FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition a post-hoc exploratory analysis was performed on the data sets from the joint analysis (JA) NSABP B-31/NCCTG N9831* and BCIRG 006 clinical studies combining DFS events and symptomatic cardiac events and summarised in table 11:
Danish: Desuden blev en post-hoc eksplorativ analyse udført på datasættene fra den samlede analyse fra studierne NSABP B-31/NCCTG N9831* og BCIRG 006, hvor sygdomsfri overlevelse og symptomatiske kardielle hændelser blev kombineret.
English: The recommended weekly maintenance dose of KANJINTI is 2 mg/kg body weight, beginning one week after the loading dose.
Danish: Den anbefalede ugentlige vedligeholdelsesdosis af KANJINTI er 2 mg/kg legemsvægt og påbegyndes én uge efter støddosis.
English: Weak to moderate complete, basolateral or lateral membranous reactivity in ≥ 10% of tumour cells
Danish: En svag til moderat komplet, basolateral eller lateral membranøs reaktivitet i ≥ 10 % af tumorcellerne
English: Combination therapy
Danish: Kombinationsterapi
English: LIST OF EXCIPIENTS Excipients: histidine, histidine monohydrochloride, trehalose dihydrate, polysorbate 20.
Danish: LISTE OVER HJÆLPESTOFFER Hjælpestoffer: histidin, histidin monohydrochlorid, trehalosedihydrat, polysorbat 20.
English: Table 9 Overview of efficacy analyses BCIRG 006 AC→D versus AC→DH Parameter
Danish: Oversigt over effektanalyserne af AC→D versus AC→DH fra BCIRG 006-studiet
English: The recommended starting dose is 8 mg/kg body weight.
Danish: Den anbefalede startdosis er 8 mg/kg legemsvægt.
English: 8 mg/kg + 6 mg/kg q3w
Danish: 8 mg/kg + 6 mg/kg 3ugers doseringsr egime
English: + 7.2 mL
Danish: 150 mg hætteglas + 7,2 ml
English: How to store KANJINTI
Danish: Sådan får du KANJINTI
English: • The recommended starting dose for the once weekly cycle is 4 mg/kg body weight.
Danish: • Den anbefalede startdosis i den ugentlige serie er 4 mg/kg legemsvægt.
English: • respiratory distress
Danish: • åndedrætsbesvær
English: Presented in Table 1 are adverse reactions that have been reported in association with the use of intravenous trastuzumab alone or in combination with chemotherapy in pivotal clinical trials and in the post-marketing setting.
Danish: Bivirkninger, som er blevet rapporteret i forbindelse med anvendelse af intravenøst trastuzumab alene eller i kombination med kemoterapi i pivotale kliniske studier og efter markedsføringen, er præsenteret i tabel 1.
English: KANJINTI 420 mg powder for concentrate for solution for infusion 50 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film and aluminium seal flip-off dust cover containing 420 mg of trastuzumab.
Danish: KANJINTI 420 mg pulver til koncentrat til infusionsvæske, opløsning 50 ml klart type I hætteglas med butylgummiprop lamineret med en fluor-resin film og aluminiumsforsegling med flip-off hætte som indeholder 420 mg trastuzumab.
English: Table 4 Efficacy results from the monotherapy and combination therapy studies
Danish: Effektresultater fra studier med monoterapi og kombinationsterapi
English: - following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.
Danish: - i kombination med paclitaxel eller docetaxel efter adjuverende kemoterapi med doxorubicin og cyclophosphamid.
English: 1+ A faint/barely perceptible membrane staining is detected in > 10% of the tumour cells.
Danish: 1+ Svag/lige akkurat synlig membranfarvning detekteres i > 10 % af tumorcellerne.
English: Disease-free survival No. patients with event p = 0.0003
Danish: Sygdomsfri overlevelse - Antal patienter med en hændelse p = 0,0003
English: Amongst the most serious and/or common adverse reactions reported in trastuzumab usage to date are cardiac dysfunction, infusion-related reactions, haematotoxicity (in particular neutropenia), infections and pulmonary adverse reactions.
