natgillin/translations-raw huggingface dataset:
Antal patienter 
No. of patients
Hos patienter med svært nedsat nyrefunktion (n = 5) var eksponeringen forhøjet med 2,2 gange for Cmax og med 3,7 gange for AUC. 
In subjects with severe renal impairment (n = 5) increase of exposure was 2.2-fold for Cmax and 3.7-fold for AUC.
Behandling med silodosin fører til en reduktion i mængden af sæd, der frigives under orgasme, hvilket midlertidigt kan påvirke den mandlige fertilitet. 
Treatment with silodosin leads to a decrease in the amount of semen released during orgasm that may temporarily affect male fertility.
I det aktivt kontrollerede, kliniske studie udført i Europa blev det vist, at silodosin 8 mg én gang dagligt var non-inferior sammenlignet med tamsulosin 0,4 mg én gang dagligt: Den justerede gennemsnitlige forskel (95 % KI) i IPSS total-score mellem behandlinger i pr. protokol-populationen var 0,4 (-0,4 til 1,1). 
In the active-controlled clinical study conducted in Europe, silodosin 8 mg once daily was shown to be non inferior to tamsulosin 0.4 mg once daily: the adjusted mean difference (95% CI) in the IPSS Total Score between treatments in the per-protocol population was 0.4 (-0.4 to 1.1).
Denne medicin indeholder mindre end 1 mmol natrium (23 mg) pr. kapsel, dvs. den er i det væsentlige natriumfri. 
This medicine contains less than 1 mmoL sodium (23 mg) per capsule, that is to say essentially ‘sodium-free'.
Hvis der forekommer svimmelhed, når De rejser Dem op, eller besvimelse, skal De informere Deres læge så snart som muligt. 
If dizziness when standing up or fainting occurs, please inform your doctor as soon as possible.
Silodosin Recordati anvendes hos voksne mænd for at behandle urinsvejssymptomer forbundet med en godartet forstørrelse af blærehalskirtlen (prostatahyperplasi), såsom: 
Silodosin Recordati is used in adult men to treat the urinary symptoms associated with benign enlargement of the prostate (prostatic hyperplasia), such as:
• Hvis De har alvorlige leverproblemer, bør De ikke tage Silodosin Recordati, da det ikke er undersøgt i forbindelse med alvorlig leversygdom. 
• If you have severe liver problems, you should not take Silodosin Recordati, as it was not tested in this condition.
I et dobbelt-blindet, placebo-kontrolleret klinisk dose-finding, Fase II-studie med silodosin 4 eller 8 mg én gang dagligt, blev der observeret en større forbedring i index score af symptomer i henhold til American Urologic Association (AUA) med silodosin 8 mg (-6,8 ± 5,8; n = 90; p = 0,0018) og silodosin 4 mg (-5,7 ± 5,5; n = 88; p = 0,0355) sammenlignet med placebo (-4,0 ± 5,5; n = 83). 
In a Phase II dose-finding, double-blind, placebo-controlled clinical study with silodosin 4 or 8 mg once daily, a greater improvement in American Urologic Association (AUA) symptom index score was observed with silodosin 8 mg (-6.8 ± 5.8, n = 90; p = 0.0018) and silodosin 4 mg (-5.7 ± 5.5, n = 88; p = 0.0355) as compared to placebo (-4.0 ± 5.5, n = 83).
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTERS AF PVC/PVDC/ALUMINIUMFOLIE 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PVC/PVDC/ALUMINIUM FOIL BLISTERS
Kapslen må ikke deles eller tygges, men skal synkes hel, helst med et glas vand. 
Do not break or chew the capsule, but swallow it whole, preferably with a glass of water.
Det er ikke relevant at anvende Silodosin Recordati hos den pædiatriske population til indikationen godartet prostatahyperplasi (BPH). 
There is no relevant use of Silodosin Recordati in the paediatric population for the indication of benign prostatic hyperplasia (BPH).
Hvis De har alvorlige nyreproblemer, bør De ikke tage Silodosin Recordati. 
If you have severe kidney problems, you should not take Silodosin Recordati.
En gennemgang af sikkerhedsdata for patienter inkluderet i alle kliniske studier tyder ikke på, at let nedsat nyrefunktion (n = 487) udgør en yderligere sikkerhedsrisiko under behandling med silodosin (såsom en forøgelse i svimmelhed eller ortostatisk hypotension), sammenlignet med patienter med normal nyrefunktion (n = 955). 
