FrancophonIA/ELRC3.0 huggingface dataset:
English: Aripiprazole has minor to moderate influence on the ability to drive and use machines due to potential nervous system and visual effects, such as sedation, somnolence, syncope, vision blurred, diplopia (see section 4.8).
Danish: Aripiprazol påvirker i mindre eller moderat grad evnen til at køre bil eller betjene maskiner som følge af den mulige indvirkning på nervesystemet og synet.
English: EU/1/04/276/011 (15 mg, 14 × 1 tablets) EU/1/04/276/012 (15 mg, 28 × 1 tablets) EU/1/04/276/013 (15 mg, 49 × 1 tablets) EU/1/04/276/014 (15 mg, 56 × 1 tablets) EU/1/04/276/015 (15 mg, 98 × 1 tablets)
Danish: EU/1/04/276/011 (15 mg, 14 × 1 tabletter) EU/1/04/276/012 (15 mg, 28 × 1 tabletter) EU/1/04/276/013 (15 mg, 49 × 1 tabletter) EU/1/04/276/014 (15 mg, 56 × 1 tabletter) EU/1/04/276/015 (15 mg, 98 × 1 tabletter)
English: ABILIFY 15 mg tablets aripiprazole
Danish: ABILIFY 15 mg tabletter aripiprazol
English: Each tablet contains 10 mg of aripiprazole.
Danish: Hver tablet indeholder 10 mg aripiprazol.
English: EU/1/04/276/006 (10 mg, 14 × 1 tablets) EU/1/04/276/007 (10 mg, 28 × 1 tablets) EU/1/04/276/008 (10 mg, 49 × 1 tablets) EU/1/04/276/009 (10 mg, 56 × 1 tablets) EU/1/04/276/010 (10 mg, 98 × 1 tablets)
Danish: EU/1/04/276/006 (10 mg, 14 × 1 tabletter) EU/1/04/276/007 (10 mg, 28 × 1 tabletter) EU/1/04/276/008 (10 mg, 49 × 1 tabletter) EU/1/04/276/009 (10 mg, 56 × 1 tabletter) EU/1/04/276/010 (10 mg, 98 × 1 tabletter)
English: Package leaflet: Information for the user ABILIFY 10 mg orodispersible tablets ABILIFY 15 mg orodispersible tablets ABILIFY 30 mg orodispersible tablets aripiprazole
Danish: Indlægsseddel: Information til brugeren ABILIFY 10 mg smeltetabletter
English: Each tablet contains 15 mg of aripiprazole.
Danish: Hver tablet indeholder 15 mg aripiprazol.
English: EU/1/04/276/001 (5 mg, 14 × 1 tablets) EU/1/04/276/002 (5 mg, 28 × 1 tablets) EU/1/04/276/003 (5 mg, 49 × 1 tablets) EU/1/04/276/004 (5 mg, 56 × 1 tablets) EU/1/04/276/005 (5 mg, 98 × 1 tablets)
Danish: EU/1/04/276/001 (5 mg, 14 × 1 tabletter) EU/1/04/276/002 (5 mg, 28 × 1 tabletter) EU/1/04/276/003 (5 mg, 49 × 1 tabletter) EU/1/04/276/004 (5 mg, 56 × 1 tabletter) EU/1/04/276/005 (5 mg, 98 × 1 tabletter)
English: Each tablet contains 5 mg of aripiprazole.
Danish: Hver tablet indeholder 5 mg aripiprazol.
