FrancophonIA/ELRC3.0 huggingface dataset:
English: What you need to know before you use TAXOTERE
Danish: Det skal du vide, før du begynder at bruge TAXOTERE
English: Frequencies are defined as: 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 available data).
Danish: Hyppigheder defineres som: meget almindelig ( 1/10); almindelig ( 1/100 til < 1/10); ikke almindelig ( 1/1000 til < 1/100); sjælden ( 1/10.000 til < 1/1000); meget sjælden (< 1/10.000); hyppighed ikke kendt (kan ikke estimeres ud fra tilgængelige data).
English: See accompanying preparation guide.
Danish: Se den medfølgende vejledning.
English: This was also statistically significant with an HR of 0.71; 95% CI 0.56-0.90; log-rank test p = 0.004.
Danish: Dette var også statistisk signifikant med en HR på 0,71; 95 % CI 0,56-0,90; log-rank test p = 0,004.
English: Before each treatment with TAXOTERE, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive TAXOTERE.
Danish: Før hver behandling med TAXOTERE, vil du få taget blodprøver for at få kontrolleret, om du har nok blodceller og den nødvendige leverfunktion til at få TAXOTERE.
English: If you have any further questions on the use of this medicine, ask your doctor, or hospital pharmacist.
Danish: Hvis du har yderligere spørgsmål om anvendelsen af dette lægemiddel, så spørg din læge eller hospitalsfarmaceut.
English: Neutropenic infection
Danish: Neutropenisk infektion
English: (521 patients in
Danish: (539 patienter i
English: The marketing authorisation holder shall submit PSUR for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: Stratified log-rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen
Danish: Stratificeret log rank test *Tærskel for statististiskl signifikans =0,0175 **PSA: Prostata-Specific Antigen
English: The name of this medicine is TAXOTERE.
Danish: Medicinen hedder TAXOTERE.
English: Unopened vial 2 years
Danish: Uåbnede hætteglas 2 år
English: The second interim analysis was done after 400 DFS events had been recorded overall, which led to a median follow-up of 55 months.
Danish: Den anden interim-analyse blev udført efter optagelse af ialt 400 DFS hændelser, hvilket førte til en median-opfølgning ved 55 måneder.
English: Among the 1776 randomised patients 1086 (61%) had metastatic disease, 362 were randomised to docetaxel in combination with standard of care, 724 received standard of care alone.
Danish: Blandt de 1776 randomiserede patienter, havde 1086 (61 %), metastatisk sygdom, 362 var randomiseret til docetaxel i kombination med standardpleje, 724 modtog standardpleje alene.
English: • if you have a severe liver disease.
Danish: • hvis du har en alvorlig leverlidelse.
English: Use immediately the medicine once added into the infusion bag.
Danish: Anvend lægemidlet umiddelbart efter tilsætning til infusionsposen.
English: A study of
Danish: Der er gennemført et studie med
English: UNIQUE IDENTIFIER - 2D BARCODE Not applicable
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE
English: Docetaxel has been shown to be both embryotoxic and foetotoxic in rabbits and rats, and to reduce fertility in rats.
Danish: Det er påvist, at docetaxel er både embryo-og føtotoksisk hos kaniner og rotter, samt at de nedsætter fertiliteten hos rotter.
English: You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy , because TAXOTERE may be harmful for the unborn baby.
Danish: Du må ikke blive gravid under behandling med dette lægemiddel, og du skal bruge effektiv prævention under behandlingen, fordi TAXOTERE kan skade det ufødte barn.
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: • if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of TAXOTERE
Danish: • hvis du er allergisk (overfølsom) overfor docetaxel eller nogle af de andre indholdsstoffer i
English: Progressive disease as best overall Response (%) *Unstratified logrank test
Danish: Progressiv sygdom som bedste overlevelse respons (%) *Ustratificerede logrank test
English: Reversibility data are available among 35.3% of patients who developed neurotoxicity following docetaxel treatment at 100 mg/m² as single agent.
