natgillin/translations-raw huggingface dataset:
Efter påbegyndelse af infusion med zoledronsyre, øges plasmakoncentrationen af den aktive substans hurtigt, og maksimal koncentration nås ved slutningen af infusionsperioden, efterfulgt af et hurtigt fald til &lt; 10% af maksimalkoncentrationen efter 4 timer og &lt; 1% af maksimalkoncentrationen efter 24 timer, med en efterfølgende forlænget periode med meget lave koncentrationer der ikke overstiger 0,1% af den maksimale koncentration.
After initiation of the zoledronic acid infusion, plasma concentrations of the active substance increased rapidly, achieving their peak at the end of the infusion period, followed by a rapid decline to &lt; 10% of peak after 4 hours and &lt; 1% of peak after 24 hours, with a subsequent prolonged period of very low concentrations not exceeding 0.1% of peak levels.
Anvendelse af Zoledronsyre Hospira til patienter med svært nedsat nyrefunktion (kreatinin clearance &lt; 35 ml/min) er kontraindiceret grundet en øget risiko for nyresvigt hos denne population.
The use of Zoledronic Acid Hospira in patients with severe renal impairment (creatinine clearance &lt; 35 ml/min) is contraindicated due to an increased risk of renal failure in this population.
InfusionsvÃ¦ske, oplÃ¸sning 1 intravenÃ¸s pose
Solution for infusion 1 intravenous bag
Anvendelse af zoledronsyre til patienter med svært nedsat nyrefunktion (kreatinin clearance &lt; 35 ml/min) er kontraindiceret grundet en øget risiko for nyresvigt hos denne population.
The use of zoledronic acid in patients with severe renal impairment (creatinine clearance &lt; 35 ml/min) is contraindicated due to an increased risk of renal failure in this population.
- Svært nedsat nyrefunktion med kreatinin clearance &lt; 35 ml/min (se pkt.
- Severe renal impairment with creatinine clearance &lt; 35 ml/min (see section 4.4).
I kliniske forsøg med zoledronsyre blev patienter med serum-kreatinin &gt; 265 μmol/l eller &gt; 3,0 mg/dl ekskluderet.
In clinical trials with zoledronic acid, patients with serum creatinine &gt; 265 µmol/l or &gt; 3.0 mg/dl were excluded.
- Øgning på 1,0 mg/dl eller 88 μmol/l hos patienter med abnorm kreatinin ved baseline ( &gt; 1,4 mg/dl eller &gt; 124 μmol/l).
- For patients with abnormal baseline creatinine ( &gt; 1.4 mg/dl or &gt; 124 µmol/l), an increase of 1.0 mg/dl or 88 µmol/l.
Det er ikke nødvendigt at dosisjustere patienter med TIH og serum-kreatinin &lt; 400 μmol/l eller &lt; 4,5 mg/dl (se pkt.
No dose adjustment is necessary in TIH patients with serum creatinine &lt; 400 µmol/l or &lt; 4.5 mg/dl (see section 4.4).
InfusionsvÃ¦ske, oplÃ¸sning 4 mg/100 ml
Solution for infusion 4 mg/100 ml
Bivirkningerne er ordnet under overskrifter om hyppighed, den hyppigste først, ved brug af de følgende konventionelle regler: 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).
Adverse reactions are ranked under headings of frequency, the most frequent first, 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).
Zoledronsyre er kontraindiceret til patienter med kreatinin clearance &lt; 35 ml/min (se pkt.
Zoledronic acid is contraindicated in patients with creatinine clearance &lt; 35 ml/min (see sections 4.3 and 4.4).
- Øgning på 0,5 mg/dl eller 44 μmol/l hos patienter med normal serum-kreatinin ved baseline ( &lt; 1,4 mg/dl eller &lt; 124 μmol/l);
- For patients with normal baseline serum creatinine ( &lt; 1.4 mg/dl or &lt; 124 µmol/l), an increase of 0.5 mg/dl or 44 µmol/l;
Følgende konventionelle klassifikation er anvendt: 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
The following conventional classification is used: 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).
&lt; 10% af maksimalkoncentrationen efter 4 timer og &lt; 1% af maksimalkoncentrationen efter 24 timer, med en efterfølgende forlænget periode med meget lave koncentrationer der ikke overstiger 0,1% af den maksimale koncentration inden den 2. infusion af zoledronsyre på dag 28.