Danish: Kardiel dysfunktion, infusionsrelaterede reaktioner, hæmatotoksicitet (specielt neutropeni), infektioner og pulmonale bivirkninger er til dato blandt de mest alvorlige og/eller almindelige bivirkninger rapporteret ved anvendelse af trastuzumab.
English: • slow heart rate
Danish: • langsom hjerterytme
English: Death (OS event) No. patients with event p = 0.0024
Danish: Død (OS hændelse) - Antal patienter med en hændelse p = 0,0024
English: Metastatic gastric cancer
Danish: Metastatisk ventrikelkræft
English: Symptoms may include kidney problems (weakness, shortness of breath, fatigue and confusion), heart problems (fluttering of the heart of a faster or slower heartbeat), seizures, vomiting or diarrhoea and tingling in the mouth, hands or feet.
Danish: hjerteproblemer (hjerteflagren eller en hurtigere eller langsommere hjerterytme), krampeanfald, opkast eller diarré, og prikkende fornemmelse i munden, på hænderne eller fødderne.
English: Disease-free survival - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation Recurrence-free survival - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation Distant disease-free survival - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation Overall survival (death) - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation
Danish: Distant sygdomsfri overlevelse - Antal patienter med en hændelse - Antal patienter uden en hændelse p-værdi versus observation Hazard ratio versus observation
English: Primary efficacy analysis DFS Hazard ratios (95% CI) p-value p < 0.0001
Danish: Primær effektanalyse Sygdomsfri overlevelse hazard ratio 95 % CI p-værdi p < 0,0001
English: Uncommon side effects (may affect up to 1 in 100 people):
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 patienter):
English: Cardiomyopathy
Danish: Kardiomyopati
English: No staining is observed or membrane staining is observed in < 10% of the tumour cells.
Danish: 0 Der ses ingen farvning eller membranfarvning ses i < 10 % af tumorcellerne.
English: For time to response and duration of response no difference could be recorded between the arms.
Danish: Der blev ikke registreret forskel mellem de to behandlingsarme med hensyn til tid til respons og responsvarighed.
English: which was followed by - CMF on day 1 and 8 every 4 weeks for 3 cycles which was followed after surgery by - additional cycles of adjuvant trastuzumab (to complete 1 year of treatment)
Danish: som efter operation blev efterfulgt af - Yderligere serier af adjuverende trastuzumab (indtil 1 års behandling var fuldført)
English: 1Heart beat irregular
Danish: 1Uregelmæssig hjerteslag
English: Reactions include chills, fever, dyspnoea, hypotension, wheezing, bronchospasm, tachycardia, reduced oxygen saturation, respiratory distress, rash, nausea, vomiting and headache (see section 4.4).
Danish: Reaktionerne inkluderer, kulderystelser, feber, dyspnø, hypotension, hvæsende vejrtrækning, bronkospasmer, takykardi, nedsat iltmætning, åndedrætsbesvær, udslæt, kvalme, opkastning og hovedpine (se pkt.
English: • difficulty in breathing when lying flat
Danish: • problemer med at trække vejret i liggende position
English: In the joint analysis of the NSABP B-31 and NCCTG N9831 studies, EBC was limited to women with operable breast cancer at high risk, defined as HER2-positive and axillary lymph node positive or
Danish: I den samlede analyse af NSABP B-31- og NCCTG N9831-studierne var tidlig brystkræft begrænset til kvinder med operabel brystkræft med høj risiko, defineret som HER2-positiv og med positive lymfeknuder i aksillen eller HER2-positiv og med negative lymfeknuder i aksillen med høje risikofaktorer (tumorstørrelse > 1 cm og ER-negativ eller tumorstørrelse > 2 cm, uanset hormonstatus).
English: Overall survival No. patients with event
Danish: Samlet overlevelse Antal patienter med en hændelse
English: The recommended scoring system to evaluate the IHC staining patterns is as stated in table 2: Table 2 Recommended scoring system to evaluate the IHC staining patterns in breast cancer Score Staining pattern
Danish: Det anbefalede scoringssystem til evaluering af de IHC-farvede mønstre er som angivet i tabel 2: Tabel 2.
English: Serious IRRs to trastuzumab infusion including dyspnoea, hypotension, wheezing, hypertension, bronchospasm, supraventricular tachyarrhythmia, reduced oxygen saturation, anaphylaxis, respiratory distress, urticaria and angioedema have been reported (see section 4.8).
Danish: Alvorlige infusionsrelaterede reaktioner, som er rapporteret efter infusion med trastuzumab, omfatter dyspnø, hypotension, hvæsende vejrtrækning, hypertension, bronkospasmer, supraventrikulær takyarytmi, nedsat iltmætning, anafylaksi, åndedrætsbesvær, urticaria og angioødem (se pkt.
English: The recommended maintenance dose of KANJINTI at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
Danish: Den anbefalede vedligeholdelsesdosis af KANJINTI ved 3-ugers intervaller er 6 mg/kg legemsvægt og den påbegyndes 3 uger efter støddosis.
English: Table 8 Final overall survival analysis from the joint analysis of trials NSABP B-31 and NCCTG N9831
Danish: Endelig analyse af samlet overlevelse (OS) fra den samlede analyse af NSABP B-31- og NCCTG N9831-studierne
English: The recommended maintenance dose at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
Danish: Den anbefalede vedligeholdelsesdosis ved 3-ugers intervaller er 6 mg/kg legemsvægt og påbegyndes 3 uger efter støddosis.
English: Response rate (95%CI)
Danish: Responsrate (95 % CI)
English: Lacrimation increased
Danish: Øget tåreflåd
English: • capecitabine - 1,000 mg/m2 orally twice daily for 14 days every 3 weeks for 6 cycles (evening of day 1 to morning of day 15 of each cycle)
Danish: Kemoterapien blev administreret som følger: - capecitabin - 1.000 mg/m2 oralt 2 gange dagligt i 14 dage hver 3. uge i 6 serier (aften på dag
English: Laryngeal oedema
Danish: Laryngeal ødem
English: Three-weekly schedule
Danish: 3-ugers doseringsregime
English: • The recommended starting dose for the three-weekly cycle is 8 mg/kg body weight.
Danish: • Den anbefalede startdosis i 3-ugers-serien er 8 mg/kg legemsvægt.
English: 4 mg/kg + 2 mg/kg qw
Danish: 4 mg/kg + 2 mg/kg ugentlig doseringsregime
English: Arthritis
Danish: Artralgi
English: Tumour cell cluster with a weak to moderate complete, basolateral or lateral membranous reactivity irrespective of percentage of tumour cells stained
Danish: Tumorcellegruppe med en svag til moderat komplet, basolateral eller lateral membranøs reaktivitet uden hensyntagen til procentdelen af farvede tumorceller
English: Respiratory, thoracic and mediastinal disorders
Danish: Luftveje, thorax og mediastinum +1Hvæsende vejrtrækning
English: • inflammation or scarring of the lungs
Danish: • inflammation (betændelseslignende reaktion) eller arvæv i lungerne
English: This yields a 21 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab.
Danish: Resultatet er 21 ml opløsning til enkeltdosisbrug, som indeholder ca. 21 mg/ml trastuzumab.
English: These may be moderate to severe and have been associated with death (see section 4.8).
Danish: Disse bivirkninger kan være moderate til alvorlige og har været dødelige i visse tilfælde (se pkt.
English: This yields a 7.4 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab.
Danish: Resultatet er 7,4 ml opløsning til enkeltdosisbrug, som indeholder ca. 21 mg/ml trastuzumab.
English: HER2 over expression should be detected using an immunohistochemistry (IHC)-based assessment of fixed tumour blocks; HER2 gene amplification should be detected using in situ hybridisation using either SISH or FISH on fixed tumour blocks.
Danish: HER2-genamplifikation bør detekteres ved brug af in situ hybridisering ved brug af enten SISH eller FISH på fikserede tumorblokke.
English: Chemotherapy was administered as follows:
Danish: Paclitaxel i kombination med trastuzumab blev administreret som følger:
English: Tumour cell cluster with a faint/barely perceptible membranous reactivity irrespective of percentage of tumour cells stained
Danish: Tumorcellegruppe med en svag/lige akkurat synlig membranøs reaktivitet uden hensyntagen til procentdelen af farvede tumorceller
English: p < 0.0001 p = 0.014**
Danish: p = 0,014**
English: • respiratory failure
Danish: • åndedrætssvigt
English: C.A.
Danish: i.v.
English: Trastuzumab washout period was assessed following q1w or q3w intravenous administration using the population PK model.
Danish: Udvaskningsperioden for trastuzumab blev vurderet efter ugentlige og 3-ugers intravenøse doseringsregimer ved hjælp af den populationsfarmakokinetiske model.
English: KANJINTI 150 mg powder for concentrate for solution for infusion KANJINTI 420 mg powder for concentrate for solution for infusion trastuzumab
Danish: KANJINTI 150 mg pulver til koncentrat til infusionsvæske, opløsning KANJINTI 420 mg pulver til koncentrat til infusionsvæske, opløsning trastuzumab
English: AC→D = doxorubicin plus cyclophosphamide, followed by docetaxel; AC→DH = doxorubicin plus cyclophosphamide, followed by docetaxel plus trastuzumab; CI = confidence interval Table 10 Overview of efficacy analyses BCIRG 006 AC→D versus DCarbH
Danish: AC→D = doxorubicin og cyclophosphamid efterfulgt af docetaxel; AC→DH = doxorubicin og cyclophosphamid efterfulgt af docetaxel og trastuzumab; CI = konfidensinterval
English: This yields a 7.4 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.1.
Danish: Resultatet er en 7,4 ml opløsning til enkeltdosisbrug, som indeholder ca. 21 mg/ml trastuzumab med en pH på ca. 6,1.
English: The recommended initial loading dose is 8 mg/kg body weight.
Danish: Den anbefalede initiale støddosis er 8 mg/kg legemsvægt.
English: KANJINTI 150 mg powder for concentrate for solution for infusion KANJINTI 420 mg powder for concentrate for solution for infusion
Danish: KANJINTI 150 mg pulver til koncentrat til infusionsvæske, opløsning KANJINTI 420 mg pulver til koncentrat til infusionsvæske, opløsning
English: Death (OS event) No. patients with event p < 0.0001
Danish: Død (OS hændelse) Antal patienter med en hændelse p < 0,0001
English: • failure of the lungs of the baby to develop in the womb
Danish: • utilstrækkelig udvikling af fostrets lunger i livmoderen
English: This yields a 21 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.1.
Danish: Resultatet er en 21 ml opløsning til enkeltdosisbrug, som indeholder ca. 21 mg/ml trastuzumab med en pH på ca. 6,1.
English: 4 cycles.
Danish: Tabel 4.
English: Single doses of trastuzumab alone greater than 10 mg/kg have not been administered in the clinical trials; a maintenance dose of 10 mg/kg q3w following a loading dose of 8 mg/kg has been studied in a clinical trial with MGC patients.
Danish: I et klinisk studie med patienter der havde metastatisk ventrikelkræft blev en vedligeholdelsesdosis på 10 mg/kg i 3-ugers intervaller efter en støddosis på 8 mg/kg undersøgt.
English: - The NSABP B-31 and NCCTG N9831 studies that comprise the joint analysis were designed to investigate the clinical utility of combining trastuzumab treatment with paclitaxel following AC chemotherapy, additionally the NCCTG N9831 study also investigated adding trastuzumab sequentially to AC→P chemotherapy in patients with HER2 positive EBC following surgery.
Danish: - NSABP B-31- og NCCTG N9831-studierne, som udgør den samlede analyse, var designet til at undersøge den kliniske anvendelighed af at kombinere trastuzumab-behandling med paclitaxel efter AC-kemoterapi.
English: Paclitaxel, in combination with trastuzumab, was administered as follows: - intravenous paclitaxel - 80 mg/m2 as a continuous intravenous infusion, given every week for
Danish: - intravenøs paclitaxel - 80 mg/m2 som kontinuerlig intravenøs infusion, administreret hver uge i 12 uger.
English: • bruising
Danish: • rysten
English: KANJINTI and anthracyclines should not be given concurrently in combination in the MBC setting.
Danish: KANJINTI og antracykliner bør ikke anvendes i kombination hos patienter med metastatisk brystkræft.
English: Histidine
Danish: Histidin
English: In the pivotal trial BO22227, trastuzumab was administered concurrently with neoadjuvant chemotherapy that contained four cycles of epirubicin (cumulative dose 300 mg/m2); at a median follow-up exceeding 70 months, the incidence of cardiac failure/congestive cardiac failure was 0.3% in the trastuzumab intravenous arm.
Danish: I det pivotale studie BO22227 blev trastuzumab administreret samtidig med neoadjuverende kemoterapi, som indeholdt fire cyklusser med epirubicin (en kumulativ dosis på 300 mg/m2).
English: KANJINTI 420 mg powder for concentrate for solution for infusion
Danish: KANJINTI 420 mg pulver til koncentrat til infusionsvæske, opløsning
English: Interruption or slowing the rate of the infusion may help control such symptoms.
Danish: Disse symptomer kan muligvis kontrolleres ved afbrydelse af infusionen eller ved at nedsætte infusionshastigheden.
English: KANJINTI 150 mg powder for concentrate for solution for infusion
Danish: KANJINTI 150 mg pulver til koncentrat til infusionsvæske, opløsning
English: Headache
Danish: Smerter
English: Tumour cell cluster with a strong complete, basolateral or lateral membranous reactivity irrespective of percentage of tumour cells stained
Danish: Tumorcellegruppe med stærk komplet, basolateral eller lateral membranøs reaktivitet uden hensyntagen til procentdelen af farvede tumorceller
English: DFS Hazard ratios (95% CI) p-value p<0.0001
Danish: Sygdomsfri overlevelse hazard ratio 95 % CI p-værdi p < 0,0001
English: Table 16 Population predicted PK parameter values at steady-state for trastuzumab intravenous dosing regimens in MBC, EBC and AGC patients
Danish: Populationsforudsagte farmakokinetiske parameter værdier ved steady state for intravenøse trastuzumab doseringsregimer hos patienter med metastatisk brystkræft, tidlig brystkræft og fremskreden ventrikelkræft
English: Hazard Ratio vs AC→D (95% CI)
Danish: Hazard ratio versus AC→D (95 % CI)
English: 1Cardiac flutter
Danish: 1Hjerteflagren
English: Papilloedema
Danish: Forstoppelse
English: Event-free survival No. patients with event
Danish: Hændelsesfri overlevelse Antal patienter med en hændelse
English: Table 14 Population predicted cycle 1 PK exposure values (median with 5th - 95th percentiles) for trastuzumab intravenous dosing regimens in MBC, EBC and AGC patients
Danish: Populations-forudsagte farmakokinetiske eksponeringsværdier (median med 5-95 percentiler) i serie 1 for intravenøse trastuzumab doseringsregimer hos patienter med metastatisk brystkræft, tidlig brystkræft og fremskreden ventrikelkræft
English: The recommended scoring system to evaluate the IHC staining patterns is as stated in table 3: Table 3 Recommended scoring system to evaluate the IHC staining patterns in gastric cancer Score Surgical specimen - staining pattern
Danish: Anbefalet scoringssystem til evaluering af de IHC-farvede mønstre ved brystkræft Score Farvningsmønstre
English: Hazard Ratio vs AC→P (95% CI) p-value
Danish: Hazard ratio versus AC→P (95 % CI) p-værdi
English: Peripheral oedema
Danish: Perifere ødemer
English: Ecchymosis
Danish: Ekkymose
English: Equivocal
Danish: Tvetydig
English: • watery eyes
Danish: • øjnene løber i vand
English: Baseline levels of the shed HER2-ECD observed in MGC patients were comparable to those in MBC and EBC patients and no apparent impact on trastuzumab clearance was observed.
Danish: Der blev observeret sammenlignelige baseline niveauer af shed HER2 ekstracellulære domæne i patienter med metastatisk ventrikelkræft og patienter med henholdsvis metastatisk brystkræft og tidlig brystkræft.
English: +Oxygen saturation decreased
Danish: +Nedsat iltmætning
English: NAME OF THE MEDICINAL PRODUCT KANJINTI 420 mg powder for concentrate for solution for infusion trastuzumab
Danish: KANJINTI 420 mg pulver til koncentrat til infusionsvæske, opløsning trastuzumab
English: • conjunctivitis
Danish: • opkastning
English: Rhinorrhoea
Danish: Rinoré
English: Haemorrhoids
Danish: Muskelkramper
English: given every 3 weeks for 6 cycles (days 1 to 5 of each cycle) Either of which was administered with:
Danish: administreret hver 3. uge i 6 serier (dag 1 til 5 af hver serie) Begge blev administreret med: - cisplatin - 80 mg/m2 hver 3. uge i 6 serier på dag 1 i hver serie.
English: • altered taste
Danish: • smagsforstyrrelser
English: NAME OF THE MEDICINAL PRODUCT KANJINTI 150 mg powder for concentrate for solution for infusion trastuzumab
Danish: KANJINTI 150 mg pulver til koncentrat til infusionsvæske, opløsning trastuzumab
English: MBC EBC Table 15 Population predicted steady-state PK exposure values (median with 5th - 95th percentiles) for trastuzumab intravenous dosing regimens in MBC, EBC and AGC patients
Danish: Populationsforudsagte steady-state farmakokinetiske eksponeringsværdier (med 5-95 percentiler) for intravenøse trastuzumab doseringsregimer hos patienter med metastatisk brystkræft, tidlig brystkræft og fremskreden ventrikelkræft
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or may take any other medicines.
Danish: Brug af anden medicin sammen med KANJINTI Fortæl det altid til lægen, apotekspersonalet eller sundhedspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: 1Palpitation
Danish: 1Muskelstivhed
English: or - intravenous paclitaxel - 175 mg/m2 as a continuous intravenous infusion, given every 3 weeks for 4 cycles (day 1 of each cycle).
Danish: eller - intravenøs paclitaxel - 175 mg/m2 som kontinuerlig intravenøs infusion, administreret hver
English: DFS analysis was also performed at the final analysis of OS from the joint analysis of studies NSABP B-31 and NCCTG N9831.
Danish: Ved den endelige analyse af samlet overlevelse fra den samlede analyse af studierne NSABP B-31 og NCCTG N9831 blev der også udført en analyse af sygdomsfri overlevelse.
English: Orthopnoea
Danish: Ortopnø
English: • fatigue
Danish: • forstoppelse
English: Amgen Europe B.V. Minervum 7061
Danish: Amgen Europe B.V.
English: Deafness
Danish: Papilødem
English: 12 weeks.
Danish: Tabel 12.
English: Retinal haemorrhage
Danish: • nakkesmerter hæmorider
English: Method of administration
Danish: Doserings -regime
English: • skin rashes
Danish: • knoglesmerter kløen
English: +Acute pulmonary oedema
Danish: +Akut lungeødem
English: Musculoskeletal and connective tissue disorders
Danish: • mund-og hudtørhed halsinfektioner
English: Doxorubicin and cyclophosphamide were administered concurrently as follows: - intravenous push doxorubicin, at 60 mg/m2, given every 3 weeks for 4 cycles.
Danish: - intravenøs bolus doxorubicin på 60 mg/m2, administreret hver 3. uge i 4 serier.
English: Onychoclasis
Danish: Sinuitis
English: neck pain haemorrhoids bone pain itchiness acne leg cramps
Danish: • acne • kramper i benene
English: Adopted at the 6-9 February 2017 PRAC
Danish: Vedtaget 6.-9. februar 2017 PRAC
English: The relationship between fluconazole use and these events is unclear.
Danish: Sammenhængen mellem brug af fluconazol og disse bivirkninger er endnu uklar.
English: An observational study has suggested an increased risk of spontaneous abortion in women treated with fluconazole during the first trimester.
Danish: Et observationsstudie har vist en øget risiko for spontan abort hos kvinder, der er blevet behandlet med fluconazol i første trimester.