natgillin/translations-raw huggingface dataset:
Endvidere har 14 børn med CF (≥ 6 til &lt; 12 år) og 13 unge med CF (≥ 12 til &lt; 17 år) fået Quinsair 180 mg eller 240 mg en gang dagligt i 14 dage.
In addition, 14 children with CF (≥ 6 to &lt; 12 years old) and 13 adolescents with CF (≥ 12 to &lt; 17 years old) received Quinsair 180 mg or 240 mg once daily for 14 days.
Der blev dog ikke foretaget dosisjusteringer i kliniske studier med Quinsair, der tillod inklusion af patienter med let til moderat nedsat nyrefunktion (estimeret kreatininclearance ≥ 20 ml/minut ved anvendelse Cockcroft-Gault-formlen hos voksne patienter og ≥ 20 ml/minut/1,73 m2 ved anvendelse af Bedside Schwartz-formlen hos patienter
However, dose adjustments were not employed in clinical studies of Quinsair which allowed for the inclusion of patients with mild to moderate renal impairment (estimated creatinine clearance ≥ 20 ml/min using the Cockcroft-Gault formula in adult patients and ≥ 20 ml/min/1.73 m2 using the Bedside Schwartz formula in patients &lt; 18 years old).
I studierne 204, 207 og 209 var den relative ændring i forventet FEV1-procent fra baseline til behandlingsafslutning i cyklus 1 af samme størrelsesorden hos de 51 unge med CF (≥ 12 til &lt; 18 år og med en vægt på ≥ 30 kg), der fik Quinsair 240 mg to gange dagligt, som hos voksne.
In Studies 204, 207 and 209, the relative change in FEV1 percent predicted from baseline to the end of treatment in Cycle 1 was of similar magnitude in the 51 adolescents with CF (≥ 12 to &lt; 18 years old and weighing ≥ 30 kg) receiving Quinsair 240 mg twice daily to that in adults.
Quinsairs sikkerhed og virkning hos børn i alderen &lt; 18 år er endnu ikke klarlagt.
The safety and efficacy of Quinsair in children aged ˂ 18 years old have not yet been established.
(Bemærk: I studie 204 blev yderligere 38 patienter randomiseret til Quinsair 120 mg en gang dagligt (≥ 18 år, n = 35 og ≥ 16 til &lt; 18 år, n = 3), og yderligere 37 patienter blev randomiseret til Quinsair 240 mg en gang daglig (≥ 18 år, n = 34 og ≥ 16 til &lt; 18 år, n = 3).
(Note: In Study 204, an additional 38 patients were randomised to Quinsair 120 mg once daily (≥ 18 years, n = 35; ≥ 16 to &lt; 18 years old, n = 3) and an additional 37patients were randomised to Quinsair 240 mg once daily (≥ 18 years, n = 34; ≥ 16 to &lt; 18 years old, n = 3).)
Quinsairs sikkerhed og virkning hos børn i alderen &lt; 18 år er ikke klarlagt (se pkt.
The safety and efficacy of Quinsair in children aged ˂ 18 years old have not yet been established (see section 4.2).
51 unge med CF (≥ 12 til &lt; 18 år) har i kliniske studier fået Quinsair 240 mg to gange dagligt, og 6 unge med CF har fået Quinsair 120 mg (n = 3) eller 240 mg (n = 3) en gang dagligt.
In clinical trials, 51 adolescents with CF (≥ 12 to &lt; 18 years old) received Quinsair 240 mg twice daily and 6 adolescents with CF received Quinsair 120 mg (n = 3) or 240 mg (n = 3) once daily.
Ialt 189 patienter blev randomiseret til Quinsair 240 mg to gange dagligt (≥ 18 år, n = 170 og ≥ 12 til &lt; 18 år, n = 19), og 93 blev randomiseret til TIS (≥ 18 år, n = 84 og ≥ 12 til &lt; 18 år, n = 9).
A total of 189 patients were randomised to Quinsair 240 mg twice daily (≥ 18 years, n = 170; ≥ 12 to &lt; 18 years old, n = 19) and 93 were randomised to TIS (≥ 18 years, n = 84; ≥ 12 to &lt; 18 years old, n = 9).
Ialt 259 patienter blev randomiseret til Quinsair 240 mg to gange dagligt i 28 dage (≥ 18 år, n = 226 og ≥ 12 til &lt; 18 år, n = 33), og 147 blev randomiseret til placebo (≥ 18 år, n = 127 og ≥ 12 til &lt; 18 år, n = 20).
A total of 259 patients were randomised to Quinsair 240 mg twice daily for 28 days (≥ 18 years, n = 226; ≥ 12 to &lt; 18 years old, n = 33) and 147 were randomised to placebo (≥ 18 years, n = 127; ≥ 12 to &lt; 18 years old, n = 20).
≥ 12 til &lt; 18 år, n (%) ≥ 18 år, n (%)
≥ 12 to &lt; 18 years, n (%) ≥ 18 years, n (%) Baseline mean (SD) Relative change from Baseline to Day 28
Quinsair bør ikke anvendes til patienter med svært nedsat nyrefunktion (kreatininclearance &lt; 20 ml/minut).
Quinsair is not recommended for use in patients with severe renal impairment (creatinine clearance ˂ 20 ml/min).
Quinsair bør dog ikke anvendes til patienter med svært nedsat nyrefunktion (kreatininclearance &lt; 20 ml/minut, se pkt.
However, Quinsair is not recommended for use in patients with severe renal impairment (creatinine clearance ˂ 20 ml/min, see section 4.2).
Forventet FEV1-procent Baseline-gennemsnit (SD) Primære endepunkt:
≥ 12 to &lt; 18 years, n (%) ≥ 18 years, n (%) FEV1 Percent predicted Baseline mean (SD) Primary endpoint:
I kliniske forsøg responderede &gt; 90 % af patienterne på disse doser og opnåede reversering af neutropeni på 2 dage i gennemsnit.
In clinical studies, &gt; 90% of patients responded at these doses, achieving reversal of neutropenia in a median of 2 days.
Infektioner kan vise sig pÃ¥ mange forskellige mÃ¥der.
There are many ways an infection may show itself.
Filgrastims sikkerhed og effekt 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
Sikkerhed og effekt af filgrastim ved administration til patienter under 55 år med de novo-AML og 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.
Forstørrelse af milten rapporteredes at være forbundet med filgrastimterapi hos &lt; 3 % af patienterne.
Splenic enlargement was reported to be related to filgrastim therapy in &lt; 3% of patients.
Herunder rapporteredes to tilfælde af trombocyttal &lt; 50 x 109/l, som tilskrives leukafereseproceduren.
Among these, two cases of platelets &lt; 50 x 109/l were reported and attributed to the leukapheresis procedure.
Det bør overvejes at indstille behandlingen midlertidigt eller nedsætte dosis af filgrastim hos patienter, der får trombocytopeni, d.v.s. trombocyttal vedvarende &lt; 100.000/mm3.
Consideration should be given to intermittent cessation or decreasing the dose of filgrastim in patients who develop thrombocytopenia, i.e. platelets consistently &lt; 100,000/mm3.
Infektioner og maligne sygdomme, der forÃ¥rsager myelosuppression Neutropeni kan forekomme i forbindelse med opportunistiske infektioner, der infiltrerer knoglemarven, sÃ¥som Mycobacterium avium-kompleks eller ved maligne sygdomme som lymfom.
Infections and malignancies causing myelosuppression Neutropenia may be due to bone marrow infiltrating opportunistic infections such as Mycobacterium avium complex or malignancies such as lymphoma.
Der kan opstå behov for yderligere dosisjustering afhængigt af patientens ANC for at opretholde et neutrofiltal 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.
Hos et mindre antal patienter ( &lt; 10 %) var det nødvendigt at give doser på op til 1,0 mio. IE
In a small number of patients ( &lt; 10%), doses up to 1.0 MIU (10 μg)/kg/day were required to achieve
Leukocytose (leukocyttal &gt; 50 x 109/l) observeredes hos 41 % af donorer, og forbigående trombocytopeni (trombocyttal &lt; 100 x 109/l) efter filgrastim og leukaferese observeredes hos 35 % af
Leukocytosis (WBC &gt; 50 x 109/l) was observed in 41% of donors and transient thrombocytopenia (platelets &lt; 100 x 109/l) following filgrastim and leukapheresis was observed in 35% of donors.
Der bør gives leukaferese, mens det absolutte neutrofiltal stiger 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.
Hvis det absolutte neutrofiltal falder til &lt; 1,0 x 109/l i løbet af behandlingen, bør doseringen af filgrastim øges igen ved at følge ovennævnte procedure i omvendt rækkefølge.
If the ANC decreases to &lt; 1.0 x 109/l during the treatment period the dose of filgrastim should be reescalated according to the above steps
Bivirkninger med mulig forbindelse til filgrastimterapi og typisk en forekomst på &lt; 2 % af patienter med svær kronisk neuropati omfattede reaktioner ved injektionsstedet, hepatomegali, artralgi, alopeci,
Undesirable effects possibly related to filgrastim therapy and typically occurring in &lt; 2% of SCN patients were injection site reaction, headache, hepatomegaly, arthralgia, alopecia, osteoporosis and
Hvis der kræves mere end én leukaferese, er det særlig vigtigt før leukaferesen at være opmærksom på donorer med trombocyttal &lt; 100 x 109/l.
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.
Der observeredes forbigående trombocytopeni (trombocyttal &lt; 100 x 109/l) efter administration af filgrastim og leukaferese hos 35 % af de undersøgte donorer.
Transient thrombocytopenia (platelets &lt; 100 x 109/l) following filgrastim administration and leukapheresis was observed in 35% of subjects studied.
Den anbefalede initialdosis filgrastim er 0,1 mio. IE (1 μg)/kg/døgn, der gives dagligt som subkutan injektion med optitrering til maksimalt 0,4 mio. IE (4 μg)/kg/døgn, indtil neutrofiltallet atter er normalt og kan fastholdes på dette niveau (ANC &gt; 2,0 x109/l).
The recommended starting dose of filgrastim is 0.1 MIU (1 μg)/kg/day given daily by subcutaneous injection with titration up to a maximum of 0.4 MIU (4 μg)/kg/day until a normal neutrophil count is reached and can be maintained (ANC &gt; 2.0 x109/l).
Infusion af PBPC accelererer hÃ¦matopoietisk bedring med reduktion af varigheden for risiko for hÃ¦moragiske komplikationer og behov for trombocyttransfusion.
Infusion of PBPCs accelerates haematopoietic recovery reducing the duration of risk for haemorrhagic complications and
For at opretholde et ANC &gt; 2,0 x 109/l kan langtidsbehandling være nødvendig.
Long-term administration may be required to maintain the ANC &gt; 2.0 x 109/l.
I kliniske forsøg var det nødvendigt at give 30 mio. IE (300 μg)/døgn i 1-7 dage om ugen for at opretholde ANC &gt; 2,0 x 109/l, med en gennemsnitlig doseringshyppighed på 3 dage om ugen.
In clinical studies, dosing with 30 MIU (300 μg)/day on 1 to 7 days per week was required to maintain the ANC
Hvis det absolutte neutrofiltal holder sig &gt; 1,0 x
Then, if ANC remains &gt; 1.0 x 109/l for 3 more
Hvis leukocyttallet stiger til &gt; 70 x109/l, bør filgrastim seponeres eller doseringen reduceres.
Filgrastim administration should be discontinued or its dosage should be reduced if the leukocyte counts rise to &gt; 70 x109/l.
Telmisartan er i høj grad bundet til plasmaprotein ( &gt; 99,5 %), hovedsagelig til albumin og Alfa Isyreglycoprotein.
Telmisartan is largely bound to plasma protein ( &gt; 99.5 %), mainly albumin and alpha-1 acid glycoprotein.
Alvorlige bivirkninger omfatter anafylaktisk reaktion og angioødem, som kan forekomme i sjældne tilfælde (≥ 1/10.000 til &lt; 1/1.000) samt akut nyresvigt.
Serious adverse drug reactions include anaphylactic reaction and angioedema which may occur rarely (≥1/10,000 to &lt; 1/1,000), and acute renal failure.
Samtidig brug af Telmisartan Teva Pharma og lægemidler indeholdende aliskiren er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR &lt; 60 ml/min/1,73 m2) (se pkt.
The concomitant use of Telmisartan Teva Pharma with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR &lt; 60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
De væsentlige risikofaktorer, hvor hyperkaliæmi kan forekomme, er: - Diabetes mellitus, nedsat nyrefunktion, alder ( &gt; 70 år) - Samtidig anvendelse af lægemidler, der påvirker renin-angiotensin-aldosteronsystemet og/eller kaliumtilskud.
The main risk factors for hyperkalaemia to be considered are: - Diabetes mellitus, renal impairment, age ( &gt; 70 years) - Combination with one or more other medicinal products that affect the renin-angiotensinaldosterone system and/or potassium supplements.
Infektionen gik vÃ¦k hos 54 % af patienterne (197 out of 362) efter 7 til 14 dages behandling med Zerbaxa sammenlignet med 53 % af de patienter (194 ud af 362), som fik meropenem.
It found Zerbaxa to be at least as effective as meropenem: the infection had resolved in 54% of patients (197 out of 362) after 7 to 14 days of treatment with Zerbaxa compared with 53% of patients (194 out of 362) on meropenem.
Der var desuden eksklusionskriterier til sikring af adækvat leverfunktion baseret på laboratorieværdier (AST, ALT &gt; 1,5 x ULN).
Exclusion criteria were also in place to ensure adequate hepatic function based on laboratory values (ALT, ALT &gt; 1.5 x ULN).
CHMP bemærkede desuden, at eksperterne ikke var overbevist om, at mipomersen ikke er konklusivt forbundet med renale og kardiovaskulære skader, og konkluderede, at den af ansøgeren forventede &gt; 50 % reduktion i femårig risiko for koronar hjertesygdom ved behandling med mipomersen er rent hypotetisk.
The CHMP also noted that the experts were not reassured that mipomersen is not conclusively linked to renal and CVS harm, and concluded that a &gt; 50% reduction in 5-year CHD risk as envisaged by the applicant for mipomersen treatment is purely hypothetical.
Nedenstående tabel angiver de observerede bivirkninger i de placebokontrollerede kliniske forsøg, inddelt efter hyppighed i henhold til MedDRA: 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 beregnes af foreliggende data).
The table below lists the adverse reactions observed in placebo-controlled clinical trials according to the MedDRA frequency 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 available data).
Det har mere potent virkning på PDE5 end på andre kendte fosfodiesteraser ( &gt; 100 gange mere end på PDE6, &gt; 1.000 gange mere end på PDE4, PDE8 og PDE10, &gt; 5.000 gange PDE2 og PDE7, &gt; 10.000 gange mere end på PDE1, PDE3, PDE9 og PDE11).
Its effect is more potent on PDE5 than on other known phosphodiesterases ( &gt; 100-fold for PDE6; &gt; 1,000-fold for PDE4, PDE8 and PDE10; &gt; 5,000-fold for PDE2 and PDE7; &gt; 10,000-fold for PDE1, PDE3, PDE9, and PDE11).
Overordnet var uønskede hændelser og bivirkninger ved behandling med avanafil hyppigere ved legemsmasseindeks (BMI) &lt; 25 (normalt BMI).
Overall adverse events and adverse reactions for avanafil-treated subjects were more frequent in subjects with a Body Mass Index (BMI) &lt; 25 (normal BMI subjects).
Avanafils virkning er &gt; 100 gange mere potent på PDE5 end på PDE6, som medvirker ved fototransduktionen i retina.
Avanafil is &gt; 100-fold more potent for PDE5 than PDE6, which is found in the retina and is responsible for phototransduction.
Hos patienter med let eller moderat nedsat nyrefunktion (kreatininclearance ≥30 ml/min, men &lt; 80 ml/min), som deltog i fase 3-studier, var virkningen nedsat i forhold til virkningen hos patienter med normal nyrefunktion.
Patients with mild or moderate renal impairment (creatinine clearance ≥30 mL/min but &lt; 80 mL/min) who were enrolled in phase 3 studies showed decreased efficacy compared to those with normal renal function.
- tidligere myokardieinfarkt, apopleksi eller livstruende arytmi inden for de seneste seks måneder - hypotension i hvile (blodtryk &lt; 90/50 mmHg) eller hypertension (blodtryk &gt; 170/100 mmHg)
- Patients who have suffered from a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months; - Patients with resting hypotension (blood pressure &lt; 90/50 mmHg) or hypertension (blood pressure &gt; 170/100 mmHg); - Patients with unstable angina, angina with sexual intercourse, or congestive heart failure categorised as New York Heart Association Class 2 or greater.
- svært nedsat nyrefunktion (kreatininclearance &lt; 30 ml/min.)
Patients with severe renal impairment (creatinine clearance &lt; 30 mL/min).
Spedra er kontraindiceret ved svært nedsat nyrefunktion (kreatininclearance &lt; 30 ml/min.)
Spedra is contraindicated in patients with severe renal impairment (creatinine clearance &lt; 30 mL/min) (see sections 4.3 and 5.2).
Der var ikke afvigende farmakokinetik hos personer med let nedsat nyrefunktion (kreatininclearance  50 - &lt; 80 ml/min) eller moderat nedsat nyrefunktion (kreatininclearance  30 - &lt; 50 ml/min) efter en enkeltdosis af avanafil på 200 mg. Der findes ikke data for patienter med svært nedsat nyrefunktion eller dialysepatienter med nyresygdom i terminalstadiet.
In subjects with mild (creatinine clearance ≥ 50 - &lt; 80 mL/min) and moderate (creatinine clearance ≥ 30 - &lt; 50 mL/min) renal impairment, the pharmacokinetics of a single 200 mg dose of avanafil were not altered.
TAC = docetaxel, doxorubicin og cyclophosphamid FAC = 5-fluoruracil, doxorubicin and cyclophosphamid CI = Konfidensinterval; ER = østrogenreceptor PR = progesteronreceptor a ER/PR-negativ eller grad 3 eller tumorstørrelse &gt; 5 cm
TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophosphamide CI = confidence interval; ER = oestrogen receptor PR = progesterone receptor a ER/PR-negative or Grade 3 or tumour size &gt; 5 cm
Med en hazard ratio &lt; 1 kan docetaxel + cisplatin+5-FU anvendes med fordel *Cox model (tilpasning til primær tumor, T og N kliniske stadier og PSWHO) **Logrank test *** Chi-square-test
Hazard ratio (95% CI) **p-value A hazard ratio of less than 1 favours docetaxel + cisplatin + 5-FU *Cox model (adjustment for Primary tumour site, T and N clinical stages and PSWHO) **Log rank test *** Chi-square test
Patienter med en udgangsværdi for neutrofile værdier på &lt; 1.500 celler/mm
Patients with baseline neutrophil count of &lt; 1,500 cells/mm3.
Patienter bør ikke genbehandles med efterfølgende cyklusser af docetaxel indtil neutrofil-antallet gendannes til et niveau  1.500 celler/mm og blodplader gendannes til et niveau
Patients should not be retreated with subsequent cycles of docetaxel until neutrophils recover to a level &gt; 1,500 cells/mm3 and platelets recover to a level &gt; 100,000 cells/mm3.
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
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 ( &lt; 500 cells/mm3) was 7 days), anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia.
445 patienter med KPS  70 blev behandlet med enten docetaxel (T) (75 mg/m2 på dag 1) i kombination med cisplatin (C) (75 mg/m på dag 1) og 5-fluoruracil (F) (750 mg/m pr. dag i 5 dage)
A total of 445 patients with KPS &gt; 70 were treated with either docetaxel (T) (75 mg/m2 on day 1) in combination with cisplatin (C) (75 mg/m2 on day 1) and 5-fluorouracil (F) (750 mg/m2 per day for 5 days) or cisplatin (100 mg/m2 on day 1) and 5-fluorouracil (1000 mg/m2 per day for 5 days).
G3/4 Forhøjet bilirubin i blodet ( &lt; 5 %);G3/4 forhøjet alkalisk fosfatase i blodet
G3/4 AST increased G3/4 Blood alkaline phosphatase increased
hos patienter med en initialdosis på 75 mg/m docetaxel i kombination med cisplatin, med en minimum blodpladeværdi under den tidligere behandlingsrunde på &lt; 25000 celler/mm
For patients who are dosed initially at docetaxel 75 mg/m2 in combination with cisplatin and whose nadir of platelet count during the previous course of therapy is &lt; 25,000 cells/mm3, or in patients who experience febrile neutropenia, or in patients with serious non-haematologic toxicities, the docetaxel dose in subsequent cycles should be reduced to 65 mg/m2.
Dysgeusi (G3/4: 0,6 %); Perifer sensorisk neuropati (G3/4: &lt;
Dysgeusia (G3/4: Peripheral sensory neuropathy (G3/4:
75 mg/m til 60 mg/m 2: Hos patienter, som under docetaxel-behandling har haft enten febril neutropeni, neutrofile leukocytter &lt; 500 celler/mm i mere end en uge, alvorlige eller kumulative reaktioner eller alvorlig perifer neuropati.
In patients who experienced either febrile neutropenia, neutrophil count &lt; 500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy, the dose of docetaxel should be reduced from 100 mg/m2 to 75 mg/m2 and/or from 75 to 60 mg/m².
Patienterne havde operabel, lymfeknude-negativ brystkræft med høj risiko for tilbagefald ifølge 1998 St. Gallen-kriterierne (tumorstørrelse &gt; 2 cm og/eller negative østrogenreceptorer (ER) og progesteronreceptorer (PR) og/eller høj histologisk/nukleær grad (grad 2 til 3) og/eller alder &lt; 35 år).
1060 patients were randomised to receive either Docetaxel Zentiva 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclophosphamide 500 mg/m2 (521 patients in FAC arm), as adjuvant treatment of operable node-negative breast cancer patients with high risk of relapse according to 1998 St. Gallen criteria (tumour size &gt; 2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age &lt; 35 years).
Børn og unge under 16 år, der får høje doser fluticasonpropionat (typisk &gt; 1000 mikg/dag), er specielt i risikogruppen.
Children and adolescents &lt; 16years taking high doses of fluticasone (typically ≥ 1000mcg/day) may be at particular risk.
Glaxo Wellcome UK Limited, trading as Allen &amp; Hanburys Stockley Park West, Uxbridge, Middlesex UB11 1BT, Det Forenede Kongerige
United Kingdom Glaxo Wellcome UK Limited Stockley Park West, Uxbridge Middlesex UB11 1BT
Moderat dosis inhalationssteroid ( &gt; 5001000mikg beclometasondipropionat eller tilsvarende/dgl.)
Medium dose ICS ( &gt; 500-1000mcg BDP or equivalent/day)
Informationsmaterialet for lÃ¦ger skal indeholde fÃ¸lgende hovedelementer:
The physician's educational material should contain the following key elements:
1/1 000), meget sjælden ( &lt; 1/10 000), ikke kendt (kan ikke beregnes af foreliggende data).
&lt; 1/1,000), very rare ( &lt; 1/10,000) and not known (cannot be estimated from the available data).
almindelig (≥ 1/100 til &lt; 1/10), ikke almindelig (≥ 1/1 000 til &lt; 1/100), sjælden (≥ 1/10 000 til &lt;
Adverse reactions are ranked according to system organ class, 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
Ældre patienter ( &gt; 65 år) cholsyre sikkerhed og virkning hos ældre patienter er ikke fastlagt.
Elderly patients (older than 65 years) The safety and efficacy of cholic acid in elderly patients has not been established.
&lt; {DD måned ÅÅÅÅ} &gt;
DD month YYYY
Det primære formål med forsøget var at sammenligne andelen af patienter, hvis SeDBT var kontrolleret (SeDBT &lt; 90 mmHg) efter 5 ugers behandling.
The primary objective of this study was to compare the proportion of patients whose SeDBP was controlled (SeDBP &lt; 90 mmHg) at Week 5 of treatment.
Hyppigheden af bivirkninger anført nedenfor defineres i henhold til følgende konventioner: 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 frequency of adverse reactions listed below is 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) - Not known (cannot be estimated from the available data)