After initiating the infusion of zoledronic acid, the plasma concentrations of zoledronic acid rapidly increased, achieving their peak at the end of the infusion period, followed by a rapid decline to &lt; 10% of peak after 4 hours and &lt; 1% of peak after 24 hours, with a subsequent prolonged period of very low concentrations not exceeding 0.1% of peak prior to the second infusion of zoledronic acid on day 28.
S. aureus (CP8) stamme SP140 inaktiveret, der udtrykker slime associated antigenic complex (SAAC) &gt; 50 RED80 (I 80 % af dyrene)
S. aureus (CP8) strain SP 140 inactivated, expressing slime associated antigenic complex (SAAC) &gt; 50 RED80 (In 80% of the animals).
E. coli J5 inaktiveret &gt; 50 RED60 (Effektiv dosis (kanin) i 60 % af dyrene (serologi)).
E. coli J5 inactivated &gt; 50 RED60 (Rabbit effective dose in 60% of the animals (serology)).
Escherichia coli (J5) inaktiveret .......................................................................... &gt; 50 RED60 * Staphylococcus aureus (CP8) stamme SP 140 inaktiveret, der udtrykker slime associated antigenic complex (SAAC) ................................................................................................ &gt; 50 RED80 ** * RED60: Effektiv dosis (kanin) i 60 % af dyrene (serologi).
Escherichia coli (J5) inactivated .......................................................................... &gt; 50 RED60* Staphylococcus aureus (CP8) strain SP 140 inactivated, expressing slime associated antigenic complex (SAAC)........................................................................ ........................................ &gt; 50 RED80** * RED60: Rabbit effective dose in 60% of the animals (serology).
Escherichia coli J5 inaktiveret ............................................................................. &gt; 50 RED60 * Staphylococcus aureus (CP8) stamme SP 140 inaktiveret, der udtrykkerslime associated antigenic complex (SAAC) ................................................................................................. &gt; 50 RED80 **
Escherichia coli J5 inactivated ............................................................................. &gt; 50 RED60* Staphylococcus aureus (CP8) strain SP 140 inactivated, expressing slime associated antigenic complex (SAAC) ............. …………………………………………… &gt; 50 RED80**
hvis De for nylig har haft et slagtilfælde, eller et hjerteanfald, eller hvis De har svær leversygdom eller meget lavt blodtryk ( &lt; 90/50 mmHg).
- if you have recently had a stroke, a heart attack or if you have severe liver disease or very low blood pressure ( &lt; 90/50 mmHg).
Patienter med venstre ventrikulær uddrivningsfraktion &lt; 45% eller venstre ventrikulær forkortningsfraktion &lt; 0,2% blev ikke undersøgt.
Patients with left ventricular ejection fraction &lt; 45% or left ventricular shortening fraction &lt; 0.2 were not studied.
Initial dosisjustering er ikke nødvendig hos patienter med nedsat nyrefunktion, inklusiv svært nedsat nyrefunktion (kreatininclearance &lt; 30 ml/min).
Initial dose adjustments are not required in patients with renal impairment, including severe renal impairment (creatinine clearance &lt; 30 ml/min).
De respektive odds-ratio var 2,92 (p=0,0087), 4,32 (p=0,0004) og 5,75 (p=0,0001).
The respective odds ratios were 2.92 (p=0.0087), 4.32 (p=0.0004) and 5.75 (p &lt; 0.0001).
Sildenafil er en svag hæmmer af CYP-isoformer 1A2, 2C9, 2C19, 2D6, 2E1 og 3A4 (IC50 &gt; 150 µM).
Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50 &gt; 150 µM).
I et klinisk studie af de hæmodynamiske virkninger efter en enkelt oral dosis på 100 mg sildenafil hos 14 patienter med alvorlig koronararteriesygdom (CAD) ( &gt; 70% stenoser i mindst 1 koronararterie) faldt det gennemsnitlige systoliske og diastoliske blodtryk i hvile med hhv. 7% og 6% sammenlignet med baseline.
In a study of the hemodynamic effects of a single oral 100 mg dose of sildenafil in 14 patients with severe coronary artery disease (CAD) ( &gt; 70% stenosis of at least one coronary artery), the mean resting systolic and diastolic blood pressures decreased by 7% and 6% respectively compared to baseline.
Hos pædiatriske patienter i alderen 1-17 år er den anbefalede dosis til patienter ≤20 kg 10 mg 3 gange dagligt, og til patienter ≥20 kg er dosis 20 mg 3 gange dagligt.
For paediatric patients aged 1 year to 17 years old, the recommended dose in patients ≤20 kg is 10 mg three times a day and for patients &gt; 20 kg is 20 mg three times a day.
Svær hypotension (blodtryk &lt; 90/50 mmHg) ved initiering.
Recent history of stroke or myocardial infarction, Severe hypotension (blood pressure &lt; 90/50 mmHg) at initiation.
Bivirkninger, der blev rapporteret hos &gt; 10% af 229 forsøgspersoner, der blev behandlet med sildenafil (alle dosisgrupper, inklusive 9 patienter, som ikke fortsatte i det langvarige studie), var infektion i øvre luftveje (31%), hovedpine (26%), opkastning (22%), bronkitis (20%), pharyngitis (18%), pyreksi (17%), diarré (15%) samt influenza og epistaxis (12% hver).
Adverse reactions reported in &gt; 10% of 229 subjects treated with sildenafil (combined dose group, including 9 patients that did not continue into the long-term study) were upper respiratory infection (31%), headache (26%), vomiting (22%), bronchitis (20%), pharyngitis (18%), pyrexia (17%), diarrhoea (15%), and influenza, epistaxis (12% each).
I et placebo-kontrolleret studie med sildenafil til patienter i alderen 1-17 år med pulmonal arteriel hypertension blev i alt 174 patienter behandlet med enten lavdosis (10 mg til patienter &gt; 20 kg, ingen patienter ≤20 kg fik lavdosis), middeldosis (10 mg til patienter ≥8-20 kg, 20 mg til patienter ≥2045 kg, 40 mg til patienter &gt; 45 kg) eller højdosis (20 mg til patienter ≥8-20 kg, 40 mg til patienter ≥2045 kg, 80 mg til patienter &gt; 45 kg) sildenafil og 60 blev behandlet med placebo.
In the placebo-controlled study of sildenafil in patients 1 to 17 years of age with pulmonary arterial hypertension, a total of 174 patients were treated three times a day with either low (10 mg in patients &gt; 20 kg; no patients ≤20 kg received the low dose), medium (10 mg in patients ≥8-20 kg; 20 mg in patients ≥20-45 kg; 40 mg in patients &gt; 45 kg) or high dose (20 mg in patients ≥8-20 kg; 40 mg in patients ≥20-45 kg; 80 mg in patients &gt; 45 kg) regimens of sildenafil and 60 were treated with placebo.
For patienter med 6MWD &lt; 325 meter ved baseline blev der set bedre effekt ved højere doser (placebo-korrigeret stigning på 58 meter, 65 meter og 87 meter for hhv. 20 mg, 40 mg og 80 mg 3 gange dagligt).
For patients with a baseline 6MWD &lt; 325 m improved efficacy was observed with higher doses (placebo-corrected improvements of 58 metres, 65 metres and 87 metres for 20 mg, 40 mg and 80 mg doses TID, respectively).
I dette studie var 63 af 234 (27%) af patienterne &lt; 7 år (sildenafil lavdosis=2, middeldosis=17, højdosis=28, placebo=16), og 171 af 234 (73%) af patienterne var &gt; 7 år (sildenafil lavdosis=40, middeldosis=37, højdosis=49, placebo=44 se nedenfor).
In this trial, 63 of 234 (27%) patients were &lt; 7 years old (sildenafil low dose = 2; medium dose = 17; high dose = 28; placebo = 16) and 171 of 234 (73%) patients were 7 years or older (sildenafil low dose = 40; medium dose = 38; and high dose = 49; placebo = 44).
De hyppigste bivirkninger (med en frekvens ≥1%) hos sildenafil-patienter (kombinerede doser) og med en frekvens på &gt; 1% i forhold til placebo-patienter var pyreksi, øvre luftvejsinfektioner (hver 11,5%), opkastning (10,9%), kraftigere erektion (herunder spontane erektioner hos drenge) (9,0%), kvalme, bronkitis (hver 4,6%), pharyngitis (4,0%), næseflåd (3,4%) samt pneumoni og rhinitis (hver 2,9%).
