FrancophonIA/ELRC3.0 huggingface dataset:
English: • swelling of the legs or feet (peripheral oedema)
Danish: • hævede ben og fødder (perifert ødem)
English: Therefore, no dose modification is required for ixazomib with co-administration of strong CYP3A inhibitors.
Danish: Dosisjustering er derfor ikke nødvendig ved samtidig behandling med ixazomib og potente CYP3A-hæmmere.
English: How to take NINLARO
Danish: Sådan skal du tage NINLARO
English: It should not be crushed, chewed, or opened (see section 6.6).
Danish: Kapslen skal sluges hel sammen med vand og må ikke knuses, tygges eller åbnes (se pkt.
English: For additional information regarding lenalidomide and dexamethasone, refer to the Summary of Product Characteristics (SmPC) for these medicinal products.
Danish: For yderligere information om lenalidomid og dexamethason, se produktresuméet for disse lægemidler.
English: • reactivation of the chicken pox virus (shingles) that can cause a skin rash and pain (herpes zoster)
Danish: • hvilende (latent) skoldkoppevirus bliver aktivt, hvilket kan forårsage hududslæt og smerter
English: • Withhold ixazomib and lenalidomide until platelet count ≥ 30,000/mm3.
Danish: • Udsæt ixazomib og lenalidomid, indtil trombocyttallet er ≥ 30.000/mm3.
English: As ixazomib is administered in combination with lenalidomide and dexamethasone, refer to the SmPC for these medicinal products for additional information on fertility, pregnancy and lactation.
Danish: Da ixazomib anvendes i kombination med lenalidomid og dexamethason, henvises der til produktresuméet for disse lægemidler vedrørende oplysninger om fertilitet, graviditet og amning.
English: • If attributable to ixazomib, resume ixazomib at the next lower dose following recovery.
Danish: • Hvis toksiciteten tilskrives ixazomib, genoptag dosering af ixazomib ved den næste lavere dosis.
English: The capsule shell contains: gelatin, titanium dioxide (E171) and red iron oxide (E172) The printing ink contains: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E172).
Danish: Kapselskal: gelatine, titandioxid (E 171) og rød jernoxid (E 172) Prægeblæk: shellac, propylenglycol, kaliumhydroxid og sort jernoxid (E 172).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1094/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1094/001
English: This includes any medicines obtained without a prescription, such as vitamins or herbal remedies.
Danish: har taget anden medicin eller planlægger at tage anden medicin Det gælder også al håndkøbsmedicin, f.eks. vitaminer og naturlægemidler.
English: Thrombocytopenia has been reported with ixazomib (see section 4.8) with platelet nadirs typically occurring between Days 14-21 of each 28-day cycle and recovery to baseline by the start of the next cycle (see section 4.8).
Danish: 4.8), typisk med laveste trombocytniveau mellem dag 14 og 21 i hver 28-dages cyklus og med restitution til baseline-niveau ved starten af den næste cyklus (se pkt.
English: INFORMATION IN BRAILLE NINLARO 4 mg
Danish: INFORMATION I BRAILLESKRIFT NINLARO 4 mg
English: NINLARO 2.3 mg hard capsules NINLARO 3 mg hard capsules NINLARO 4 mg hard capsules ixazomib
Danish: NINLARO 2,3 mg kapsler, hårde NINLARO 3 mg kapsler, hårde NINLARO 4 mg kapsler, hårde ixazomib
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1094/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1094/002
English: INFORMATION IN BRAILLE NINLARO 2.3 mg
Danish: INFORMATION I BRAILLESKRIFT NINLARO 2,3 mg
English: Diarrhoea resulted in discontinuation of one or more of the three medicinal products in 1% of patients in the ixazomib regimen and < 1% of patients in the placebo regimen.
Danish: Diarré resulterede i seponering af et eller flere af de tre lægemidler hos 1% af patienterne i ixazomib-gruppen og < 1% af patienterne i placebogruppen.
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING WALLET
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN MELLEMSTE EMBALLAGE BLISTERMAPPE
English: NAME OF THE MEDICINAL PRODUCT NINLARO 2.3 mg hard capsules NINLARO 3 mg hard capsules NINLARO 4 mg hard capsules
Danish: LÆGEMIDLETS NAVN NINLARO 2,3 mg kapsler, hårde NINLARO 3 mg kapsler, hårde NINLARO 4 mg kapsler, hårde
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1094/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1094/003
English: Peripheral neuropathy resulted in discontinuation of one or more of the three medicinal products in 1% of patients in the ixazomib regimen compared to <1% of patients in the placebo regimen.
Danish: Perifer neuropati resulterede i seponering af et eller flere af de tre lægemidler hos 1% af patienterne i ixazomib-gruppen mod < 1% i placebo-gruppen.
English: Non-haematological toxicities
Danish: Ikke-hæmatologiske toksiciteter Anbefalede handlinger
English: What NINLARO contains NINLARO 2.3 mg hard capsule: The active substance is ixazomib.
Danish: NINLARO 2,3 mg kapsel, hård: Det aktive stof er ixazomib.
English: • feeling tired or weak (fatigue)
Danish: • træthed eller svaghed
English: Thrombocytopenia can be managed with dose modifications (see section 4.2) and platelet transfusions as per standard medical guidelines.
Danish: Trombocytopeni kan håndteres med dosisjusteringer (se pkt.
English: INFORMATION IN BRAILLE NINLARO 3 mg
Danish: INFORMATION I BRAILLESKRIFT NINLARO 3 mg
English: Closely monitor patients for disease control if coadministration with a strong CYP3A inducer cannot be avoided.
Danish: Hvis samtidig administration af en potent CYP3A-induktor ikke kan undgås, skal patienten monitoreres tæt med henblik på sygdomskontrol.
English: Each capsule contains 4 mg of ixazomib (as 5.7 mg of ixazomib citrate).
Danish: Hver kapsel indeholder 4 mg ixazomib (som 5,7 mg ixazomibcitrat).
English: In the pooled dataset from the pivotal, Phase 3, global C16010 study (n=720) and the double-blind, placebo-controlled, C16010 China Continuation Study (n=115), the following adverse reactions occurred with a similar rate between the ixazomib and placebo regimens: fatigue (26% vs. 24%),
Danish: I det puljede datasæt fra det pivotale globale C16010 fase 3-studie (N = 720) og det dobbeltblindede, placebokontrollerede C16010 China Continuation Study (n = 115) forekom følgende bivirkninger med en sammenlignelig hyppighed i ixazomib- og placebogrupperne: træthed (26% mod 24%), appetitløshed (12% mod 9%), hypotension (4% for begge), hjertesvigt† (3% for begge), arytmi† (12% mod 11%) og nedsat leverfunktion, herunder enzymændringer† (8% mod 6%).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING WALLET UNIT PACKS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAKNING MED BLISTERMAPPER I KARTON
English: NINLARO 2.3 mg hard capsules
Danish: NINLARO 2,3 mg kapsler, hårde
English: Peripheral neuropathy has been reported with ixazomib (see section 4.8).
Danish: Der er blevet rapporteret perifer neuropati i forbindelse med ixazomib (se pkt.
English: Thrombocytopenia resulted in discontinuation of one or more of the three medicinal products in < 1% of patients in the ixazomib regimen and 1% of patients in the placebo regimen.
Danish: Trombocytopeni resulterede i seponering af et eller flere af de tre lægemidler hos < 1% af patienterne i ixazomib-gruppen og < 1% af patienterne i placebogruppen.
English: Ixazomib did not prolong the QTc interval at clinically relevant exposures based on the results of a pharmacokinetic-pharmacodynamic analysis of data from 245 patients.
Danish: Baseret på resultaterne fra en farmakokinetisk-farmakodynamisk analyse af data fra 245 patienter forlænger ixazomib ikke QTc-intervallet ved klinisk relevante eksponeringer.
English: Titanium dioxide (E171) Black iron oxide (E172)
Danish: Titandioxid (E 171) Sort jernoxid (E 172)
English: Grade 3 rash was reported in 2% of patients in the ixazomib regimen compared to 1% of patients in the placebo regimen.
Danish: Udslæt af grad 3 blev rapporteret hos 2% af patienterne i ixazomib-gruppen og hos 1% i placebogruppen.
English: The dose of dexamethasone should be adjusted per its prescribing information or ixazomib for Grade 3 or 4 symptoms (see section 4.2).
Danish: Ved grad 3- eller 4-symptomer skal dosis af dexamethason (i henhold til doseringsvejledningen) eller af ixazomib justeres (se pkt.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 4 mg of ixazomib (as 5.7 mg of ixazomib citrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 4 mg ixazomib (som 5,7 mg ixazomibcitrat).
English: As ixazomib is administered in combination with lenalidomide and dexamethasone, refer to the SmPC for these medicinal products for additional special warnings and precautions for use.
Danish: Da ixazomib anvendes i kombination med lenalidomid og dexamethason, henvises der til disse lægemidlers produktresuméer vedrørende yderligere særlige advarsler og forsigtighedsregler vedrørende brugen.
English: Each capsule contains 3 mg of ixazomib (as 4.3 mg of ixazomib citrate) NINLARO 4 mg hard capsules
Danish: Hver kapsel indeholder 3 mg ixazomib (som 4,3 mg ixazomibcitrat) NINLARO 4 mg kapsler, hårde
English: The PK of ixazomib is similar in patients with normal renal function and in patients with mild or moderate renal impairment (creatinine clearance ≥ 30 mL/min) based on the results of a population PK analysis.
Danish: Baseret på resultaterne af en populationsfarmakokinetisk analyse er PK for ixazomib sammenlignelig hos patienter med normal nyrefunktion og patienter med let eller moderat nedsat nyrefunktion (kreatininclearance ≥ 30 ml/min.
English: • Following recovery, resume ixazomib at the next lower dose.
Danish: Efter restitution, genoptag dosering af ixazomib ved den næste lavere dosis.
English: As ixazomib is administered in combination with lenalidomide and dexamethasone, refer to the SmPC for these medicinal products for additional contraindications.
Danish: Da ixazomib gives i kombination med lenalidomid og dexamethason, henvises der til disse lægemidlers produktresuméer vedrørende yderligere kontraindikationer.
English: Do not crush, chew or open the capsule.
Danish: Kapslen må ikke knuses, tygges eller åbnes.
English: • Following recovery, resume lenalidomide at the next lower dose according to its prescribing information and resume ixazomib at its most recent dose.
Danish: • Efter restitution, genoptag dosering af lenalidomid ved den næste lavere dosis i henhold til ordinationsoplysningerne og ixazomib ved den senest givne dosis.
English: The reduced dose of 3 mg is recommended in patients with severe renal impairment (creatinine clearance < 30 mL/min) or end-stage renal disease (ESRD) requiring dialysis.
Danish: Den reducerede dosis på 3 mg anbefales til patienter med alvorligt nedsat nyrefunktion (kreatininclearance < 30 ml/min.)
English: • Following recovery, resume ixazomib at the next lower dose and resume lenalidomide at its most recent dose.
Danish: • Efter restitution, genoptag dosering af ixazomib ved den næste lavere dosis og af lenalidomid ved den senest givne dosis.
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING CARTON CONTAINING WALLET UNIT
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN MELLEMSTE EMBALLAGE EMBALLAGE MED KARTON MED BLISTERMAPPE
English: NINLARO 4 mg hard capsules
Danish: NINLARO 4 mg kapsler, hårde
English: Titanium dioxide (E171) Red iron oxide (E172)
Danish: Titandioxid (E 171) Rød jernoxid (E 172)
English: NAME OF THE MEDICINAL PRODUCT NINLARO 2.3 mg ixazomib
Danish: LÆGEMIDLETS NAVN NINLARO 2,3 mg ixazomib
English: Co-administration of ixazomib with strong CYP1A2 inhibitors did not result in a clinically meaningful change in the systemic exposure of ixazomib based on the results of a population pharmacokinetic (PK) analysis.
Danish: Baseret på resultaterne af en farmakokinetisk (PK) populationsanalyse resulterer samtidig behandling med ixazomib og potente CYP1A2-hæmmere ikke i en klinisk relevant ændring i den systemiske eksponering af ixazomib.
English: Takeda GmbH Podružnica Slovenija Tel.+ 386 (0) 59 082 480
Danish: Tel.+ 386 (0) 59 082 480
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 2.3 mg of ixazomib (as 3.3 mg of ixazomib citrate)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 2,3 mg ixazomib (som 3,3 mg ixazomibcitrat)
English: Each capsule contains 2.3 mg of ixazomib (as 3.3 mg of ixazomib citrate) NINLARO 3 mg hard capsules
Danish: Hver kapsel indeholder 2,3 mg ixazomib (som 3,3 mg ixazomibcitrat) NINLARO 3 mg kapsler, hårde
English: The PK of ixazomib is similar in patients with normal hepatic function and in patients with mild hepatic impairment (total bilirubin ≤ ULN and AST > ULN or total bilirubin > 1-1.5 x ULN and any AST) based on the results of a population PK analysis.
Danish: Baseret på resultaterne fra en populationsfarmakokinetisk analyse er farmakokinetikken (PK) for ixazomib sammenlignelig hos patienter med normal leverfunktion og patienter med let nedsat leverfunktion (total-bilirubin < ULN og ASAT > ULN eller total-bilirubin > 1-1,5 x ULN og enhver ASAT).
English: NAME OF THE MEDICINAL PRODUCT NINLARO 4 mg ixazomib
Danish: LÆGEMIDLETS NAVN NINLARO 4 mg ixazomib
English: • Following recovery, resume lenalidomide at the next lower dose according to its SmPC.
Danish: Efter restitution, genoptag dosering af lenalidomid ved den næste lavere dosis i henhold til produktresuméet.
English: NINLARO 3 mg hard capsules
Danish: NINLARO 3 mg kapsler, hårde
English: Each capsule contains 2.3 mg of ixazomib (as 3.3 mg of ixazomib citrate).
Danish: Hver kapsel indeholder 2,3 mg ixazomib (som 3,3 mg ixazomibcitrat).
English: • Following recovery, resume lenalidomide at the next lower dose according to its SmPC and resume ixazomib at its most recent dose.
Danish: • Efter restitution, genoptag dosering af lenalidomid ved den næste lavere dosis i henhold til produktresuméet og af ixazomib ved den senest givne dosis.
English: As ixazomib is administered in combination with lenalidomide and dexamethasone, refer to the SmPC for these medicinal products for additional undesirable effects.
Danish: Da ixazomib anvendes i kombination med lenalidomid og dexamethason, henvises til disse lægemidlers produktresuméer vedrørende yderligere bivirkninger.
English: If you take more NINLARO than you should
Danish: Hvis du har taget for meget NINLARO
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 3 mg of ixazomib (as 4.3 mg of ixazomib citrate)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 3 mg ixazomib (som 4,3 mg ixazomibcitrat)
English: Do not crush, open or chew the capsules.
Danish: Kapslerne må ikke knuses, åbnes eller tygges.
English: Each capsule contains 3 mg of ixazomib (as 4.3 mg of ixazomib citrate).
Danish: Hver kapsel indeholder 3 mg ixazomib (som 4,3 mg ixazomibcitrat).
English: NAME OF THE MEDICINAL PRODUCT NINLARO 2.3 mg hard capsules ixazomib
Danish: LÆGEMIDLETS NAVN NINLARO 2,3 mg kapsler, hårde ixazomib
English: Other medicines and NINLARO
Danish: Virkning og anvendelse af NINLARO
English: NAME OF THE MEDICINAL PRODUCT NINLARO 3 mg ixazomib
Danish: LÆGEMIDLETS NAVN NINLARO 3 mg ixazomib
English: Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172)
Danish: Titandioxid (E 171) Gul jernoxid (E 172) Rød jernoxid (E 172)
English: If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: Spørg lægen, apotekspersonalet eller sygeplejersken, hvis der er mere, du vil vide.
English: Light pink, size 4 gelatin hard capsule, marked “Takeda” on the cap and “2.3 mg” on the body with black ink.
Danish: Lyserød hård gelatinekapsel, størrelse 4, mærket med "Takeda" på overdel og "2.3 mg" på underdel med sort farve.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med NINLARO Fortæl altid lægen, apotekspersonalet eller sygeplejersken, hvis du tager anden medicin for nylig.
English: The PK of ixazomib was characterized in patients with normal hepatic function at 4 mg (N=12), moderate hepatic impairment at 2.3 mg (total bilirubin > 1.5-3 x ULN, N=13) or severe hepatic impairment at 1.5 mg (total bilirubin > 3 x ULN, N=18).
Danish: Hos patienter med moderat nedsat leverfunktion (total-bilirubin > 1,5-3 x ULN, N = 13) blev PK for ixazomib bestemt ved en dosis på 2,3 mg og hos patienter med alvorligt nedsat leverfunktion (total-bilirubin > 3 x ULN, N = 18) ved en dosis på 1,5 mg. Ikke-bundet dosis-normaliseret AUC var 27% højere hos patienter med moderat eller alvorligt nedsat leverfunktion sammenlignet med patienter med normal leverfunktion (se pkt.
English: Peripheral oedema has been reported with ixazomib (see section 4.8).
Danish: Der er blevet rapporteret perifert ødem i forbindelse med ixazomib (se pkt.
English: NINLARO 3 mg hard capsule: Light grey, size 4, marked “Takeda” on the cap and “3 mg” on the body with black ink.
Danish: NINLARO 3 mg kapsel, hård: Lysegrå, størrelse 4, mærket med "Takeda" på overdel og "3 mg" på underdel med sort farve.
English: NAME OF THE MEDICINAL PRODUCT NINLARO 4 mg hard capsules ixazomib
Danish: LÆGEMIDLETS NAVN NINLARO 4 mg kapsler, hårde ixazomib
English: Excretion
Danish: Obstipation
English: • Following recovery, resume ixazomib at its most recent dose.
Danish: Efter restitution, genoptag dosering af ixazomib ved den senest givne dosis.
English: NINLARO 4 mg hard capsule: Light orange, size 3, marked “Takeda” on the cap and “4 mg” on the body with black ink.
Danish: NINLARO 4 mg kapsel, hård: Lysorange, størrelse 3, mærket med "Takeda" på overdel og "4 mg" på underdel med sort farve.
English: If you are uncertain whether the condition above applies to you, talk to your doctor, pharmacist or nurse before taking NINLARO.
Danish: Kontakt lægen, apotekspersonalet eller sygeplejersken, før du tager NINLARO, hvis du er i tvivl, om dette gælder for dig.
English: What NINLARO looks like and contents of the pack NINLARO 2.3 mg hard capsule: Light pink, size 4, marked “Takeda” on the cap and “2.3 mg” on the body with black ink.
Danish: NINLARO 2,3 mg kapsel, hård: Lyserød, størrelse 4, mærket med "Takeda" på overdel og "2.3 mg" på underdelen med sort farve.
English: Date of Last Renewal: 16 September 2019
Danish: December 2019
English: Adverse reactions (all grades)
Danish: (alle grader)
English: Gastrointestinal disorders Diarrhoea
Danish: M ave -tarm-kanalen Diarré
English: Each capsule contains 4 mg of ixazomib (as 5.7 mg of ixazomib citrate) For the full list of excipients, see section 6.1.
Danish: Hver kapsel indeholder 4 mg ixazomib (som 5,7 mg ixazomibcitrat) Alle hjælpestoffer er anført under pkt.
English: NAME OF THE MEDICINAL PRODUCT NINLARO 3 mg hard capsules ixazomib
Danish: LÆGEMIDLETS NAVN NINLARO 3 mg kapsler, hårde ixazomib
English: Grade 4 peripheral neuropathy Discontinue treatment regimen.
Danish: Grad 4 perifer neuropati
English: Rash has been reported with ixazomib (see section 4.8).
Danish: Der er blevet rapporteret udslæt i forbindelse med ixazomib (se pkt.
English: What NINLARO is used for
Danish: NINLARO indeholder
English: For other concomitant medicinal products that may be required, refer to the current lenalidomide and dexamethasone SmPC.
Danish: Se de aktuelle produktresuméer for lenalidomid og dexamethason vedrørende eventuel nødvendig samtidig behandling med andre lægemidler.
English: How to store NINLARO
Danish: Virkning af NINLARO
English: Light orange, size 3 gelatin hard capsule, marked “Takeda” on the cap and “4 mg” on the body with black ink.
Danish: Lysorange hård gelatinekapsel, størrelse 3, mærket med "Takeda" på overdel og "4 mg" på underdel med sort farve.
English: Light grey, size 4 gelatin hard capsule, marked “Takeda” on the cap and “3 mg” on the body with black ink.
Danish: Lysegrå hård gelatinekapsel, størrelse 4, mærket med "Takeda" på overdel og "3 mg" på underdel med sort farve.
English: The active substance is ixazomib.
Danish: Potente induktorer kan reducere effektiviteten af ixazomib.
English: What you need to know before you take NINLARO 3.
Danish: Oversigt over indlægssedlen Virkning og anvendelse af NINLARO Det skal du vide, før du begynder at tage NINLARO Sådan skal du tage NINLARO Bivirkninger
English: Marketing Authorisation Holder Takeda Pharma A/S Dybendal Alle 10
Danish: Inde have r af marke ds førings tillade lsen Takeda Pharma A/S
English: Takeda Products Ireland Limited Tel: +353 (0) 1 6420021
Danish: Tel: +353 (0) 1 6420021
English: Dosing schedule: NINLARO taken with lenalidomide and dexamethasone Take medicine 28-day cycle (a 4-week cycle) Week 1
Danish: Doseringsskema: NINLARO taget sammen med lenalidomid og dexamethason Tag lægemidlet
English: Takeda Pharmaceuticals SRL Tel: +40 21 335 03 91
Danish: Tel: +40 21 335 03 91
English: Grade 4 adverse reactions
Danish: Grad 3-bivirkninger Grad 4-bivirkninger
English: Prepare a clean working area.
Danish: Forbered et rent arbejdsområde.
English: You may need urgent medical treatment.
Danish: Du kan have brug for akut medicinsk behandling.
English: Your doctor will discuss this with you.
Danish: Det vil din læge diskutere med dig.
English: • Being breathless when you do not expect it.
Danish: • Du bliver forpustet, når du ikke forventer det.
English: This target has not been established clinically.
Danish: Dette mål er ikke blevet fastlagt klinisk.
English: • You should normally have your injections at the same times each day.
Danish: • Du skal normalt have din injektion på samme tid hver dag.
English: Alternative therapies were also discussed.
Danish: Alternative behandlinger blev også drøftet.
English: Children under 3 months of age
Danish: Børn under 3 måneder
English: Check that the vial is intact and has not been damaged.
Danish: Tjek, at hætteglasset er intakt og ikke er blevet skadet.
English: It is very important that you take the antibiotic at the right dose, at the right times and for the right number of days.
Danish: Det er meget vigtigt, at du tager antibiotikummet i den korrekte dosis, på det korrekte tidspunkt og i det korrekte antal dage.
English: The signs may include a sudden onset of:
Danish: Tegnene kan omfatte pludselig forekomst af:
English: • Red or brown urine.
Danish: • Rød eller brun urin.
English: These studies recruited patients with LRTI, which was appropriate at that time.
Danish: Til disse undersøgelser blev der rekrutteret patienter med LRTI, hvilket var relevant på det tidspunkt.
English: Symptomatic treatments should be considered.
Danish: Symptomatisk behandling bør overvejes.
English: Not known pain at the injection site
Danish: Ikke kendt smerte på injektionsstedet
English: - This medicine has been prescribed for you.
Danish: - Denne medicin er ordineret til dig personligt.
English: Do not take a double dose (two injections at the same time) to make up for a forgotten dose.
Danish: Du må ikke tage en dobbeltdosis (to injektioner på samme tid) som erstatning for den glemte dosis.
English: • if you have had severe diarrhoea after taking other antibiotics.
Danish: • Hvis du har fået alvorlig diarré, efter du har taget andre antibiotika.
English: The latter manufacturer is also approved in the majority of the MSs and is therefore also mentioned in the harmonised documentation.
Danish: Sidstnævnte producent er også godkendt i de fleste medlemsstater og er derfor ligeledes nævnt i den harmoniserede dokumentation.
English: If you miss an injection, you should have it as soon as possible.
Danish: Hvis du har glemt at få en injektion, skal du have den så snart som muligt.
English: In particular the sub-section specific for neonates was appreciated.
Danish: Især underafsnittet, som specifikt omhandlede nyfødte børn, blev værdsat.
English: • Your injection should not be mixed with or added to solutions that contain other medicines.
Danish: • Din injektion bør ikke blandes med eller tilsættes opløsninger, som indeholder anden medicin.
English: The CHMP noted that the indication of neutropenia is currently approved in most of the Member States.
Danish: CHMP bemærkede, at indikationen for neutropeni på nuværende tidspunkt er godkendt i de fleste medlemsstater.
English: Your doctor may do blood tests from time to time.
Danish: Din læge kan af og til tage blodprøver på dig.