FrancophonIA/ELRC3.0 huggingface dataset:
English: Papaellinas Ltd Τηλ: +357 22741741
Danish: C.A. Papaellinas Ltd Τηλ: +357 22741741
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: D. BETINGELSER ELLER BEGRÆ NSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆ GEMIDLET
English: It is also used in combination with medicines called aromatase inhibitors with patients with high levels of HER2 and hormone receptor-positive metastatic breast cancer (cancer that is sensitive to the presence of female sex hormones).
Danish: Det anvendes også i kombination med medicin, som kaldes aromatasehæ mmere til patienter med høje koncentrationer af HER2 samt hormonreceptor-positiv metastatisk brystkræ ft (brystkræ ft der er følsom over for tilstedevæ relsen af kvindelige kønshormoner).
English: In patients with EBC eligible for neoadjuvant-adjuvant treatment, Herzuma should be used concurrently with anthracyclines only in chemotherapy-naive patients and only with low-dose anthracycline regimens i.e. maximum cumulative doses of doxorubicin 180 mg/m or epirubicin
Danish: Hos patienter med tidlig brystkræ ft, som er egnede til neoadjuverende-adjuverende behandling, bør Herzuma kun bruges samtidig med antracykliner hos kemoterapi-naive patienter og kun i regimer med lave antracyklindoser dvs. maksimale kumulative doser af doxorubicin 180 mg/m eller epirubicin
English: Total CL range from Cmax,ss to Cmin,ss (L/day)
Danish: Samlet CL- interval fra Cmax,ss til Cmin,ss (l/dag)
English: They include weakening of the heart muscle possibly leading to heart failure, inflammation of the lining around the heart and heart rhythm disturbances.
Danish: De inkluderer svæ kkelse af hjertemusklen, der muligvis kan føre til hjertesvigt, betæ ndelse i hinden omkring hjertet og forstyrrelser i hjerterytmen.
English: Trastuzumab binds with high affinity and specificity to sub-domain IV, a juxta-membrane region of HER2's extracellular domain.
Danish: Trastuzumab binder med høj affinitet og specificitet til subdomæ ne IV, en juxtamembranregion i HER2´s ekstracelluæ re domæ ne.
English: Risk factors associated with interstitial lung disease include prior or concomitant therapy with other anti-neoplastic therapies known to be associated with it such as taxanes, gemcitabine, vinorelbine and radiation therapy.
Danish: Risikofaktorer for interstitiel lungesygdom omfatter tidligere eller samtidig behandling med andre anti-neoplastiske stoffer, som er kendt for at væ re forbundet med interstitiel lungesygdom, såsom taxaner, gemcitabin og vinorelbin, og strålebehandling.
English: Patients who receive anthracyclines after stopping Herzuma may possibly be at increased risk of cardiac dysfunction.
Danish: Patienter, som får antracykliner efter ophør af Herzuma-behandling, kan muligvis have øget risiko for kardiel dysfunktion.
English: A final analysis was performed after a median follow-up of 8 years, which showed that 1 year trastuzumab treatment is associated with a 24% risk reduction compared to observation only (HR=0.76, 95% CI 0.67, 0.86).
Danish: En endelig analyse blev udført efter en median opfølgning på 8 år, hvilket viste, at 1 års trastuzumab-behandling er associeret med 24 % risikoreduktion sammenlignet med observation alene (hazard ratio = 0,76; 95 % konfidensinterval 0,67-0,86).
English: The following information is intended for medical or healthcare professionals only
Danish: Nedenstående oplysninger er til læ ger og sundhedspersonale
English: - intravenous paclitaxel - 80 mg/m as a continuous intravenous infusion, given every week for 12 weeks.
Danish: - intravenøs paclitaxel - 80 mg/m som kontinuerlig intravenøs-infusion, administreret hver uge i 12 uger.
English: Herzuma may be prescribed in combination with the chemotherapy medicine paclitaxel or docetaxel as first treatment for metastatic breast cancer or it may be prescribed alone if other treatments have proved unsuccessful.
Danish: Herzuma kan ordineres i kombination med kemoterapilæ gemidlerne paclitaxel og docetaxel som første behandling for metastatisk brystkræ ft, eller det kan ordineres alene, hvis andre behandlinger har vist sig ikke at virke.
English: If LVEF percentage drops ≥ 10 points from baseline AND to below 50%, treatment should be suspended and a repeat LVEF assessment performed within approximately 3 weeks.
Danish: Ved et fald i LVEF-procenten på ≥10 point fra baseline OG til under 50 %, bør behandlingen seponeres, og en ny LVEF-måling udføres inden for ca. 3 uger.
English: Patients with MBC who have previously received anthracyclines are also at risk of cardiac dysfunction with Herzuma treatment, although the risk is lower than with concurrent use of Herzuma and anthracyclines.
Danish: Patienter med metastatisk brystkræ ft, som tidligere har fået antracykliner, er også i risikogruppe for kardiel dysfunktion ved Herzuma-behandling, selvom risikoen er lavere end ved samtidig brug af Herzuma og antracykliner.
English: In the neoadjuvant-adjuvant treatment setting, study MO16432, a multicentre randomised trial, was designed to investigate the clinical efficacy of concurrent administration of trastuzumab with neoadjuvant chemotherapy including both an anthracycline and a taxane, followed by adjuvant trastuzumab, up to total treatment duration of 1 year.
Danish: I den neoadjuverende-adjuverende behandling var studie MO16432, et multicenter randomiseret studie, designet til at undersøge den kliniske virkning af samtidig administration af trastuzumab og neoadjuverende kemoterapi inkluderende både et antracyklin og et taxan, efterfulgt af adjuverende trastuzumab til en total behandlingsvarighed på 1 år.
English:  you have metastatic gastric cancer with high levels of HER2, when it is in combination with the other cancer medicines capecitabine or 5-fluorouracil and cisplatin.
Danish: • du har metastatisk mavekræft med høje koncentrationer af HER2, når det er i kombination med de andre kræ ftlæ gemidler, capecitabin eller 5-fluoruracil og cisplatin.
English: In addition, caution should be exercised in treating patients with increased cardiac risk, e.g. hypertension, documented coronary artery disease, CHF, LVEF of < 55%, older age.
Danish: Herudover skal der udvises forsigtighed ved behandling af patienter med risikofaktorer for hjertesygdom f.eks. hypertension, dokumenteret koronararteriesygdom, kongestiv hjerteinsufficiens, LVEF <55 %, æ ldre patienter.
English: If you receive Herzuma with any other medicine to treat cancer, such as paclitaxel, docetaxel, an aromatase inhibitor, capecitabine, 5-fluorouracil, or cisplatin you should also read the patient information leaflets for these products.
Danish: Hvis du får Herzuma sammen med andre læ gemidler til at behandle kræ ft, såsom paclitaxel, docetaxel, en aromatasehæ mmer, capecitabin, 5-fluoruracil eller cisplatin, skal du også læ se indlæ gssedlerne for disse læ gemidler.
English: Other medicines and Herzuma
Danish: Brug af anden medicin sammen med Herzuma
English: On the basis of the scientific conclusions for trastuzumab the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing trastuzumab is unchanged subject to the proposed changes to the product information
Danish: På baggrund af de videnskabelige konklusioner for trastuzumab er CHMP af den opfattelse, at benefit/risk-forholdet for det læ gemiddel/de læ gemidler, der indeholder trastuzumab, forbliver uæ ndret under forudsæ tning af, at de foreslåede æ ndringer indføres i produktinformationen.
English: Do not use this medicine after the expiry date which is stated on the outer carton and on the vial label after EXP.
Danish: Brug ikke læ gemidlet efter den udløbsdato, der står på den ydre karton og på etiketten på hæ tteglasset efter EXP. Udløbsdatoen er den sidste dag i den næ vnte måned.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Danish: MÆ RKNING, DER SKAL ANFØ RES PÅ DEN YDRE EMBALLAGE
English: In one of the 3 pivotal studies conducted in which a median follow-up of 5.5 years was available (BCIRG006) a continuous increase in the cumulative rate of symptomatic cardiac or LVEF events was observed in patients who were administered trastuzumab concurrently with a taxane following anthracycline therapy up to 2.37% compared to approximately 1% in the two comparator arms (anthracycline plus cyclophosphamide followed by taxane and taxane, carboplatin and trastuzumab).
Danish: I et af de 3 pivotale studier, hvor en median opfølgningstid på 5,5 år var tilgæ ngelig (BCIRG 006), blev der observeret en kontinuerlig stigning i det samlede antal af symptomatiske kardielle eller LVEF hæ ndelser hos patienter, som fik trastuzumab administreret samtidig med et taxan efter antracyklinbehandling, på op til 2,37 %, sammenlignet med ca. 1 % i de to komparatorarme (antracyklin plus cyclophosphamid efterfulgt af taxan; taxan, carboplatin og trastuzumab).
English: It is not known whether trastuzumab is secreted in human milk.
Danish: Det er ukendt, om trastuzumab udskilles i human mæ lk.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
English: In BCIRG 006 study, 213/1075 patients in the DCarbH (TCH) arm, 221/1074 patients in the AC→DH (AC→TH) arm, and 217/1073 in the AC→D (AC→T) arm had a Karnofsky performance status ≤ 90 (either 80 or 90).
Danish: I BCIRG 006-studiet havde 213/1.075 patienter i DCarbH (TCH)-armen, 221/1.074 patienter i AC→DH (AC→TH)-armen og 217/1.073 patienter i AC→D (AC→T)-armen en Karnofsky performance status ≤90 (enten 80 eller 90).
English: Women of childbearing potential should be advised to use effective contraception during treatment with Herzuma and for 7 months after treatment has concluded (see section 5.2).
Danish: Kvinder i den fertile alder skal rådes til at bruge sikker kontraception under behandlingen med Herzuma og i 7 måneder efter afslutning af behandlingen (se pkt.
English: Herzuma may have a minor influence on the ability to drive or use machines (see section 4.8).
Danish: Herzuma kan have en mindre påvirkning på evnen til at føre motorkøretøj og betjene maskiner (se pkt.
English: 4.4 Special warnings and precautions for use
Danish: 4.4 Sæ rlige advarsler og forsigtighedsregler vedrørende brugen
English: Overall survival, median months Progression-free survival, median months
Danish: Progressionsfri overlevelse Median måneder
English: - in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab.
Danish: - i kombination med en aromatasehæmmer til behandling af postmenopausale patienter med hormon-receptor-positiv metastatisk brystkræ ft, der ikke tidligere er blevet behandlet med trastuzumab.
English: Infusion-related reactions and hypersensitivity
Danish: Infusionsrelaterede reaktioner og overfølsomhed
English: • numbness or tingling of the fingers and toes
Danish: • følelsesløshed eller snurren i fingre og tæer
English: As a result, trastuzumab has been shown, in both in vitro assays and in animals, to inhibit the proliferation of human tumour cells that overexpress HER2.
Danish: Som følge heraf har trastuzumab, både i in vitro analyser og på dyr, vist sig at hæ mme proliferationen af humane tumorceller med overekspression af HER2.
English: For early breast cancer, metastatic breast cancer and metastatic gastric cancer, Herzuma is given every 3 weeks.
Danish: Ved tidlig brystkræ ft, metastatisk brystkræ ft og metastatisk mavekræ ft gives Herzuma hver 3. uge.
English: Trastuzumab is designed to bind selectively to an antigen called human epidermal growth factor receptor 2 (HER2).
Danish: Trastuzumab er designet til at binde selektivt til et antigen kaldet human epidermal væ kstfaktorreceptor 2 (HER2).
English: So far, no results are available which compare the efficacy of trastuzumab administered with chemotherapy in the adjuvant setting with that obtained in the neo-adjuvant/adjuvant setting.
Danish: Der er ingen tilgæ ngelige resultater, der sammenligner virkningen af trastuzumab, administreret med kemoterapi i den adjuverende behandling, med virkningen i den neoadjuverende-adjuverende behandling.
English: A volume overage of 4% ensures that the labelled dose of 150 mg can be withdrawn from each vial.
Danish: Et volumenoverskud på 4 % sikrer, at den angivne dosis på 150 mg kan træ kkes op af hvert hæ tteglas.
English: In general, SISH or FISH is considered positive if the ratio of the HER2 gene copy number per tumour cell to the chromosome 17 copy number is greater than or equal to 2.
Danish: Generelt anses SISH eller FISH for at væ re positive, hvis forholdet mellem antallet af HER2-genkopier per tumorcelle og antallet af kromosom 17-kopier er større end eller lig med 2.
English: Table 12 Efficacy results from MO16432
Danish: Virkningsresultater fra MO16432
English: In order to prevent medication errors it is important to check the vial labels to ensure that the medicine being prepared and given is Herzuma (trastuzumab) and not trastuzumab emtansine.
Danish: For at undgå fejlmedicinering er det også vigtigt at kontrollere hæ tteglassets etiket for at sikre, at det præ parat, som klargøres og gives, er Herzuma (trastuzumab) og ikke trastuzumabemtansin.
English: Herzuma in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.
Danish: Herzuma er, i kombination med capecitabin eller 5-fluoruracil og cisplatin, indiceret til behandling af voksne patienter med HER2-positivt metastatisk adenokarcinom i ventriklen eller den gastro-øsofageale overgang, som ikke tidligere har fået anticancer-behandling for deres metastatiske sygdom.
English: Trastuzumab has been studied in combination with anastrozole for first line treatment of MBC in HER2 overexpressing, hormone-receptor (i.e. estrogen-receptor [ER] and/or progesterone-receptor [PR]) positive postmenopausal patients.
Danish: Trastuzumab er blevet undersøgt i kombination med anastrozol ved 1. linjebehandling af metastatisk brystkræ ft hos HER2-positive, hormon-receptor-positive (dvs. østrogen-receptor og/eller progesteronreceptor) postmenopausale patienter.
English: AUC0-21days (μg.day/mL)
Danish: AUC0-21 dage (mikrogram.dag/ml)
English: If patients have a continued decrease in left ventricular function, but remain asymptomatic, the physician should consider discontinuing therapy if no clinical benefit of Herzuma therapy has been seen.
Danish: Hvis patienten har vedvarende nedsat venstre ventrikelfunktion, men forbliver asymptomatisk, bør læ gen overveje at seponere Herzuma, hvis der ikke ses nogen klinisk fordel.
English: - Study BO16348 was designed to compare one and two years of three-weekly trastuzumab treatment versus observation in patients with HER2 positive EBC following surgery, established chemotherapy and radiotherapy (if applicable).
Danish: - Studie BO16348 var designet til at sammenligne 1 og 2-års trastuzumab-behandling hver 3. uge versus observation hos patienter med HER2-positiv tidlig brystkræ ft efter operation, standard-kemoterapi og strålebehandling (hvis indiceret).
English: To ensure validation of testing procedures and the generation of accurate and reproducible results, HER2 testing must be performed in a laboratory staffed by trained personnel.
Danish: For at sikre validering af testmetoderne og produktion af præ cise og reproducerbare resultater skal HER2-testning udføres i et laboratorium med træ net personale.
English: SPECIAL STORAGE CONDITIONS
Danish: SÆ RLIGE OPBEVARINGSBETINGELSER
English: Only an accurate and validated assay should be used to detect HER2 over expression or HER2 gene amplification.
Danish: Kun en præ cist og valideret analysemetode bør bruges til at bestemme HER2-overekspression eller HER2-genamplifikation.
English: The test method for HER2 overexpression used to determine eligibility of patients in the pivotal trastuzumab monotherapy and trastuzumab plus paclitaxel clinical trials employed immunohistochemical staining for HER2 of fixed material from breast tumours using the murine monoclonal antibodies CB11 and 4D5.
Danish: Den testmetode for overekspression af HER2, som blev brugt til at bestemme patienternes egnethed i det pivotale studie med trastuzumab-monoterapi og i de kliniske studier med trastuzumab plus paclitaxel, anvendte immunhistokemisk farvning for HER2 af fikseret materiale fra brysttumorer ved hjæ lp af de murine monoklonale antistoffer CB11 og 4D5.
English: Currently no data from clinical trials are available on re-treatment of patients with previous exposure to Herzuma in the adjuvant setting.
Danish: Der foreligger ingen tilgæ ngelige data fra kliniske studier for genbehandling hos patienter, der tidligere har fået adjuverende behandling med Herzuma.
English: There was a correlation between shed antigen and SGOT/AST levels; part of the impact of shed antigen on clearance may have been explained by SGOT/AST levels.
Danish: Der var en sammenhæ ng mellem niveauerne af shed-antigen og serum-aspartataminotransferase; en del af shed-antigenets indvirkning på clearance kan muligvis forklares ud fra serum-aspartat-aminotransferase niveauet.
English: In the neoadjuvant-adjuvant EBC study (BO22227), at a median follow-up exceeding 70 months, 10.1% (30/296) of patients treated with trastuzumab intravenous developed antibodies against trastuzumab.
Danish: I det neoadjuverende-adjuverende studie af tidlig brystkræ ft (BO22227) udviklede 10,1 % (30/296) af patienterne behandlet med intravenøst trastuzumab antistoffer mod trastuzumab ved en median opfølgningstid på mere end 70 måneder.
English: For overall survival, the HR was 0.75 (95% CI 0.51 - 1.11) in the IHC 2+/FISH+ group and the HR was 0.58 (95% CI 0.41 - 0.81) in the IHC 3+/FISH+ group.
Danish: For den samlede overlevelse var hazard ratio 0,75 (95 % konfidensinterval 0,51 - 1,11) i IHC2+/FISH+ gruppen og 0,58 (95 % konfidensinterval 0,41 - 0,81) i ICH3+/FISH+ gruppen.
English: What Herzuma contains
Danish: Herzuma indeholder:
English:  you have had heart failure, coronary artery disease, heart valve disease (heart murmurs), high blood pressure, taken any high blood pressure medicine or are currently taking any high blood pressure medicine.
Danish: • du har haft hjertesvigt, koronararteriesygdom, hjerteklapsygdom (hjertemislyd) eller forhøjet blodtryk, eller hvis du tager eller har taget medicin mod forhøjet blodtryk.
English: No reductions in the dose of Herzuma were made during clinical trials.
Danish: Herzuma-dosis blev ikke reduceret i de kliniske studier.
English: There were no restrictions on the relative timing of trastuzumab and anastrozole at administration (for dose, see the SmPC for anastrozole or other aromatase inhibitors).
Danish: Der var ingen tidsmæ ssige restriktioner for administrationen af trastuzumab og anastrozol (se dosis i produktresuméet for anastrazol eller andre aromatasehæ mmere).
English: +Pulmonary fibrosis
Danish: Pulmonal fibrose
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Danish: DATO FOR FØ RSTE MARKEDSFØ RINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Once the infusion is prepared it should be administered immediately.
Danish: Når infusionsvæ sken først er fremstillet skal den anvendes med det samme.
English: No reactivity or membranous reactivity in < 10% of tumour cells
Danish: Ingen reaktivitet eller membranøs reaktivitet i <10 % af tumorcellerne
English: The efficacy results from the non-comparative monotherapy and combination therapy studies are summarised in Table 5:
Danish: Virkningsresultaterne fra ikke-komparative monoterapi og kombinationsterapi studier er sammenfattet i tabel 5:
English: The infusion may be continued after the symptoms improve.
Danish: Infusionen kan fortsæ ttes, når symptomerne er blevet formindsket.
English: In Study BO16348, after a median follow-up of 8 years the incidence of severe CHF (NYHA Class III & IV) in the trastuzumab 1 year treatment arm was 0.8%, and the rate of mild symptomatic and asymptomatic left ventricular dysfunction was 4.6%.
Danish: I studie BO16348 var incidensen af svæ r kongestiv hjerteinsufficiens (NYHA-klasse III & IV) efter 1 års trastuzumab-behandling 0,8 % efter en median opfølgning på 8 år, og hyppigheden af let symptomatisk og asymptomatisk dysfunktion af venstre ventrikel var 4,6 %.
English: In 3 pivotal clinical trials of adjuvant trastuzumab given in combination with chemotherapy, the incidence of grade 3/4 cardiac dysfunction (specifically symptomatic Congestive Heart Failure) was similar in patients who were administered chemotherapy alone (i.e. did not receive trastuzumab) and in patients who were administered trastuzumab sequentially after a taxane (0.3 - 0.4%).
Danish: I 3 pivotale kliniske studier, hvor adjuverende trastuzumab blev administreret i kombination med kemoterapi, var hyppigheden af kardiel dysfunktion af grad 3/4 (isæ r symptomatisk kongestiv hjerteinsufficiens) tilsvarende hos patienter, der fik administreret kemoterapi alene (dvs. som ikke fik trastuzumab), som hos patienter, der fik trastuzumab sekventielt efter ettil taxan (0,3 - 0,4 %).
English: - capecitabine - 1000 mg/m 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: - capecitabin - 1.000 mg/m oralt 2 gange dagligt i 14 dage hver 3. uge i 6 serier (aften på dag 1 til morgen på dag 15 i hver serie)
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 HER2 positive and lymph node negative with high risk features (tumour size > 1 cm and ER negative or tumour size > 2 cm, regardless of hormonal status).
Danish: I den samlede analyse af NSABP B-31- og NCCTG N9831-studierne var tidlig brystkræ ft begræ nset til kvinder med operabel brystkræ ft 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: There are no immunogenicity data available for trastuzumab in gastric cancer.
Danish: Der foreligger ingen data om immunogenicitet for trastuzumab ved ventrikelkræ ft.
English: In order to prevent medication errors it is important to check the vial labels to ensure that the medicinal product being prepared and administered is Herzuma (trastuzumab) and not Kadcyla (trastuzumab emtansine).
Danish: For at forebygge fejlmedicinering er det vigtigt at kontrollere hæ tteglassets etiket for at sikre, at det læ gemiddel, der klargøres og administreres, er Herzuma (trastuzumab) og ikke Kadcyla (trastuzumabemtansin).
English: Treatment with AC→PH resulted in a statistically significant improvement in OS compared with AC→P (stratified HR=0.64; 95% CI [0.55, 0.74]; log-rank p-value < 0.0001).
Danish: Behandling med AC→PH resulterede i en statistisk signifikant forbedring af samlet overlevelse sammenlignet med AC→P (stratificeret hazard ratio = 0,64; 95 % konfidensinterval = 0,55-0,74; log-rank p-væ rdi <0,0001).
English: A volume overage of 4% ensures that the labelled dose of 420 mg can be withdrawn from each vial.
Danish: Et volumenoverskud på 4 % sikrer, at den angivne dosis på 420 mg kan træ kkes op af hvert hæ tteglas.
English: One case of tumour lysis syndrome with trastuzumab administration as monotherapy lends further support.
Danish: Ét tilfæ lde af tumorlyse syndrom med trastuzumab som monoterapi behandling støtter dette yderligere.
English: What you need to know before you use Herzuma
Danish: Det skal du vide, før du begynder at bruge Herzuma
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Danish: INDHOLD ANGIVET SOM VÆ GT, VOLUMEN ELLER ANTAL DOSER
English: Blood pressure increased
Danish: 1Forhøjet blodtryk
English: Healthcare professionals are asked to report any suspected adverse reactions.
Danish: Læ ger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger.