
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Da granisetron kan reducere tarmmotiliteten, skal patienter med symptomer på subakut tarmobstruktion observeres nøje efter administration af Kytril.
English: As a precautionary measure, breast-feeding should not be advised during treatment with Kytril.
Danish: For en sikkerheds skyld kan amning ikke anbefales under Kytril-behandling.
English: Urinary excretion of unchanged granisetron averages 12% of dose while that of metabolites amounts to about 47% of dose.
Danish: Af den indgivne dosis udskilles gennemsnitligt 12 % uændret renalt og omkring 47 % som metabolitter via urinen.
English: Mean plasma half-life in patients by the oral and intravenous route is approximately 9 hours, with a wide inter-subject variability.
Danish: Hos patienter er den gennemsnitlige plasmahalveringstid efter oral og intravenøs administration omkring 9 timer, med stor inter-individuel variation.
English: In rats, granisetron had no harmful effects on reproductive performance or fertility.
Danish: Granisetron har ingen skadelig virkning på forplantningsevne eller fertilitet hos rotter.
English: There are no special precautions required for its use in either elderly patients or those patients with renal or hepatic impairment.
Danish: Speciel forsigtighed er ikke påkrævet ved anvendelse af Kytril til ældre patienter eller til patienter med nedsat nyre- eller leverfunktion.
English: In patients with severe renal failure, data indicate that pharmacokinetic parameters after a single intravenous dose are generally similar to those in normal subjects.
Danish: Hos patienter med alvorlig nyreinsufficiens indikerer data, at de farmakokinetiske parametre efter en intravenøs engangsdosis generelt er sammenlignelige med tilsvarende parametre hos normale forsøgspersoner.
English: If you think you have taken too many of the tablets talk to your doctor or nurse.
Danish: Hvis du tror, at du har taget for mange tabletter, så tal med lægen eller sundhedspersonalet.
English: Paediatric use
Danish: Pædiatrisk anvendelse
English: The most frequently reported adverse reactions for Kytril are headache and constipation which may be transient.
Danish: De hyppigst rapporterede bivirkninger for Kytril er hovedpine og obstipation, som kan være forbigående.
English: The tablets are white to almost white triangular biconvex tablets imprinted with K2 on one side.
Danish: Tabletterne er hvide til næsten hvide, trekantede, bikonvekse tabletter mærket med K2 på den ene side.
English: The tablets are white to almost white triangular biconvex tablets imprinted with K1 on one side.
Danish: Tabletterne er hvide til næsten hvide, trekantede, bikonvekse tabletter mærket med K1 på den ene side.
English: Ask your doctor, nurse or pharmacist for advice before taking any medicine.
Danish: Spørg lægen, sundhedspersonalet eller apoteket til råds, før du tager nogen form for medicin.
English: You will be given the injection before your radio- or chemotherapy starts.
Danish: Du vil få injektionen før påbegyndelse af strålebehandling eller kemoterapi.
English: Elderly and renal impairment
Danish: Ældre og nedsat nyrefunktion
English: In patients concurrently treated with medicinal products known to prolong QT interval and/or which are arrhythmogenic, this may lead to clinical consequences (see section 4.4).
Danish: For patienter, som samtidigt behandles med lægemidler, der kan forlænge QT-intervallet og/eller er arytmogene, kan dette have kliniske konsekvenser (se pkt.
English: You should not have this injection if you are pregnant, trying to get pregnant or are breast-feeding, unless your doctor has told you to.
Danish: Du må ikke få denne injektion, hvis du er gravid, planlægger at blive gravid eller ammer, medmindre lægen har sagt, at du må.
English: If you forget to take Kytril
Danish: Hvis du har glemt at tage Kytril
English: However, when administered in higher doses and over a prolonged period of time the risk of carcinogenicity cannot be ruled out.
Danish: Dog kan risikoen for karcinogenicitet ikke udelukkes ved administration af højere doser og i en længere periode.
English: The 5-HT3 receptors are located in three sites: vagal nerve terminals in the gastrointestinal tract and chemoreceptor trigger zones located in the area postrema and the nucleus tractus solidarius of the vomiting center in the brainstem.
Danish: 5-HT3-receptorer er lokaliseret tre steder: Vagale nerveterminaler i mavetarmkanalen, kemoreceptor-trigger-zoner lokaliseret i area postrema samt nucleus tractus solitarius i opkastningscentret i hjernestammen.
English: Blister - [To be completed nationally]
Danish: Blister - [Udfyldes nationalt]
English: Each tablet contains 138.76 mg of lactose monohydrate.
Danish: Hver tablet indeholder 138,76 mg lactosemonohydrat.
English: On the basis of its kinetics, whilst no dosage adjustment is necessary, granisetron should be used with a certain amount of caution in this patient group (see section 5.2).
Danish: Dosisjustering er ikke nødvendig, men på baggrund af granisetrons kinetik bør det anvendes med en vis forsigtighed hos denne patientgruppe (se pkt.