A review of safety data of patients enrolled in all clinical studies does not indicate that mild renal impairment (n = 487) poses an additional safety risk during silodosin therapy (such as an increase in dizziness or orthostatic hypotension) as compared to patients with normal renal function (n = 955).
• Hvis De skal gennemgå en øjenoperation på grund af uklarhed af linsen (operation for grå stær), er det vigtigt, at De straks informerer Deres øjenspecialist om, at De tager eller tidligere har taget Silodosin Recordati. 
• If you are undergoing eye surgery because of cloudiness of the lens (cataract surgery), it is important that you immediately inform your eye specialist that you are using or have previously used Silodosin Recordati.
Medikamentel eruption1 
Drug eruption1
< 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data). 
In the table below, adverse reactions reported in all clinical studies and in the worldwide post-marketing experience for which a reasonable causal relationship exists are listed by MedDRA system organ class and frequency: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from available data).
Silodosin gennemgår omfattende metabolisme via glukuronidation (UGT2B7), alkohol- og aldehyddehydrogenase og via oxidative metaboliseringsveje, primært CYP3A4. 
Silodosin undergoes extensive metabolism through glucuronidation (UGT2B7), alcohol and aldehyde dehydrogenase and oxidative pathways, mainly CYP3A4.
Intraoperativt Floppy-irissyndrom 
Intraoperative Floppy Iris Syndrome
Silodosins farmakokinetik hos patienter med svært nedsat leverfunktion er ikke blevet undersøgt. 
The pharmacokinetics of silodosin in patients with severe hepatic impairment has not been studied.
• medicin mod svampeinfektion (såsom ketoconazol eller itraconazol), medicin der anvendes mod hiv-infektion/AIDS (såsom ritonavir) eller medicin der anvendes efter transplantationer for at forhindre organafstødning (såsom ciclosporin), da disse former for medicin kan forhøje koncentrationen af Silodosin Recordati i blodet. 
• antifungal medicines (such as ketoconazole or itraconazole), medicines used for HIV-AIDS (such as ritonavir) or medicines used after transplants to prevent organ rejection (such as cyclosporin) because these medicines can increase the blood concentration of Silodosin Recordati.
Almindelig Ikke almindelig 
Common Uncommon Rare
Hos raske mandlige frivillige blev de følgende farmakokinetiske parametre opnået inden for målintervallet for alder (n = 16, gennemsnitlig alder 55 ± 8 år) efter oral administration én gang dagligt på 8 mg straks efter morgenmaden i 7 dage: Cmax 87 ± 51 ng/ml (SD), tmax 2,5 timer (interval 1,0-3,0), AUC 433 ± 286 ng • h/ml. 
In healthy male subjects of the target age range (n = 16, mean age 55 ± 8 years) after once-a-day oral administration of 8 mg immediately after breakfast for 7 days, the following pharmacokinetic parameters were obtained: Cmax 87 ± 51 ng/mL (sd), tmax 2.5 hours (range 1.0-3.0), AUC 433 ± 286 ng • h/mL.
• medicin til behandling af problemer med at få og opretholde en erektion (såsom sildenafil eller tadalafil), da samtidig anvendelse med Silodosin Recordati kan føre til et let blodtryksfald. 
• medicines used for treating problems in getting or keeping an erection (such as sildenafil or tadalafil), since the concomitant use with Silodosin Recordati might lead to a slight decrease in blood pressure.
Patienter med ortostatisk hypotension bør ikke behandles med silodosin. 
In patients with orthostatic hypotension, treatment with silodosin is not recommended.
I et enkeltdosisstudie var silodosins farmakokinetik uændret hos ni patienter med moderat nedsat leverfunktion (Child-Pugh-scoringer fra 7 til 9), sammenlignet med ni raske frivillige. 
In a single-dose study, the pharmacokinetics of silodosin was not altered in nine patients with moderate hepatic impairment (Child-Pugh scores 7 to 9), compared to nine healthy subjects.
Silodosin er i høj grad selektiv over for α1A-adrenoreceptorer, som hos mennesker primært befinder sig i blærehalskirtlen, den nederste del af blæren, blærehalsen, prostatakapslen og pars prostatica urethrae. 
