FrancophonIA/ELRC3.0 huggingface dataset:
English: As a precautionary measure, it is preferable to avoid the use of granisetron during pregnancy.
Danish: For en sikkerheds skyld bør granisetron undgås under graviditet.
English: Therefore caution should be exercised in patients with cardiac co-morbidities, on cardiotoxic chemotherapy and/or with concomitant electrolyte abnormalities (see section 4.5).
Danish: Der skal derfor udvises forsigtighed hos patienter med hjertesygdomme og hos patienter, som får kardiotoksisk kemoterapi og/eller har ledsagende elektrolytforstyrrelser (se pkt.
English: even if their symptoms are the same as yours.
Danish: Det kan være skadeligt for andre, selvom de har de samme symptomer, som du har.
English: In vitro liver microsomal studies show that granisetron's major route of metabolism is inhibited by ketoconazole, suggestive of metabolism mediated by the cytochrome P-450 3A subfamily (see section 4.5).
Danish: In vitro studier med levermikrosomer viser, at granisetrons primære metaboliseringsvej hæmmes af ketoconazol, hvilket tyder på en metabolisme medieret af CYP3Asubfamilien (se pkt.
English: • a medicine called ketoconazole used in the treatment of fungal infections
Danish: • ketoconazol, som bruges til at behandle svampeinfektioner
English: The most Kytril you will be given is 9 mg a day.
Danish: Du vil højst få 9 mg Kytril om dagen.
English: The signs may include red, raised itchy bumps
Danish: Symptomerne kan inkludere røde, hævede, kløende ujævnheder
English: Administration may be as either a slow intravenous injection (over 30 seconds) or as an intravenous infusion diluted in 20 to 50 ml infusion fluid and administered over 5 minutes.
Danish: Administrationen kan enten foregå ved langsom intravenøs injektion (over 30 sekunder) eller ved intravenøs infusion fortyndet med 20-50 ml infusionsvæske og administreret over 5 minutter.
English: The efficacy of parenteral granisetron may be enhanced by an additional intravenous dose of an adrenocortical steroid e.g. by 8-20 mg dexamethasone administered before the start of the cytostatic therapy or by 250 mg methyl-prednisolone administered prior to the start and shortly after the end of the chemotherapy.
Danish: Effekten af parenteral granisetron kan forstærkes ved en supplerende intravenøs dosis kortikosteroid f.eks. 8-20 mg dexamethason, administreret inden påbegyndelse af cytostatikabehandling, eller 250 mg methylprednisolon, administreret inden påbegyndelse og kort efter afslutning af kemoterapi.
English: The solution for injection is primary packed in standard colourless glass ampoules with 1 ml 3 ml nominal volume [To be completed nationally]
Danish: Injektionsvæsken dispenseres i standard farveløse glasampuller med et deklareret volumen på 1 ml eller 3 ml.
English: Pharmacotherapeutic group: Antiemetics and antinauseants, Serotonin (5HT3) antagonists.
Danish: Farmakoterapeutisk klassifikation: Antiemetika og midler mod kvalme, serotonin-(5-HT3)antagonister.
English: Pharmacological properties of granisetron
Danish: Granisetrons farmakologiske egenskaber
English: 4.5 Interaction with other medicinal products and other forms of interaction As for other 5-HT3 antagonists, cases of ECG modifications including QT prolongation have been reported with granisetron.
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion Som for andre 5-HT3-antagonister er der rapporteret ekg-ændringer, herunder forlængelse af QTintervallet, for granisetron.
English: The dose will be either one or two 1 mg tablets or one 2 mg tablet once a day for up to a week after your radio- or chemotherapy.
Danish: Dosis vil enten være én eller to 1 mg tabletter eller én 2 mg tablet én gang daglig i op til en uge efter strålebehandling eller kemoterapi.
English: The solution for injection should not be use after the expiry date which is stated on the carton and/or ampoule after EXP.
Danish: Brug ikke injektionsvæsken efter den udløbsdato, der står på pakningen og/eller ampullen efter EXP. Udløbsdatoen (EXP) er den sidste dag i den nævnte måned.