English: • seizure,
Danish: • døsighed,
English: EU/1/04/276/024 (10 mg, 14 × 1 orodispersible tablets) EU/1/04/276/025 (10 mg, 28 × 1 orodispersible tablets) EU/1/04/276/026 (10 mg, 49 × 1 orodispersible tablets)
Danish: EU/1/04/276/024 (10 mg, 14 × 1 smeltetabletter) EU/1/04/276/025 (10 mg, 28 × 1 smeltetabletter) EU/1/04/276/026 (10 mg, 49 × 1 smeltetabletter)
English: ABILIFY 30 mg tablets Red iron oxide (E 172)
Danish: ABILIFY 30 mg tabletter Rød jernoxid (E 172)
English: EU/1/04/276/027 (15 mg, 14 × 1 orodispersible tablets) EU/1/04/276/028 (15 mg, 28 × 1 orodispersible tablets) EU/1/04/276/029 (15 mg, 49 × 1 orodispersible tablets)
Danish: EU/1/04/276/027 (15 mg, 14 × 1 smeltetabletter) EU/1/04/276/028 (15 mg, 28 × 1 smeltetabletter) EU/1/04/276/029 (15 mg, 49 × 1 smeltetabletter)
English: Hepatobiliary
Danish: Diplopi
English: ABILIFY 10 mg tablets Red iron oxide (E 172)
Danish: ABILIFY 10 mg tabletter Rød jernoxid (E 172)
English: How to store ABILIFY
Danish: Sådan vil du få ABILIFY
English: ABILIFY 10 mg orodispersible tablets Red iron oxide (E 172)
Danish: ABILIFY 10 mg smeltetabletter Rød jernoxid (E 172)
English: • inflammation of the pancreas,
Danish: • betændelse i bugspytkirtlen,
English: • excessive sweating,
Danish: • øget svedtendens,
English: ABILIFY 30 mg orodispersible tablets aripiprazole
Danish: ABILIFY 30 mg smeltetabletter aripiprazol
English: ABILIFY 30 mg orodispersible tablets Red iron oxide (E 172)
Danish: ABILIFY 30 mg smeltetabletter Rød jernoxid (E 172)
English: Each orodispersible tablet contains 30 mg of aripiprazole.
Danish: Hver smeltetablet indeholder 30 mg aripiprazol.
English: ABILIFY solution for injection contains sodium.
Danish: ABILIFY injektionsvæske, opløsning, indeholder natrium.
English: ABILIFY 10 mg orodispersible tablets aripiprazole
Danish: ABILIFY 10 mg smeltetabletter aripiprazol
English: Yellow iron oxide (E 172)
Danish: gul jernoxid (E172)
English: ABILIFY 15 mg orodispersible tablets Yellow iron oxide (E 172)
Danish: ABILIFY 15 mg tabletter Gul jernoxid (E 172)
English: • indigestion,
Danish: • fordøjelsesbesvær,
English: Each orodispersible tablet contains 10 mg of aripiprazole.
Danish: Hver smeltetablet indeholder 10 mg aripiprazol.
English: • vomiting,
Danish: • leverbetændelse,
English: Each orodispersible tablet contains 15 mg of aripiprazole.
Danish: Hver smeltetablet indeholder 15 mg aripiprazol.
English: If you are given more ABILIFY than you need
Danish: Hvis du har fået for meget ABILIFY
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Danish: • Kontakt lægen eller apotekspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt i denne indlægsseddel.
English: IM use
Danish: Hikke
English: ABILIFY 15 mg orodispersible tablets aripiprazole
Danish: ABILIFY 15 mg smeltetabletter aripiprazol
English: ABILIFY 30 mg orodispersible tablets:
Danish: ABILIFY 30 mg smeltetabletter:
English: • baldness,
Danish: • vægttab,
English: ABILIFY 10 mg orodispersible tablets:
Danish: ABILIFY 10 mg smeltetabletter:
English: • fainting,
Danish: • ørhed,
English: • abdominal discomfort,
Danish: • ufrivillig vandladning,
English: Hepatitis Jaundice
Danish: Hovedpine Sedation
English: PHARMACOLOGICAL PROPERTIES
Danish: FARMACEUTISKE OPLYSNINGER
English: Orodispersible tablets
Danish: Tabletovertræk
English: Your doctor will discuss this with you.
Danish: Din læge vil drøfte dette med dig.
English: This can lead to symptoms such as:
Danish: Dette kan medføre symptomer som:
English: which was followed by
Danish: som blev efterfulgt af
English: TTP = time to progression; "ne" indicates that it could not be estimated or it was not yet reached.
Danish: TTP = tid til progression, "ne" betyder, at grænsen ikke kunne estimeres, eller at den endnu ikke var nået.
