FrancophonIA/ELRC3.0 huggingface dataset:
English: INFORMATION IN BRAILLE neorecormon 30.000 IU
Danish: INFORMATION I BRAILLESKRIFT neorecormon 30.000 IE
English: The weekly dose can be given as one injection per week or in divided doses 3 to 7 times per week.
Danish: Den ugentlige dosis kan gives som én injektion ugentligt, eller den kan deles og gives 3-7 gange ugentligt.
English: MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 30,000 IU pre-filled syringe
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON 30.000 IE fyldt injektionssprøjte
English: MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 5000 IU pre-filled syringe
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON 5.000 IE fyldt injektionssprøjte
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS 4000 IU pre-filled syringe
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKETTER 4.000 IE fyldt injektionssprøjte
English: Administering the subcutaneous injection 11 Move the safety shield away from the needle in direction to the syringe barrel.
Danish: Fjern beskyttelseshylstret fra nålen i retning mod injektionssprøjtens glasbeholder.
English: · Do not touch the tip of the syringe.
Danish: ● Rør ikke ved spidsen af injektionssprøjten.
English: NeoRecormon 10,000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.6 ml solution for injection contains 10,000 international units (IU) corresponding to 83 micrograms epoetin beta* (recombinant human erythropoietin).
Danish: NeoRecormon 10.000 IE injektionsvæske, opløsning, i fyldt injektionssprøjte En fyldt injektionssprøjte med 0,6 ml injektionsvæske, opløsning indeholder 10.000 internationale enheder (IE) svarende til 83 mikrogram epoetin beta* (rekombinant humant erythropoietin).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS 30,000 IU pre-filled syringe
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKETTER 30.000 IE fyldt injektionssprøjte
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS 10,000 IU pre-filled syringe
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKETTER 10.000 IE fyldt injektionssprøjte
English: 6 Attach the needle to the syringe.
Danish: Indsæt nålen i blodåren.
English: INFORMATION IN BRAILLE neorecormon 2000 IU
Danish: INFORMATION I BRAILLESKRIFT neorecormon 2.000 IE
English: MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 6000 IU pre-filled syringe
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON 6.000 IE fyldt injektionssprøjte
English: NeoRecormon 2000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.3 ml solution for injection contains 2000 international units (IU) corresponding to 16.6 micrograms epoetin beta* (recombinant human erythropoietin).
Danish: NeoRecormon 2.000 IE injektionsvæske, opløsning, i fyldt injektionssprøjte En fyldt injektionssprøjte med 0,3 ml injektionsvæske, opløsning indeholder 2.000 internationale enheder (IE) svarende til 16,6 mikrogram epoetin beta* (rekombinant humant erythropoietin).
English: MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 4000 IU pre-filled syringe
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON 4.000 IE fyldt injektionssprøjte
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS 3000 IU pre-filled syringe
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKETTER 3.000 IE fyldt injektionssprøjte
English: - Intravenous administration:
Danish: - Intravenøs injektion:
English: · Treating anaemia with related symptoms in adult cancer patients receiving chemotherapy · Treating people donating their own blood before surgery.
Danish: • behandling af blodmangel med relaterede symptomer hos voksne cancerpatienter som modtager kemoterapi.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION NeoRecormon 500 IU injection epoetin beta
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) NeoRecormon 500 IE injektion epoetin beta i.v./s.c.
English: 4 pre-filled syringes (0.6 ml) and 4 needles (27G1/2)
Danish: 4 fyldte injektionssprøjter (0,6 ml) og 4 nåle (27G1/2)
English: NeoRecormon Multidose is supplied as a lyophilisate for solution for injection in vials.
Danish: NeoRecormon Flerdosis leveres som lyofilisat til injektionvæske, opløsning i hætteglas, der opløses med indholdet af medfølgende solvens ampul som angivet nedenfor.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/032
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/97/031/032
English: After the injection: follow steps 17 to 19.
Danish: Efter injektionen følg pkt.
English: · if you have blood pressure problems that cannot be controlled · if you are donating your own blood before surgery, and: · you had a heart attack or stroke in the month before your treatment · you have unstable angina pectoris - new or increasing chest pain · you are at risk of blood clots in the veins (deep venous thrombosis) - for example, if you have had clots before.
Danish: • hvis du har risiko for at udvikle blodpropper i venerne (dyb venetrombose), f.eks. hvis du har haft blodpropper før
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS 2000 IU pre-filled syringe
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKETTER 2.000 IE fyldt injektionssprøjte
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION NeoRecormon 30,000 IU injection epoetin beta
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) NeoRecormon 30.000 IE injektion epoetin beta i.v./s.c.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial contains 50,000 IU epoetin beta.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 hætteglas indeholder 50.000 IE epoetin beta.
English: 1 vial contains: Urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate, disodium hydrogen phosphate, calcium chloride, glycine, L-Leucine, L-Isoleucine, L-Threonine, L-Glutamic acid, and L-Phenylalanine.
Danish: 1 hætteglas indeholder: Urea, natriumchlorid, polysorbat 20, natriumdihydrogenphosphat, dinatriumhydrogenphosphat, calciumchlorid, glycin, L-Leucin, L-Isoleucin, L-Threonin, LGlutaminsyre og L-Phenylalanin.
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 500 IU solution for injection in pre-filled syringe Epoetin beta
Danish: NeoRecormon 500 IE injektionsvæske, opløsning, i fyldt injektionssprøjte epoetin beta
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION NeoRecormon 6000 IU injection epoetin beta
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) NeoRecormon 6.000 IE injektion epoetin beta i.v./s.c.
English: 1 syringe contains: Urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, calcium chloride dihydrate, glycine, L-Leucine, L-Isoleucine, L-Threonine, L-glutamic acid, L-Phenylalanine, and water for injections.
Danish: 1 injektionssprøjte indeholder: Urea, natriumchlorid, polysorbat 20, natriumdihydrogenphosphatdihydrat, dinatriumphosphatdodecahydrat, calciumchloriddihydrat, glycin, L-Leucin, L-Isoleucin, L-Threonin, L-Glutaminsyre, L-Phenylalanin og vand til injektionsvæsker.
English: MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 10,000 IU pre-filled syringe
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON 10.000 IE fyldt injektionssprøjte
English: 1 pre-filled syringe (0.3 ml) and 1 needle (27G1/2)
Danish: 1 fyldt injektionssprøjte (0,3 ml) og 1 nål (27G1/2)
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 20,000 IU solution for injection in pre-filled syringe Epoetin beta
Danish: NeoRecormon 20.000 IE injektionsvæske, opløsning, i fyldt injektionssprøjte epoetin beta
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION NeoRecormon 20,000 IU injection epoetin beta
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) NeoRecormon 20.000 IE injektion epoetin beta i.v./s.c.
English: Female patients
Danish: Kvinder
English: Adverse reactions attributed to the treatment with NeoRecormon in controlled clinical trials in CKD patients System organ class
Danish: Tabel 1: Bivirkninger hos patienter med kronisk nyresygdom relateret til behandlingen med NeoRecormon i kontrollerede, kliniske studier
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 2000 IU epoetin beta.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 fyldt injektionssprøjte indeholder 2.000 IE epoetin beta.
English: 9 Select a vein.
Danish: (5) Sæt devicet på hætteglasset.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 3000 IU epoetin beta.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 fyldt injektionssprøjte indeholder 3.000 IE epoetin beta.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/038
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/97/031/038
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/025
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/97/031/025
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/046
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/97/031/046
English: 6 pre-filled syringes (0.3 ml) and 6 needles (27G1/2)
Danish: 6 fyldte injektionssprøjter (0,3 ml) og 6 nåle (27G1/2)
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 30,000 IU epoetin beta.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 fyldt injektionssprøjte indeholder 30.000 IE epoetin beta.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 5000 IU epoetin beta.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 fyldt injektionssprøjte indeholder 5.000 IE epoetin beta.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/035
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/97/031/035
English: If you are donating your own blood before surgery, your doctor will need to: · check that you are capable of giving blood, especially if you weigh less than 50 kg · check that you have a sufficient level of red blood cells (haemoglobin of at least 11 g/dL) · make sure that only 12 % of your blood will be donated at once.
Danish: Kontrollere, at du er i stand til at give blod, især hvis du vejer mindre end 50 kg.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/033
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/97/031/033
English: MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 3000 IU pre-filled syringe
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON 3.000 IE fyldt injektionssprøjte
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/034
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/97/031/034
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION NeoRecormon 4000 IU injection epoetin beta
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) NeoRecormon 4.000 IE injektion epoetin beta i.v./s.c.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/026
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/97/031/026
English: 6 pre-filled syringes (0.6 ml) and 6 needles (27G1/2)
Danish: 6 fyldte injektionssprøjter (0,6 ml) og 6 nåle (27G1/2)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/045
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/97/031/045
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/037
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/97/031/037
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION NeoRecormon 10,000 IU injection epoetin beta
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) NeoRecormon 10.000 IE injektion epoetin beta i.v./s.c.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/043
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/97/031/043
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION NeoRecormon 5000 IU injection epoetin beta
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) NeoRecormon 5.000 IE injektion epoetin beta i.v./s.c.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/042
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/97/031/042
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/036
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/97/031/036
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 500 IU epoetin beta.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 fyldt injektionssprøjte indeholder 500 IE epoetin beta.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/029
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/97/031/029
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 5000 IU solution for injection in pre-filled syringe Epoetin beta
Danish: NeoRecormon 5.000 IE injektionsvæske, opløsning, i fyldt injektionssprøjte epoetin beta
English: 1 pre-filled syringe (0.6 ml) and 1 needle (27G1/2)
Danish: 1 fyldt injektionssprøjte (0,6 ml) og 1 nål (27G1/2)
English: · If you get anyside effects talk to your doctor or pharmacist.
Danish: • Kontakt lægen eller apotekspersonalet, hvis en bivirkning bliver værre, eller du får bivirkninger,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/044
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/97/031/044
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/030
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/97/031/030
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 10,000 IU epoetin beta.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 fyldt injektionssprøjte indeholder 10.000 IE epoetin beta.
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 4000 IU solution for injection in pre-filled syringe Epoetin beta
Danish: NeoRecormon 4.000 IE injektionsvæske, opløsning, i fyldt injektionssprøjte epoetin beta
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 4000 IU epoetin beta.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 fyldt injektionssprøjte indeholder 4.000 IE epoetin beta.
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 6000 IU solution for injection in pre-filled syringe Epoetin beta
Danish: NeoRecormon 6.000 IE injektionsvæske, opløsning, i fyldt injektionssprøjte epoetin beta
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 30,000 IU solution for injection in pre-filled syringe Epoetin beta
Danish: NeoRecormon 30.000 IE injektionsvæske, opløsning, i fyldt injektionssprøjte epoetin beta
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/041
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/97/031/041
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 10,000 IU solution for injection in pre-filled syringe Epoetin beta
Danish: NeoRecormon 10.000 IE injektionsvæske, opløsning, i fyldt injektionssprøjte epoetin beta
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/031
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/97/031/031
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/019
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/97/031/019
English: INFORMATION IN BRAILLE neorecormon 3000 IU
Danish: INFORMATION I BRAILLE-SKRIFT neorecormon 3.000 IE
English: · The other ingredients are: urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, calcium chloride dihydrate, glycine, L-Leucine, L-Isoleucine, L-Threonine, L-Glutamic acid, and L-Phenylalanine and water for injections.
Danish: • De øvrige indholdsstoffer er: I tørstof: urea, natriumchlorid, polysorbat 20, natriumdihydrogenphosphat, dinatriumhydrogenphosphat, calciumchlorid, glycin, L-Leucin, L-Isoleucin, L-Threonin, LGlutaminsyre og L-Phenylalanin.
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 3000 IU solution for injection in pre-filled syringe Epoetin beta
Danish: NeoRecormon 3.000 IE injektionsvæske, opløsning, i fyldt injektionssprøjte epoetin beta
English: MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 2000 IU pre-filled syringe
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON 2.000 IE fyldt injektionssprøjte
English: The maximum dose should not exceed · for injections into veins: 1600 IU for every 1 kg of your body weight per week · for injections under the skin: 1200 IU for every 1 kg of your body weight per week.
Danish: • Ved injektion under huden: 1200 IE pr. kg legemsvægt pr. uge Hvis du tager for meget NeoRecormon
English: · Do not touch the injection site again before giving the injection.
Danish: ● Kom ikke hætten på injektionsnålen igen.
English: Keep the pre-filled syringe in the outer carton, in order to protect from light
Danish: Opbevar den fyldte injektionssprøjte i originalemballage, beskyttet mod lys
English: Keep the pre-filled syringe in the outer carton, in order to protect from light.
Danish: Opbevar den fyldte injektionssprøjte i originalemballage, beskyttet mod lys.
English: These can include:
Danish: Dette kan omfatte:
English: Let it warm up on its own.
Danish: Lad det varme op af sig selv.
English: Steady state was reached after 110 days.
Danish: Steady state blev nået efter 110 dage.
English: Allow the area to dry.
Danish: Lad området tørre.
English: Allow to stand for 5 minutes.
Danish: Lad det stå i 5 minutter.
English: Satisfactory clinical response after 7 days?
Danish: Tilfredsstillende klinisk respons efter 7 dage?
English: Date of first authorisation: 23 October 2009 Date of latest renewal: 19 June 2014
Danish: Dato for første markedsføringstilladelse: 23. oktober 2009 Dato for seneste fornyelse: 19. juni 2014
English: Please note that the preparation of the injection takes about 30 minutes.
Danish: Bemærk, at forberedelserne til indsprøjtningen tager omkring 30 minutter.
English: Physician Global Assessment < 2
Danish: Physician Global Assessment-score <2
English: Long term data from observational study
Danish: Langtidsdata fra observationsstudie
English: Your doctor may decide to delay or interrupt your treatment, but only if necessary.
Danish: Lægen kan beslutte at udsætte eller afbryde din behandling, men kun hvis det er nødvendigt.
English: If MAS occurs, or is suspected, evaluation and treatment should be started as early as possible.
Danish: Hvis MAS opstår eller mistænkes, skal vurdering og behandling startes så hurtigt som muligt.
English: Overall study population; N=454
Danish: Total studiepopulation; N=454
English: You should then continue with injections at the recommended intervals as before.
Danish: Derefter skal du fortsætte med indsprøjtningerne med det anbefalede mellemrum som før.
English: Bioavailability (AUCss) was not affected.
Danish: Biotilgængeligheden (AUCss) var ikke påvirket.
English: Your doctor may check your blood regularly if considered necessary.
Danish: Din læge vil undersøge dit blod regelmæssigt, hvis det er nødvendigt.
English: Reported experience with overdose is limited.
Danish: Rapporteret erfaring med overdosis er begrænset.
English: Particularly in adult patients, this evaluation should include a detailed medical history.
Danish: Særlig hos voksne patienter bør denne evaluering inkludere en detaljeret anamnese.
English: However, clinical experience in such patients is limited.
Danish: Den kliniske erfaring hos sådanne patienter er imidlertid begrænset.
English: Essential preparation
Danish: Nødvendig forberedelse
English: Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Danish: De foreliggende data er beskrevet i punkt 4.8, 5.1 og 5.2, men der kan ikke gives nogen anbefalinger vedrørende dosering.
English: Then talk to the doctor to discuss when you should inject the next dose.
Danish: Dernæst kontakt lægen for at drøfte, hvornår du skal indsprøjte den næste dosis.
English: The total treatment duration ranged from 6 months to 2 years.
Danish: Den totale behandlingsvarighed varierede fra 6 måneder til 2 år.
English: Do not stop taking Ilaris unless your doctor tells you to.
Danish: Hold ikke op med at tage Ilaris, medmindre lægen siger det.
English: if you have or have ever had tuberculosis or direct contact with a person with an active tuberculosis infection.
Danish: hvis du har eller har haft tuberkulose eller direkte kontakt med en person med aktiv tuberkulose.
English: The studies were 12 weeks followed by 12-week double-blind extension.
Danish: Studierne varede i 12 uger efterfulgt af 12-ugers dobbelt-blindet forlængelse.
English: Two open-label, uncontrolled, long-term phase III studies were performed.
Danish: To open-label, ukontrollerede længerevarende fase III-studier blev udført.
English: - if you have, or suspect you have, an active and severe infection.
Danish: hvis du har eller har en mistanke om, at du har en aktiv og alvorlig infektion.
English: The mean terminal half-life was 26 days.
Danish: Den gennemsnitlige terminale halveringstid var 26 dage.
English: Wash your hands with soap and water.
Danish: Vask hænderne med vand og sæbe.
English: Of the patients who had achieved a complete response, 89.3% maintained response without relapsing.
Danish: Af de patienter, der havde opnået fuldt respons, vedligeholdt 89,3 % responset uden tilbagefald.
English: Fever lasting longer than 3 days or any other symptoms that might suggest a serious infection.
Danish: Feber, der varer i mere end 3 dage, eller andre symptomer, som tyder på en alvorlig infektion.
English: If you feel a spinning sensation or feel tired, do not drive or use any tools or machines until you are feeling normal again.
Danish: Hvis du føler, at alting snurrer rundt, eller du føler dig træt, må du ikke føre motorkøretøj eller bruge nogen som helst form for værktøj eller maskiner, før du føler dig normal igen.
English: (There will be water remaining in the vial.)
Danish: (Der vil være vand tilbage i hætteglasset).
English: 9/l were also observed (see section 4.4).
Danish: 9/l blev også observeret (se pkt.
English: The clinical significance of this observation is unknown.
Danish: Den kliniske betydning af denne observation er ukendt.
English: Before initiation of therapy, all patients must be evaluated for both active and latent tuberculosis infection.
Danish: Inden initiering af behandling skal alle patienter evalueres for både aktiv og latent tuberkuloseinfektion.
English: Subcutaneous absorption rate was estimated to decrease with age and appeared to be fastest in the youngest patients.
Danish: Subkutan absorptionshastighed var estimeret til at falde med alderen og var tilsyneladende hurtigst hos de yngste patienter.
English: Centre de Biotechnologie 8, rue de l'Industrie 68330 Huningue France
Danish: Centre de Biotechnologie 8, rue de l'Industrie 68330 Huningue Frankrig
English: The study consisted of two parts with two independent primary endpoints (successful steroid taper and time to flare).
Danish: Studiet bestod af to dele med to uafhængige primære endepunkter (successfuld steroidreduktion og tid til udbrud).
English: The primary objective was to assess the proportion of patients who were free of relapse at week 24, including those patients whose dose was increased.
Danish: Det primære formål var at vurdere antallet af patienter, der var relapsfrie ved uge 24, inklusive de patienter, hvor dosis blev øget.
English: Ilaris is also indicated for the treatment of:
Danish: Ilaris er også indiceret til behandling af:
English: This additional dose could be provided as early as 7 days after the first treatment dose.
Danish: Den supplerende dosis kunne gives så tidligt som 7 dage efter den første dosis.
English: These are used mainly in rheumatic and autoimmune diseases.
Danish: Disse bruges hovedsageligt til gigtsygdomme og autoimmune sygdomme.
English: Canakinumab also reduced the risk of subsequent attacks (see Table 5).
Danish: Canakinumab reducerede også risikoen for efterfølgende anfald (se Tabel 5).
English: This may affect your ability to drive or use tools or machines.
Danish: Dette kan påvirke din evne til at føre motorkøretøj eller betjene værktøj eller maskiner.
English: It is important to tell your doctor if you are pregnant, if you think you may be pregnant or are planning to have a baby.
Danish: Det er vigtigt, at du fortæller det til lægen, hvis du er gravid, hvis du tror, at du kan være gravid, eller hvis du har planer om at blive gravid.