English: Combination with adrenocortical steroid
Danish: Kombination med kortikosteroider
English: Very rare (<1/10,000)
Danish: Meget sjælden: < 1/10.000
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægssedlen inden brug Intravenøs anvendelse.
English: Granisetron administered intravenously has been shown to prevent nausea and vomiting associated with cancer chemotherapy in adults and children 2 to 16 years of age.
Danish: Intravenøst administreret granisetron er vist at kunne forebygge kvalme og opkastning i forbindelse med cancerkemoterapi hos voksne og børn i alderen 2 til 16 år.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
Danish: ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN Opbevares utilgængeligt for børn
English: The other ingredients are: [To be completed nationally]
Danish: Øvrige indholdsstoffer: [Udfyldes nationalt]
English: 4.7 Effects on ability to drive and use machines Kytril has no or negligible influence on the ability to drive and use machines.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner Kytril påvirker ikke eller i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: The safety and efficacy of Kytril solution for injection in children aged 2 years and above has been well established for the prevention and treatment (control) of acute nausea and vomiting associated with chemotherapy and the prevention of delayed nausea and vomiting associated with chemotherapy.
Danish: Sikkerheden og virkningen af Kytril injektionsvæske hos børn fra 2 år og opefter er veletableret ved forebyggelse og behandling (kontrol) af akut kvalme og opkastning i forbindelse med kemoterapi og ved forebyggelse af forsinket kvalme og opkastning i forbindelse med kemoterapi.
English: Each tablet contains 69.38 mg of lactose monohydrate.
Danish: Hver tablet indeholder 69,38 mg lactosemonohydrat.
English: 4.7 Effects on ability to drive and use machines Kytril is not expected to impair the ability to drive or to use machines.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner Kytril forventes ikke at påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: The steroid will be given either as a dose between 8 and 20 mg dexamethasone before your radioor chemotherapy or as 250 mg methyl-prednisolone, which will be given both before and after your radio- or chemotherapy.
Danish: Steroidet kan gives enten som 8-20 mg dexamethason før strålebehandling eller kemoterapi eller som 250 mg methylprednisolon både før og efter strålebehandling eller kemoterapi.
English: Kytril is not likely to affect your ability to drive or use any tools or machines.
Danish: Det er ikke sandsynligt, at Kytril påvirker dine evner til at køre motorkøretøj eller bruge værktøj eller maskiner.
English: The tablets should not be used after the expiry date which is stated on the {container [TO be completed nationally] } and carton after EXP.
Danish: Brug ikke tabletterne efter den udløbsdato, der står på {beholderen [Udfyldes nationalt]} og pakningen efter EXP. Udløbsdatoen (EXP) er den sidste dag i den nævnte måned.
English: Uncommon 1/1,000 to <1/100 Rare (1/10,000 to <1/1,000) Very rare (<1/10,000)
Danish: Ikke almindelig: ≥ 1/1.000 til < 1/100 Sjælden: ≥ 1/10.000 til < 1/1.000 Meget sjælden: < 1/10.000
English: Kytril has no or negligible affect on your ability to drive or use any tools or machines.
Danish: Kytril påvirker ikke eller i ubetydelig grad dine evner til at køre motorkøretøj eller bruge værktøj eller maskiner.
English: Doses of up to 38.5 mg of Kytril as a single injection have been reported, with symptoms of mild headache but no other reported sequelae.
Danish: Efter doser på op til 38,5 mg Kytril, administreret som en enkelt injektion, er let hovedpine blevet rapporteret som eneste sequala.
English: In elderly subjects after single intravenous doses, pharmacokinetic parameters were within the range found for non-elderly subjects.
Danish: Efter administration af en intravenøs engangsdosis til ældre personer lå de farmakokinetiske parametre inden for samme interval som set hos ikke ældre personer.
English: Cross-sensitivity between 5-HT3 antagonists (e.g. dolasetron, ondansetron) has been reported.
Danish: Der er rapporteret om krydsallergi blandt 5-HT3-antagonister (f.eks. dolasetron, ondasetron).