English: Final concentration
Danish: Slutkoncentration
English: If this happens to you, contact your doctor immediately.
Danish: Hvis dette sker for dig, skal du øjeblikkeligt kontakte en læge.
English: Side effects of not known frequency: frequency cannot be estimated from the available data
Danish: Bivirkninger, hvor hyppigheden ikke er kendt: hyppigheden kan ikke vurderes ud fra tilgængelige data
English: A careful risk-benefit assessment should be made before deciding to treat with trastuzumab.
Danish: Der skal foretages en grundig risk-benefit vurdering før det besluttes, om der skal behandles med trastuzumab.
English: Heart problems can sometimes occur during treatment and occasionally after treatment has stopped and can be serious.
Danish: Hjerteproblemer kan nogle gange forekomme under behandlingen og lejlighedsvis efter, at behandlingen er stoppet, og kan være alvorlige.
English: If an alternate route of administration is required, other trastuzumab products offering such an option should be used
Danish: Hvis en anden administrationsvej er nødvendig, skal der anvendes andre trastuzumab-produkter, der tilbyder en sådan mulighed.
English: • Your doctor will advise you of the risks and benefits of taking Ogivri during pregnancy.
Danish: • Lægen vil rådgive dig om risici og fordele ved at tage Ogivri under graviditet.
English: Ogivri should only be given by a doctor or nurse.
Danish: Ogivri må kun gives af en læge eller sygeplejerske.
English: • breathlessness (including breathlessness at night),
Danish: • åndenød (herunder åndenød om natten),
English: The product is not intended to be stored after reconstitution and dilution unless this has taken place under controlled and validated aseptic conditions.
Danish: Produktet er ikke beregnet til opbevaring efter rekonstituering og fortynding, med mindre dette har fundet sted under kontrollerede og validerede aseptiske betingelser.
English: Ogivri can cause breathing difficulties, especially when it is first given.
Danish: Ogivri kan forårsage vejrtrækningsproblemer, specielt når det gives første gang.
English: The bioactivity of D7D and the clinical impact of the elevation of this metabolite were unclear.
Danish: Den biologiske aktivitet af D7D og den kliniske betydning af øget eksponering for denne metabolit var uklar.
English: If you stop using Ogivri
Danish: Hvis du holder op med at bruge Ogivri
English: Therefore, your doctor may decide to continue to check your heart functions, even after you finish treatment.
Danish: Derfor kan din læge beslutte at fortsætte med at undersøge din hjertefunktion, efter din behandling er stoppet.
English: Children and adolescents Ogivri is not recommended for anyone under the age of 18 years.
Danish: Børn og unge Ogivri er frarådet til børn og unge under 18 år.
English: *Cmin,ss - Cmin at steady state **Cmax,ss = Cmax at steady state *** time to 90% of steady-state
Danish: *Cmin,ss - Cmin ved steady state **Cmax,ss = Cmax ved steady state *** tid til 90 % af steady-state
English: Ogivri may also be given once a week for metastatic breast cancer.
Danish: Ogivri kan også gives én gang om ugen ved metastatisk brystkræft.
English: The following information is intended for healthcare professionals only
Danish: Nedenstående oplysninger er til læger og sundhedspersonale
English: Your doctor will monitor your heart regularly during and after treatment but you should tell your doctor immediately if you notice any of the above symptoms.
Danish: Lægen vil kontrollere dit hjerte regelmæssigt under og efter behandlingen, men du skal øjeblikkeligt fortælle det til lægen, hvis du får nogle af ovenstående symptomer.
English: Some of the side effects you experience may be due to your underlying breast cancer.
Danish: Nogle af de bivirkninger, som du oplever, kan skyldes din underliggende brystkræft.
English: In this section, the following categories of frequency have been used: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: I dette punkt er følgende kategorier for hyppighed blevet anvendt: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Only patients with a large amount of HER2 will be treated with Ogivri.
Danish: Kun patienter med store mængder HER2 vil blive behandlet med Ogivri.
