FrancophonIA/ELRC3.0 huggingface dataset:
English: Within each frequency grouping adverse reactions are reported in order of decreasing seriousness.
Danish: Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige, de er.
English: Considering the potential for serious adverse reactions due to fulvestrant in breast-fed infants, use during lactation is contraindicated (see section 4.3).
Danish: Med henblik på muligheden for potentielt alvorlige bivirkninger hos ammede børn på grund af fulvestrant, er anvendelse under amning kontraindiceret (se pkt.
English: In rats, a reversible reduction in female fertility and embryonic survival, dystocia and an increased incidence of foetal abnormalities including tarsal flexure were observed.
Danish: Hos rotter sås en reversibel nedsat kvindelig fertilitet og embryo-overlevelse, dyctocia samt en øget forekomst af fosterabnormaliteter inkl.
English: Leukopenia includes the following PTs: Leukopenia, White blood cell count decreased.
Danish: Leukopeni inkluderer de følgende PTs: leukopeni, nedsat antal hvide blodlegemer.
English: Comparison between groups (Faslodex 500 mg/Faslodex 250 mg) Absolute difference in %
Danish: Sammenligning mellem grupper (Faslodex 500 mg/Faslodex 250 mg) Absolut forskel i %
English: massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver involvement), were not eligible for enrolment into the study.
Danish: livstruende komplikationer på kort sigt (herunder patienter med massivt ukontrolleret ekssudat [pleural, perikardiel, peritoneal], pulmonal lymfangitis samt mere end 50 % leverpåvirkning), var ikke egnede til deltagelse i studiet.
English: Table 5 Efficacy results - PALOMA3 study (Investigator assessment, intent-to-treat population)
Danish: Tabel 5 Effektresultater - PALOMA-3-studiet (investigatorvurdering, intent-to-treat-population)
English: Combined analysis of both studies showed the hazard ratio of Faslodex 250 mg to anastrozole for progression-free survival was 0.95 (95% CI 0.82 to 1.10).
Danish: Kombineret analyse for begge studier viste, at hazard ratio for Faslodex 250 mg i forhold til anastrozol, med henblik på progressionsfri overlevelse var 0,95 (95% konfidensinterval 0,82-1,10).
English: • Increase of bilirubin (bile pigment produced by the liver)
Danish: • Forhøjet bilirubin (galdefarvestof, der dannes i leveren)
English: A 2-week study in healthy postmenopausal volunteers treated with 20 μg per day ethinylestradiol showed that pretreatment with Faslodex 250 mg resulted in significantly reduced stimulation of the postmenopausal endometrium, compared to pre-treatment with placebo, as judged by ultrasound measurement of endometrium thickness.
Danish: Et forsøg på 2 uger med raske postmenopausale frivillige forsøgspersoner, behandlet med 20 μg ethinylestradiol dagligt, viste, at præmedicinering med Faslodex 250 mg resulterede i en signifikant reduceret stimulation af det postmenopausale endometrium, sammenlignet med placebo, vurderet via ultralydsmålinger af endometriets tykkelse.
English: • Peel open the safety needle (SafetyGlide) outer packaging.
Danish: • Åbn den ydre pakning af den beskyttede kanyle (SafetyGlide).
English: The steady-state trough concentrations of fulvestrant in children in this study were consistent with that in adults (see section 5.2).
Danish: Steady state-dalkoncentrationen af fulvestrant hos børnene i denne undersøgelse svarede til den, som blev observeret hos voksne (se pkt.
English: The paediatric patients were aged 1 to 8 years and received 4 mg/kg monthly intramuscular dose of fulvestrant.
Danish: De pædiatriske patienter var i alderen 1 til 8 år og fiken intramuskulær dosis på 4 mg fulvestrant/kg hver måned.
English: No dose adjustments are recommended for patients with mild to moderate hepatic impairment.
Danish: Dosisjustering anbefales ikke til patienter med let til moderat nedsat leverfunktion.
English: • Allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and/or throat that may be signs of anaphylactic reactions
Danish: • Allergiske reaktioner (overfølsomhed), der kan omfatte hævelser i ansigt, læber, tunge og/eller svælg, som kan være tegn på anafylaktisk reaktion/shock.
English: Visceral Disease
Danish: Visceral sygdom
English: No dose adjustments are recommended for patients with mild to moderate renal impairment (creatinine clearance 30 ml/min).
Danish: Dosisjustering anbefales ikke til patienter med let til moderat nedsat nyrefunktion (kreatinin clearance ≥ 30 ml/min).
English: An open-label Phase 2 study investigated the safety, efficacy and pharmacokinetics of fulvestrant in 30 girls aged 1 to 8 years with Progressive Precocious Puberty associated with McCune Albright Syndrome (MAS).
Danish: Et åben-label fase-2-forsøg undersøgte sikkerhed og virkning samt farmakokinetiske egenskaber ved fulvestrant hos 30 piger i alderen 1 til 8 år med progressiv pubertas præcox i forbindelse med McCune Albright-syndrom (MAS).
English: All Patients -AE subgroup (n=296) -AI subgroup (n=205) CBR
Danish: Alle patienter -AE-undergruppe (n=296) -AI-undergruppe (n=205) CBR
English: The safety and efficacy of Faslodex in children from birth to 18 years of age have not been established.
Danish: Faslodex' sikkerhed og virkning hos børn i alderen 0 til 18 år er ikke klarlagt.
English: System Organ Class Frequency Preferred Term
Danish: Systemorganklasse Hyppighed
English: Other medicines and Faslodex
Danish: Brug af anden medicin sammen med Faslodex
English: • Attach the safety needle to the Luer-Lok and twist until firmly seated (see Figure 3).
Danish: • Fastgør den beskyttede kanyle til sprøjtens LuerLock system og drej indtil den er tilstrækkelig fastgjort (se figur 3).
English: Table 1 Adverse Drug Reactions reported in patients treated with Faslodex monotherapy
Danish: Bivirkninger rapporteret hos patienter behandlet med Faslodex monoterapi
English: Temperature excursions have a cumulative effect on the product quality and the 28-day time period must not be exceeded over the duration of the 4-year shelf life of Faslodex.
Danish: Temperaturudsving har en kumulativ virkning på produktkvaliteten, og perioden på 28 dage må ikke overskrides i løbet af Faslodex opbevaringstiden på 4 år for Faslodex.
English: Interference with estradiol antibody assays
Danish: Interferens med estradiol antistofanalyser
English: Faslodex is indicated in patients whose disease had recurred or progressed on an antiestrogen therapy.
Danish: Faslodex er indiceret til patienter med recidiverende eller progredierende sygdom under antiøstrogen-behandling.
English: Anastrozole 1 mg (N=232)
Danish: Anastrozol 1 mg (N=232)
English: The pharmacokinetics of fulvestrant has been evaluated in a clinical study conducted in 30 girls with Progressive Precocious Puberty associated with McCune Albright Syndrome (see section 5.1).
Danish: Fulvestrants farmakokinetiske egenskaber er blevet evalueret i et klinisk studie med 30 piger med progressiv pubertas præcox i forbindelse med McCune Albright Syndrom (se pkt.
English: Exposure to temperatures below 2°C will not damage the product providing it is not stored below -20°C.
Danish: Udsættelse for temperaturer under 2 °C vil ikke beskadige produktet, forudsat at det ikke opbevares ved temperaturer under -20 °C.
English: Table 4 Summary of results of the primary efficacy endpoint (PFS) and key secondary efficacy endpoints (Investigator Assessment, Intent-To-Treat Population) ─ FALCON study
Danish: Tabel 4 Sammenfatning af resultater af de primære effektmål (PFS) og vigtige sekundære effektmål (investigatorvurdering, intent-to-treat-population) ─ FALCON-studiet
English: A total of 521 pre/peri- and postmenopausal women who had progressed on or within 12 months from completion of adjuvant endocrine therapy on or within 1 month from prior endocrine therapy for advanced disease, were randomised 2:1 to Faslodex plus palbociclib or Faslodex plus placebo and stratified by documented sensitivity to prior hormonal therapy, menopausal status at study entry (pre/peri- versus postmenopausal), and presence of visceral metastases.
Danish: I alt 521 præ-/peri- og postmenopausale kvinder, som havde progredieret under eller inden for 12 måneder efter fuldførelse af adjuverende endokrin behandling, under eller inden for 1 måned efter tidligere endokrin behandling mod fremskreden sygdom, blev randomiseret 2:1 til Faslodex plus palbociclib eller Faslodex plus placebo og stratificeret efter dokumenteret følsomhed over for tidligere hormonbehandling, menopausalstatus ved studiets start (præ-/peri- versus postmenopausal) og forekomst af viscerale metastaser.
English: If you have any questions about palbociclib, please ask your doctor.
Danish: Spørg lægen, hvis du har spørgsmål om palbociclib.
English: Stomatitis includes the following PTs: Aphthous stomatitis, Cheilitis, Glossitis, Glossodynia, Mouth ulceration, Mucosal inflammation, Oral pain, Oropharyngeal discomfort, Oropharyngeal pain, Stomatitis.
Danish: Stomatitis inkluderer de følgende PTs: aftøs stomatitis, cheilitis, glossitis, glossodyni, mundsår, slimhindeinflammation, mundsmerter, orofaryngealt ubehag, orofaryngeale smerter, stomatitis.
English: Faslodex 500 mg (2 x 250 mg/5 ml solution for injection) should be administered using two pre-filled syringes, see section 3.
Danish: Faslodex 500 mg (2 x 250 mg/5 ml injektionsvæske, opløsning) skal administreres med 2 fyldte injektionssprøjter, se pkt.
English: Solution for injection.
Danish: Til intramuskulær injektion.
English: This was evident for pre/perimenopausal women (HR of 0.46 [95% CI: 0.28, 0.75]) and postmenopausal women (HR of 0.52 [95% CI: 0.40, 0.66]) and patients with visceral site of metastatic disease (HR of 0.50 [95% CI: 0.38, 0.65]) and non-visceral site of metastatic disease (HR of 0.48 [95% CI: 0.33, 0.71]).
Danish: Dette var tydeligt for præ-/perimenopausale kvinder (HR på 0,46 [95 % CI: 0,28; 0,75]) og postmenopausale kvinder (HR på 0,52 [95 % CI: 0,40; 0,66]) samt patienter med visceral metastatisk sygdom (HR på 0,50 [95 % CI: 0,38; 0,65]) og ikke-visceral metastatisk sygdom (HR på 0,48 [95 % CI: 0,33; 0,71]).
English: A two-year oncogenicity study in rats (intramuscular administration of Faslodex) showed increased incidence of ovarian benign granulosa cell tumours in female rats at the high dose, 10 mg/rat/15 days and an increased incidence of testicular Leydig cell tumours in males.
Danish: Et to-årigt onkogenicitetsstudie med rotter (intramuskulær administration af Faslodex) viste øget forekomst af godartede ovarietumorer i granulosa-celler hos hunrotter ved den høje dosis på 10 mg/rotte/15 dage og en øget forekomst af Leydigs tumorer i testiklerne hos hanrotter.
English: The most common (≥2%) Grade ≥3 adverse reactions were neutropenia, leukopenia, anaemia, infections, AST increased, thrombocytopenia, and fatigue.
Danish: De mest almindelige (≥2 %) grad ≥3-bivirkninger var neutropeni, leukopeni, anæmi, infektioner, øget ASAT, trombocytopeni og træthed.
English: This includes avoiding storage at temperatures exceeding 30°C, and not exceeding a 28 day period where the average storage temperature for the product is below 25°C (but above 2°C - 8°C).
Danish: Dette indbefatter at undgå opbevaring ved temperaturer, der overstiger 30 °C, samt at undgå at overskride en periode på 28 dage med gennemsnitlig opbevaringstemperatur for produktet på under 25 °C (men over 2 °C - 8 °C ).
English: • as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: - not previously treated with endocrine therapy, or - with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy.
Danish: • som monoterapi til behandling af østrogen-receptor-positiv, lokal fremskreden eller metastatisk brystkræft hos postmenopausale kvinder: - der ikke tidligere har modtaget endokrin behandling, eller - med sygdomstilbagefald under eller efter adjuverende behandling med antiøstrogen, eller sygdomsprogression under antiøstrogenbehandling.
English: Each pre-filled syringe (5 ml) contains 250 mg fulvestrant.
Danish: Hver fyldt injektionssprøjte (5 ml) indeholder 250 mg fulvestrant.
English: The hazard ratio of Faslodex 250 mg to anastrozole for time to death was 1.01 (95% CI 0.86 to 1.19).
Danish: Hazard ratio for Faslodex 250 mg i forhold til anastrozol for tid til død, var 1,01 (95% konfidensinterval, 0,86 til 1,19).
English: PRE-FILLED SYRINGE LABEL
Danish: FYLDT SPRØJTE ETIKET
English: The study included 423 patients whose disease had recurred or progressed during antiestrogen therapy (AE subgroup) and 313 patients whose disease had recurred or progressed during aromatase inhibitor therapy (AI subgroup).
Danish: Forsøget omfattede 423 patienter med recidiverende eller progredierende sygdom under antiøstrogen-behandlingen (AE-undergruppe), og 313 patienter med recidiverende eller progredierende sygdom under aromatasehæmmer-behandlingen (AI-undergruppe).
English: With the other hand, take hold of the cap (A) and carefully tilt back and forth until the cap disconnects and can be pulled off, do not twist (see Figure 1).
Danish: Hold fast i låget (A) med den anden hånd og vip forsigtigt frem og tilbage, indtil låget brækkes af og kan trækkes af, drej ikke låget.
English: Benefit was also observed regardless of lines of prior therapy in the metastatic setting, whether 0 (HR of 0.59 [95% CI: 0.37, 0.93]), 1 (HR of 0.46 [95% CI: 0.32, 0.64]), 2 (HR of 0.48 [95% CI: 0.30, 0.76]), or ≥3 lines (HR of 0.59 [95% CI: 0.28, 1.22]).
Danish: Der blev også observeret fordele uanset tidligere behandlingslinjer i metastatisk regi, uden hensyntagen til om det var 0 (HR på 0,59 [95 % CI: 0,37; 0,93]), 1 (HR på 0,46 [95 % CI: 0,32; 0,64]), 2 (HR på 0,48 [95 % CI: 0,30; 0,76]) eller ≥3 linjer (HR på 0,59 [95 % CI: 0,28; 1,22]).
English: Faslodex contains 750 mg benzyl benzoate per injection, equivalent to 150 mg/ml.
Danish: Faslodex indeholder 750 mg benzylbenzoat per injektion, hvilket svarer til 150 mg/ml.
English: Fifty-five percent (55.0%) of patients had visceral metastasis at baseline.
Danish: 55 % af patienterne havde viscerale metastaser ved studiets udgangspunkt.
English: • alone, to treat postmenopausal women with a type of breast cancer called estrogen receptor positive breast cancer that is locally advanced or has spread to other parts of the body (metastatic), or
Danish: • alene, til behandling af postmenopausale kvinder med en type brystkræft kaldet østrogenreceptor-positiv brystkræft, der er lokalt fremskreden eller har spredt sig til andre dele af kroppen (metastatisk), eller
English: The most common (≥20%) adverse reactions of any grade reported in patients receiving fulvestrant in combination with palbociclib were neutropenia, leukopenia, infections, fatigue, nausea, anaemia, stomatitis, diarrhoea, and thrombocytopenia.
Danish: De mest almindelige bivirkninger (≥20 %) af enhver grad rapporteret hos patienter, der fik fulvestrant i kombination med palbociclib, var neutropeni, leukopeni, infektioner, træthed, kvalme, anæmi, stomatitis, diarré og trombocytopeni.
English: Patients with advanced/metastatic, symptomatic, visceral spread, that were at risk of life-threatening complications in the short term (including patients with
Danish: Patienter med fremskreden/metastatisk, symptomatisk, visceral spredning, som havde risiko for
English: Keep the pre-filled syringe in the original package, in order to protect from light.
Danish: Behold den fyldte injektionssprøjte i den originale pakning, for at beskytte den mod lys.
English: was the primary endpoint; key secondary efficacy endpoints included objective response rate (ORR), clinical benefit rate (CBR) and overall survival (OS).
Danish: Blandt de vigtigste sekundære effektendepunkter var objektiv responsrate (ORR), klinisk gevinstrate (CBR) og total overlevelse (OS).
English: At the no-effect level for these findings, systemic exposure levels (AUC) were, in rats, approximately 1.5-fold the expected human exposure levels in females and 0.8-fold in males, and in mice, approximately 0.8-fold the expected human exposure levels in both males and females.
Danish: Ved niveauet ”ingen effekt” for disse fund var den systemiske eksponering (AUC) cirka 1,5 gange niveauet af den forventede humane eksponeringer hos hunrotter og 0,8 gange hos hanrotter.
English: Figure 1 Kaplan-Meier Plot of Progression-Free Survival (Investigator Assessment, Intent-ToTreat Population) ─ FALCON Study
Danish: Figur 1 Kaplan-Meier-diagram over progressionsfri overlevelse (investigatorvurdering, intent-to-treat-population) ─ FALCON-studiet
English: An updated RMP should be submitted • At the request of the European Medicines Agency;
Danish: En opdateret RMP skal fremsendes
English: Caution should be taken if injecting Faslodex at the dorsogluteal site due to the proximity of the underlying sciatic nerve.
Danish: Der bør udvises forsigtighed, hvis Faslodex injiceres i det dorsogluteale område på grund af den nært underliggende iskiasnerve.
English: Kaplan-Meier plot of progression-free survival (investigator assessment, intent-to-treat population) - PALOMA3 study
Danish: Kaplan-Meier-diagram over progressionsfri overlevelse (investigatorvurdering, intent-to-treat-population) - PALOMA-3-studiet
English: A Phase 3, randomised, double-blind, double-dummy, multicentre study of Faslodex 500 mg versus anastrozole 1 mg was conducted in postmenopausal women with ER-positive and/or PgR-positive locally advanced or metastatic breast cancer who had not previously been treated with any hormonal therapy.
Danish: Der blev udført et randomiseret, dobbeltblindet, dobbelt-dummy, fase 3-multicenterstudie med Faslodex 500 mg versus anastrozol 1 mg med postmenopausale kvinder med ER-positiv og/eller PgR-positiv lokalt fremskreden eller metastatisk brystkræft, som ikke tidligere havde fået hormonbehandling.
English: Safety needles (BD SafetyGlide) for connection to each barrel are also provided.
Danish: Der vedlægges også beskyttede kanyler (BD SafetyGlide) til montering på hver sprøjte.
English: Store the pre-filled syringe in the original package in order to protect from light.
Danish: Opbevar den fyldte sprøjte i den originale pakning for at beskytte mod lys.
English: Neoadjuvant treatment for up to 16 weeks in breast cancer patients treated with either Faslodex 500 mg or Faslodex 250 mg did not result in clinically significant changes in endometrial thickness, indicating a lack of agonist effect.
Danish: Neoadjuverende behandling af brystkræftpatienter i op til 16 uger, med enten Faslodex 500 mg eller Faslodex 250 mg, viste ingen klinisk signifikante ændringer i endometriets tykkelse, hvilket indikerer manglende agonistvirkning.
English: A Phase 3, international, randomised, double-blind, parallel-group, multicentre study of Faslodex 500 mg plus palbociclib 125 mg versus Faslodex 500 mg plus placebo was conducted in women with HR-positive, HER2-negative locally advanced breast cancer not amenable to resection or radiation therapy with curative intent or metastatic breast cancer, regardless of their menopausal status, whose disease progressed after prior endocrine therapy in the (neo) adjuvant or metastatic setting.
Danish: Der blev udført et internationalt, randomiseret, dobbeltblindet, fase 3-multicenterstudie med parallelgrupper med Faslodex 500 mg plus palbociclib 125 mg versus Faslodex 500 mg plus placebo med kvinder med HR-positiv, HER2-negativ lokalt fremskreden brystkræft, der ikke var modtagelig for resektion eller strålebehandling med henblik på helbredelse, eller metastatisk brystkræft, uanset menopausalstatus, hvis sygdom progredierede efter tidligere endokrin behandling i (neo)adjuverende eller metastatisk regi.
English: Ethanol (96 per cent) Benzyl alcohol Benzyl benzoate Castor oil refined
Danish: Ethanol (96 procent) Benzylalkohol Benzylbenzoat Ricinusolie, renset
English: A Phase 3 clinical study was completed in 736 postmenopausal women with advanced breast cancer who had disease recurrence on or after adjuvant endocrine therapy or progression following endocrine therapy for advanced disease.
Danish: Et klinisk fase 3-studie blev gennemført hos 736 postmenopausale kvinder med fremskreden brystkræft, som havde sygdomstilbagefald under, eller efter, adjuvant endokrin behandling, eller progression efter endokrin behandling for fremskreden sygdom.
English: • Thick, whitish vaginal discharge and candidiasis (infection)
Danish: • Tykt, hvidligt udflåd fra skeden og svamp (infektion)
English: Very common
Danish: Meget almindelig Udslæt
English: • in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy (see section 5.1).
Danish: • i kombination med palbociclib til behandling af hormonreceptor (HR)-positiv, human epidermal vækstfaktor-receptor 2 (HER2)-negativ lokalt fremskreden eller metastatisk brystkræft hos kvinder, der tidligere har modtaget endokrin behandling (se pkt.
English: Temperature excursions have a cumulative effect on the product quality and the 28 day time period must not be exceeded over the duration of the 4-year shelf life of Faslodex (see section 6.3).
Danish: Temperaturudsving har en kumulativ virkning på produktkvaliteten, og perioden på 28 dage må ikke overskrides i løbet af Faslodex' opbevaringstid på 4 år for Faslodex (se pkt.
English: Faslodex is used either:
Danish: Faslodex anvendes enten
English: • in combination with palbociclib to treat women with a type of breast cancer called hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer, that is locally advanced or has spread to other parts of the body (metastatic).
Danish: • i kombination med palbociclib til behandling af kvinder med en type brystkræft kaldet hormonreceptor positiv, human epidermal vækstfaktor receptor 2-negativ brystkræft, der er lokalt fremskreden eller har spredt sig til andre dele af kroppen (metastatisk).
English: Faslodex 250 mg solution for injection fulvestrant
Danish: Faslodex 250 mg injektionsvæske, opløsning fulvestrant
English: In the pooled dataset of fulvestrant monotherapy, the most frequently reported adverse reactions were injection site reactions, asthenia, nausea, and increased hepatic enzymes (ALT, AST, ALP).
Danish: I de poolede datasæt med fulvestrant som monoterapi var de hyppigst rapporterede bivirkninger reaktioner ved injektionsstedet, asteni, kvalme og forhøjede leverenzymer (ALAT, ASAT, alkalisk fosfatase (ALP)).
English: Store and transport in a refrigerator (2°C - 8°C).
Danish: Opbevares i køleskab og transporteres nedkølet (2 °C - 8 °C)
English: The term injection site reactions does not include the terms injection site haemorrhage, injection site haematoma, sciatica, neuralgia and neuropathy peripheral.
Danish: Termen reaktioner ved injektionsstedet dækker ikke termerne blødning ved injektionsstedet, hæmatom ved injektionsstedet, iskias, neuralgi og perifer neuropati.
English: ORR Odds Ratio (95% CI) and p-value
Danish: ORR-odds ratio (95 % CI) og p-værdi
English: How to use Faslodex
Danish: Sådan skal du bruge Faslodex
English: Progression-Free Survival Median [months (95% CI)] Hazard ratio (95% CI) and p-value
Danish: Progressionsfri overlevelse Median [måneder (95 % CI)] Hazard ratio (95 % CI) og p-værdi
English: Two Phase 3 clinical studies were completed in a total of 851 postmenopausal women with advanced breast cancer who had disease recurrence on or after adjuvant endocrine therapy or progression following endocrine therapy for advanced disease.
Danish: To kliniske fase 3-studier blev gennemført med i alt 851 postmenopausale kvinder med fremskreden brystkræft, som havde sygdomstilbagefald under, eller efter, adjuvant endokrin behandling, eller progression efter endokrin behandling for fremskreden sygdom.
English: A safety needle (BD SafetyGlide) for connection to the barrel is also provided.
Danish: Der vedlægges også en beskyttet kanyle (BD SafetyGlide) til montering på sprøjten.
English: • Urinary tract infections
Danish: • Urinvejsinfektion