Silodosin is highly selective for α1A-adrenoreceptors that are primarily located in the human prostate, bladder base, bladder neck, prostatic capsule and prostatic urethra.
Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige de er. 
Within each frequency grouping the observed adverse reactions are presented in order of decreasing seriousness.
Silodosinglukuronids proteinbinding er 91 %. 
Protein binding of silodosin glucuronide is 91%.
• Behandling med Silodosin Recordati kan føre til unormal ejakulation (reduktion i mængden af sæd, der frigives under samleje), hvilket midlertidigt kan påvirke den mandlige frugtbarhed. 
• The treatment with Silodosin Recordati may lead to an abnormal ejaculation (decrease in the amount of semen released during sex) that may temporarily affect male fertility.
Denne virkning forsvinder, når behandlingen med Silodosin Recordati ophører. 
This effect disappears after discontinuation of Silodosin Recordati.
I et placebo-kontrolleret studie af 24 patienter i alderen 45-78 år i behandling med silodosin inducerede samtidig administration af sildenafil 100 mg eller tadalafil 20 mg ingen gennemsnitlige fald i systolisk eller diastolisk blodtryk af klinisk betydning ved en vurdering ved hjælp af ortostatiske studier (stående versus liggende på ryggen). 
In a placebo-controlled study in 24 subjects 45-78 years of age receiving silodosin, the co-administration of sildenafil 100 mg or tadalafil 20 mg induced no clinically meaningful mean decreases in systolic or diastolic blood pressure, as assessed by orthostatic tests (standing versus supine).
I den langvarige åbne forlængelsesfase i disse kontrollerede studier fik patienterne silodosin i op til 1 år. 
In the long-term open-label extension phase of these controlled studies, in which patients received silodosin for up to 1 year, the symptom improvement induced by silodosin at week 12 of treatment was maintained over 1 year.
Denne virkning forsvinder efter seponering af silodosin (se pkt. 
This effect disappears after discontinuation of silodosin (see section 4.8).
Overvågning af plasmaniveauerne i et klinisk Fase III-studie viste, at niveauerne af total silodosin efter 4 ugers behandling ikke ændrede sig hos patienter med let nedsat nyrefunktion (n = 70), sammenlignet med patienter med normal nyrefunktion (n = 55), mens niveauerne i gennemsnit var dobbelt så store hos patienter med moderat nedsat nyrefunktion (n = 7). 
Plasma level monitoring in a Phase III clinical study showed that levels of total silodosin after 4 weeks of treatment did not change in patients with mild impairment (n = 70), compared to patients with normal renal function (n = 155), while the levels were doubled on average in patients with moderate impairment (n = 7).
Kontakt lægen eller apotekspersonalet, før De tager Silodosin Recordati. 
Talk to your doctor or pharmacist before taking Silodosin Recordati
Ældre Det er ikke nødvendigt at justere dosis hos ældre (se pkt. 
No dose adjustment is required in the elderly (see section 5.2).
Eksponeringen over for den primære metabolit i plasma, silodosinglukuronid (KMD-3213G) ved steady-state er ca. 3 gange så høj som over for det oprindelige stof. 
The exposure to the main metabolite in plasma, silodosin glucuronide (KMD-3213G), at steady-state is about 3-fold that of the parent substance.
• Nedsat sexlyst 
• Decreased sexual drive
Silodosin Recordati kan ikke anvendes til at behandle prostatakræft. 
Silodosin Recordati does not treat prostate cancer.
PDE-5-hæmmere 
PDE-5 inhibitors
Det skal De vide, før De begynder at tage Silodosin Recordati Tag ikke Silodosin Recordati hvis De er allergisk over for silodosin eller et af de øvrige indholdsstoffer i Silodosin Recordati (angivet i punkt 6). 
Do not take Silodosin Recordati if you are allergic to silodosin or any of the other ingredients of this medicine (listed in section 6).
Det er ikke nødvendigt at justere dosis hos patienter med let nedsat nyrefunktion (CLCR ≥ 50 til ≤ 80 ml/min). 
No dose adjustment is required for patients with mild renal impairment (CLCR ≥ 50 to ≤ 80 mL/min).
Hvis indtagelsen af en overdosis er sket for nylig, kan det overvejes at fremprovokere opkastning eller foretage ventrikeltømning. 
If ingestion is recent, induction of vomiting or gastric lavage may be considered.
