natgillin/translations-raw huggingface dataset:
a Værdierne repræsenterer behandlingsforskellen mellem placebo og reslizumab 3 mg/kg baseret på justerede gennemsnit over den specificerede tidsperiode for hver behandlingsgruppe undtagen for ændringen til uge 16 for AQLQ, som var det første tidspunkt, hvor AQLQ blev vurderet.
(p &lt; 0.0001) a The values represent the treatment difference between placebo and reslizumab 3 mg/kg based on adjusted means over the specified time period for each treatment group, except for the change to week 16 for AQLQ, which was the first timepoint where AQLQ was assessed.
InfusionsvÃ¦sken mÃ¥ ikke gives samtidigt med andre lÃ¦gemidler i den samme intravenÃ¸se slange.
The solution for infusion should not be infused concomitantly in the same intravenous line with other medicinal products.
De fleste patienter havde normale leverfunktionsprøver (n = 766, ca. 95 %) eller let forhøjede leverfunktionsprøver (enten, i det første tilfælde, total-bilirubin &gt; øvre normalgrænse [ULN], men ≤ 1,5 gange ULN, eller i det andet tilfælde, aspartat-aminotransferase &gt; ULN, og total-bilirubin ≤ ULN; n = 35, ca. 4 %).
Most patients had normal liver function tests (n=766, approximately 95%) or mildly increased liver function tests (either, in the first case, total bilirubin above the upper limit of normal [ULN] but less than or equal to 1.5 times the ULN or, in the second case, aspartate aminotransferase greater than the ULN and total bilirubin less than or equal to the ULN; n=35, approximately 4%).
Da der er observeret sammenlignelige eksponeringer for reslizumab hos patienter over 65 år og patienter mellem 18 og &lt; 65 år, anbefales dosisjustering ikke (se pkt.
Based on the similar reslizumab exposure observed in patients older than 65 years of age as compared to patients 18 to &lt; 65 years of age, no dose adjustment is recommended (see section 5.2).
I undergruppen med patienter, der havde behov for behandling med OCS for astmaeksacerbationer, blev det vist, at reslizumab nedsatte hyppigheden af astmaeksacerbationer med hhv. 56 % (p &lt; 0,0001) og 60 % (p &lt; 0,0001) i studie I og studie II.
In the subset of patients requiring courses of OCS treatment for management of their asthma exacerbation, reslizumab was shown to reduce the frequency of asthma exacerbations by 56% (p &lt; 0.0001) and 60% (p &lt; 0.0001) in Study I and Study II, respectively.
( &gt; 1/10), almindelig (≥ 1/100 til &lt; 1/10), ikke almindelig (≥ 1/1.000 til &lt; 1/100), sjælden (≥ 1/10.000
Adverse reactions are listed below in Table 2 by system organ class and frequency (frequencies are defined as: very common (≥1/10), common (≥1/100 to &lt; 1/10), uncommon (≥ 1/1,000 to &lt; 1/100), rare (≥1/10,000 to &lt; 1/1,000), very rare ( &lt; 1/10,000), not known
InfusionsvÃ¦sken skal gives som intravenÃ¸s infusion i lÃ¸bet af 20-50 minutter.
The solution for infusion should be infused intravenously over 20 - 50 minutes.
Infusionen skal afbrydes straks, hvis patienten oplever en overfÃ¸lsomhedsreaktion over for reslizumab eller over for et eller flere af hjÃ¦lpestofferne (se pkt.
The infusion must be discontinued immediately if the patient experiences a hypersensitivity reaction to reslizumab or to any of the excipients (see section 4.4).
{MM/ÅÅÅÅ}
&lt; {MM/YYYY} &gt;
Infektioner og maligniteter som forÃ¥rsager myelosuppression
Infections and malignancies causing myelosuppression
Sikkerheden og virkningen af filgrastim er ikke undersøgt hos raske donorer &lt; 16 år eller &gt; 60 år.
The safety and efficacy of filgrastim have not been assessed in normal donors &lt; 16 years or &gt; 60 years.
Sikkerheden og virkningen af administration af filgrastim hos de novo-AML-patienter i alderen &lt; 55 år med god cytogenetik [t(8;21), t(15;17) og inv(16)] er ikke fastlagt.
The safety and efficacy of filgrastim administration in de novo AML patients aged &lt; 55 years with good cytogenetics [t(8;21), t(15;17), and inv(16)] have not been established.
Der blev ikke observeret nogen samlet forskel i sikkerhed og virkning hos personer over 65 år, sammenlignet med yngre voksne ( &gt; 18 år) personer, der fik cytotoksisk kemoterapi, og klinisk erfaring har ikke identificeret nogen forskelle i respons mellem ældre og yngre voksne patienter.
No overall differences in safety or effectiveness were observed between subjects over 65 years of age compared to younger adult ( &gt; 18 years of age) subjects receiving cytotoxic chemotherapy and clinical experience has not identified differences in the responses between elderly and younger adult patients.
I kliniske studier responderede &gt; 90 % af patienterne på denne dosis og opnåede normale neutrofilværdier efter gennemsnitligt 2 dage.
In clinical studies, &gt; 90% of patients responded at these doses, achieving reversal of neutropenia in a median of 2 days.
I kliniske studier var det nødvendigt med doser på 30 mill. E/dag (300 μg/dag) i 1-7 dage om ugen for at opretholde et ANC &gt; 2,0 x 109/l med en median-dosisfrekvens på 3 gange ugentligt.
In clinical studies, dosing with 30 MU/day (300 μg/day) on 1 - 7 days per week was required to maintain the ANC &gt; 2.0 x 109/l, with the median dose frequency being 3 days per week.
Leukocytose (leukocytter &gt; 50 x 109/l) blev observeret hos 41 % af donorerne, og forbigående trombocytopeni (trombocytter &lt; 100 x 109/l) efter filgrastim og leukaferese blev observeret hos 35 % af donorerne (se pkt.
Leukocytosis (WBC &gt; 50 x 109/l) was observed in 41% of normal donors and transient thrombocytopenia (platelets &lt; 100 x 109/l) following filgrastim and leukapheresis was observed in 35% of donors (see section 4.4).
Hos patienter behandlet med filgrastim fortyndet til koncentrationer på &lt; 1,5 mill. E/ml (15 μg/ml) bør der tilføjes humant serumalbumin (HSA) til en slutkoncentration på 2 mg/ml.
For patients treated with filgrastim diluted to concentrations &lt; 1.5 MU/ml (15 μg/ml), human serum albumin (HSA) should be added to a final concentration of 2 mg/ml.
Leukaferese bør udføres i det tidsrum, hvor det absolutte neutrofiltal øges fra &lt; 0,5 x 109/l til &gt; 5,0 x 109/l.
Leukapheresis should be performed during the period when the ANC rises from &lt; 0.5 x 109/l to &gt; 5.0 x 109/l.
Fortynding til en slutkoncentration &lt; 0,2 MU/ml (2 μg/ml) frarådes.
Dilution to a final concentration &lt; 0.2 MU/ml (2 μg/ml) is not recommended at any time.
Ved administration til perifer blodstamcellemobilisering bør filgrastim seponeres eller dosis reduceres, hvis leukocyttallet stiger til &gt; 70 x 109/l.
When administered for PBPC mobilisation, filgrastim should be discontinued or its dosage should be reduced if the leukocyte counts rise to &gt; 70 x 109/l.
Såfremt ANC falder til &lt; 1,0 x 109/l under behandlingen, bør dosis af filgrastim igen øges ved at følge ovenstående procedure.