English: 6.2 Incompatibilities [To be completed nationally]
Danish: 6.2 Uforligeligheder [Udfyldes nationalt]
English: • are taking other ‘5-HT3 receptor antagonist' medicines.
Danish: • hvis du tager anden medicin, der indeholder en 5-HT3-receptorantagonist.
English: Do not use Kytril
Danish: Tag ikke Kytril
English: The injection will take between 30 seconds and 5 minutes and the dose will usually be between 1 and 3 mg.
Danish: Injektionen vil tage mellem 30 sekunder og 5 minutter, og den sædvanlige dosis er mellem 1 og 3 mg.
English: These include dolasetron, ondansetron used like Kytril in the treatment and prevention of nausea and vomiting.
Danish: Disse inkluderer dolasetron og ondansetron, som bruges til at forebygge og behandle kvalme og opkastning, ligesom Kytril.
English: ECG changes including QT prolongation have been reported with Kytril (see sections 4.4 and 4.5).
Danish: Ekg-ændringer, herunder forlængelse af QT-intervallet, er blevet rapporteret for Kytril (se pkt.
English: Check with your doctor, nurse or pharmacist before using Kytril if you:
Danish: Tal med lægen, sundhedspersonalet eller apoteket, før du får Kytril:
English: In particular, tell your doctor, nurse or pharmacist if you are taking the following medicines:
Danish: Fortæl det specielt til lægen, sundhedspersonalet eller på apoteket, hvis du tager nedenstående medicin:
English: 2.2 Qualitative and quantitative composition Each film-coated tablet contains 1 mg granisetron (as the hydrochloride).
Danish: 2.2 Kvalitativ og kvantitativ sammensætning Hver filmovertrukken tablet indeholder 1 mg granisetron (som hydrochlorid).
English: Very common: 1/10;
Danish: Meget almindelig: ≥ 1/10
English: A dose of 1 mg (10 g/kg) of Kytril solution for injection should be administered by slow intravenous injection.
Danish: En dosis på 1 mg (10 µg/kg) Kytril injektionsvæske administreres som langsom intravenøs injektion.
English: Children will be given Kytril by injections into the vein as described above with the dose depending on the child's weight.
Danish: Børn vil få Kytril som injektion i en blodåre som beskrevet ovenfor.
English: If you are not sure, talk to your doctor, nurse or pharmacist before having the injection.
Danish: Hvis du er i tvivl, så spørg lægen, sundhedspersonalet eller på apoteket, før du får injektionen.
English: Use in children in the prevention or treatment of feeling or being sick following radio- or chemotherapy
Danish: Brug hos børn til forebyggelse eller behandling af kvalme og opkastning efter strålebehandling eller kemoterapi
English: Granisetron administered intravenously has been shown to be effective for prevention and treatment of post-operative nausea and vomiting in adults.
Danish: Intravenøst administreret granisetron er vist at være effektivt til forebyggelse og behandling af postoperativ kvalme og opkastning hos voksne.
English: Post-operative nausea and vomiting
Danish: Postoperativ kvalme og opkastning
English: Granisetron administered orally has been shown to be effective for prevention and treatment of post-operative nausea and vomiting in adults.
Danish: Oralt administreret granisetron er vist at være effektivt til forebyggelse og behandling af postoperativ kvalme og opkastning hos voksne.
English: Use in children in the prevention or treatment of feeling or being sick following surgery
Danish: Brug hos børn til forebyggelse og behandling af kvalme og opkastning efter operation
English: • are having problems with your bowel movements because of a blockage of your gut (intestines)
Danish: • hvis du har problemer med afføringen på grund af forstoppelse
English: HOW TO TAKE KYTRIL
Danish: SÅDAN SKAL DU TAGE KYTRIL
English: Interaction with neurotropic and other active substances through its activity on P 450-cytochrome has been reported (see section 4.5).
Danish: Der er rapporteret om interaktion med neurotrope og andre aktive stoffer på grund af granisetrons CYP-aktivitet (se pkt.
English: Kytril and associated names (see Annex I) 1 mg film-coated tablets Kytril and associated names (see Annex I) 2 mg film-coated tablets
Danish: Kytril og relaterede navne (se bilag I) 1 mg filmovertrukne tabletter Kytril og relaterede navne (se bilag I) 2 mg filmovertrukne tabletter
English: Marketing Authorisation Holder and Manufacturer [To be completed nationally]
Danish: Indehaver af markedsføringstilladelsen og fremstiller [Udfyldes nationalt]
English: If you are not sure, talk to your doctor, nurse or pharmacist before taking these tablets.
Danish: Hvis du er i tvivl, så spørg lægen, sundhedspersonalet eller på apoteket, før du tager disse tabletter.
English: A dose of 1-3 mg (10-40 g/kg) of Kytril solution for injection should be administered either as a slow intravenous injection or as a diluted intravenous infusion 5 minutes prior to the start of chemotherapy.
Danish: En dosis på 1-3 mg (10-40 µg/kg) Kytril injektionsvæske administreres enten som langsom intravenøs injektion eller som fortyndet intravenøs infusion 5 minutter inden påbegyndelse af kemoterapi.
English: Common: affects 1 to 10 users in 100
Danish: Almindeligt: Forekommer hos mellem 1 og 10 ud af 100 patienter
English: Take special care with Kytril
Danish: Vær ekstra forsigtig med at tage Kytril
English: Rare (1/10,000 to <1/1,000)
Danish: Sjælden: ≥ 1/10.000 til < 1/1.000
English: The injection into your veins will take between 30 seconds and 5 minutes and the dose will usually be between 1 and 3 mg.
Danish: Injektionen ind i blodåren vil tage mellem 30 sekunder og 5 minutter, og den sædvanlige dosis er mellem 1 og 3 mg.
English: Granisetron administered orally has been shown to prevent nausea and vomiting associated with cancer chemotherapy in adults.
Danish: Oralt administreret granisetron er vist at kunne forebygge kvalme og opkastning i forbindelse med cancerkemoterapi hos voksne.
English: Check with your doctor, nurse or pharmacist before using these tablets, if you:
Danish: Tal med lægen, sundhedspersonalet eller apoteket, før du tager disse tabletter:
English: • skin rashes or an allergic skin reaction or “nettle-rash” or “hives” (urticaria).
Danish: • hududslæt eller allergiske hudreaktioner eller nældefeber.
English: As for other 5-HT3 antagonists, ECG changes including QT interval prolongation have been reported with granisetron.
Danish: Som for andre 5-HT3-antagonister er ekg-ændringer, herunder forlængelse af QT-intervallet, blevet rapporteret for granisetron.
English: Kytril solution for injection is indicated in children aged 2 years and above for the prevention and treatment of acute nausea and vomiting associated with chemotherapy.
Danish: Kytril injektionsvæske er indiceret til børn i alderen 2 år og opefter til forebyggelse og behandling af akut kvalme og opkastning i forbindelse med kemoterapi.
English: - If you have any further questions, ask your doctor, nurse or pharmacist.
Danish: Er du i tvivl, så spørg lægen, sundhedspersonalet eller på apoteket.
English: Kytril is used to prevent or treat nausea and vomiting (feeling and being sick) caused by other medical treatments, such as chemotherapy or radiotherapy for cancer.
Danish: Kytril bruges til at forebygge og behandle kvalme og opkastning forårsaget af anden behandling, som for eksempel kemoterapi eller strålebehandling ved kræft.
English: What Kytril is and what it is used for Before you are given Kytril How Kytril will be given Possible side effects How to store Kytril Further information
Danish: Oversigt over indlægssedlen: Virkning og anvendelse Det skal du vide, før du får Kytril Sådan bliver du behandlet med Kytril Bivirkninger
English: Common 1/100 to <1/10;
Danish: Almindelig: ≥ 1/100 til < 1/10
English: Kytril is used to prevent or treat nausea and vomiting (feeling and being sick) caused by other medical treatments, such as chemotherapy or radiotherapy for cancer, and by surgery.