The most common adverse reactions that occurred (with a frequency ≥1%) in sildenafil patients (combined doses) and with a frequency &gt; 1% over placebo patients were pyrexia, upper respiratory tract infection (each 11.5%), vomiting (10.9%), erection increased (including spontaneous penile erections in male subjects) (9.0%), nausea, bronchitis (each 4.6%), pharyngitis (4.0%), rhinorrhoea (3.4%), and pneumonia, rhinitis (each 2.9%).
Den sædvanlige dosis til børn og unge i alderen 1-17 år er 10 mg 3 gange dagligt ved legemsvægt 20 kg eller derunder og 20 mg 3 gange dagligt ved legemsvægt over 20 kg. Granpidam kan tages sammen med eller uden mad.
For children and adolescents aged 1 year to 17 years old, the recommended dose is either 10 mg three times a day for children and adolescents ≤20 kg or 20 mg three times a day for children and adolescents &gt; 20 kg, taken with or without food.
Hos frivillige forsøgspersoner med svært nedsat nyrefunktion (kreatininclearance &lt; 30 ml/min) reduceres sildenafils clearance, hvilket fører til gennemsnitlige stigninger i AUC og Cmax på hhv. 100% og 88% sammenlignet med forsøgspersoner i samme alderskategori uden nedsat nyrefunktion.
In volunteers with severe renal impairment (creatinine clearance &lt; 30 ml/min), sildenafil clearance was reduced, resulting in mean increases in AUC and Cmax of 100% and 88% respectively compared to age-matched volunteers with no renal impairment.
Placebokorrigeret behandlingseffekt af mPAP var -2,7 mmHg (p=0,04), -3,0 mmHg (p=0,01) og -5,1 mmHg (p &lt; 0,0001) for hhv. sildenafil 20 mg, 40 mg og 80 mg 3 gange dagligt.
Placebo-corrected treatment effects with mPAP were -2.7 mmHg (p = 0.04), -3.0 mm Hg (p = 0.01) and -5.1 mm Hg (p &lt; 0.0001) for sildenafil 20 mg, 40 mg and 80 mg TID respectively.
Placebokorrigeret behandlingseffekt af PVR var -178 dyn.sek/cm5 (p=0,0051), -195 dyn.sek/cm5 (p=0,0017) og -320 dyn.sek/cm5 (p &lt; 0,0001) for hhv. 20 mg, 40 mg og 80 mg 3 gange dagligt.
Placebo-corrected treatment effects with PVR were -178 dyne.sec/cm5 (p=0.0051), -195 dyne.sec/cm5 (p=0.0017) and -320 dyne.sec/cm5 (p &lt; 0.0001) for sildenafil 20 mg, 40 mg and 80 mg TID,
Forsøgspersoner, der vejede ≤ 20 kg, blev inkluderet i middel- eller højdosisgruppen (1:1), mens forsøgspersoner, der vejede &gt; 20 kg, blev inkluderet i lav-, middel- eller højdosisgruppen (1:1:1).
Subjects who had been in the placebo group in the short-term study were randomly reassigned to sildenafil treatment; subjects weighing ≤20 kg entered the medium or high dose groups (1:1), while subjects weighing &gt; 20 kg entered the low, medium or high dose groups (1:1:1).
Kaplan-Meier-estimat af overlevelse efter 3 år for patienter &gt; 20 kg ved baseline var hhv. 94%, 93% og 85% for lav-, middel- og højdosis-grupperne.
Kaplan-Meier estimates of survival at 3 years in patients &gt; 20 kg in weight at baseline were 94%, 93% and 85% in the low, medium and high dose groups, respectively; for patients ≤20 kg in weight at baseline, the survival estimates were 94% and 93% for subjects in the medium and high dose groups respectively (see sections 4.4 and 4.8).
Placebo-korrigeret stigning i 6MWD var 45 meter (p &lt; 0,0001), 46 meter (p &lt; 0,0001) og 50 meter (p &lt; 0,0001) for hhv. sildenafil 20 mg, 40 mg og 80 mg. Der var ingen signifikant forskel i effekten mellem sildenafildoserne.
Placebo corrected increases in 6MWD were 45 metres (p &lt; 0.0001), 46 metres (p &lt; 0.0001) and 50 metres (p &lt; 0.0001) for sildenafil 20 mg, 40 mg and 80 mg TID respectively.
I alt 106 ud af 234 (45%) forsøgspersoner kunne evalueres ved CPET, hvilket omfattede børn ≥7 år, som udviklingsmæssigt var i stand til at udføre testen.
A total of 106 out of 234 (45%) subjects were evaluable for CPET, which comprised those children ≥7 years old and developmentally able to perform the test. Children &lt; 7 years (sildenafil combined dose = 47; placebo = 16) were evaluable only for the secondary endpoints.
Hos patienter med en baseline gangdistance på 325 m var behandlingseffekten 38,4 m til sildenafils fordel.
For patients with a baseline walking distance ≥325 metres, the treatment effect was 38.4 metres in favour of sildenafil; for patients with a baseline walking distance &lt; 325 metres, the treatment effect was 2.3 metres in favour of placebo.
Bivirkninger, der forekommer hos &gt; 1% af sildenafil-behandlede patienter, og som er hyppigere ( &gt; 1% forskel) for sildenafil i pivotal-studiet eller i det sildenafilkombinerede datasæt for begge placebokontrollerede studier med pulmonal arteriel hypertension i doser på 20 mg, 40 mg eller 80 mg 3 gange dagligt, er anført i skemaet nedenfor.
Adverse reactions which occurred in &gt; 1% of sildenafil-treated patients and were more frequent ( &gt; 1% difference) on sildenafil in the pivotal study or in the sildenafil combined data set of both the placebo-controlled studies in pulmonary arterial hypertension, at doses of 20, 40 or 80 mg TID are listed in the table below by class and frequency grouping (very common (≥1/10), common (≥1/100 to &lt; 1/10), uncommon (≥1/1,000 to ≤1/100) and not known (cannot be estimated from the available data).
Der blev udført en post hoc-analyse i undergruppen af patienter (n=288) med funktionelt handicap og nedsat livskvalitet (defineret som Migraine Specific Quality of Life, MSQ &lt; 80).
A post-hoc analysis was performed in the sub-group of patients (n=288) with functional handicap and quality of life (QOL) decrease (defined by Migraine Specific Quality of Life, MSQ &lt; 80).
Hyppighed er vurderet i henhold til 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), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Frequencies have been evaluated according to 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).
Alle forsøgspersoner havde svær (faktor IX-niveau &lt; 1 %) eller moderat svær (faktor IX-niveau ≤2 %) hæmofili B. Alle 23 forsøgspersoner fik profylaktisk behandling med RIXUBIS i minimum 3 måneder og blev inkluderet i vurderingen af den profylaktiske virkning.
All subjects had severe (factor IX level &lt; 1%) or moderately severe (factor IX level ≤2%) haemophilia B. All 23 subjects received prophylactic treatment with RIXUBIS for a minimum of 3 months and were included in the efficacy evaluation for prophylaxis.
6- &lt; 12 år (N=12)
6 - &lt; 12 years (N=12)
Alle forsøgspersoner havde svær (faktor IX-niveau &lt; 1 %) eller moderat svær (faktor IX-niveau ≤2 %) hæmofili B. 59 tidligere behandlede patienter fik RIXUBIS profylaktisk.
All subjects had severe (factor IX level &lt; 1%) or moderately severe (factor IX level ≤2%) haemophilia B. Fifty-nine PTPs received RIXUBIS for prophylaxis.
Trinvis bedring for RIXUBIS 30 minutter efter infusion, pædiatriske patienter &lt; 6 år:
Incremental recovery for RIXUBIS 30 minutes after infusion, paediatric patients &lt; 6 years:
Profylakse og blødningskontrol hos tidligere behandlede patienter under 12 år: RIXUBIS' virkning er blevet vurderet i et kombineret fase 2/3-studie, hvor i alt 23 tidligere behandlede drenge mellem 1,8 og 11,8 år (medianalder 7,10 år) med 11 patienter &lt; 6 år fik RIXUBIS profylaktisk og til kontrol af blødningsepisoder.
The efficacy of RIXUBIS has been evaluated in a combined phase 2/3 study, in which a total of 23 male PTPs between 1.8 and 11.8 years (median age 7.10 years) with 11 patients &lt; 6 years, received RIXUBIS for prophylaxis and control of bleeding episodes.
Trinvis bedring for RIXUBIS 30 minutter efter infusion, pædiatriske patienter 6 til &lt; 12 år:
Incremental recovery for RIXUBIS 30 minutes after infusion, paediatric patients 6 to &lt; 12 years:
&lt; 6 år (N=11)
&lt; 6years (N=11)
NN: {nummer}
SN: {number} &lt; NN: {number} &gt;
Disse lægemidler er godkendt i EØS's medlemslande under følgende navne: &lt; {Medlemslandets navn} &gt; &lt; {Lægemidlets navn} &gt; &lt; {Medlemslandets navn} &gt; &lt; {Lægemidlets navn} &gt; [Se bilag I - Udfyldes nationalt]
These medicinal products are authorised in the Member States of the EEA under the following names: &lt; {Name of the Member State} &gt; &lt; {Name of the medicinal product} &gt; &lt; {Name of the Member State} &gt; &lt; {Name of the medicinal product} &gt; &lt; [See Annex I - To be completed nationally] &gt;
( &lt; 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Not known (cannot be estimated from the available data)”.
&lt; 1/10), ikke almindelig (≥1/1.000 til &lt; 1/100), sjælden (≥1/10.000 til &lt; 1/1.000) og meget sjælden
The frequencies classification follows the 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), and very rare ( &lt; 1/10,000)
INFORMATION I BRAILLESKRIFT &lt; Fritaget fra krav om brailleskrift &gt;
INFORMATION IN BRAILLE &lt; Justification for not including Braille accepted &gt;
Du kan finde yderligere oplysninger om dette lægemiddel på {name of MS Agency (link)}
Other sources of information &lt; Detailed information on this medicine is available on the website of {name of MS Agency (link)} &gt;
&lt; [Udfyldes nationalt] &gt;
&lt; [To be completed nationally] &gt;
For E. coli, Campylobacter og Enterococci, blev både vild- og ikke vild-fænotyper observerede (MIC-værdier mellem 1- &gt; 64µg/ml).
For E. coli, Campylobacter and Enterococci, both wild type and non-wild type phenotypes were observed (MIC range 1- &gt; 64 µg/ml).
Bivirkningerne (tabel 1) er ordnet i frekvensgrupper med den mest almindelige først og ved anvendelse af følgende definition: 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), inklusive enkeltstående rapporter.
The adverse drug reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100, &lt; 1/10); uncommon (≥1/1,000, &lt; 1/100); rare (≥1/10,000, &lt; 1/1,000); very rare ( &lt; 1/10,000), including isolated reports.
Tekturna er ikke undersøgt i kliniske studier med hypertensive patienter, der har svært nedsat nyrefunktion (serumkreatinin ≥ 150 μmol/l eller 1,70 mg/dl hos kvinder og ≥ 177 μmol/l eller 2,00 mg/dl hos mænd og/eller estimeret glomerulær filtrationsrate (GFR) &lt; 30 ml/min.
In clinical studies Tekturna has not been investigated in hypertensive patients with severe renal impairment (serum creatinine ≥ 150 μmol/l or 1.70 mg/dl in women and ≥ 177 μmol/l or 2.00 mg/dl in men and/or estimated glomerular filtration rate (GFR) &lt; 30 ml/min), history of dialysis, nephrotic syndrome or renovascular hypertension.
Blandt 480 patienter med &gt; 2 log viral reduktion, men målbar virus i uge 12, fortsatte sammenlagt 188 patienter behandlingen.
Among 480 patients with &gt; 2 log viral reduction but detectable virus at week 12, altogether 188 patients continued therapy.
Det vedvarende respons ved slutningen af opfølgningen var signifikant forhøjet ved tilføjelsen af Rebetol til interferon alfa-2b (41 % mod 16 %, p &lt; 0,001).
The sustained response at the end of follow-up was significantly increased by the addition of Rebetol to interferon alfa-2b (41 % vs 16 %, p &lt; 0.001).
I de tilfælde, hvor der ikke er angivet specifikke anbefalinger vedrørende dosis, skal følgende dosis anvendes: Patientens vægt &lt; 75 kg: 1.000 mg og &gt; 75 kg: 1.200 mg.
In the cases in which no specific dose recommendation is made, the following dose should be used: Patient weight: &lt; 75 kg =1,000 mg and &gt; 75 kg = 1,200 mg.