If the ANC decreases to &lt; 1.0 x 109/l during the treatment period, the dose of filgrastim should be re-escalated according to the above steps ANC = absolute neutrophil count
Hos et lille antal patienter ( &lt; 10 %) var det nødvendigt med doser på 1,0 mill. E/kg/dag (10 μg/kg/dag) for at opnå normale neutrofilværdier.
In a small number of patients ( &lt; 10%), doses up to 1.0 MU/kg/day (10 μg/kg/day) were required to achieve reversal of neutropenia.
Langtidsadministration kan være nødvendigt for at fastholde et absolut neutrofiltal &gt; 2,0 x 109/l.
Long-term administration may be required to maintain the ANC &gt; 2.0 x 109/l.
Der er set forbigående trombocytopeni (trombocytter &lt; 100 x 109/l) efter administration af filgrastim og leukaferese hos 35 % af de undersøgte forsøgspersoner.
Transient thrombocytopenia (platelets &lt; 100 x 109/l) following filgrastim administration and leukapheresis was observed in 35% of subjects studied.
Hvis det er nødvendigt med mere end én leukaferese, bør der udvises særlig opmærksomhed over for donorer med trombocytter &lt; 100 x 109/l før leukaferese.
If more than one leukapheresis is required, particular attention should be paid to donors with platelets &lt; 100 x 109/l prior to leukapheresis; in general apheresis should not be performed if platelets &lt; 75 x 109/l.
Blandt disse blev der rapporteret om to tilfælde af trombocytter &lt; 50 x 109/l.
Among these, two cases of platelets &lt; 50 x 109/l were reported and attributed to the leukapheresis procedure.
Infusion af perifere blodstamceller fremmer den hÃ¦matopoietiske restitution og forkorter perioden med risiko for blÃ¸dningskomplikationer og behovet for trombocyttransfusioner.
Infusion of PBPC accelerates haematopoietic recovery reducing the duration of risk for haemorrhagic complications and the need for platelet transfusions.
Sjælden til &lt; 1/1.000)
Rare (≥ 1/10,000 to
Afhængigt af patientens absolutte neutrofiltal kan det blive nødvendigt med yderligere dosisjustering for at bevare neutrofiltallet på &gt; 2,0 x 109/l.
Further dose adjustment may be necessary, as determined by the patient's ANC, to maintain the neutrophil count at &gt; 2.0 x 109/l.
0,4 mill. E/kg/dag (4 μg/kg/dag), indtil et normalt neutrofiltal er nået og kan vedligeholdes (absolut neutrofiltal &gt; 2,0 x 109/l).
For reversal of neutropenia The recommended starting dose of filgrastim is 0.1 MU/kg/day (1 μg/kg/day), with titration up to a maximum of 0.4 MU/kg/day (4 μg/kg/day) until a normal neutrophil count is reached and can be maintained (ANC &gt; 2.0 x 109/l).
Hos patienter med svær kronisk neutropeni, der udvikler trombocytopeni (trombocyttal &lt; 100 x 109/l), bør midlertidig seponering eller dosisreduktion af filgrastim overvejes.
Consideration should be given to temporary discontinuation or dose reduction of filgrastim in patients with severe chronic neutropenia who develop thrombocytopenia (platelet count &lt; 100 x 109/l).
Tillæg af palbociclib til fulvestrant gav en symptomfordel ved i betydelig grad at forsinke tiden indtil forværring i smertesymptomer sammenlignet med fulvestrant plus placebo (median 8,0 måneder versus 2,8 måneder; HR på 0,64 [95 % CI: 0,49; 0,85]; p &lt; 0,001).
Addition of palbociclib to fulvestrant resulted in a symptom benefit by significantly delaying Time-to-Deterioration in pain symptom compared with fulvestrant plus placebo (median 8.0 months versus 2.8 months; HR of 0.64 [95% CI: 0.49, 0.85]; p &lt; 0.001).
Infektioner og parasitÃ¦re sygdomme Meget almindelig Infektionerb Blod og lymfesystem Meget almindelig Neutropenic Leukopenid AnÃ¦mie Thrombocytopenif Ikke almindelig Febril neutropeni Metabolisme og ernÃ¦ring Meget almindelig Nedsat appetit Nervesystemet Almindelig Dysgeusi Ãjne Almindelig Ãget tÃ¥resekretion SlÃ¸ret syn TÃ¸rre Ã¸jne Luftveje, thorax og mediastinum Almindelig Epistaxis Mave-tarm-kanalen Meget almindelig Kvalme
Infections and infestations Very common Infectionsb Blood and lymphatic system disorders Very common Neutropeniac Leukopeniad Anaemiae Thrombocytopeniaf Uncommon Febrile neutropenia Metabolism and nutrition disorders Very common Decreased appetite Nervous system disorders Common Dysgeusia Eye disorders Common Lacrimation increased Vision blurred Dry eye Respiratory, thoracic and mediastinal disorders Common Epistaxis Gastrointestinal disorders Very common Nausea
Fulvestrant skal anvendes med forsigtighed til patienter med meget nedsat nyrefunktion (kreatininclearance &lt; 30 ml/min).
Fulvestrant should be used with caution in patients with severe renal impairment (creatinine clearance less than 30 ml/min).
(kreatinin-clearance &lt; 30 ml/min), og derfor anbefales forsigtighed ved behandling af disse patienter (se pkt.
Safety and efficacy have not been evaluated in patients with severe renal impairment (creatinine clearance &lt; 30 ml/min), and, therefore, caution is recommended in these patients (see section 4.4).
Patienter med estimeret kreatininclearance &lt; 30 ml/min.
Patients with estimated creatinine clearance &lt; 30 ml/min.
Meget almindelig ( &gt; 1/10), almindelig ( &gt; 1/100 og &lt; 1/10), ikke almindelig ( &gt; 1/1000 og 1/100), sjælden ( &gt; 1/10.000 og &lt; 1/1000), meget sjælden ( &lt; 1/10.000, inklusive enkeltstående rapporter).
[Very Common ( &gt; 1/10), Common (³1/100, &lt; 1/10) Uncommon (³1/1000, &lt; 1/100) Rare (³1/10,000, &lt; 1/1000) Very rare ( &lt; 1/10,000 including isolated cases)]
Svær leverdysfunktion (serumalbumin &lt; 25 g/l eller Child-Pugh score ³ 10).
Severe hepatic dysfunction (serum albumin &lt; 25 g/l or Child-Pugh score ³10).
Yderligere bivirkninger rapporteret efter markedsføring omfattende &gt; 70 millioner behandlede patienter omfatter hovedpine, kvalme, artralgi samt de bivirkninger, som i følgende liste er skrevet med kursiv, og som er anført under meget sjælden.
Additional reactions reported from post-marketing experience in &gt; 70 million treated patients include headache, nausea and arthralgia, and the reactions included as very rare, in italics in the list below.
Hyppigheden af klinisk betydende fald i hæmoglobin ( &gt; 2 g/dl), bekræftet ved gentagne målinger, var signifikant lavere hos patienter med celecoxib i forhold til NSAID-gruppen (relativ risiko 0,29, 95% CI 0,17-0,48).
The incidence of clinically significant decreases in haemoglobin ( &gt; 2 g/dL), confirmed by repeat testing, was significantly lower in patients on celecoxib compared to the NSAID group, relative risk 0.29, 95% CI 0.17- 0.48.
Patienter med svær nedsat leverfunktion (serumalbumin under 25 g/l) er ikke undersøgt, hvorfor celecoxib er kontraindiceret til denne patientgruppe.
Patients with severe hepatic impairment (serum albumin &lt; 25 g/l) have not been studied and celecoxib is contraindicated in this patient group.
Som hos yngre voksne bør 200 mg være den initiale daglige dosis.
Elderly &gt; 65 years: As in younger adults, 200 mg per day should be used initially.
Infektioner og infestationer Almindelig: bihulebetÃ¦ndelse, Ã¸vre luftvejsinfektion Ikke almindelig: urinvejsinfektion
Infections and infestations Common: sinusitis, upper respiratory tract infection Uncommon: urinary tract infection
Hos ældre kvinder (over 65 år) er plasmakoncentrationen af celecoxib ca. 100% forhøjet.
The plasma concentration of celecoxib is approximately 100% increased in elderly women ( &gt; 65 years).
Infusionen kan vÃ¦re forbundet med allergiske reaktioner, og patienten bÃ¸r overvÃ¥ges under og efter infusionen.
The infusion may be associated with allergic reactions, so the patient should be monitored during and after the infusion.
Magnesiumværdierne lå hovedsagelig i området mellem 1,025 mmol/l og &gt; 1,5 mmol/l, og der blev ikke indberettet kliniske tegn eller symptomer i nogen af tilfældene.
Magnesium levels mainly ranged from 1.025 mmol/L to &gt; 1.5 mmol/L and no clinical signs or symptoms were reported for any of the cases.
151 25 Maroussi Athen Grækenland
4 Theotokopoulou &amp; Astronafton str 151 25 Maroussi Athens Greece
I de kliniske studier er der rapporteret om følgende bivirkninger, som er opstillet efter hyppighed i henhold til denne konvention: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til &lt; 1/10), ikke almindelig (≥ 1/1.000 til &lt; 1/100); sjælden (≥ 1/10.000 til &lt; 1/1.000); meget sjælden ( &lt; 1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
The following adverse reactions have been reported during clinical trials and are ranked using the following frequency: very common (≥1/10); common (≥1/100 to &lt; 1/10); uncommon (≥1/1,000 to &lt; 1/100); rare (≥1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000); not known (cannot be estimated from the available data).
Initialdosis var 0,02 mg/kg to gange dagligt i aldersgruppen [6-12] måneder, 0,05 mg/kg to gange dagligt ved [1-3] år og [3-18] år &lt; 40 kg, og 2,5 mg to gange dagligt i aldersgruppen [3-18] år og ≥ 40 kg.
The starting dose was 0.02 mg/kg bid in age-subset [6-12]months, 0.05 mg/kg bid in [1-3]years and [3-18]years &lt; 40 kg, and 2.5 mg bid in [3-18]years and ≥40 kg.
De gennemsnitlige ivabradindoser som muliggør opnåelse af 20% reduktion i hjertefrekvens, var hhv. 0,13 ± 0,04 mg/kg to gange dagligt; 0,10 ± 0,04 mg/kg to gange dagligt og 4,1 ± 2,2 mg to gange dagligt i aldersgrupperne [1-3] år, [3-18] år og &lt; 40 kg og [3-18] år og ≥ 40 kg.
The mean ivabradine doses allowing to achieve a 20% HRR were 0.13 ± 0.04 mg/kg bid, 0.10 ± 0.04 mg/kg bid and 4.1 ± 2.2 mg bid in the age subsets [1-3]years, [3-18]years and &lt; 40 kg and [3-18] years and ≥40 kg, respectively.
I et større studie, BEAUTIFUL, der omfattede 10.917 patienter med koronararteriesygdom og dysfunktion af venstre ventrikel (LVEF &lt; 40%), blev ivabradin givet sammen med optimal igangværende behandling, hvor 86,9% af patienterne fik β-blokkere.
A large outcome study, BEAUTIFUL, was performed in 10,917 patients with coronary artery disease and left ventricular dysfunction (LVEF &lt; 40%) on top of optimal background therapy with 86.9% of patients receiving beta-blockers.
Studiet påviste en klinisk og statistisk signifikant relativ risikoreduktion på 18% for det primære sammensatte endepunkt, der omfatter kardiovaskulær mortalitet og hospitalsindlæggelse pga. tiltagende hjerteinsufficiens (hazard ratio: 0,82; 95% KI [0,75;0,90]; p &lt; 0,0001), som var åbenbar inden for 3 måneder efter behandlingsstart.
The study demonstrated a clinically and statistically significant relative risk reduction of 18% in the rate of the primary composite endpoint of cardiovascular mortality and hospitalisation for worsening heart failure (hazard ratio: 0.82, 95% CI [0.75;0.90] - p &lt; 0.0001) apparent within 3 months of initiation of treatment.
Der blev udført et stort outcome-studie, SIGNIFY, der omfattede 19.102 patienter med koronararteriesygdom og uden klinisk hjerteinsufficiens (LVEF &gt; 40%) i optimal igangværende behandling.
A large outcome study, SIGNIFY, was performed in 19,102 patients with coronary artery disease and without clinical heart failure (LVEF &gt; 40%), on top of optimal background therapy.
I undergruppen med patienter med hjertefrekvens ≥ 75 slag i minuttet (n=4.150) sås en større risikoreduktion for det primære sammensatte endepunkt på 24% (hazard ratio: 0,76; 95% KI [0,68;0,85]; p &lt; 0,0001) og for de sekundære endepunkter inklusive død uanset årsag (hazard ratio: 0,83; 95% KI [0,72;0,96]; p=0,0109) og kardiovaskulær død (hazard ratio: 0,83; 95% KI [0,71;0,97]; p=0,0166).
In the subgroup of patients with HR ≥75 bpm (n = 4,150), a greater reduction was observed in the primary composite endpoint of 24% (hazard ratio: 0.76, 95% CI [0.68;0.85] - p &lt; 0.0001) and for other secondary endpoints, including all cause death (hazard ratio: 0.83, 95% CI [0.72;0.96] - p = 0.0109) and CV death (hazard ratio: 0.83, 95% CI [0.71;0.97] - p = 0.0166).
- Hjertefrekvens i hvile under 70 slag/min før behandlingen - Kardiogent shock - Akut myokardieinfarkt - Svær hypotension ( &lt; 90/50 mmHg) - Svær leverinsufficiens - Syg sinus-syndrom - Sinuatrialt blok - Ustabil eller akut hjerteinsufficiens - Afhængighed af pacemaker (hjertefrekvensen styres udelukkende af pacemaker) - Ustabil angina pectoris - 3. grads AV-blok - Samtidig behandling med stærke CYP3A4-hæmmere som fx azol-antimykotika (ketoconazol,
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Resting heart rate below 70 beats per minute prior to treatment - Cardiogenic shock - Acute myocardial infarction - Severe hypotension ( &lt; 90/50 mmHg) - Severe hepatic insufficiency - Sick sinus syndrome - Sino-atrial block - Unstable or acute heart failure - Pacemaker dependent (heart rate imposed exclusively by the pacemaker) - Unstable angina - AV-block of 3rd degree - Combination with strong cytochrome P450 3A4 inhibitors such as azole antifungals (ketoconazole,
Almindelig (≥ 1/100 og &lt; 1/10) Ikke almindelig (≥ 1/1000 og &lt; 1/100) Sjælden (≥ 1/10.000 og &lt; 1/1000) Meget sjælden ( &lt; 1/10.000)
Uncommon (≥1/1,000 to &lt; 1/100) Rare (≥1/10,000 to &lt; 1/1,000) Very rare ( &lt; 1/10,000)
Norvartis Vaccines and Diagnostics GmbH &amp; Co.KG
Novartis Vaccines and Diagnostics GmbH &amp; Co. KG
For CLL-patienter, hvis lymfocyttal er &gt; 25 x 109/l, anbefales det at administrere 100 mg prednison/prednisolon intravenøst kort før infusionen med Blitzima for at reducere hastigheden og sværhedsgraden af akutte infusionsreaktioner og/eller cytokinfrigivelsessyndrom.
For CLL patients whose lymphocyte counts are &gt; 25 x 109/L it is recommended to administer prednisone/prednisolone 100 mg intravenous shortly before infusion with Blitzima to decrease the rate and severity of acute infusion reactions and/or cytokine release syndrome.
Frekvenserne er defineret som meget almindelig (≥ 1/10), almindelig (≥ 1/100 til &lt; 1/10), ikke almindelig (≥ 1/1.000 til ≤ 1/100) og meget sjælden ( &lt; 1/10.000).
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to &lt; 1/10), uncommon (≥ 1/1000 to &lt; 1/100) and very rare ( &lt; 1/10000).
Information til patienten om Blitzima skal indeholde fÃ¸lgende nÃ¸gle-elementer:
The Patient information about Blitzima should contain the following key elements:
Informationen til lÃ¦gen om Blitzima skal indeholde fÃ¸lgende nÃ¸gle-elementer:
The Physician information about Blitzima should contain the following key elements:
Elimination sker primært via nyrerne ( &gt; 85% af dosen efter oral eller intravenøs administration).
Elimination is primarily by the renal route ( &gt; 85% of the dose following oral or intravenous administration).
Hyppighedskategorierne defineres ved anvendelse af følgende konvention: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til &lt; 1/10), ikke almindelig (≥ 1/1.000 til &lt; 1/100), sjælden (≥ 1/10.000 til &lt; 1/1.000), meget sjælden ( &lt; 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
The frequency categories are defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to &lt; 1/10); uncommon (≥ 1/1,000 to &lt; 1/100); rare (≥ 1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000); and not known (cannot be estimated from the available data).
Disse metabolitter udgør &lt; 5% af dosen efter systemisk administration og udskilles i urin.
These metabolites account for ˂ 5% of the dose following systemic administration and are excreted in urine.
a ANCOVA med betingelser for behandling, område, alder (16 til 18 år, &gt; 18 år) og forventet baseline-FEV1
a ANCOVA with terms for treatment, region, age (16 to 18 years, &gt; 18 years), and baseline FEV1 percent predicted as quartiles.
Virkningen er ikke evalueret hos de 14 børn med CF (≥ 6 til &lt; 12 år) og 13 unge med CF (≥ 12 til &lt; 17 år), der deltog i studie 206.
Efficacy was not evaluated in the 14 children with CF (≥ 6 to &lt; 12 years old) and 13 adolescents with CF (≥ 12 to &lt; 17 years old) who participated in Study 206.
Studier med systemisk administration af levofloxacin viser, at farmakokinetikken for levofloxacin påvirkes af nedsat nyrefunktion, idet faldende nyrefunktion (estimeret kreatininclearance &lt; 50 ml/minut) medfører faldende renal elimination og clearance og stigende eliminationshalveringstid.
Studies using systemic administration of levofloxacin show that the pharmacokinetics of levofloxacin are affected by renal impairment; with decreasing renal function (estimated creatinine clearance &lt; 50 ml/min), renal elimination and clearance are decreased, and elimination half-life increased.
Endvidere er farmakokinetikken for vægtbaserede doser af levofloxacin administreret ved inhalation en gang dagligt i 14 dage til pædiatriske patienter med CF (≥ 6 til &lt; 12 år, n = 14 og ≥ 12 til &lt; 17 år, n = 13) blevet evalueret i studie 206.
In addition, the pharmacokinetics of weight-based doses of levofloxacin administered by inhalation once daily for 14 days in paediatric patients with CF (≥ 6 to &lt; 12 years old, n = 14 and ≥ 12 to &lt; 17 years old, n = 13) were evaluated in Study 206.
Voksne og unge (≥ 12 til &lt; 18 år og med en vægt på ≥ 30 kg) patienter, der havde en forventet FEV1-procent på mellem 25% og 85%, blev inkluderet.
Adult and adolescent (≥ 12 to &lt; 18 years old and weighing ≥ 30 kg) patients who had a FEV1 percent predicted between 25% and 85% were enrolled.