Danish: Kytril bruges til at forebygge og behande kvalme og opkastning forårsaget af anden behandling, som for eksempel kemoterapi eller strålebehandling ved kræft og efter operationer.
English: A dose of 1-3 mg (10-40 g/kg) of Kytril solution for injection should be administered either as a slow intravenous injection or as a diluted intravenous infusion and administered over 5 minutes.
Danish: En dosis på 1-3 mg (10-40 µg/kg) Kytril injektionsvæske administreres enten som langsom intravenøs injektion eller som fortyndet intravenøs infusion over 5 minutter.
English: Kytril and associated names (see Annex I) 1 mg/1 ml solution for injection Kytril and associated names (see Annex I) 3 mg/3 ml solution for injection Kytril and associated names (see Annex I) 3 mg/1 ml solution for injection Kytril and associated names (see Annex I) 3 mg/5 ml solution for injection [See Annex I - To be completed nationally]
Danish: Kytril og relaterede navne (se bilag I) 1 mg/1 ml injektionsvæske, opløsning Kytril og relaterede navne (se bilag I) 3 mg/3 ml injektionsvæske, opløsning Kytril og relaterede navne (se bilag I) 3 mg/1 ml injektionsvæske, opløsning Kytril og relaterede navne (se bilag I) 3 mg/5 ml injektionsvæske, opløsning [Se bilag I - Udfyldes nationalt]
English: • medicines used to treat an irregular heartbeat, other ‘5-HT3 receptor antagonist' medicines such as dolasetron or ondansetron (see “Take special care with Kytril” above)
Danish: HT3-receptorantagonist såsom dolasetron eller ondansetron (se ”Lægen eller sundhedspersonalet vil være ekstra forsigtige med at behandle dig med Kytril” ovenfor)
English: Kytril and associated names (see Annex I) 1 mg/1 ml solution for injection Kytril and associated names (see Annex I) 3 mg/3 ml solution for injection Kytril and associated names (see Annex I) 3 mg/1 ml solution for injection Kytril and associated names (see Annex I) 3 mg/5 ml solution for injection
Danish: Kytril og relaterede navne (se bilag I) 1 mg/1 ml injektionsvæske, opløsning Kytril og relaterede navne (se bilag I) 3 mg/3 ml injektionsvæske, opløsning Kytril og relaterede navne (se bilag I) 3 mg/1 ml injektionsvæske, opløsning Kytril og relaterede navne (se bilag I) 3 mg/5 ml injektionsvæske, opløsning
English: Hypersensitivity reactions e.g. anaphylaxis, urticaria
Danish: Overfølsomhedsreaktioner såsom anafylaksi, urticaria
English: • medicines used to treat an irregular heartbeat other ‘5-HT3 receptor antagonist' medicines such as dolasetron or ondansetron (see “Take special care with Kytril” above)
Danish: HT3-receptorantagonist såsom dolasetron eller ondansetron (se ”Vær ekstra forsigtig med at tage Kytril” ovenfor)
English: The solution should be diluted to 5ml per mg. Further maintenance doses of Kytril solution for injection may be administered at least 10 minutes apart.
Danish: Yderligere vedligeholdelsesdoser af Kytril injektionsvæske kan administreres med mindst 10 minutters interval.
English: Do not take Kytril tablets
Danish: Hvis du har taget for mange Kytril tabletter
English: The injections will be diluted and be given before radio- or chemotherapy and will take 5 minutes.
Danish: Medicinen vil blive fortyndet og givet før strålebehandling eller kemoterapi.
English: Because the injection will be given to you by a doctor or nurse, it is unlikely that you will be given too much.
Danish: Det er usandsynligt, at du får for meget, da du får injektionen af en læge eller sygeplejerske.