Derfor er det ikke nødvendigt at justere dosis hos patienter med let nedsat nyrefunktion. 
Accordingly, no dose adjustment is required in patients with mild renal impairment.
Hududslæt1, Pruritus1 
Skin rash1, Pruritus1
Silodosin Recordati kan nedsætte mængden af sædceller og dermed midlertidigt påvirke Deres evne til at gøre en kvinde gravid. 
Silodosin Recordati may reduce the amount of sperm, and so could temporarily affect your ability to father a child.
I dyrestudier (påvirker skjoldbruskkirtlen hos gnavere) blev der kun iagttaget virkninger af doser, der anses for at overstige den maksimale humane eksponering i væsentlig grad. 
Effects in animals (affecting the thyroid gland in rodents) were observed only at exposures considered sufficiently in excess of the maximum human exposure, indicating little relevance to clinical use.
Silodosin Recordati er kun beregnet til brug hos mænd. 
Silodosin Recordati is not intended for use by women.
Øvrige indholdsstoffer: pregelatineret majsstivelse, mannitol (E421), magnesiumstearat, natriumlaurilsulfat, gelatine, titandioxid (E171), gul jernoxid (E172). 
The other ingredients are pregelatinised maize starch, mannitol (E421), magnesium stearate, sodium laurilsulfate, gelatin, titanium dioxide (E171), yellow iron oxide (E172).
Potente CYP3A4-hæmmere (såsom ketoconazol, itraconazol, ritonavir eller ciclosporin) bør ikke anvendes samtidig med Silodosin Recordati. 
Concomitant use with potent CYP3A4 inhibitors (such as ketoconazole, itraconazole, ritonavir or cyclosporine) is not recommended.
Øvrige indholdsstoffer: pregelatineret majsstivelse, mannitol (E421), magnesiumstearat, natriumlaurilsulfat, gelatine, titandioxid (E171). 
The other ingredients are pregelatinised maize starch, mannitol (E421), magnesium stearate, sodium laurilsulfate, gelatin, titanium dioxide (E171).
I et enkeltdosisstudie resulterede eksponeringen over for silodosin (ubundet) hos patienter med let (n = 8) og moderat nedsat nyrefunktion (n = 8) i gennemsnit i en forhøjelse af Cmax (med 1,6 gange) og AUC (med 1,7 gange) i forhold til patienter med normal nyrefunktion (n = 8). 
In a single-dose study, exposure to silodosin (unbound) in subjects with mild (n = 8) and moderate renal impairment (n = 8) resulted, on average, in an increase of Cmax (1.6-fold) and AUC (1.7-fold) relative to subjects with normal renal function (n = 8).
• Løbende eller tilstoppet næse 
• Runny or blocked nose
Unormale leverfunktionsprøver1 
Abnormal liver function tests1
Det er ikke nødvendigt at justere dosis hos patienter med let til moderat nedsat leverfunktion. 
No dose adjustment is required for patients with mild to moderate hepatic impairment.
Da der ikke foreligger data for patienter med svært nedsat leverfunktion, bør silodosin ikke anvendes til disse patienter (se pkt. 
Since no data are available in patients with severe hepatic impairment, the use of silodosin in these patients is not recommended (see sections 4.2 and 5.2).
Da der kun er begrænset erfaring med patienter med moderat nedsat nyrefunktion (n = 35), anbefales en lavere startdosis på 4 mg. Silodosin Recordati bør ikke anvendes til patienter med svært nedsat nyrefunktion. 
Since only limited experience exists in patients with moderate renal impairment (n = 35), a lower starting dose of 4 mg is recommended.
Silodosin Recordati påvirker nogle receptorer, som findes i blærehalskirtlen, blæren og urinrøret. 
Silodosin Recordati is selective for the receptors located in the prostate, bladder and urethra.
• Hurtigere puls 
• Faster heart rate
Allergilignende reaktioner herunder hævelse af ansigt og tunge og faryngealt ødem1 
Allergictype reactions including facial swelling, swollen tongue and pharyngeal oedema1
Ortostatiske virkninger 
Orthostatic effects
Til dette formål findes Silodosin Recordati 4 mg hårde kapsler. 
For this purpose Silodosin Recordati 4 mg hard capsules are available.
Fortæl det til Deres læge så hurtigt som muligt, hvis De har taget flere end én kapsel. 