Danish: Reversibilitets-data tilgængelige hos 35,3 % af de patienter, som udviklede neurotoksicitet efter docetaxel-behandling med 100 mg/m som enkelt stof.
English: SOLVENT for TAXOTERE
Danish: SOLVENS til TAXOTERE
English: TAXOTERE contains ethanol (alcohol)
Danish: TAXOTERE indeholder ethanol (alkohol)
English: • decrease of the potassium, calcium and/or phosphate in your blood.
Danish: • Reduktion af kalium, calcium og/eller fosfat i dit blod.
English: The kinetic profile of docetaxel is dose independent and consistent with a three-compartment pharmacokinetic model with half-lives for the ,  and  phases of 4 min, 36 min and 11.1 h, respectively.
Danish: Docetaxels kinetiske profil er dosis-uafhængig og i overensstemmelse med en 3compartment farmakokinetisk model, med halveringstider for ,  og  faserne på henholdsvis 4 min., 36 min. og 11,1 time.
English: Patients previously treated with chemotherapy with or without radiotherapy
Danish: Patienter, der tidligere har fået behandling med kemoterapi med eller uden strålebehandling
English: Older people treated with TCF should be closely monitored.
Danish: Ældre patienter, som behandles med TCF, bør monitores nøje.
English: decrease  20% (13.1% versus 6.1%), absolute LVEF decrease  30% (6.2% versus 1.1%).
Danish: LVEF-nedsættelse > 20 % (13,1 % versus 6,1 %), total LVEF-nedsættelse > 30 % (6,2 % versus 1,1 %).
English: Rare occurrences of dehydration have been reported as a consequence of gastrointestinal events including enterocolitis and gastrointestinal perforation.
Danish: Der er rapporter om sjælden forekomst af dehydrering som en konsekvens af gastrointestinale lidelser, herunder enterocolitis og gastrointestinal perforation.
English: Febrile neutropenia and neutropenic infection occurred in 17.2% and 13.5% of patients respectively, regardless of G-CSF use.
Danish: Febril neutropeni og neutropenisk infektion forekom hos respektivt 17,2 % og 13,5 % af patienterne, uanset anvendelse af G-CSF.
English: The most commonly reported adverse reactions of docetaxel alone are: neutropenia (which was reversible and not cumulative; the median day to nadir was 7 days and the median duration of severe neutropenia (< 500 cells/mm
Danish: De mest almindeligt rapporterede bivirkninger med docetaxel var: Neutropeni (som var reversibel og ikke kumulativ, median-dagen til nadir var 7 dage og median-varigheden af alvorlig neutropeni ( 500 celler/mm
English: If signs and symptoms suggestive of these reactions appear discontinuation of docetaxel should be considered.
Danish: Hvis der synes tegn og symptomer, der tyder på disse reaktioner, bør seponering af docetaxel overvejes.
English: Blood and lymphatic system disorders Rare: bleeding episodes associated with grade 3/4 thrombocytopenia.
Danish: Blod og lymfesystem Sjældent: Blødningsepisoder associeret med grad 3/4 trombocytopeni.
English: Patients with operable node-positive breast cancer (TAX 316)
Danish: Patienter med operabel, lymfeknude-positiv brystkræft (TAX 316)
English: Docetaxel belongs to the group of anti-cancer medicines called taxoids.
Danish: Docetaxel hører til gruppen af kræftmedicin, der kaldes taxaner.
English: Overall response rate (CR+PR) (%) p-value
Danish: Responsrate i alt (CR+PR) (%) p-værdi
English: Oesophagitis (severe:
Danish: Oesophagitis (alvorlig:
English: TAXOTERE must NOT be administered if you are pregnant unless clearly indicated by your doctor.
Danish: TAXOTERE må IKKE anvendes, hvis du er gravid eller planlægger at blive gravid, medmindre din læge udtrykkelig ønsker det.
English: Vascular disorders Venous thromboembolic events have rarely been reported.
Danish: Vaskulære sygdomme Venøse tromboemboliske tilfælde er sjældent rapporteret.
English: Usual dose
Danish: Den sædvanlige dosis er
English: The severity of adverse events of TAXOTERE may be increased when TAXOTERE is given in combination with other chemotherapeutic agents.
Danish: Alvorligheden af bivirkningerne ved TAXOTERE kan forøges, når TAXOTERE gives i kombination med andre kemoterapeutiske lægemidler.
English: Febrile neutropenia and neutropenic infection occurred respectively in 12.1% and 3.4% of patients when patients received prophylactic G-CSF, in 15.6% and 12.9% of patients without prophylactic G-CSF (see section 4.2).
Danish: Febril neutropeni og neutropenisk infektion forekom respektivt hos 12,1 % og 3,4 % af patienterne, når patienterne modtog profylaktisk G-CSF, hos 15,6 % og 12,9 % af patienterne uden profylaktisk G-CSF (se punkt 4.2).
English: TAXOTERE will be given by infusion into one of your veins (intravenous use).
Danish: TAXOTERE gives som infusion i en vene (intravenøs anvendelse).
English: Sanofi-Aventis Deutschland GmbH Industriepark Höchst 65926 Frankfurt am Main Germany
Danish: Sanofi-Aventis Deutschland GmbH Industriepark Höchst 65926 Frankfurt am Main Tyskland
English: In about 20% of these cases there were no risk factors for acute renal failure such as concomitant nephrotoxic medicinal products and gastrointestinal disorders.
Danish: I ca 20% af tilfældene var der ingen risikofaktorer for akut nyresvigt såsom samtidig behandling med nefrotoksiske lægemidler og gastrointestinale sygdomme.
English: Without primary G-CSF prophylaxis (n = 111) n (%)
Danish: Uden primær G-CSFprofylakse (n = 111) n (%)
English: Based on a population pharmacokinetic analysis, there are no special instructions for use in older people.
Danish: Baseret på de farmakokinetiske studier findes der ingen særlige retningslinjer for ældre personer.
English: Exploratory subgroup analyses for disease-free survival for patients who meet the 2009 St. Gallen chemotherapy criteria - (ITT population) were performed and presented here below:
Danish: Der blev udført eksplorativ undergruppeanalyse af sygdoms-fri overlevelse for patienter, der opfylder kriterierne for kemoterapi ifølge 2009 St. Gallen-kriterierne - (ITT population).
English: Recommendations for the safe handling
Danish: Anbefaling for sikker håndtering
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: Overfølsomhedsreaktioner forårsaget af det aktive stof eller et af hjælpestofferne anført i pkt 6.1.
English: Dyspnoea (severe:
Danish: Dyspnø (alvorlig:
English: Use the vial immediately after its opening.
Danish: Anvend hætteglasset umiddelbart efter åbning.
English: TAXOTERE is supplied as single-dose vials.
Danish: TAXOTERE leveres som enkeltdosis hætteglas.
English: Single-use vials - discard unused contents appropriately.
Danish: Enkelt dosis hætteglas - kasser ubrugt indhold på passende måde.
English: Pharmacotherapeutic group: Taxanes, ATC Code: L01CD 02
Danish: Farmakoterapeutisk klassifikation : Taxaner, ATC kode: L01CD 02
English: TAXOTERE vials should be stored between 2°C and 25°C and protected from light.
Danish: TAXOTERE hætteglas skal opbevares mellem +2ºC - +25ºC og beskyttes mod lys.
English: Patients who received docetaxel every three weeks demonstrated significantly longer overall survival compared to those treated with mitoxantrone.
Danish: De patienter, der fik docetaxel hver 3. uge, viste signifikant længere total overlevelse sammenlignet med dem, der fik mitoxantron.
English: C-docetaxel has been conducted in three cancer patients.
Danish: C-mærket docetaxel på 3 kræftpatienter.
English: For more details see summary of product characteristics of trastuzumab.
Danish: For flere detaljer se produktresumé for trastuzumab.
English: Myalgia (severe: 1.4%) Arthralgia
Danish: Myalgi (alvorlig: 1,4 %) Artralgi
English: In the docetaxel plus trastuzumab arm, 64% had received a prior anthracycline as adjuvant therapy compared with 55% in the docetaxel arm alone.
Danish: I docetaxel - plus trastuzumabarmen, havde 64 % modtaget en tidligere behandling med antracyclin som adjuverende behandling sammenlignet med 55 % i docetaxel-armen alene.
English: 1 vial of solvent for TAXOTERE
Danish: 1 hætteglas solvens til TAXOTERE
English: Pharmacotherapeutic group: Taxanes, ATC Code: L01CD02
Danish: Farmakoterapeutisk klassifikation : Taxaner, ATC kode: L01CD02
English: Sanofi Mature IP, 54 rue La Boétie, 75008 Paris, France
Danish: Sanofi Mature IP, 54 rue La Boétie, 75008 Paris, Frankrig
English: Each box contains one vial.
Danish: Hver karton indeholder et hætteglas.
English: 2 ml (Fill 2.36 ml)
Danish: 2 ml (påfyldt 2,36 ml)
English: In the case of severe neutropenia (< 500 cells/mm for seven days or more) during a course of docetaxel therapy, a reduction in dose for subsequent courses of therapy or the use of appropriate symptomatic measures are recommended (see section 4.2).
Danish: Hvis der opstår alvorlig neutropeni (< 500 celler/mm3) i mere end 7 dage i løbet af en docetaxelbehandling, anbefales det at reducere dosis i de efterfølgende cyklusser eller at tage passende symptomatiske forholdsregler (se pkt.
English: More patients aged ≥65 years in the docetaxel arm reported hypersensitivity reaction, neutropenia, anaemia, fluid retention, dyspnea, and nail changes when compared to the patients aged less than 65 years.
Danish: Flere patienter i alderen ≥ 65 år, i docetaxel-armen, rapportede overfølsomhedsreaktioner, neutropeni, anæmi, væskeretention, dyspnø, og negleforandringer, når sammenlignet med patienter i alderen yngre end 65 år.
English: The median TTP was 37.3 weeks (95% CI: 33.4 - 42.1) in AT arm and 31.9 weeks (95% CI: 27.4 - 36.0) in AC arm.
Danish: TTP-medianen var 37,3 uger (95 %CI: 33,4 - 42,1) i AT-armen og 31,9 uger (95 %CI: 27,4 - 36,0) i AC-armen.
English: • Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) (blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet) with or without a rash.
Danish: • Stevens-Johnson syndrom og toksisk epidermal nekrolyse (blærer, afskrælning eller blødning på dele af huden (herunder dine læber, øjne, mund, næse, kønsorganer, hænder eller fødder) med eller uden udslæt.
English: TAXOTERE was administered as a 1-hour infusion, all other medicinal products were given intraveinously on day 1 every three weeks.
Danish: TAXOTERE blev administreret som infusion over 1 time, alle andre lægemidler blev givet intravenøst på dag 1 hver 3. uge.
English: Number of patients Median overall survival (months) All patients
Danish: Samlet medial overlevelse (måneder) Alle patienter
English: Number of metastatic prostate cancer patients
Danish: Antallet af metastatiske prostatskræft patienter
English: *a hazard ratio (TAC/FAC) of less than 1 indicates that TAC is associated with a longer disease free survival compared to FAC.
Danish: Post-menopausal * Hazard ratio (TAC/FAC) på mindre end 1 indikerer, at der er en sammenhæng mellem TAC og en længere sygdoms-fri overlevelse, sammenlignet med FAC.
English: Discard unused contents appropriately in accordance with local requirements.
Danish: Kasser ubrugt indhold på passende måde i henhold til gældende retningslinjer.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 6 hours below 25°C including the one hour infusion.
Danish: Hvis det ikke anvendes straks, er opbevaringstid og -forhold brugerens ansvar og vil normalt ikke være længere end 6 timer ved opbevaring under 25°C inklusive den time, patienten får infusionen.
English: TAXOTERE in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:
Danish: TAXOTERE i kombination med doxorubicin og cyclophosphamid er indiceret til adjuverende behandling af patienter med:
English: TAXOTERE in combination with doxorubicin
Danish: TAXOTERE i kombination med doxorubicin
English: The premix solution contains 10 mg/ml docetaxel and should be used immediately after preparation.
Danish: Præmixen indeholder 10 mg/ml docetaxel og skal bruges straks efter tilberedning.
English: Severe Cutaneous Adverse Reactions (SCARs) such as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) and Acute Generalized Exanthematous Pustulosis (AGEP) have been reported with docetaxel treatment.
Danish: Alvorlige kutane bivirkninger (SCARs) så som Stevens-Johnson syndrom (SJS), toksisk epidermal nekrolyse (TEN) og akut generaliseret eksantematøs pustulose (AGEP) er blevet rapporteret i forbindelse med docetaxel behandling.
English: Infections (G3/4: 5.7%; including sepsis and pneumonia, fatal in
Danish: Infektioner (G3/4: 5,7 %; inklusive sepsis og pneumoni, letal hos
English: Shelf life in infusion bag: see the leaflet.
Danish: For holdbarhed i infusionspose: Se indlægssedlen.
English: Disseminated intravascular coagulation (DIC), often in association with sepsis or multi-organ failure, has been reported.
Danish: Der er rapporter om dissemineret intravaskulær koagulation (DIC), ofte i forbindelse med sepsis eller multiorgan-svigt.
English: With primary G-CSF prophylaxis (n = 421) n (%)
Danish: Med primær G-CSFprofylakse (n = 421) n (%)
English: Histological grade Grade1 (includes grade not assessed) Grade 2
Danish: Grad 1 (inklusiv grader, der ikke er fastsat)
English: TAXOTERE should not be used after the expiry date shown on the carton, blister pack and vials.
Danish: TAXOTERE må ikke anvendes efter udløbsdatoen vist på karton, blisterpakning og hætteglas.
English: At the median follow-up time of 77 months, significantly longer disease-free survival for the TAC arm compared to the FAC arm was demonstrated.
Danish: Ved den mediane opfølgningsperiode på 77 måneder blev der vist signifikant længere sygdoms-fri overlevelse (DFS) i TAC-armen sammenlignet med FAC-armen.
English: (26.8-ne) TTP = time to progression; “ne” indicates that it could not be estimated or it was not yet reached.
Danish: ”ne” indikerer at dette ikke kunne estimeres eller ikke blev nået.
English: It should be used within 6 hours (including the one hour infusion intravenous administration).
Danish: Den bør anvendes inden for 6 timer (inklusive den ene time til i.v.-infusion).
English: All materials that have been utilised for dilution and administration should be disposed of according to standard procedures.
Danish: Alt materiale, som har været brugt i forbindelse med fortynding og infusion, skal bortskaffes i henhold til standardprocedurer.
English: In this study, 358 patients with inoperable locally advanced SCCHN, and WHO performance status 0 or 1, were randomised to one of two treatment arms.
Danish: I dette studie blev 358 patienter med inoperabelt, lokalt fremskreden SCCHN og WHO funktionsstatus 0 eller 1, randomiseret i en af to behandlingsarme.
English: The incidence of the following adverse events (all grades): lethargy, stomatitis, neutropenic infection occurred at rates  10% higher in patients who were 65 years of age or older compared to younger patients.
Danish: Forekomsten af de følgende bivirkninger (alle grader): Letargi, stomatitis, neutropenisk infektion opstod  10 % oftere hos de patienter, som var 65 år eller derover end hos de yngre patienter.
English: Remove the syringe and needle and mix manually by repeated inversions for at least 45 seconds.
Danish: Fjern sprøjten, og bland miksturen manuelt ved at vende hætteglasset gentagne gange i mindst 45 sekunder.
English: Very rare cases of transient visual disturbances (flashes, flashing lights, scotomata) typically occurring during infusion of the medicinal product and in association with hypersensitivity reactions have been reported.
Danish: Der er observeret meget sjældne tilfælde af forbigående synsforstyrrelser (glimt, lysglimt, pletter i synsfeltet) typisk forekommende under infusion med lægemidlet og i forbindelse med overfølsomheds-reaktioner.
English: Infusion site reaction; Pain
Danish: Reaktiner på infusionsstedet; Smerter
English: (539 patients in TAC arm), or doxorubicin
Danish: (521 patienter i FAC-armen) som adjuverende behandling.
English: The incidence of related fever, diarrhoea, anorexia, and peripheral oedema occurred at rates  10% higher in patients who were 75 years of age or greater versus less than 65 years.
Danish: Hyppigheden af relateret feber, diarré, anoreksi og perifere ødemer var  10 % højere hos patienter som var 75 år eller ældre end hos patienter under 65 år.
English: The primary endpoint in this study, progression-free survival (PFS), was significantly longer in the TPF arm compared to the PF arm, p = 0.0042 (median PFS: 11.4 vs. 8.3 months respectively) with an overall median follow up time of 33.7 months.
Danish: Det primære endepunkt i dette studie, progression-fri overlevelse (PFS), var signifikant længere i TPF-armen sammenlignet med PF-armen, p = 0,0042 (median PFS: 11,4 vs. 8,3 måneder respektivt) med en samlet median opfølgningstid på 33,7 måneder.
English: 4.1.3 Inject the entire contents of the syringe into the corresponding TAXOTERE vial.
Danish: 4.1.3 Injicer hele indholdet fra sprøjten i det tilsvarende TAXOTERE-hætteglas.
English: Disease-free survival (DFS) was the primary efficacy endpoint and Overall survival (OS) was the secondary efficacy endpoint.
Danish: Sygdoms-fri overlevelse (DFS) var det primære effektendepunkt og total overlevelse (OS) var det sekundære effektendepunkt.
English: 2-year Survival (%)
Danish: 2-års overlevelse (%)
English: 256 patients were randomised to treatment with docetaxel alone (100 mg/m as a 1 hour intravenous infusion every 3 weeks).
Danish: 256 patienter blev randomiseret til behandling med docetaxel alene (100 mg/ m som 1 times intravøs infusion hver 3. uge).
English: • swelling caused by faulty lymphatic drainage
Danish: • Hævelse forårsaget af mangelfuld lymfeafløb
English: ** PSA response: Prostate-Specific Antigen response: PSA level <0.2 ng/mL measured for two consecutive measurements at least 4 weeks apart.
Danish: Responseratio variabler: Fisher's Exact test * p-værdi for beskrivende formål **PSA response: Prostata-specifik antigen respons: PSA niveau <0,2 ng/ml målte to på hinanden følgende målinger med mindst 4 ugers mellemrum.
English: Disease Free Survival
Danish: Sygdoms-fri overlevelse
English: Severe skin problems such as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Acute Generalized Exanthematous Pustulosis (AGEP) have been reported with TAXOTERE: - SJS/TEN symptoms may include blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet) with or without a rash.
Danish: Alvorlige hudproblemer såsom, Stevens-Johnson syndrom (SJS), toksisk epidermal nekrolyse (TEN) og akut generaliseret eksantematøs pustulose (AGEP) er blevet rapporteret med TAXOTERE: - SJS/TEN symptomer kan omfatte blærer, afskrælning eller blødning på dele af huden (herunder dine læber, øjne, mund, næse, kønsorganer, hænder eller fødder) med eller uden udslæt.
English: • infection of the upper respiratory tract.
Danish: • Infektion i de øvre luftveje.
English: 4.2.1 More than one premix vial may be necessary to obtain the required dose for the patient.
Danish: 4.2.1 Det kan være nødvendigt at anvende mere end et hætteglas præmix for at opnå den dosis, der er nødvendig til patienten.
English: Mild to moderate neuro-sensory signs are characterised by paresthesia, dysesthesia or pain including burning.
Danish: Milde til moderate neurosensoriske symptomer er karakteriseret ved paræstesi, dysæstesi eller smerter inklusiv brændende fornemmelser.
English: 0.5 ml (Fill 0.61 ml)
Danish: 0,5 ml (påfyldt 0,61 ml)