English: NAME OF THE MEDICINAL PRODUCT Kytril and associated names (see Annex I) 1 mg film-coated tablets Kytril and associated names (see Annex I) 2 mg film-coated tablets [See Annex I - To be completed nationally]
Danish: Kytril og relaterede navne (se bilag I) 1 mg filmovertrukne tabletter Kytril og relaterede navne (se bilag I) 2 mg filmovertrukne tabletter [Se bilag I - Udfyldes nationalt]
English: Chemotherapy- and radiotherapy-induced nausea and vomiting
Danish: Kemoterapi- og strålebehandlingsinduceret kvalme og opkastning
English: Hypersensitivity to the active substance or to any of the excipients.
Danish: Overfølsomhed over for granisetron eller over for et eller flere af hjælpestofferne.
English: Uncommon 1/1,000 to <1/100
Danish: Ikke almindelig: ≥ 1/1.000 til < 1/100
English: Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen, sundhedspersonalet eller på apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
English: Kytril film-coated tablets are indicated in adults for the prevention and treatment of acute nausea and vomiting associated with chemotherapy and radiotherapy.
Danish: Kytril filmovertrukne tabletter er indiceret hos voksne til forebyggelse og behandling af akut kvalme og opkastning i forbindelse med kemoterapi eller strålebehandling.
English: Kytril solution for injection is indicated for the prevention of delayed nausea and vomiting associated with chemotherapy and radiotherapy.
Danish: Kytril injektionsvæske er indiceret til forebyggelse af forsinket kvalme og opkastning i forbindelse med kemoterapi eller strålebehandling.
English: Kytril film-coated tablets are indicated in adults for prevention of delayed nausea and vomiting associated with chemotherapy and radiotherapy.
Danish: Kytril filmovertrukne tabletter er indiceret hos voksne til forebyggelse af forsinket kvalme og opkastning i forbindelse med kemoterapi eller strålebehandling.
English: 6.1 List of excipients [To be completed nationally]
Danish: 6.1 Hjælpestoffer [Udfyldes nationalt]
English: Uncommon: affects 1 to 10 users in 1,000
Danish: Ikke almindeligt: Forekommer hos mellem 1 og 10 ud af 1.000 patienter
English: Elevated hepatic transaminases*
Danish: Forhøjede leveraminotransferaser*
English: Prevention of feeling or being sick following radio- or chemotherapy
Danish: Forebyggelse af kvalme og opkastning efter strålebehandling eller kemoterapi
English: As for other 5-HT3 antagonists, ECG changes including QT prolongation have been reported with granisetron (see sections 4.4 and 4.5).
Danish: Som for andre 5-HT3-antagonister er ekg-ændringer, herunder forlængelse af QT-intervallet, blevet rapporteret for granisetron (se pkt.
English: Each film-coated tablet contains 2 mg granisetron (as hydrochloride).
Danish: Hver filmovertrukken tablet indeholder 2 mg granisetron (som hydrochlorid).
English: Detailed information on this medicinal product is available on the website of the
Danish: Yderligere information om dette lægemiddel er tilgængelig på Lægemiddelstyrelsens hjemmeside www.laegemiddelstyrelsen.dk
English: You should check with your doctor, nurse or pharmacist if you are not sure.
Danish: Spørg lægen, sundhedspersonalet eller på apoteket, hvis der er noget, du er i tvivl om.
English: Treatment of feeling or being sick following surgery
Danish: Behandling af kvalme og opkastning efter operation
English: Treatment of feeling or being sick following radio- or chemotherapy
Danish: Behandling af kvalme og opkastning efter strålebehandling eller kemoterapi
English: Detailed information on this product is available on the website of
Danish: Tilgængelige data bliver beskrevet i pkt.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients [To be completed nationally]
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Hjælpestoffer [Udfyldes nationalt] 6.2 Uforligeligheder [Udfyldes nationalt] 6.3 Opbevaringstid [Udfyldes nationalt]
English: BEFORE YOU ARE GIVEN KYTRIL
Danish: DET SKAL DU VIDE, FØR DU FÅR KYTRIL
English: Each film-coated tablet contains 1 mg granisetron (as hydrochloride).
Danish: Hver filmovertrukken tablet indeholder 1 mg granisetron (som hydrochlorid).
English: The doctor will work out how much to give you.
Danish: Lægen vil bestemme din dosis.