If you have taken more than one capsule, inform your doctor as soon as possible.
Nedsat libido 
Libido decreased
I et interaktionsstudie blev der ved samtidig administration af en potent CYP3A4-hæmmer (ketoconazol 400 mg) observeret en forhøjelse på 3,7 gange af silodosins maksimale plasmakoncentrationer og en forhøjelse i silodosin-eksponering på 3,1 gange (dvs. AUC). 
In an interaction study, a 3.7-fold increase in maximum silodosin plasma concentrations and a 3.1-fold increase in silodosin exposure (i.e. AUC) were observed with concurrent administration of a potent CYP3A4 inhibitor (ketoconazole 400 mg).
Denne dosis kan forøges til 8 mg én gang dagligt efter en uges behandling, afhængig af den enkelte patients respons. 
A starting dose of 4 mg once daily is recommended in patients with moderate renal impairment (CLCR 30 to < 50 mL/min), which may be increased to 8 mg once daily after one week of treatment, depending on the individual patient's response.
Den anbefalede dosis er én kapsel Silodosin Recordati 8 mg dagligt. 
The recommended dose is one capsule of Silodosin Recordati 8 mg daily.
Kvalme Mundtørhed 
Diarrhoea Nausea Dry mouth
Der bør ikke påbegyndes behandling med silodosin hos patienter med en planlagt operation for grå stær. 
The initiation of therapy with silodosin is not recommended in patients for whom cataract surgery is scheduled.
Den anbefalede dosis er en kapsel Silodosin Recordati 8 mg pr. dag givet oralt (gennem munden). 
The recommended dose is one capsule of Silodosin Recordati 8 mg per day by oral administration.
Silodosin Recordati 8 mg hårde kapsler Hver hård kapsel indeholder 8 mg silodosin. 
Silodosin Recordati 8 mg hard capsules Each hard capsule contains 8 mg silodosin.
Takykardi1 
Tachycardia1 Palpitations1
Brug af anden medicin sammen med Silodosin Recordati 
Other medicines and Silodosin Recordati
Det er kun meget små mængder uændret lægemiddel, der kan genfindes i urinen. 
Silodosin is excreted mainly as metabolites, very low amounts of unchanged drug are recovered in urine.
Hvis De har glemt at tage Silodosin Recordati 
If you forget to take Silodosin Recordati
Hvis De holder op med at tage Silodosin Recordati 
If you stop taking Silodosin Recordati
Derved forbedres LUTS-symptomer (lower urinary tract symptoms), der er associeret med godartet prostatahyperplasi både med hensyn til blærens evne til at opbevare urin (irritativ) og blæretømningen (obstruktiv). 
This causes an improvement of both storage (irritative) and voiding (obstructive) symptoms (Lower urinary tract symptoms, LUTS) associated with benign prostatic hyperplasia.
I kliniske studier blev der observeret forekomst af ejakulat, med reduceret mængde sæd eller ingen sæd under behandlingen med silodosin (se pkt. 
In clinical studies, the occurrence of ejaculation with reduced or no semen has been observed during treatment with silodosin (see section 4.8), due to the pharmacodynamic properties of silodosin.
Hver kapsel indeholder 4 mg silodosin. 
Each capsule contains 4 mg of silodosin.
Hver kapsel indeholder 8 mg silodosin. 
Each capsule contains 8 mg of silodosin.
Silodosin Recordati 4 mg og 8 mg hårde kapsler Kapselindhold 
Silodosin Recordati 4 mg and 8 mg hard capsules Capsule content
Det skal De vide, før De begynder at tage Silodosin Recordati Sådan skal De tage Silodosin Recordati Bivirkninger 
What Silodosin Recordati is and what it is used for What you need to know before you take Silodosin Recordati How to take Silodosin Recordati Possible side effects
Silodosin Recordati 4 mg er gule, uigennemsigtige, hårde gelatinekapsler, størrelse 3 (cirka 15,9 x 5,8 mm). 
Silodosin Recordati 4 mg are yellow, opaque, hard gelatin capsules, size 3 (approximately 15.9 x 5.8 mm).
Silodosin Recordati 4 mg hårde kapsler Gul, uigennemsigtig, hård gelatinekapsel, størrelse 3 (cirka 15,9 x 5,8 mm). 
Silodosin Recordati 4 mg hard capsules Yellow, opaque, hard gelatin capsule, size 3 (approximately 15.9 x 5.8 mm).
Silodosin Recordati 8 mg hårde kapsler Hvid, uigennemsigtig, hård gelatinekapsel, størrelse 0 (cirka 21,7 x 7,6 mm). 
Silodosin Recordati 8 mg hard capsules White, opaque, hard gelatin capsule, size 0 (approximately 21.7 x 7.6 mm).
Silodosin Recordati 8 mg er hvide, uigennemsigtige, hårde gelatinekapsler, størrelse 0 (cirka 21,7 x 7,6 mm). 
Silodosin Recordati 8 mg are white, opaque, hard gelatin capsules, size 0 (approximately 21.7 x 7.6 mm).
Synkope Bevidstløshed1 
Syncope Loss of consciousness1
Silodosin Recordati 4 mg hårde kapsler Hver hård kapsel indeholder 4 mg silodosin. 
QUALITATIVE AND QUANTITATIVE COMPOSITION Silodosin Recordati 4 mg hard capsules Each hard capsule contains 4 mg silodosin.
Silodosin Recordatis anvendelse 
What Silodosin Recordati is used for
silodosin recordati 4 mg 
INFORMATION IN BRAILLE silodosin recordati 4 mg
Silodosin Recordati 4 mg hårde kapsler Silodosin Recordati 8 mg hårde kapsler 
Silodosin Recordati 8 mg hard capsules Silodosin Recordati 4 mg hard capsules silodosin
Intraoperativt Floppy-iris-syndrom (IFIS) IFIS er blevet indberettet under operation for grå stær (se pkt. 
IFIS has been reported during cataract surgery (see section 4.4).
Sådan skal De tage Silodosin Recordati 
How to take Silodosin Recordati
Silodosin bør ikke anvendes til patienter med svært nedsat nyrefunktion (CLCR < 30 ml/min) (se pkt. 
The use of silodosin in patients with severe renal impairment (CLCR < 30 mL/min) is not recommended (see sections 4.2 and 5.2).
silodosin recordati 8 mg 
INFORMATION IN BRAILLE silodosin recordati 8 mg
Lægemidlet bør ikke anvendes til patienter med svært nedsat nyrefunktion (CLCR < 30 ml/min) (se pkt. 
The use in patients with severe renal impairment (CLCR < 30 mL/min) is not recommended (see sections 4.4 and 5.2).
Tlf: + 353 21 4379400 
Puh/Tel: + 353 21 4379400
Silodosin Recordati 8 mg hårde kapsler silodosin 
Silodosin Recordati 8 mg hard capsules
Bør ikke anvendes til patienter med svært nedsat leverfunktion (se pkt. 
As no data are available, the use in patients with severe hepatic impairment is not recommended (see sections 4.4 and 5.2).
Silodosin Recordati 4 mg hårde kapsler silodosin 
NAME OF THE MEDICINAL PRODUCT Silodosin Recordati 4 mg hard capsules silodosin
Tal med lægen, hvis De føler, at Deres seksualliv er påvirket. 
If you feel that your sexual life is affected, please tell your doctor.
Pakningsstørrelser og yderligere oplysninger Silodosin Recordati indeholder: 
How to store Silodosin Recordati Contents of the pack and other information
Dato for første tilladelse: 24. januar 2003 Dato for fornyelse: 20. maj 2008 
Date of first authorisation: 24 January 2003 Date of renewal: 20 May 2008
Diffusion ind i erythrocytter forekommer ikke. 
Diffusion into erythrocytes is non existent.
DATO FOR REVISION AF TEKSTEN 
DATE OF REVISION OF THE TEXT
Proteinbinding er ikke fastlagt. 
Protein binding has not been determined.
Deres område var konsistent med dem, der blev målt hos raske voksne, selv hos nyfødte spædbørn. 
Their range was consistent with those measured in healthy adults, even in newborn infants.
Det kan være skadeligt for andre, selvom de har de samme symptomer, som De/du har. 
It may harm them, even if their symptoms are the same as yours.
Få rådgivning af Deres læge, hvis De er gravid eller planlægger at blive gravid. 
Please consult your doctor for advice if you are pregnant or planning to become pregnant.
Læs hele denne indlægsseddel grundigt, inden De begynder at tage dette lægemiddel. 
Read all of this leaflet carefully before you start taking this medicine.