English: 21 (mg/mL, concentration of reconstituted solution)
Danish: 21 (mg/ml, koncentration af rekonstitueret opløsning)
English: * defined as absence of any invasive cancer both in the breast and axillary nodes
Danish: * defineret som fravær af hvilken som helst invasiv kræft både i bryst og aksilknuder
English: Some of these symptoms can be serious and some patients have died (see section 2 under “Warnings and precautions”).
Danish: Nogle af disse sympomer kan være alvorlige, og nogle patienter er døde (se afsnit 2 under ”Advarsler og forsigtighedsregler”).
English: In addition, comparison of two years of trastuzumab treatment versus one year of trastuzumab treatment was performed.
Danish: Derudover blev der foretaget en sammenligning af 2 års trastuzumab-behandling versus 1 års trastuzumab-behandling.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Danish: Hvis produktet ikke anvendes med det samme, er opbevaringstiderne efter åbning og opbevaringsbetingelserne før anvendelse brugerens ansvar.
English: Ogivri is for single-use only, as the product contains no preservatives.
Danish: Ogivri er kun til engangsbrug, da produktet ikke indeholder konserveringsmidler.
English: When Ogivri binds to HER2 it stops the growth of such cells and causes them to die.
Danish: Når Ogivri bindes til HER2, stopper det væksten af sådanne celler, hvilket resulterer i, at de dør.
English: • increased muscle tone or tension (hypertonia)
Danish: • øget muskeltonus eller muskelspænding (hypertoni)
English: Other side effects can occur at any time during treatment with Ogivri, not just related to an infusion.
Danish: Andre bivirkninger kan indtræffe på ethvert tidspunkt under behandlingen med Ogivri og er ikke kun relateret til en infusion.
English: As animal reproduction studies are not always predictive of human response, trastuzumab should be avoided during pregnancy unless the potential benefit for the mother outweighs the potential risk to the foetus.
Danish: Da reproduktionsstudier på dyr ikke altid er prædiktive for mennesker, bør trastuzumab undgås under graviditet, med mindre den potentielle fordel for moderen opvejer den potentielle risiko for fostret.
English: Therefore, these patients should not be treated with trastuzumab (see section 4.3).
Danish: Disse patienter bør derfor ikke behandles med trastuzumab (se pkt.
English: The efficacy results from the interim efficacy analysis crossed the protocol pre-specified statistical boundary for the comparison of 1-year of trastuzumab versus observation.
Danish: Effektresultaterne fra den interime effektanalyse krydsede protokollens præspecificerede statistiske grænse for sammenligningen af 1 år med trastuzumab versus observation.
English: These medicines (or any other anthracyclines) can damage heart muscle and increase the risk of heart problems with Ogivri.
Danish: Disse lægemidler (og ethvert andet antracyklin) kan skade hjertemusklen og øge risikoen for hjerteproblemer sammen med Ogivri.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications Breast cancer
Danish: KLINISKE OPLYSNINGER 4.1 Terapeutiske indikationer Brystkræft
English: A detailed history with regards to HFI symptoms has to be taken of each patient prior to being given this medicinal product.
Danish: Der skal optages en detaljeret anamnese for den enkelte patient med hensyn til HFI-symptomer, inden patienten får dette lægemiddel.
English: Ogivri is a biosimilar medicinal product.
Danish: Ogivri er et biosimilært lægemiddel.
English: Patients may continue therapy during periods of reversible, chemotherapy-induced myelosuppression but they should be monitored carefully for complications of neutropenia during this time.
Danish: Patienterne kan fortsætte behandlingen i perioder med reversibel, kemoterapi-induceret myelosuppression, men de skal monitoreres omhyggeligt for komplikationer relateret til neutropeni i denne periode.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler skal navnet og batchnummeret på det administrerede præparat tydeligt registreres.
English: • if you have severe breathing problems at rest due to your cancer or if you need oxygen treatment.
Danish: • hvis du har alvorlige problemer med at trække vejret i hvile på grund af din cancer, eller hvis du har behov for behandling med ilt.
English: Trastuzumab 1 Year N = 1702***
Danish: Trastuzumab 1 år N = 1702***
English: Anaphylactoid reactions have been observed in isolated cases.
Danish: Der er observeret anafylaktoide reaktioner i enkeltstående tilfælde.
English: The results of these simulations indicate that at least 95 % of patients will reach concentrations that are < 1 mcg/mL (approximately 3 % of the population predicted Cmin,ss, or about 97 % washout) by 7 months.
Danish: Resultaterne af disse simuleringer indikerer, at mindst 95 % af patienterne vil nå koncentrationer < 1 mikrogram/ml (ca. 3 % af den populationsforudsagte Cmin,ss, eller omkring 97 % udvaskning) i løbet af 7 måneder.
English: It is not known whether trastuzumab is secreted in human milk.
Danish: Det er ukendt, om trastuzumab udskilles i human mælk.
English: Paediatric population There is no relevant use of trastuzumab in the paediatric population.
Danish: Pædiatrisk population Det er ikke relevant at anvende trastuzumab hos den pædiatriske population.
English: If you experience any of the above symptoms when your treatment with Ogivri has finished, you should see your doctor and tell them that you have previously been treated with Ogivri.
Danish: Hvis du får nogle af ovenstående symptomer, når behandlingen med Ogivri er stoppet, skal du kontakte din læge og fortælle, at du tidligere er blevet behandlet med Ogivri.
English: No incompatibilities between Ogivri and polyvinylchloride, polyethylene or polypropylene bags have been observed.
Danish: Der er ikke set uforligeligheder mellem Ogivri og polyvinylchlorid-, polyethylen- eller polypropylenposer.
English: Ogivri may affect your ability to drive a car or operate machines.
Danish: Ogivri kan påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: Switching treatment between trastuzumab intravenous and trastuzumab subcutaneous formulation and vice versa.
Danish: Skift mellem trastuzumab intravenøs og trastuzumab subkutan formulering og omvendt
English: Ogivri should be carefully handled during reconstitution.
Danish: Ogivri skal behandles med forsigtighed under rekonstitution.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 December 2018
Danish: Dato for første markedsføringstilladelse: 12. december 2018
English: Trastuzumab loading dose should be administered as a 90-minute intravenous infusion.
Danish: En støddosis af trastuzumab bør administreres som en 90 minutters intravenøs infusion.
English: 4.4 Special warnings and precautions for use Traceability
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Sporbarhed
English: Infusion reactions, allergic-like reactions and hypersensitivity It is estimated that approximately 40 % of patients who are treated with trastuzumab will experience some form of infusion-related reaction.
Danish: Infusionsreaktioner, allergilignende reaktioner og overfølsomhed Det estimeres, at ca. 40 % af patienterne, som bliver behandlet med trastuzumab, vil opleve infusionsrelaterede reaktioner i en eller anden form.
English: There is no experience with overdose in human clinical trials.
Danish: Der er ingen erfaring med overdosering i humane kliniske studier.
English: If the first dose is well tolerated the next doses may be given over 30 minutes (see section 2 under “Warnings and precautions”).
Danish: Hvis den første dosis tåles godt, kan de efterfølgende doser gives over 30 minutter (se afsnit 2 under ”Advarsler og forsigtighedsregler”).
English: The dose of Ogivri depends on your body weight.
Danish: Ogivri-dosis afhænger af din legemsvægt.
English: The incidence of symptomatic cardiac dysfunction was 1.7 % in the trastuzumab arm.
Danish: Hyppigheden af symptomatisk kardiel dysfunktion var 1,7 % i trastuzumab-armen.
English: Therefore, you should tell your doctor, pharmacist or nurse that you have had Ogivri if you start any new medicine in the 7 months after stopping treatment.
Danish: Du bør derfor fortælle din læge, apotekspersonalet eller sundhedspersonalet, at du har fået Ogivri, hvis du begynder at anvende enhver form for nyt lægemiddel inden for 7 måneder efter ophør med Ogivri-behandlingen.
English: Glucose solutions must not be used for dilution since these cause aggregation of the protein.
Danish: Må ikke fortyndes med glukoseopløsninger, da disse kan forårsage aggregation af proteinet.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge, apotekspersonalet eller sundhedspersonalet til råds, før du tager dette lægemiddel.
English: You must tell your doctor before receiving this medicine if you have HFI or if you can no longer take sweet foods or drinks because you feel sick, vomit or get unpleasant effects such as bloating, stomach cramps or diarrhoea.
Danish: Inden du får dette lægemiddel, skal du fortælle din læge, hvis du har HFI, eller hvis du ikke længere må få sød mad eller drikke, fordi du føler dig syg, kaster op eller får ubehagelige bivirkninger som oppustethed, mavekramper eller diarré.
English: Serious reactions have been treated successfully with supportive therapy such as oxygen, beta agonists, and corticosteroids.
Danish: Alvorlige reaktioner er blevet behandlet succesfuldt med understøttende behandling såsom ilt, beta-agonister og kortikosteroider.
English: • You should use effective contraception during treatment with Ogivri and for at least 7 months after treatment has ended.
Danish: • Du skal anvende sikker kontraception under behandlingen med Ogivri og i mindst 7 måneder efter, at behandlingen er stoppet.
English: However, trastuzumab may elevate the overall exposure of one doxorubicin metabolite, (7-deoxy-13 dihydro-doxorubicinone, D7D).
Danish: Trastuzumab kan dog øge den samlede eksponering for en af doxorubicins metabolitter (7-deoxy-13dihydro-doxorubicinon, D7D).
English: If diluted aseptically, it may be stored for 24 hours (do not store above 30°C).
Danish: Hvis infusionsvæsken er fortyndet under aseptiske betingelser, kan den opbevares i 24 timer (må ikke opbevares ved temperaturer over 30 °C).
English: These events may occur as part of an infusion-related reaction or with a delayed onset.
Danish: Disse bivirkninger kan optræde som en del af en infusionsrelateret reaktion eller med forsinket frembrud.
English: In this trial, 87 % of patients entered had disease that was IHC3+, and 95 % of patients entered had disease that was IHC3+ and/or FISH-positive.
Danish: I dette studie havde 87 % af de inkluderede patienter sygdom, som var IHC3+, og 95 % af de inkluderede patienter havde sygdom, der var IHC3+ og/eller FISH-positiv.
English: • palpitations (heart fluttering or irregular heart beat).
Danish: • hjertebanken (flakkende hjerte eller uregelmæssig hjerterytme).
English: From a microbiological point of view, the reconstituted solution and Ogivri infusion solution should be used immediately.
Danish: Set fra et mikrobiologisk synspunkt skal den rekonstituerede opløsning og infusionsvæsken med Ogivri anvendes med det samme.
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC03
Danish: Farmakoterapeutisk klassifikation: antineoplastiske midler, monoklonale antistoffer, ATC-kode: L01XC03
English: Always keep this medicine in the closed original pack at a temperature of 2ºC - 8 ºC in a refrigerator.
Danish: Opbevar altid dette lægemiddel i den lukkede originalpakning i køleskab ved en temperatur på 2 °C - 8 °C.
English: *Co-primary endpoint of DFS of 1 year versus observation met the pre-defined statistical boundary **Final analysis (including crossover of 52 % of patients from the observation arm to trastuzumab) *** There is a discrepancy in the overall sample size due to a small number of patients who were randomised after the cut-off date for the 12-month median follow-up analysis
Danish: *Co-primært endepunkt for sygdomsfri overlevelse på 1 år versus observation overholdt de prædefinerede statistiske grænser ** Endelig analyse (inkluderende overgang af 52 % af patienterne fra observations-armen til trastuzumab) ***Der er diskrepans i den samlede prøvestørrelse grundet et lille antal patienter, der blev randomiseret efter skæringsdatoen for analysen for 12 måneders median opfølgning.
English: 6.6 Special precautions for disposal and other handling Ogivri should be carefully handled during reconstitution.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Ogivri skal behandles med forsigtighed under rekonstitution.
English: - The active substance is trastuzumab.
Danish: - Aktivt stof: trastuzumab.
English: Your doctor may prescribe Ogivri for the treatment of breast and gastric cancer when:
Danish: Din læge kan ordinere Ogivri til behandling af bryst- og mavekræft, hvis: